chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Inflammation, Pruritus, Rash, Skin irritation
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A male patient, of an unspecified age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, in left arm, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Historical vaccine included the first dose of BNT162B2, on an unspecified date, for COVID-19 immunization. Patient stated after receiving his second vaccination, he developed a strong skin rash/irritation on his right forearm (opposite to the injection). This rash started out as small dots, and has grown and spread. It looked more like a reaction to poison ivy. First itching and irritation; then blisters developed; now he has swelling and inflammation in several spots on an unspecified date. A doctor recommended he reach out to inform about this. At the time of report, outcome of the event: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A male patient, of an unspecified age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, in left arm, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Historical vaccine included the first dose of BNT162B2, on an unspecified date, for COVID-19 immunization. Patient stated after receiving his second vaccination, he developed a strong skin rash/irritation on his right forearm (opposite to the injection). This rash started out as small dots, and has grown and spread. It looked more like a reaction to poison ivy. First itching and irritation; then blisters developed; now he has swelling and inflammation in several spots on an unspecified date. A doctor recommended he reach out to inform about this. At the time of report, outcome of the event: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dry throat, Dysphagia, Fatigue, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: just "some fatigue."; his throat is "very sore" and "very dry"; his throat is "very sore" and "very dry"; reports that it is difficult to swallow; his throat does still feel "a bit swollen."; This is a spontaneous report from a Pfizer-sponsored program with Regulatory Authority Support from a contactable consumer or other non HCP. A 57-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot number was unknown), via an unspecified route of administration on 29Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced, fatigue, oropharyngeal pain, dry throat, dysphagia, pharyngeal swelling. The outcome of the events was unknown. Caller states that he received his first dose of the Pfizer BioNTech COVID-19 vaccine on 29MAR2021 and states his second dose has been scheduled for 12ARP2021 which is 14 days and would like to know if this is okay as he states that he knows the recommended interval is 21 days. Caller also reports that after his first dose, he did not experience any side effects initially, just some fatigue. However, he states that this morning his throat is very sore and very dry and reports that it is difficult to swallow. He states that it has been a couple of hours and he feels a bit better but reports that his throat does still feel a bit swollen. E-transmitting AE due to long hold time. Response: Spoke from the attached document regarding CDC's considerations that the second dose may be given as early as 17 days and if given mistakenly earlier than this, the dose does not need to be repeated. He would like to know if these side effects he is experiencing with his throat are common with the vaccine or if he could just be getting a cold. He states that he did read that there is an issue with lymph nodes and thinks that the throat is a common area where lymph nodes are. Response: Spoke from the attached document to let caller know that while the commonly reported side effects does not mention anything about the symptoms he's experiencing with his throat, this list does not include all possible side effects of the vaccine. Referred caller back to HCP for further guidance.  No follow-up attempts are possible; No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Events off label use, inappropriate schedule of vaccine administered were deleted and narrative was amended.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Myalgia, Neck pain, Pain in extremity
Clinical narrative: neck and shoulders hurt; neck and shoulders hurt; right side down the side hurts too; She was having muscle and joint aches; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on 29Mar2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was unknown), via an unspecified route of administration on an unspecified date (on 01Mar2021 or 08Mar2021 she believes) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had some symptoms, but she didn't know it was from that, and it still couldn't be from that maybe. She was having muscle and joint aches and she always uses a remedy, and it will go away but with this first shot it came but then it went and came back and went again and she didn't though anything else about it. The patient's concomitant medications were not reported. On an unspecified date, the patient shoulder was having pain in her muscles. She put cream on the muscle ache and it will help for a while. She had no problems through the day but when she lays down and gets up in the morning, it hurts. She puts the cream on at night because her neck and shoulders hurt and her right side down the side hurts too. She had arthritis but her pain has never gone this long before. She was reading the pamphlet and it says you can have muscle and joint aches. The patient questioned that this was something she needs to be concerned with or what. She will also follow up with her doctor and wanted her question addressed at this time. She had never had anything compared to this muscle ache that she has. Now it was a little different, maybe there was something else going on. Outcome of the events was unknown.   No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Myalgia, Neck pain, Pain
Clinical narrative: neck and shoulders hurt; neck and shoulders hurt; right side down the side hurts too; She was having muscle and joint aches; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on 29Mar2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was unknown), via an unspecified route of administration on an unspecified date (on 01Mar2021 or 08Mar2021 she believes) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had some symptoms, but she didn't know it was from that, and it still couldn't be from that maybe. She was having muscle and joint aches and she always uses a remedy, and it will go away but with this first shot it came but then it went and came back and went again and she didn't though anything else about it. The patient's concomitant medications were not reported. On an unspecified date, the patient shoulder was having pain in her muscles. She put cream on the muscle ache and it will help for a while. She had no problems through the day but when she lays down and gets up in the morning, it hurts. She puts the cream on at night because her neck and shoulders hurt and her right side down the side hurts too. She had arthritis but her pain has never gone this long before. She was reading the pamphlet and it says you can have muscle and joint aches. The patient questioned that this was something she needs to be concerned with or what. She will also follow up with her doctor and wanted her question addressed at this time. She had never had anything compared to this muscle ache that she has. Now it was a little different, maybe there was something else going on. Outcome of the events was unknown.   No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster, Pruritus, Rash, Swelling face
Clinical narrative: post nasal drip; Eczema; Rash; Pressure behind ear/some pressure in her ear; underneath chin swelling; This is a spontaneous report from a contactable Consumer or other non-health professional (Patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported, Expiry date: not reported) via an unspecified route of administration on 16Mar2021 as a dose number unknown, single for COVID-19 immunization. The patient medical history included dermatitis, seasonal allergies (that are pretty bad), ear infections all are from an unknown date unknown if ongoing. Concomitant medication included Zyrtec (Lot number and expiration date: unknown via unspecified route of administration from an unknown date indicated for allergy to an unspecified stop date. Allegra 180mg once daily via unspecified route of administration from a specified date in 2021 indicated for allergy unknown if ongoing (Count size is 90 and there was no seal). Patient stated this was keeping her from panicking. She just started taking Allegra for 3 days. The Zyrtec maybe was not helping, and the doctor said maybe she should change so she did. They switched her allergy medication from Zyrtec to Allegra. It was reported that on 18Mar2021 patient felt like she had some pressure in her ear and underneath chin swelling. On an unspecified date It might have felt like it was, but they said it was postnasal drip. On 24Mar2021, patient woke up with a rash and a lot of pressure in her ear. The rash was not spreading on her neck. It was just one side and one spot on chest below her neck. It almost looked like Eczema. Her ENT did not think they are related. He does not think ears are related to red splotches because she has had ear infections in the past. She has a blocked tube in ear. It did not look like she had an ear infection. But there is fluid in it. This was after the vaccine. She went in this morning. She has not taken an Allegra today because she was not sure what the doctors would have her take when she went to see them today. He said it looked like Eczema. She has not been diagnosed with Eczema but does have contact dermatitis. Patient would like to know if she should take second one. It was not really a rash. There was a Product Complaint. It was reported that, she could not see anyone and someone said to take Benadryl, but it did not help.  She did not change anything.  She provided Lot SFM061, Expiration May2022. Dose is 5-10 mg.  She took 10 ml.  Total size in 1 bottle is 118ml.  She would be willing to send a sample. She would be willing to send a sample.  It was sealed and intact. Outcome of all the events were unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear discomfort, Eczema, Rash, Swelling, Upper-airway cough syndrome
Clinical narrative: post nasal drip; Eczema; Rash; Pressure behind ear/some pressure in her ear; underneath chin swelling; This is a spontaneous report from a contactable Consumer or other non-health professional (Patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported, Expiry date: not reported) via an unspecified route of administration on 16Mar2021 as a dose number unknown, single for COVID-19 immunization. The patient medical history included dermatitis, seasonal allergies (that are pretty bad), ear infections all are from an unknown date unknown if ongoing. Concomitant medication included Zyrtec (Lot number and expiration date: unknown via unspecified route of administration from an unknown date indicated for allergy to an unspecified stop date. Allegra 180mg once daily via unspecified route of administration from a specified date in 2021 indicated for allergy unknown if ongoing (Count size is 90 and there was no seal). Patient stated this was keeping her from panicking. She just started taking Allegra for 3 days. The Zyrtec maybe was not helping, and the doctor said maybe she should change so she did. They switched her allergy medication from Zyrtec to Allegra. It was reported that on 18Mar2021 patient felt like she had some pressure in her ear and underneath chin swelling. On an unspecified date It might have felt like it was, but they said it was postnasal drip. On 24Mar2021, patient woke up with a rash and a lot of pressure in her ear. The rash was not spreading on her neck. It was just one side and one spot on chest below her neck. It almost looked like Eczema. Her ENT did not think they are related. He does not think ears are related to red splotches because she has had ear infections in the past. She has a blocked tube in ear. It did not look like she had an ear infection. But there is fluid in it. This was after the vaccine. She went in this morning. She has not taken an Allegra today because she was not sure what the doctors would have her take when she went to see them today. He said it looked like Eczema. She has not been diagnosed with Eczema but does have contact dermatitis. Patient would like to know if she should take second one. It was not really a rash. There was a Product Complaint. It was reported that, she could not see anyone and someone said to take Benadryl, but it did not help.  She did not change anything.  She provided Lot SFM061, Expiration May2022. Dose is 5-10 mg.  She took 10 ml.  Total size in 1 bottle is 118ml.  She would be willing to send a sample. She would be willing to send a sample.  It was sealed and intact. Outcome of all the events were unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear disorder, Eczema, Eustachian tube obstruction, Hypersensitivity, Rash macular
Clinical narrative: post nasal drip; Eczema; Rash; Pressure behind ear/some pressure in her ear; underneath chin swelling; This is a spontaneous report from a contactable Consumer or other non-health professional (Patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported, Expiry date: not reported) via an unspecified route of administration on 16Mar2021 as a dose number unknown, single for COVID-19 immunization. The patient medical history included dermatitis, seasonal allergies (that are pretty bad), ear infections all are from an unknown date unknown if ongoing. Concomitant medication included Zyrtec (Lot number and expiration date: unknown via unspecified route of administration from an unknown date indicated for allergy to an unspecified stop date. Allegra 180mg once daily via unspecified route of administration from a specified date in 2021 indicated for allergy unknown if ongoing (Count size is 90 and there was no seal). Patient stated this was keeping her from panicking. She just started taking Allegra for 3 days. The Zyrtec maybe was not helping, and the doctor said maybe she should change so she did. They switched her allergy medication from Zyrtec to Allegra. It was reported that on 18Mar2021 patient felt like she had some pressure in her ear and underneath chin swelling. On an unspecified date It might have felt like it was, but they said it was postnasal drip. On 24Mar2021, patient woke up with a rash and a lot of pressure in her ear. The rash was not spreading on her neck. It was just one side and one spot on chest below her neck. It almost looked like Eczema. Her ENT did not think they are related. He does not think ears are related to red splotches because she has had ear infections in the past. She has a blocked tube in ear. It did not look like she had an ear infection. But there is fluid in it. This was after the vaccine. She went in this morning. She has not taken an Allegra today because she was not sure what the doctors would have her take when she went to see them today. He said it looked like Eczema. She has not been diagnosed with Eczema but does have contact dermatitis. Patient would like to know if she should take second one. It was not really a rash. There was a Product Complaint. It was reported that, she could not see anyone and someone said to take Benadryl, but it did not help.  She did not change anything.  She provided Lot SFM061, Expiration May2022. Dose is 5-10 mg.  She took 10 ml.  Total size in 1 bottle is 118ml.  She would be willing to send a sample. She would be willing to send a sample.  It was sealed and intact. Outcome of all the events were unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash papular, Upper-airway cough syndrome
Clinical narrative: post nasal drip; Eczema; Rash; Pressure behind ear/some pressure in her ear; underneath chin swelling; This is a spontaneous report from a contactable Consumer or other non-health professional (Patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported, Expiry date: not reported) via an unspecified route of administration on 16Mar2021 as a dose number unknown, single for COVID-19 immunization. The patient medical history included dermatitis, seasonal allergies (that are pretty bad), ear infections all are from an unknown date unknown if ongoing. Concomitant medication included Zyrtec (Lot number and expiration date: unknown via unspecified route of administration from an unknown date indicated for allergy to an unspecified stop date. Allegra 180mg once daily via unspecified route of administration from a specified date in 2021 indicated for allergy unknown if ongoing (Count size is 90 and there was no seal). Patient stated this was keeping her from panicking. She just started taking Allegra for 3 days. The Zyrtec maybe was not helping, and the doctor said maybe she should change so she did. They switched her allergy medication from Zyrtec to Allegra. It was reported that on 18Mar2021 patient felt like she had some pressure in her ear and underneath chin swelling. On an unspecified date It might have felt like it was, but they said it was postnasal drip. On 24Mar2021, patient woke up with a rash and a lot of pressure in her ear. The rash was not spreading on her neck. It was just one side and one spot on chest below her neck. It almost looked like Eczema. Her ENT did not think they are related. He does not think ears are related to red splotches because she has had ear infections in the past. She has a blocked tube in ear. It did not look like she had an ear infection. But there is fluid in it. This was after the vaccine. She went in this morning. She has not taken an Allegra today because she was not sure what the doctors would have her take when she went to see them today. He said it looked like Eczema. She has not been diagnosed with Eczema but does have contact dermatitis. Patient would like to know if she should take second one. It was not really a rash. There was a Product Complaint. It was reported that, she could not see anyone and someone said to take Benadryl, but it did not help.  She did not change anything.  She provided Lot SFM061, Expiration May2022. Dose is 5-10 mg.  She took 10 ml.  Total size in 1 bottle is 118ml.  She would be willing to send a sample. She would be willing to send a sample.  It was sealed and intact. Outcome of all the events were unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster, Pruritus, Rash, Swelling face
Clinical narrative: allergies; ear issues; post nasal drip; ear was blocked from drainage and allergies; she had red spots on the right side of her face, neck and chest; she had red spots on the right side of her face, neck and chest; eczema; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 57, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration, administered in her left side on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history included contact dermatitis. The concomitant medications included Allegra and Zertec. Yesterday morning (24Mar2021), she had red spots on the right side of her face, neck and chest that looks like eczema although she was never diagnosed with eczema, but she has a history of contact dermatitis. The red spots did not itch or burn but it did not go away. She also took Allegra which was switched to Zertec last week. They were not strong enough to prevent whatever this was. She noted that she was also dealing with allergies and postnasal drip caused ear issues right then. Went to her Ear-Nose-Throat doctor. Her ear was blocked from drainage and allergies. She was given an antibiotic and oral steroid. Reporter would like to know whether she should get the 2nd dose after the side effects she experienced after the first dose of the covid vaccine. The outcome of events was unknown.  No follow-up attempts were possible, information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear discomfort, Eczema, Rash, Swelling, Upper-airway cough syndrome
Clinical narrative: allergies; ear issues; post nasal drip; ear was blocked from drainage and allergies; she had red spots on the right side of her face, neck and chest; she had red spots on the right side of her face, neck and chest; eczema; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 57, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration, administered in her left side on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history included contact dermatitis. The concomitant medications included Allegra and Zertec. Yesterday morning (24Mar2021), she had red spots on the right side of her face, neck and chest that looks like eczema although she was never diagnosed with eczema, but she has a history of contact dermatitis. The red spots did not itch or burn but it did not go away. She also took Allegra which was switched to Zertec last week. They were not strong enough to prevent whatever this was. She noted that she was also dealing with allergies and postnasal drip caused ear issues right then. Went to her Ear-Nose-Throat doctor. Her ear was blocked from drainage and allergies. She was given an antibiotic and oral steroid. Reporter would like to know whether she should get the 2nd dose after the side effects she experienced after the first dose of the covid vaccine. The outcome of events was unknown.  No follow-up attempts were possible, information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear disorder, Eczema, Eustachian tube obstruction, Hypersensitivity, Rash macular
Clinical narrative: allergies; ear issues; post nasal drip; ear was blocked from drainage and allergies; she had red spots on the right side of her face, neck and chest; she had red spots on the right side of her face, neck and chest; eczema; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 57, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration, administered in her left side on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history included contact dermatitis. The concomitant medications included Allegra and Zertec. Yesterday morning (24Mar2021), she had red spots on the right side of her face, neck and chest that looks like eczema although she was never diagnosed with eczema, but she has a history of contact dermatitis. The red spots did not itch or burn but it did not go away. She also took Allegra which was switched to Zertec last week. They were not strong enough to prevent whatever this was. She noted that she was also dealing with allergies and postnasal drip caused ear issues right then. Went to her Ear-Nose-Throat doctor. Her ear was blocked from drainage and allergies. She was given an antibiotic and oral steroid. Reporter would like to know whether she should get the 2nd dose after the side effects she experienced after the first dose of the covid vaccine. The outcome of events was unknown.  No follow-up attempts were possible, information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash papular, Upper-airway cough syndrome
Clinical narrative: allergies; ear issues; post nasal drip; ear was blocked from drainage and allergies; she had red spots on the right side of her face, neck and chest; she had red spots on the right side of her face, neck and chest; eczema; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 57, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration, administered in her left side on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history included contact dermatitis. The concomitant medications included Allegra and Zertec. Yesterday morning (24Mar2021), she had red spots on the right side of her face, neck and chest that looks like eczema although she was never diagnosed with eczema, but she has a history of contact dermatitis. The red spots did not itch or burn but it did not go away. She also took Allegra which was switched to Zertec last week. They were not strong enough to prevent whatever this was. She noted that she was also dealing with allergies and postnasal drip caused ear issues right then. Went to her Ear-Nose-Throat doctor. Her ear was blocked from drainage and allergies. She was given an antibiotic and oral steroid. Reporter would like to know whether she should get the 2nd dose after the side effects she experienced after the first dose of the covid vaccine. The outcome of events was unknown.  No follow-up attempts were possible, information about lot/batch number could not be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased immune responsiveness, Eye infection, Facial pain, Headache, Herpes zoster
Clinical narrative: stomach upset; lose bowels; fatigue; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 77-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN2613, expiry date: not reported, Age at vaccination: 77-year-old) via an unspecified route of administration in arm left on 20Mar2021 01:15 PM as DOSE 2, single for COVID-19 immunisation. Medical history included hip replacements and cataract surgery and Pollen allergies. The patient's concomitant medications included Tylenol, advil, claritin, fluticasone prop nasal spray. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6202, expiry date: not reported, Age at vaccination: 77-year-old) via an unspecified route of administration in arm left on 27Feb2021 12:00 PM as DOSE 1, single for COVID-19 immunisation. On 21Mar2021, patient experienced stomach upset and lose bowels, great fatigue. Treatment for adverse events was eucerin on nose and rash; much sleep 2nd one. No other vaccine received in four weeks. No other vaccine received in two weeks. Patient had not covid prior vaccination. Patient was not covid tested post vaccination. Lab test included antigen test: unknown result. The outcome of events was recovered.  No follow up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lacrimation increased, Nasopharyngitis, Ophthalmological examination, Rash
Clinical narrative: stomach upset; lose bowels; fatigue; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 77-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN2613, expiry date: not reported, Age at vaccination: 77-year-old) via an unspecified route of administration in arm left on 20Mar2021 01:15 PM as DOSE 2, single for COVID-19 immunisation. Medical history included hip replacements and cataract surgery and Pollen allergies. The patient's concomitant medications included Tylenol, advil, claritin, fluticasone prop nasal spray. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6202, expiry date: not reported, Age at vaccination: 77-year-old) via an unspecified route of administration in arm left on 27Feb2021 12:00 PM as DOSE 1, single for COVID-19 immunisation. On 21Mar2021, patient experienced stomach upset and lose bowels, great fatigue. Treatment for adverse events was eucerin on nose and rash; much sleep 2nd one. No other vaccine received in four weeks. No other vaccine received in two weeks. Patient had not covid prior vaccination. Patient was not covid tested post vaccination. Lab test included antigen test: unknown result. The outcome of events was recovered.  No follow up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Investigation
Clinical narrative: stomach upset; lose bowels; fatigue; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 77-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN2613, expiry date: not reported, Age at vaccination: 77-year-old) via an unspecified route of administration in arm left on 20Mar2021 01:15 PM as DOSE 2, single for COVID-19 immunisation. Medical history included hip replacements and cataract surgery and Pollen allergies. The patient's concomitant medications included Tylenol, advil, claritin, fluticasone prop nasal spray. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6202, expiry date: not reported, Age at vaccination: 77-year-old) via an unspecified route of administration in arm left on 27Feb2021 12:00 PM as DOSE 1, single for COVID-19 immunisation. On 21Mar2021, patient experienced stomach upset and lose bowels, great fatigue. Treatment for adverse events was eucerin on nose and rash; much sleep 2nd one. No other vaccine received in four weeks. No other vaccine received in two weeks. Patient had not covid prior vaccination. Patient was not covid tested post vaccination. Lab test included antigen test: unknown result. The outcome of events was recovered.  No follow up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Burning sensation, Erythema, Pruritus, Rash, Urticaria
Clinical narrative: little itchy and slightly itchy/body itched every place there was skin; bumps on the back of her thighs; Flat hives; allergic reaction to the ingredients in the Pfizer COVID19 vaccine; difficulty sleeping/fitful sleep; rash; slight headache; slight fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6205, expiration date was not reported) via an unspecified route of administration, on 20Mar2021 15:30 (at the age of 68-year-old), at dose 2, single for covid-19 immunization. Medical history included allergy to bee stings. The patient was administered with unspecified concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6200, expiration date was not reported) via an unspecified route of administration, on 27Feb2021 16:00 (at the age of 68-year-old), at dose 1, single for covid-19 immunization and experienced headache and a little headache and a little fever; she had the fever for a few hours and then it disappeared/ fever and headache for 3 days just for a few hours each day. The patient experienced slight headache, slight fever on 21Mar2021. On 23Mar2021, the 4th day from her second dose of the vaccine and just before midnight she woke up and was a little itchy and slightly itchy and there are some bumps on the back of her thighs and on the back top part of her thighs; she checked it out and looked in a mirror and took photos and then looked online and saw that this is a rash that covid19 can once in a while can have with the covid19 virus but not with the vaccination, also had flat hives and may be an allergic reaction to the ingredients in the vaccine, had some difficulty sleeping and put some 1% hydrocortisone anti-itch cream on the area on her thighs and tried to go back to sleep and she had a very fitful sleep and her entire body itched every place there was skin except where the rash was where she put the hydrocortisone cream. The outcome of the events was unknown. Therapeutic measures were taken included 1% hydrocortisone anti-itch cream on the area on her thighs for bumps, flat hives, allergic reaction to vaccine, entire body itched/rash and tried to go back to sleep.  Follow-up (24Mar2021): No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Pyrexia, Urticaria
Clinical narrative: little itchy and slightly itchy/body itched every place there was skin; bumps on the back of her thighs; Flat hives; allergic reaction to the ingredients in the Pfizer COVID19 vaccine; difficulty sleeping/fitful sleep; rash; slight headache; slight fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6205, expiration date was not reported) via an unspecified route of administration, on 20Mar2021 15:30 (at the age of 68-year-old), at dose 2, single for covid-19 immunization. Medical history included allergy to bee stings. The patient was administered with unspecified concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6200, expiration date was not reported) via an unspecified route of administration, on 27Feb2021 16:00 (at the age of 68-year-old), at dose 1, single for covid-19 immunization and experienced headache and a little headache and a little fever; she had the fever for a few hours and then it disappeared/ fever and headache for 3 days just for a few hours each day. The patient experienced slight headache, slight fever on 21Mar2021. On 23Mar2021, the 4th day from her second dose of the vaccine and just before midnight she woke up and was a little itchy and slightly itchy and there are some bumps on the back of her thighs and on the back top part of her thighs; she checked it out and looked in a mirror and took photos and then looked online and saw that this is a rash that covid19 can once in a while can have with the covid19 virus but not with the vaccination, also had flat hives and may be an allergic reaction to the ingredients in the vaccine, had some difficulty sleeping and put some 1% hydrocortisone anti-itch cream on the area on her thighs and tried to go back to sleep and she had a very fitful sleep and her entire body itched every place there was skin except where the rash was where she put the hydrocortisone cream. The outcome of the events was unknown. Therapeutic measures were taken included 1% hydrocortisone anti-itch cream on the area on her thighs for bumps, flat hives, allergic reaction to vaccine, entire body itched/rash and tried to go back to sleep.  Follow-up (24Mar2021): No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Allergy to vaccine, Headache, Insomnia, Pruritus, Pyrexia
Clinical narrative: little itchy and slightly itchy/body itched every place there was skin; bumps on the back of her thighs; Flat hives; allergic reaction to the ingredients in the Pfizer COVID19 vaccine; difficulty sleeping/fitful sleep; rash; slight headache; slight fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6205, expiration date was not reported) via an unspecified route of administration, on 20Mar2021 15:30 (at the age of 68-year-old), at dose 2, single for covid-19 immunization. Medical history included allergy to bee stings. The patient was administered with unspecified concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6200, expiration date was not reported) via an unspecified route of administration, on 27Feb2021 16:00 (at the age of 68-year-old), at dose 1, single for covid-19 immunization and experienced headache and a little headache and a little fever; she had the fever for a few hours and then it disappeared/ fever and headache for 3 days just for a few hours each day. The patient experienced slight headache, slight fever on 21Mar2021. On 23Mar2021, the 4th day from her second dose of the vaccine and just before midnight she woke up and was a little itchy and slightly itchy and there are some bumps on the back of her thighs and on the back top part of her thighs; she checked it out and looked in a mirror and took photos and then looked online and saw that this is a rash that covid19 can once in a while can have with the covid19 virus but not with the vaccination, also had flat hives and may be an allergic reaction to the ingredients in the vaccine, had some difficulty sleeping and put some 1% hydrocortisone anti-itch cream on the area on her thighs and tried to go back to sleep and she had a very fitful sleep and her entire body itched every place there was skin except where the rash was where she put the hydrocortisone cream. The outcome of the events was unknown. Therapeutic measures were taken included 1% hydrocortisone anti-itch cream on the area on her thighs for bumps, flat hives, allergic reaction to vaccine, entire body itched/rash and tried to go back to sleep.  Follow-up (24Mar2021): No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Rash, Skin disorder, Urticaria
Clinical narrative: little itchy and slightly itchy/body itched every place there was skin; bumps on the back of her thighs; Flat hives; allergic reaction to the ingredients in the Pfizer COVID19 vaccine; difficulty sleeping/fitful sleep; rash; slight headache; slight fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6205, expiration date was not reported) via an unspecified route of administration, on 20Mar2021 15:30 (at the age of 68-year-old), at dose 2, single for covid-19 immunization. Medical history included allergy to bee stings. The patient was administered with unspecified concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6200, expiration date was not reported) via an unspecified route of administration, on 27Feb2021 16:00 (at the age of 68-year-old), at dose 1, single for covid-19 immunization and experienced headache and a little headache and a little fever; she had the fever for a few hours and then it disappeared/ fever and headache for 3 days just for a few hours each day. The patient experienced slight headache, slight fever on 21Mar2021. On 23Mar2021, the 4th day from her second dose of the vaccine and just before midnight she woke up and was a little itchy and slightly itchy and there are some bumps on the back of her thighs and on the back top part of her thighs; she checked it out and looked in a mirror and took photos and then looked online and saw that this is a rash that covid19 can once in a while can have with the covid19 virus but not with the vaccination, also had flat hives and may be an allergic reaction to the ingredients in the vaccine, had some difficulty sleeping and put some 1% hydrocortisone anti-itch cream on the area on her thighs and tried to go back to sleep and she had a very fitful sleep and her entire body itched every place there was skin except where the rash was where she put the hydrocortisone cream. The outcome of the events was unknown. Therapeutic measures were taken included 1% hydrocortisone anti-itch cream on the area on her thighs for bumps, flat hives, allergic reaction to vaccine, entire body itched/rash and tried to go back to sleep.  Follow-up (24Mar2021): No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Gait disturbance, Hypoaesthesia
Clinical narrative: GILLIAN BARRE
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: GILLIAN BARRE
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling
Clinical narrative: Shoulder hurting; Pain in the lower part of my head; Gland in the back of my neck is swollen; This is a spontaneous report from a contactable consumer (patient).  A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6204) Via an unspecified route of administration on 24Mar2021 09:15 (at the age of 59-year-old)as dose 2, single for COVID-19 immunization. The patient Medical history include aneurysm, type 2 diabetic. The patient Concomitant medications was not reported. Patient stated that she received second Pfizer on 24Mar2021 at 9:15. And yesterday on unspecified date she just had blah and then last night she was fine, woke up at like 4 o'clock this morning with her shoulder hurting, and the gland in the back of her neck was swollen. The shoulder, and then the gland in her neck on the right side and that's the side she had the shot was swollen and she had, it causes right up into pain in the lower part of her head. And Tylenol will not take. When confirmed that the consumer took a Tylenol, consumer stated, Yeah and it doesn't help. she was told not to take her pain meds. Patient reported that she read somewhere people had problems with gland swelling in the neck. Patient stated, that because she don't even want her daughter to go and have her second shot next week with the way she feel. Patient received Tylenol (Extra strength 500 mg) for the treatment of events reported. Patient queried for if she should be going to Emergency Room (ER) or not. She was type 2 diabetic. Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal discomfort, Pain, Swelling
Clinical narrative: Shoulder hurting; Pain in the lower part of my head; Gland in the back of my neck is swollen; This is a spontaneous report from a contactable consumer (patient).  A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6204) Via an unspecified route of administration on 24Mar2021 09:15 (at the age of 59-year-old)as dose 2, single for COVID-19 immunization. The patient Medical history include aneurysm, type 2 diabetic. The patient Concomitant medications was not reported. Patient stated that she received second Pfizer on 24Mar2021 at 9:15. And yesterday on unspecified date she just had blah and then last night she was fine, woke up at like 4 o'clock this morning with her shoulder hurting, and the gland in the back of her neck was swollen. The shoulder, and then the gland in her neck on the right side and that's the side she had the shot was swollen and she had, it causes right up into pain in the lower part of her head. And Tylenol will not take. When confirmed that the consumer took a Tylenol, consumer stated, Yeah and it doesn't help. she was told not to take her pain meds. Patient reported that she read somewhere people had problems with gland swelling in the neck. Patient stated, that because she don't even want her daughter to go and have her second shot next week with the way she feel. Patient received Tylenol (Extra strength 500 mg) for the treatment of events reported. Patient queried for if she should be going to Emergency Room (ER) or not. She was type 2 diabetic. Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Mass, Muscular weakness, Musculoskeletal discomfort, Speech disorder
Clinical narrative: Shoulder hurting; Pain in the lower part of my head; Gland in the back of my neck is swollen; This is a spontaneous report from a contactable consumer (patient).  A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6204) Via an unspecified route of administration on 24Mar2021 09:15 (at the age of 59-year-old)as dose 2, single for COVID-19 immunization. The patient Medical history include aneurysm, type 2 diabetic. The patient Concomitant medications was not reported. Patient stated that she received second Pfizer on 24Mar2021 at 9:15. And yesterday on unspecified date she just had blah and then last night she was fine, woke up at like 4 o'clock this morning with her shoulder hurting, and the gland in the back of her neck was swollen. The shoulder, and then the gland in her neck on the right side and that's the side she had the shot was swollen and she had, it causes right up into pain in the lower part of her head. And Tylenol will not take. When confirmed that the consumer took a Tylenol, consumer stated, Yeah and it doesn't help. she was told not to take her pain meds. Patient reported that she read somewhere people had problems with gland swelling in the neck. Patient stated, that because she don't even want her daughter to go and have her second shot next week with the way she feel. Patient received Tylenol (Extra strength 500 mg) for the treatment of events reported. Patient queried for if she should be going to Emergency Room (ER) or not. She was type 2 diabetic. Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch cannot be obtained.