chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Headache, Malaise, Pyrexia
Clinical narrative: Low cough; Not feeling good; Wasn't feeling good; I ran 99.6 fever; I am still, I am running 100.8 fever; Bad headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she received the first shot on Thursday, it was the 29th, and was perfectly healthy. The patient got the shot and Saturday night on the 31st, she started with low cough and not feeling good and then yesterday, the patient ran 99.6 fever, had a bad headache and wasn't feeling good. Patient reported feeling better today but was still running 100.8 fever. The patient underwent lab tests and procedures which included body temperature: 99.6  and body temperature: 100.8 on unspecified date. Patient took Tylenol and Ibuprofen as treatment for event. The outcome of the event not recovered.   Information on Batch/Lot number requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vein disorder
Clinical narrative: sharp pain come up into in her leg for about five hours; has bulging veins in that area; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0217, Expiration Date: 30Sep2021), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that about half an hour after first dose of the Pfizer Covid 19 Vaccine she noted sharp pain come up into in her leg for about five hours and has bulging veins in that area. Patient asked if this was in the range of muscle and joint pain or was there anything to keep an eye out for or be wary of. She states she does not know if these were normal side effects or not. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a Pfizer sponsored program  from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. On an unspecified date the patient experienced sore arm. Both shots were of Pfizer's. He did not have any reaction other than a sore arm for maybe the next day. No side effects so far. So, he had wait to until something happens, this type of thing has got him worried. The clinical outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Nausea, Polymenorrhoea
Clinical narrative: Several hours after I got my second shot, I began spotting blood even though my period was not expected for another 17 days. Since the vaccine, my periods have been heavier, I've experienced intense nausea, and I have had more painful cramps.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Blood test, Computerised tomogram, Deafness neurosensory, Deafness unilateral
Clinical narrative: On 8/14/21 my ears felt like pressure was building up inside the canal.  At 3:00 I exit my vehicle and while at home my left ear proceeded to get worse.  Within 3 hours I lost complete hearing in that ear.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Labyrinthitis, Magnetic resonance imaging, Sudden hearing loss
Clinical narrative: On 8/14/21 my ears felt like pressure was building up inside the canal.  At 3:00 I exit my vehicle and while at home my left ear proceeded to get worse.  Within 3 hours I lost complete hearing in that ear.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Pain
Clinical narrative: pain; This is a spontaneous report from a contactable consumer (patient herself). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EY0584, Expiry Date: Unknown), via an unspecified route of administration, administered in Arm Left on 29Jun2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were none. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0182 and Expiry Date: Unknown), via an unspecified route of administration, in arm left on 04Jun2021 11:00 as dose 1, single for COVID-19 immunisation and experienced with pain was excruciating, Chills and Fever, No appetite, Occasionally feels flushed and Neck, Upper Arm, Thigh Pain. It was reported that, she was scheduled to get her second dose of the COVID Vaccine on 25Jun2021. Due to her symptoms going on at that time she did not get it on that date. She felt well enough to get it on 29Jun2021. On 29Jun2021, patient experienced pain. The patient underwent lab tests and procedures which included full blood count normal was everything was fine, 2 Lyme tests on her was negative, resistance test with her arms and legs, CBS was everything was fine on these tests and SARS-COV-2 antibody test was positive on an unspecified date in 2021. Patient took Tylenol for the pain, but that Tylenol never helps her with pain anyway. She said that the doctor ordered Percocet (combination of Oxycodone and Acetaminophen), as one tablet every 6 hours on the 29Jun2021 to take around the clock for three days. She mentioned that there was a Product Complaint for Tylenol and Percocet, which did not help with pain. The outcome of events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for male patient (reporter's husband). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/ batch number unknown), via an unspecified route of administration on unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that her husband has tinnitus and his started four days after the vaccine. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Depression, Disorientation, Dizziness, Facial pain
Clinical narrative: dizziness/she has a friend who is going through something very similar; Vision disorientation/she has a friend who is going through something very similar; ringing in her ears/she has a friend who is going through something very similar; pains in her face/she has a friend who is going through something very similar; anxiety/she has a friend who is going through something very similar; depression/she has a friend who is going through something very similar; This is a spontaneous report from a contactable consumer (patient's friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizziness, vision disorientation, ringing in her ears, pains in her face, anxiety and depression. At the time of this report, the outcome of event was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.  F/U (PRD/SRD 25aug2021): Follow-up activities closed: Batch/lot number not available.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: dizziness/she has a friend who is going through something very similar; Vision disorientation/she has a friend who is going through something very similar; ringing in her ears/she has a friend who is going through something very similar; pains in her face/she has a friend who is going through something very similar; anxiety/she has a friend who is going through something very similar; depression/she has a friend who is going through something very similar; This is a spontaneous report from a contactable consumer (patient's friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizziness, vision disorientation, ringing in her ears, pains in her face, anxiety and depression. At the time of this report, the outcome of event was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.  F/U (PRD/SRD 25aug2021): Follow-up activities closed: Batch/lot number not available.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Somnolence, Vaccination site erythema, Vaccination site pain
Clinical narrative: Injection site pain; Injection site pain which is swelling, red, and hot; Injection site pain which is swelling, red, and hot; Injection site pain which is swelling, red, and hot; They both don't have energy to cook or anything and are sleeping a lot.; They both don't have energy to cook or anything and are sleeping a lot.; They are in a fog and can't think/Feel like they've been run over by a car; This is a spontaneous report from a contactable consumer (patient's daughter) via Medical Information team. An 84-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FA7484; Expiration Date: 30Sep2021, NDC 59267-1000-02), dose 2 via an unspecified route of administration, administered in right arm on 02Aug2021 (at the age of 84-year-old) as 0.3 mL single for covid-19 immunisation. Medical history included pacemaker, fall from 13Feb2021. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0181, expiration date 30Aug2021, NDC number: 59267-1000-02) dose 1 via an unspecified route of administration on 12Jul2021 (at the age of 84-year-old) as 0.3 mL single for covid-19 immunisation. The patient had nothing with the first one, she was just tired and sluggish and worn out all a week. This started the day of the vaccine and lasted a week or so, she didn't even want to cook or eat. This improved then she got second dose. Since receiving second doses, patient have been experiencing "injection site pain which was swelling, red, and hot" on 02Aug2021. Her mother's site "was really hot" and "looks like the size of a baseball". Duration of pain at the injection site after Dose 2 was 2.5 days. They want to know if these reactions are normal and how to treat. Asked what if the reaction last longer than 2 days. The patient's looks like a baseball on her arm. The patient's arm is so hot she could fry an egg on her arm. The patient's arm did not bleed when she took the Band-Aid off. In Aug2021, she felt she had been run over by a car. She does not have energy to cook or anything and sleeping a lot. The patient feels like she was in a fog and can't think in Aug2021. The patient's arm was red and very very hot. The redness started right away. Outcome of the events injection site pain which was swelling, red, and hot was not recovered; for other events was unknown.  Follow up information completed.no further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100999212 Same reporter/product, similar event, different patient
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site pain; Injection site pain which is swelling, red, and hot; Injection site pain which is swelling, red, and hot; Injection site pain which is swelling, red, and hot; They both don't have energy to cook or anything and are sleeping a lot.; They both don't have energy to cook or anything and are sleeping a lot.; They are in a fog and can't think/Feel like they've been run over by a car; This is a spontaneous report from a contactable consumer (patient's daughter) via Medical Information team. An 84-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FA7484; Expiration Date: 30Sep2021, NDC 59267-1000-02), dose 2 via an unspecified route of administration, administered in right arm on 02Aug2021 (at the age of 84-year-old) as 0.3 mL single for covid-19 immunisation. Medical history included pacemaker, fall from 13Feb2021. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0181, expiration date 30Aug2021, NDC number: 59267-1000-02) dose 1 via an unspecified route of administration on 12Jul2021 (at the age of 84-year-old) as 0.3 mL single for covid-19 immunisation. The patient had nothing with the first one, she was just tired and sluggish and worn out all a week. This started the day of the vaccine and lasted a week or so, she didn't even want to cook or eat. This improved then she got second dose. Since receiving second doses, patient have been experiencing "injection site pain which was swelling, red, and hot" on 02Aug2021. Her mother's site "was really hot" and "looks like the size of a baseball". Duration of pain at the injection site after Dose 2 was 2.5 days. They want to know if these reactions are normal and how to treat. Asked what if the reaction last longer than 2 days. The patient's looks like a baseball on her arm. The patient's arm is so hot she could fry an egg on her arm. The patient's arm did not bleed when she took the Band-Aid off. In Aug2021, she felt she had been run over by a car. She does not have energy to cook or anything and sleeping a lot. The patient feels like she was in a fog and can't think in Aug2021. The patient's arm was red and very very hot. The redness started right away. Outcome of the events injection site pain which was swelling, red, and hot was not recovered; for other events was unknown.  Follow up information completed.no further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100999212 Same reporter/product, similar event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: 102 fever; Sick for 2 days; This is a spontaneous report from Pfizer-Sponsored Program. This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included illness from an unknown date and unknown if ongoing, reported that the patient as a baby had always got sick when got vaccines. The patient's concomitant medications were not reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, the patient experienced 102 fever, and was sick for 2 days. The patient underwent lab tests and procedures which included body temperature: 102 on an unspecified date. The caller stated that her daughter, when the patient got her vaccine, she did not think this had anything to do with it, but her second dose, she had a 102 fever, she was sick for 2 days. The patient recovered from the event sick for 2 days and the outcome for the event 102 fever was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: her arm is sore at the injection site; This is a spontaneous report from a non contactable consumer (Patient). A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 04Aug2021 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 72 years). Medical history and patient's concomitant medications were not reported. On 05Aug2021 the patient had experienced her arm is sore at the injection site. It was reported that when she did the shot, it was wonderful and she could barely feel anything. After a while, it was sore and also reported that they scheduled her for another shot in two weeks for 25Aug2021. She would like to know when is the latest she can get the second dose. She will be out of town and wants to know if it needs to be done in 2 months, 3 months, 5 months, or whenever is the time frame she would need to have it done in or does she have to schedule another one. She did not wish to provide a mailing address or email and did not wish to complete report. She requested to be transferred to have her question answered. The clinical outcome was unknown.   Information on the lot/batch number has been requested
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: she had complaints of fever; This is a spontaneous report from a contactable consumer or other non-HCP (patient mother) via Medical Information Team. A 22-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 22-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced complaints of fever on an unspecified date. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain with both doses; This is a spontaneous report from a contactable consumer or other non hcp.    A 56-years-old male patient received first and second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that her 56-year-old husband (patient) had complaints of muscle pain with both doses of the Pfizer Covid-19 vaccine on an unspecified date. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: periods became very irregular; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on an unspecified date, as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On unspecified date, the patient experienced periods became very irregular. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site mass, Vaccination site swelling
Clinical narrative: Hard knot, swelling, and redness at injection site/ it felt hard in that spot; hard knot, swelling, and redness at injection site; hard knot, swelling, and redness at injection site; hurt a little more, she has more soreness; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that:  A female patient of unspecified age had received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178, Expiration date ??-AUG-2021), via an unspecified route of administration, administered on left arm on 03AUG2021 at single dose for COVID-19 immunisation. Patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178) via an unspecified route of administration on 13Jul2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. After first dose patient had didn't have too much of a reaction maybe a little soreness on Jul2021. After 2nd dose on 03Aug2021, patient had experienced did hurt a little more, she has more soreness but throughout the day she noticed a knot, it felt hard in that spot it felt hard in that spot. Yesterday she noticed that in the area it looks like it was getting swollen like a big mosquito bite that spreads when you scratch it. She iced it yesterday and it still is like that today. She didn't have a reaction the 1st time but she did with the 2nd. Do they put something different in there the 2nd time She was concerned. At the time of reporting, the outcome of the events were not recovered.  Description of complaint:  Caller reporting AEs following the 1st and 2nd dose of the Pfizer COVID vaccine asked if they put something different in there the 2nd time? She is concerned since she did not have this side effect with the 1st dose.  Probed for NDC, lot number and expiry date and caller does not see the NDC or expiry date on the COVID vaccination record card for the 1st dose and doesn't see an NDC for the 2nd dose. Therapy start date populated as the date for the caller's first COVID vaccine and the therapy stop date populated as the date for the caller's second COVID vaccine. Populated 2nd dose lot and expiry date within formal fields since caller's main concern was after the 2nd dose.  Caller confirms that both doses have the same lot number.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: fatigue; Joint aches; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular, administered in Arm Left on 14Jul2021 afternoon (age at vaccination 63-years-old) (Batch/Lot Number: EW0180) as single dose for COVID-19 immunization. Medical history included hypothyroid from an unknown date. The patient had no medical history at time of vaccine or w/in 3 mo of vaccine. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE) taken for hypothyroid from an unspecified start date and ongoing. The patient did not receive any prior vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular, administered in Arm Left on 23Jun2021 afternoon (age at vaccination 63-years-old) (Batch/Lot Number: EW0217) for COVID-19 immunization and experienced minor headache, swollen eyelids and eye puffiness. On 24Jul2021 afternoon, the patient experienced fatigue, joint aches. The patient did not receive any treatment for the events. Outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blepharospasm, Cardiac disorder, Chills, Fatigue, Myalgia
Clinical narrative: intermittent feeling in his heart; fevers; chills; fatigue; muscular pain; eye twitching; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) via medical information team.   A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 22Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced intermittent feeling in his heart, fevers, chills, fatigue, muscular pain, eye twitching. It was reported that the patient received the 1st dose of the Pfizer COVID-19 Vaccine on 22Jul2021. Afterwards the patient reported of having had some of the side effects. The patient reported that he also had different things that he does not see listed on the information sheet. He stated he had fevers, chills, fatigue, muscular pain and then the day after the vaccine he had eye twitching. Also the twitching happens all the time but then he reported an intermittent feeling in his heart that was similar to the what it feels like when you have the chills. The patient reported of having a feeling of the chills but in his heart. This was reported to be an intermittent occurrence. The patient reported that he had a side effect after the first dose of the vaccine and enquired if he should get the second dose. The patient had an appointment next Thursday with his HCP to address his concerns he had experienced post vaccination of dose one. The patient reported that he had an upcoming appointment with his HCP regarding his concerns noted next Thursday, however this was the same day that he was also scheduled to receive his 2nd dose of the vaccine and he was concerned there will not be time to address these concerns and was concerned that he will not have time or have the proper guidance he wanted in regards to getting the second dose of the vaccine. Patient would like to know if we have more information on these 2 side effects that he has experienced that do not seem to be listed on the document he has. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: intermittent feeling in his heart; fevers; chills; fatigue; muscular pain; eye twitching; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) via medical information team.   A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 22Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced intermittent feeling in his heart, fevers, chills, fatigue, muscular pain, eye twitching. It was reported that the patient received the 1st dose of the Pfizer COVID-19 Vaccine on 22Jul2021. Afterwards the patient reported of having had some of the side effects. The patient reported that he also had different things that he does not see listed on the information sheet. He stated he had fevers, chills, fatigue, muscular pain and then the day after the vaccine he had eye twitching. Also the twitching happens all the time but then he reported an intermittent feeling in his heart that was similar to the what it feels like when you have the chills. The patient reported of having a feeling of the chills but in his heart. This was reported to be an intermittent occurrence. The patient reported that he had a side effect after the first dose of the vaccine and enquired if he should get the second dose. The patient had an appointment next Thursday with his HCP to address his concerns he had experienced post vaccination of dose one. The patient reported that he had an upcoming appointment with his HCP regarding his concerns noted next Thursday, however this was the same day that he was also scheduled to receive his 2nd dose of the vaccine and he was concerned there will not be time to address these concerns and was concerned that he will not have time or have the proper guidance he wanted in regards to getting the second dose of the vaccine. Patient would like to know if we have more information on these 2 side effects that he has experienced that do not seem to be listed on the document he has. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: My arm is still, I mean its still, it is swollen; It is still sore; It is still sore like still red; This is a spontaneous report from a contactable consumer (patient herself).  A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration administered in Arm Left on 03Aug2021 at 11:30 (age at vaccination was 68 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included cholesterol, which was ongoing and stroke in Apr2021. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and atorvastatin calcium (AVASTATIN) taken for blood cholesterol. The patient reported I got my first shot yesterday and yesterday afternoon (03Aug2021), it caused my arm sore and it looks like it's just sore a little red around it. She stated my arm is still, I mean its still, it is swollen and I put a ice pack on it and it is still sore like still red. So, can you tell me for this what I can do to heal it. The only thing I was trying to find out was just what else I need to do? Do I need to take Ibuprofen or what I need to do? It caused my arm sore and it looks like it' s just sore a little red around it. No treatment was received by the patient. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Culture throat, Pain in extremity
Clinical narrative: her arm is sore post vaccination; This is a spontaneous report from a Regulatory Authortity  . A contactable consumer or other non HCP (patient) reported that a 77-year-old female patient received bnt162b2 (BNT162B2, Formulation; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Aug2021 11:10 (Batch/Lot Number: EW0179) as DOSE 1, SINGLE (at the age of 77-year-old) for covid-19 immunisation. Medical history included ongoing asthma (since 3 or 4 years) and sore throat issue from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not have any family medical history relevant with event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient not received other product. The patient experienced her arm is sore post vaccination on 05Aug2021 at 11.10. The patient asked if she could apply ice to help alleviate the soreness. The patient had question as if she gets a headache can she take Tylenol of extra strength. The patient did not visit emergency room or physician office. It was reported that patient could have not hit incorrectly, and she felt sore right away. The patient doesn't have much time as she needs to call her primary care doctor at 16.00 PM. It was reported that patient had a sore throat and needs to have an endoscope done. She went to the throat doctor and had this problem for some time predating the vaccination; she thinks it was allergies and dripping down throat. The patient underwent lab tests and procedures which included swab of throat for Strep: unknown on an unknown date of 2021. The outcome of the event was reported as not recovered.  No follow-up attempts needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Pain in extremity, Tremor
Clinical narrative: the patient is shaking really bad/I got the shivers until a little while about an hour ago I start shaking/I shake the whole body; the patient is shaking really bad/I got the shivers until a little while about an hour ago I start shaking/I shake the whole body; Leg pain/her legs are bothering her really bad/arm pain; back pain; This is a spontaneous report from a contactable consumer (patients' sister) and two consumers. A 80-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number: Not Provided) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the caller was calling on behalf of her sister who was from out of town visiting the caller. Her sister got the Pfizer vaccine yesterday who was the patient was shaking really bad, her legs are bothering her really bad. The patient got on the line to explain what was going on. More concerned about the shaking wanting to know if it was a side effect of COVID-19 vaccine. First dose last night around 8'clock I believe I took it and then I got the shivers until a little while about an hour ago I start shaking like a leaf. Leg pain, back pain, arm pain. But the shakes, do you have reports someone shake like this I shake the whole body on an unspecified date. I'll go to a urgent care. Caller clarifies she was referring to the Pfizer COVID-19 vaccine. The caller wants to know if those are side effects? The caller states she did read the reports and she didn't read anything about the shakes. Caller declines to complete a report at this time, requesting immediate transfer stating she can't stand it no more. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Had a little shoulder soreness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 13Jul2021 (Batch/Lot Number: EW0178) as SINGLE for covid-19 immunization. The patient denied for any medical history and concomitant medications. It was reported that the patient took her 1st dose in Jul2021, maybe the second week of Jul2021 and had a little shoulder soreness that day and it had only lasted a couple of days. She didn't even see a mark barely where shoulder the COVID vaccine. The patient confirms that she recovered completely from this. The outcome of event was recovered in Jul2021.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Body temperature, Illness, Malaise
Clinical narrative: he is real sick; He is weak; Low grade fever like 100, 99, 100; had 'back' pain; he is kind of not feeling good; This is a spontaneous report from a contactable consumer. A male patient of unspecified age and gender received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: Unknown, Expiration date: Unknown), on an unspecified date in Jul2021 as Dose 1 single for covid 19 immunization.The patient had not received any other vaccine and other medication in two weeks. The patient had not affected with covid19 before or after vaccination. Medical history and Concomitant medications were not reported. On an unspecified date 9 days ago (Jul2021) after they both got the Pfizer Covid shot and reporter did not had any side effect but her husband was real sick and he got sick the next day he came out the bed. He was weak and had got a low grade fever like 100, 99, 100 also he had back pain and had not got better and was kind of not feeling good. Reporter stated that she just want to know if that was one of the symptom and she also had went to the symptoms but it did not say anything about the back pain. It was reported that when they told about the role of Pfizer drug safety and Medical information department, she said that she did not understand and told them to forgot about it. No known Allergies were reported. On an unknown date in Jul2021 patient underwent lab tests and procedures which included body temperature (100,99,100). No therapeutic treatments were received. The outcome of the events were reported as unknown and back pain was reported as Not recovered/Not resolved.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: he is real sick; He is weak; Low grade fever like 100, 99, 100; had 'back' pain; he is kind of not feeling good; This is a spontaneous report from a contactable consumer. A male patient of unspecified age and gender received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: Unknown, Expiration date: Unknown), on an unspecified date in Jul2021 as Dose 1 single for covid 19 immunization.The patient had not received any other vaccine and other medication in two weeks. The patient had not affected with covid19 before or after vaccination. Medical history and Concomitant medications were not reported. On an unspecified date 9 days ago (Jul2021) after they both got the Pfizer Covid shot and reporter did not had any side effect but her husband was real sick and he got sick the next day he came out the bed. He was weak and had got a low grade fever like 100, 99, 100 also he had back pain and had not got better and was kind of not feeling good. Reporter stated that she just want to know if that was one of the symptom and she also had went to the symptoms but it did not say anything about the back pain. It was reported that when they told about the role of Pfizer drug safety and Medical information department, she said that she did not understand and told them to forgot about it. No known Allergies were reported. On an unknown date in Jul2021 patient underwent lab tests and procedures which included body temperature (100,99,100). No therapeutic treatments were received. The outcome of the events were reported as unknown and back pain was reported as Not recovered/Not resolved.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Pain, Peripheral swelling
Clinical narrative: Had unbelievable arthritis pain/ my flare; Hands and fingers were swollen; Had unbelievable arthritis pain/pain woke the patient up at night; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at an dose number unknown, single for COVID-19 immunization. The patient's medical history was not reported. The concomitant medications were not reported. The patient previously took Xeljanz (XELJANZ) and experienced lack of efficacy and arthritis pain. The patient stated that she spoke with safety department yesterday. The patient has been taking Xeljanz for years. The patient retired recently and had to change her insurance. Starting 01Jul, the patient got 3 bottles of Xeljanz in the mail. After that first bottle and started the second bottle, it was like the patient was not taking any Xeljanz at all. The patient knew what that feels like because when she got the COVID vaccine, her doctor wanted her to pause Xeljanz and she had unbelievable arthritis pain. The patient's hands and fingers were swollen. The pain woke the patient up at night. The patient told her doctor about her flare and he told her double her prednisone dose. The outcome of events were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-hcp. A female patient of an unknown age received (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown, expiration date: unknown), via an unspecified route, on an unknown date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter mentioned that she looked online this morning when she was trying to do some research on her own and she saw that there was another lady arm that looked just like that. The caller had her son take a picture and the caller's arm looks just like the lady's arm that she saw online where the COVID vaccine went in. Reporter stated that this was just something that she saw when she was looking up her own side effects and searched swelling in arm and she was looking at someone's website, maybe USA Today, and they had a picture of the lady arm. The outcome of event is unknown.  Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Interchange of vaccine products
Clinical narrative: Chest pain; I have the AstraZeneca on July 24 the 1st shot and then I had Pfizer 2nd one; This is a spontaneous report from a contactable consumer (patient, self-reported). A 59-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0179 and expiry date was not reported), via an unspecified route of administration, on 31Jul2021 (age at vaccination: 59 years), as a single dose for COVID-19 immunization and first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19, lot number and expiry date were not reported), via an unspecified route of administration, on 24Jul2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on 01Aug2021, the patient experienced Chest pain and I have the AstraZeneca on 24lthe 1st shot and then I had Pfizer 2nd one on an unspecified date in 2021. The patient stated, "Well little bit concerned, I have the AstraZeneca (Further not clarified hence captured as Unspecified vaccine) on July 24 the 1st shot and then I had Pfizer 2nd one the Pfizer (Confirmed as Covid 19 vaccine) Yes, the Pfizer would be second one the 1st one is 24Jul AtraZeneca the second one was Pfizer I took it on July 31st on the Aug 1st, I had chest pain and I didn't go and see doctor today." The patient stated, "the reason I called is just wanna ask how bad would this chest pain going to be and how long would it it last normally the CDC has indicated it last may be 14 days." Further probing could not be done as the consumer was not willing to provide further information. Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Rash, Urticaria
Clinical narrative: Rash started developing all over my body, on both of my forearms and all over my neck, started moving up to my face; Rash started developing all over my body, on both of my forearms and all over my neck, started moving up to my face; Rash started developing all over my body, on both of my forearms and all over my neck, started moving up to my face; Rash started developing all over my body, on both of my forearms and all over my neck, started moving up to my face; Have rash on my chest, it look like hives; Migraine; This is a spontaneous report from a contactable consumer (Patient).   A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 28Jul2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 02Aug2021, the patient experienced Migraine. On 03Aug2021, the patient experienced Rash started developing all over my body, on both of my forearms and all over my neck, started moving up to my face and Have rash on my chest, it look like hives. It was reported that Consumer stated, I got my Pfizer Vaccine last week on Wednesday and on Monday I had a migraine and on Tuesday a rash all started developing all over my body now it's Thursday I have a rash on both of my forearms and rash all over my neck, started moving up to my face and I have rash on my chest, it look like hives my little Pink sheet from the(Clarification unknown) says to call this number to report any side effects but I am hoping if you could tell me what to take to counteract, so it can go away and how long the rash was normally being reported or how long it stays. Outcome of all the events was unknown.  Information about the Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Quite Skin rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot Number: EW0179), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had a rash from the Covid shot (Vaccine) and also reported that I woke up with quite skin rash and stated I know that, It was a side effect and  enquired as "Can I take Benadryl or Benadryl cream on the rash?" The patient stated I want to know, Can I take a Benadryl. You know the Benadryl has been anti-histamine to help with itching rash and can I take Over the Counter Benadryl?". The outcome of the event was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea, Thyroiditis subacute
Clinical narrative: Thyroiditis sabacute; I had a menstrual period that lasted for over 2 weeks; This is a spontaneous report from contactable other health professional (patient). A 27-year-old non pregnant female patient reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch number/Lot number: EW0177), via an unspecified route of administration, administered in left arm on 01Jul2021 at 04:45 PM (age at vaccination was 27 years) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Vaccination facility was pharmacy or drug store. Medical history and concomitant medications were not reported. No known allergies reported. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks. After getting the first vaccination, on 05Jul2021 at 08:00 AM, the patient experienced subacute thyroiditis, as per Endocrinologist and also had a menstrual period that lasted for over 2 weeks, despite having a normal cycle the week prior to taking the vaccine. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for adverse events. No covid prior vaccination and not tested covid post vaccination. Outcome of the events was recovered/resolved with sequel.