chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: PSA levels going up after the Pfizer Covid-19 vaccine; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that a 75-year-old male patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on Jan2021, as 2ND DOSE, SINGLE for COVID-19 immunisation. He reports that he had both doses of the Pfizer Covid-19 vaccine within the month of Jan but could not tell the exact dates. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection) in Jan2021 as historical vaccination as 1st dose, single dose for covid-19 immunisation. The patient's PSA levels going up after the Pfizer Covid-19 vaccine, on an unspecified date. The patient reports that, he continues to see his urologist, but he was "just curious". The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Burning sensation
Clinical narrative: Burning sensation; Pain in the right shoulder and armpit; Pain in the right shoulder and armpit; This is a spontaneous report from a contactable consumer (patient).  A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date (at the age of 72-year-old),as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date after receiving the 1st dose, the patient experienced burning sensation, pain in the right shoulder and armpit.The patient would like to know about taking the second shot, would it be needed after 42 days.  Outcome of the events was unknown  Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 37-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIOECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Left on 11Jun2021 09:45 as second dose, single for covid-19 immunization. (Vaccine Administered at Military Facility: No) (Vaccination facility type: clinic by public health department). Medical history included ongoing Hereditary coproporphyria, ongoing arthritis and degenerative disc disease of spine , intervertebral disc degeneration from an unknown date and unknown if ongoing. Concomitant medication included baclofen (BACLOFEN) taken arthritis and degenerative disc disease of spine from an unspecified start date and ongoing. Has been taking 6 years. Nerves messed up in spinal column from L1-S1. The patient and her son just got second doses on 11Jun2021 and she reported side effects he experienced she did not have a reaction, on 11Jun2021 around 13.00 she had sore arm. She was adds she do not want to crying, she got lab work reports got back today. And her doctor was told she may have blood cancer because blood cells are severely abnormal different sizes, shapes, colors and so many of them and he has not seen this in a very long time. She was also states he also said something about smudge cells. AE not resulted to ER visit and physician office visit. The outcome for the event was resolved on 11Jun2021.   Follow up attempts are needed. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Product dose omission issue
Clinical narrative: Headache; Chills; She missed her appointment for her second dose; This is a spontaneous report from a contactable consumer (patient's daughter). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Mar2021 as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced headache, chills, she missed her appointment for her second dose. It was stated that now patient would like to get her second dose but she do not know if she needed to start over the vaccination series and what she should do. She received response that second dose of Pfizer-BioNTech vaccine should be administered as close to the recommended interval as possible, but not earlier than recommended (3 weeks [Pfizer-BioNTech]). But if it was not possible to give the second dose at 3-weeks and a delay could not be avoided, it might be given up to 6 weeks (42 days) after the first dose. If the second dose was given later than 6 weeks (42 days), the vaccination series does not need to be repeated. There were only limited information available on how well the vaccine protects against COVID-19 if given after this amount of time. Stated she was working right now and the reason she called was that she do not want to wait any longer. The clinical outcome of the headache, chills, she missed her appointment for her second dose were unknown.  Information on lot/batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Pain, Pain in extremity, Swelling
Clinical narrative: the right arm pit is more swollen than the left arm pit. He says there are no bumps in the arm pit, just swelling./swollen and there is little bumps present.; Concerned about the inflammation; That evening he had pain in his arms; and body aches which today have resolved; This is a spontaneous report from a contactable consumer (patient) reported for himself for the 1st Dose administered.   A 40-years-old male patient received bnt162b2 (BNT162B2, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 13Jun2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced the right arm pit is more swollen than the left arm pit and said there are no bumps in the arm pit, just swelling. swollen and there is little bumps present. (swelling on 15Jun2021 with outcome of not recovered , that evening he had pain in his arms on 13Jun2021 with outcome of recovered , and body aches which today have resolved on 13Jun2021 with outcome of recovered , concerned about the inflammation on 15Jun2021 with outcome of not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac disorder, Chills, Dry mouth, Dysphagia
Clinical narrative: First the left Jaw; joints knee hurt; dry mouth; throat could not swallow; Chill hot cold; Heartfelt; This is a spontaneous report from a contactable other HCP reported for the patient in response to HCP letter [sent to physician] via follow-up letter.  A female patient of an unspecified age received first dose of BNT162B2 (Solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced left jaw when it starts. 62 days getting worse left side of jaw also it starts every not about midnight. First the left jaw, joints knee hurt, dry mouth, throat could not swallow, heartfelt and chills hot cold. It was reported that, 'Must take pain xxx tramadol' and 'adult 4 CBD oil'. This has been 62 days doctor ER knew wat to do. Same symptoms every night for 62 days the patient withheld same issue only one dose Pfizer. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Face injury
Clinical narrative: First the left Jaw; joints knee hurt; dry mouth; throat could not swallow; Chill hot cold; Heartfelt; This is a spontaneous report from a contactable other HCP reported for the patient in response to HCP letter [sent to physician] via follow-up letter.  A female patient of an unspecified age received first dose of BNT162B2 (Solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced left jaw when it starts. 62 days getting worse left side of jaw also it starts every not about midnight. First the left jaw, joints knee hurt, dry mouth, throat could not swallow, heartfelt and chills hot cold. It was reported that, 'Must take pain xxx tramadol' and 'adult 4 CBD oil'. This has been 62 days doctor ER knew wat to do. Same symptoms every night for 62 days the patient withheld same issue only one dose Pfizer. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Headache, Neck pain, Pain
Clinical narrative: having body aches all over; body aches all over, neck; body aches all over shoulders; body aches all over,toes and under her feet; Pt reported being unsure of the headaches; This report is received from Xeljanz C&P Program. This is a spontaneous report from contactable other HCP and consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date, as unknown, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included methylprednisolone (Manufacturer unknown), for unknown indication. On an unspecified date the patient reported having body aches all over, body aches all over neck, body aches all over shoulders, body aches all over, toes and under her feet and patient also reported being unsure of the headaches on an unspecified date. It was reported as, the patient reported being unsure of the headaches were from not enough water. no exact dates or further details. The patient underwent lab tests and procedures, and patient reported her rheumatologist advised all of her blood work was normal. The outcome of events was unknown.  Follow up needed; Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: having body aches all over; body aches all over, neck; body aches all over shoulders; body aches all over,toes and under her feet; Pt reported being unsure of the headaches; This report is received from Xeljanz C&P Program. This is a spontaneous report from contactable other HCP and consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date, as unknown, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included methylprednisolone (Manufacturer unknown), for unknown indication. On an unspecified date the patient reported having body aches all over, body aches all over neck, body aches all over shoulders, body aches all over, toes and under her feet and patient also reported being unsure of the headaches on an unspecified date. It was reported as, the patient reported being unsure of the headaches were from not enough water. no exact dates or further details. The patient underwent lab tests and procedures, and patient reported her rheumatologist advised all of her blood work was normal. The outcome of events was unknown.  Follow up needed; Information on the lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Pruritus
Clinical narrative: his hands and feet and legs were just itching and burning all day almost; little pain; his hands and feet and legs were just itching and burning all day almost; little pain; his hands and feet and legs were just itching and burning all day almost; little pain; his hands and feet and legs were just itching and burning all day almost; little pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-years-old male patient received bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Left on 05Jun2021 09:41 (Batch/Lot Number: ER8731) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation (51-years-old at the time of vaccination). The patient medical history was not reported. Concomitant medication included ubidecarenone (COQ-10) taken for an unspecified indication. Patient had no prior vaccination. No family history of itchy hands and legs. The patient previously took first dose of BNT162B2 on 15May2021 (Age-51-year-old) (Batch/Lot Number: ER8733) for covid-19 immunisation with no reaction (No events reported). Consumer stated, he had second shot Pfizer Covid vaccine on 05Jun2021 and when he woke up that morning his hands and feet and legs were just itching and burning all day almost in jun2021 (About two days, 14Jun2021 (not clarified)).Consumer was informed about Pfizer Medical Information department. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered.  Information on lot/batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: I have been having like vivid dreams every night; This is a spontaneous report from a contactable consumer (patient) reported that: An unspecified age and gender patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730; Formulation: solution for injection: expiration date: unknown), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE and second dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0161) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, "I was just wondering I got the Pfizer Covid 19 vaccine. I got two doses and I have been having like vivid dreams every night on an unspecified date''.  The patient did not know like if other people were reporting that and was just wondering like know if other people were reporting it.  Patient was enquiring that was said like it eventually goes away or was it continue for a long period of time. The patient glad to report what side effect the patient having but the main concern was to know do they have like other people that reported it and if so like did it eventually go away. Also enquiring about was their experience that it went away after a month or two, or does it keep continuing. The patient just wanting to get some information because right now patient having strange dreams, they were not like before and some of them were very scary. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Lethargy, Polymerase chain reaction, Pyrexia
Clinical narrative: fever; chills; lethargy; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EP7534), via an unspecified route of administration in left arm on 28Mar2021 at 10:00 (age at vaccination 20-year-old), as a 1st dose, single for covid-19 immunisation at Pharmacy or Drug Store. The patient medical history was not reported. Patient do not have any known allergies. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 20Apr2021 at 12:00, patient experienced fever, chills, and lethargy. The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included Polymerase chain reaction test (Nasal Swab): negative on 22Apr2021, 25Apr2021 and 26May2021. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Lethargy, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; chills; lethargy; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EP7534), via an unspecified route of administration in left arm on 28Mar2021 at 10:00 (age at vaccination 20-year-old), as a 1st dose, single for covid-19 immunisation at Pharmacy or Drug Store. The patient medical history was not reported. Patient do not have any known allergies. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 20Apr2021 at 12:00, patient experienced fever, chills, and lethargy. The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included Polymerase chain reaction test (Nasal Swab): negative on 22Apr2021, 25Apr2021 and 26May2021. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: having tingling and numbing on the whole left side of my body and my right arm; The first one it was just a little bit on my foot; having tingling and numbing on the whole left side of my body and my right arm; The first one it was just a little bit on my foot; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number was not reported) and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number was not reported) both via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced having tingling and numbing on the whole left side of body and right arm; the first one it was just a little bit on foot. Patient started experiencing like numbness in the left side about a week after the 1st dose. The reporter stated that the first one, it was just a little bit on foot (Confirmed experienced after first shot) and the second one was whole left side (Confirmed experienced after second shot). Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Feeling hot, Hyperhidrosis
Clinical narrative: She started having fever like 101 and I give her Tylenol, it helped a little bit; she started having high fever again at around 5'Oclock came back around 102;  she is shivering a lot as well; She started having fever like 101 and I give her Tylenol, it helped a little bit; she started having high fever again at around 5'Oclock came back around 102; she is shivering a lot as well; She started having a lot of sweats; she felt warm and sweat; this morning she woke up kind of warm with 99.9; She started having a lot of sweats; she felt warm and sweat; this morning she woke up kind of warm with 99.9; she had also Diarrhea; This is a spontaneous report from a contactable consumer (patient's mother). A 23-year-old female patient received second dose of BNT162B2 (Solution for injection, NDC/UPC number: Unknown, Expiry date: Unknown) via an unspecified route of administration on 15Jun2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (at age of 23 years) for COVID-19 immunization and no reaction was reported on previous exposure to vaccine. On 15Jun2021, the patient started having a lot of sweats; she felt warm and sweat; and morning she woke up kind of warm with 99.9. She started having fever like 101 and was given TYLENOL (NDC/UPC number: Unknown, Expiry date: Unknown) which helped a little bit; she started having high fever again at around 5'O clock came back around 102; she was shivering a lot as well. She also had diarrhea and had taken her to the emergency room. Reporter stated, "her daughter had Pfizer, the second shot yesterday afternoon and last night she started having a lot of sweats. So, she felt warm and sweat which we thought was going to pass. But then, morning she woke up kind of warm with 99.9 and then she thought it was going to pass. But then she started having fever like 101 and she gave her TYLENOL (captured as suspect), it helped a little bit. But that afternoon she started having high fever again at around 5'O clock came back around 102. So, she took another 2 TYLENOLs, and it was already 10:17, was not sure, 10:25 and she just check out her temperatures she was 102.3. So, her question was should she take her to emergency room because she was shivering a lot as well". Reporter was requested to take the patient to the nearest emergency room or contact a healthcare provider. Reporter was informed to contact Pfizer Medical Information Department as well. However, the department was closed currently. Further probing could not be done as reporter did not want to share further information. Hence, limited information was available over the call. Reporter seriousness was reported as unspecified. Outcome of the event sweating and diarrhea was unknown, whereas other events was not recovered.  Information related to batch/Lot no. was requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: She started having fever like 101 and I give her Tylenol, it helped a little bit; she started having high fever again at around 5'Oclock came back around 102;  she is shivering a lot as well; She started having fever like 101 and I give her Tylenol, it helped a little bit; she started having high fever again at around 5'Oclock came back around 102; she is shivering a lot as well; She started having a lot of sweats; she felt warm and sweat; this morning she woke up kind of warm with 99.9; She started having a lot of sweats; she felt warm and sweat; this morning she woke up kind of warm with 99.9; she had also Diarrhea; This is a spontaneous report from a contactable consumer (patient's mother). A 23-year-old female patient received second dose of BNT162B2 (Solution for injection, NDC/UPC number: Unknown, Expiry date: Unknown) via an unspecified route of administration on 15Jun2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (at age of 23 years) for COVID-19 immunization and no reaction was reported on previous exposure to vaccine. On 15Jun2021, the patient started having a lot of sweats; she felt warm and sweat; and morning she woke up kind of warm with 99.9. She started having fever like 101 and was given TYLENOL (NDC/UPC number: Unknown, Expiry date: Unknown) which helped a little bit; she started having high fever again at around 5'O clock came back around 102; she was shivering a lot as well. She also had diarrhea and had taken her to the emergency room. Reporter stated, "her daughter had Pfizer, the second shot yesterday afternoon and last night she started having a lot of sweats. So, she felt warm and sweat which we thought was going to pass. But then, morning she woke up kind of warm with 99.9 and then she thought it was going to pass. But then she started having fever like 101 and she gave her TYLENOL (captured as suspect), it helped a little bit. But that afternoon she started having high fever again at around 5'O clock came back around 102. So, she took another 2 TYLENOLs, and it was already 10:17, was not sure, 10:25 and she just check out her temperatures she was 102.3. So, her question was should she take her to emergency room because she was shivering a lot as well". Reporter was requested to take the patient to the nearest emergency room or contact a healthcare provider. Reporter was informed to contact Pfizer Medical Information Department as well. However, the department was closed currently. Further probing could not be done as reporter did not want to share further information. Hence, limited information was available over the call. Reporter seriousness was reported as unspecified. Outcome of the event sweating and diarrhea was unknown, whereas other events was not recovered.  Information related to batch/Lot no. was requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I could walk those miles, I can breath better/ there was positive everything today there was no negative in what I am feeling today/ I feel so excited that I feel so good; This is a spontaneous report from a contactable female consumer (patient) reported for herself. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0182) via an unspecified route of administration on 15Jun2021 10:30 as 2nd dose, single for COVID-19 immunisation. Medical history included COPD, asthma, epileptic, depression all from an unknown date and unknown if ongoing. Concomitant medications included buspirone (BUSPIRONE) 10 mg taken for depression, start and stop date were not reported; topiramate (TOPAMAX) 200 mg twice a day taken for an unspecified indication, start and stop date were not reported; oxybutynin (OXYBUTYNIN) 15 mg once a day taken for an unspecified indication, start and stop date were not reported; lamotrigine (LAMICTAL) (Lamictal 150 mg, this is at the evening, and then I get 100 in Lamictal) taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (LOT no.: EW0176) on 25May2021 for COVID-19 immunisation. On an unspecified date the patient reported that I had my second vaccination today and a lot have side effects and I had none of those today it was the opposite. I had lot of miles up to 4 miles I have to walk I had no choice. I could walk those miles, I can breathe better. I guess there was positive everything today there was no negative in what I am feeling today, and I find myself. That is just gone away. I just have my daughters know that I was going to let you guys know this is such the positive thing I got (Incomplete word) this morning. I am just excited that I feel so good. The clinical outcome of the event was unknown.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Sharp chest pains, shortness of breath.; Sharp chest pains, shortness of breath.; This is a spontaneous report from a contactable consumer (patient reported on himself). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN0199, Pfizer NTEC), via an unspecified route of administration, administered in left arm on Mar2021 07:00, as 1st dose, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: RE8734, Pfizer NTEC), via an unspecified route of administration, administered in left arm on Mar2021 07:00 (at the age of 51-years-old), as 2nd dose, single for covid-19 immunization. The most recent COVID-19 vaccine was administered in the hospital. Medical history included abdominal discomfort from an unknown date. Concomitant medication(s) included omeprazole (PROTONIX [OMEPRAZOLE]), pseudoephedrine hydrochloride (SUDAFED 12 HOUR), glucosamine (GLUCOSAMINE), l-arginine (arginine), ascorbic acid (VITAMIN C ACID) and ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient previously took PCN (penicillin nos). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. In Mar2021, the patient experienced sharp chest pains and shortness of breath. The patient did not receive any treatment. The clinical outcome for the events was not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The first shot, I just had sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736, Expiration date: Jul2021) intramuscularly on the right arm (shoulder) on 23May2021 (at the age of 58-year-old) as single for COVID-19 immunization. Medical history of the patient included rheumatoid arthritis (2010- not clarified), and asthma, it might have been, patient haven't had wheezing and it might have been about 2 weeks ago. Concomitant medication included Diclofenac Sodium Topical Gel, 4 times a day (1%, Atopic cream) taken for rheumatoid arthritis, Prednisone 5 mg once a day taken for rheumatoid arthritis, Hydrocodone 10 mg taken for rheumatoid arthritis, Albuterol (Salbutamol) taken for asthma. Patient did not receive any prior vaccinations within 4 weeks. On an unspecified date, the patient had sore arm after the first dose. Patient did not receive any treatment for the event. The outcome of the event was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: have a big bump on the shot site, knot; have a big bump and redness on the shot site; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER COVID-19 VACCINE), intramuscularly, administered in right deltoid (right shoulder as reported) on 14Jun2021 (Lot Number: EW0180; Expiration Date: Aug2021) as dose 2, single at the age of 58-year-old for covid-19 immunization. Historic vaccine was bnt162b2 (PFIZER COVID-19 VACCINE), intramuscularly, administered in right deltoid (right shoulder as reported) on 23May2021 (Lot Number: ER8736; Expiration Date: Jul2021) as dose 1, single at the age of 58-year-old for covid-19 immunization and experienced sore arm. Medical history included rheumatoid arthritis from 2010 to an unknown date (Diagnosis date: 2010), asthma from an unknown date. The patient had not had no wheezing and it might had been about 2 weeks ago. There was no prior vaccinations within 4 weeks. Concomitant medications included diclofenac sodium (topical gel), prednisone, and hydrocodone, all taken for rheumatoid arthritis; salbutamol (ALBUTEROL) taken for an unspecified indication, all start and stop date were not reported. The patient just had one concern. She got the Pfizer, her second shot yesterday (14Jun2021) and today  (15Jun2021) she had a big bump and redness on the shot site. Was that a normal reaction? After the second shot. The first shot, the patient just had sore arm. The second shot she was experiencing this knot and redness. The patient was still experiencing the issue, It's a knot and its red. Therapeutic measure were not taken as a result of events. The outcome of events was not recovered.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Pain in extremity, Vomiting
Clinical narrative: Arm pain; Stomach pain; I feel like vomiting; I feel like throwing up; This is a spontaneous report from a contactable consumer (patient father).   A 13-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0191, Expiration Date: 13Jun2021), via an unspecified route of administration, administered in left hand on 13Jun2021 as 1st dose, single dose for covid-19 immunisation. Medical history included was none and there were no concomitant medications. On 14Jun2021, Reporter stated that My daughter, she got the Pfizer COVID vaccine. She has the problem. The arm pain, which was normal because she passed all dosage stage however she keeps complaining about the stomach pain and then she says I feel like throwing up and which was, vaccination was happen on Sunday but she was keeps complaining like on 14Jun2021 Monday night, 15 Jun2021Tuesday night and also 16Jun2021 night and I thought let me update you. Is it normal or something different? She has not thrown up yet but she feel like throwing up and she was having pain in her stomach. She said, I feel like vomiting but no vomit so far but stomach pain still going on. Reporter stated that, I would like to know was that normal or she should checked by the doctor or she should  wait one or two days more to get better or any other side effects which needs to be check right away. I mean she do not have any like fever or feel like emergency or anything. She was waking up in night two times. The outcome of the event arm pain and felt like vomiting was unknown and not recovered for other events.  Information on lot/batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Mass, Muscle spasms, Vaccination site pain
Clinical narrative: caused a hard mass in his arm and he get muscle spasm; caused a hard mass in his arm and he get muscle spasm; he has shot pain; This is a spontaneous report from a contactable consumer (patients wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation solution for injection,Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date in Feb2021 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE) for covid-19 immunisation. On an unspecified date, he had the last shot, last part of February the second shot and it caused a hard mass in his arm and he get muscle spasm or a hard shot pain and the doctor, one doctor check this, and said there was a hard mass that was causing it. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling on the fingertips; Pain in the Shoulder; Numbness all around his Arm; This is a spontaneous report from a Pfizer sponsored program.   A contactable pharmacist reported for a 12-year-old male patient that who received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiry date was unknown) via Intramuscular route of administration at Left Deltoid on an unknown date (Age at vaccination was 12-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. On an unknown date patient has a few areas of painful shoulder. He has tingling in his fingertips and his arm was numb. Outcome of the events was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling of body temperature change, Pyrexia
Clinical narrative: She has got a temperature above 102 and she is feeling very high I mean, she feel high to the touch but she is cold.; She has got a temperature above 102 and she is feeling very high I mean, she feel high to the touch but she is cold.; This is a spontaneous report from a contactable consumer (grandparent). A 13-year-old female patient received second dose of BNT162B2 (Pfizer Covid 19, Solution for injection, Batch/lot number: Unknown, NDC/UPC number: Unknown, Expiry date: Unknown) via an unspecified route of administration on 14Jun2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 15Jun2021, she had got a temperature above 102 and she was feeling very high to the touch but she was cold. Reporter stated that granddaughter got the Pfizer second dose yesterday and she got a temperature above 102 and she was feeling very high, she felt high to the touch but she was cold. Permission to probe further questions: Reporter asked whether she should take 2 Tylenol (Batch/lot number: Unknown, Expiry date: Unknown). Reporter seriousness was unspecified. Limited information available over the call. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Migraine
Clinical narrative: received the 1st shot of the covid vaccine and have had an intractable migraine ever since (3weeks ago); This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date in 2021 as 1st dose, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient recently received the 1st shot of the COVID vaccine and have had an intractable migraine ever since (3 weeks ago), had to get 2 MRIs of brain and now was stuck with a 2,000 bill that patient could not afford. It was Pfizers fault because they were told it was safe and it was not. Patient would like help with paying the bill. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Malaise, Myalgia, Nausea
Clinical narrative: Running a fever; Muscle pain; Chills; Joint pain; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer or other non health professional. A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0217, Pfizer NTEC), via an unspecified route of administration on 14Jun2021 as 2nd dose, single for covid-19 immunization (at the age of 56-years-old). He was not having medical conditions but every now and then he takes something like for his gas. The patient's concomitant medications were not reported. The patient did not receive any other prior vaccinations. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0187, Pfizer NTEC), via an unspecified route of administration on 17May2021 as 1st dose, single for covid-19 immunization The reporter stated this was the second dose, the first dose, he did not get sick. On 15Jun2021 10:00 patient was not feeling well, nausea, patient wife took his temperature he was running a fever and so he was having like chills and muscle pain and joint pain. The reporter seriousness for the events was unspecified. It was further stated that, he took some Tylenol at work that morning, two Tylenol, he only had two dosage, he got some Tylenol at work and he haven't had any since then. The pharmacy said that continue taking Tylenol and liquids and fluids. The clinical outcome for the events was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Running a fever; Muscle pain; Chills; Joint pain; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer or other non health professional. A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0217, Pfizer NTEC), via an unspecified route of administration on 14Jun2021 as 2nd dose, single for covid-19 immunization (at the age of 56-years-old). He was not having medical conditions but every now and then he takes something like for his gas. The patient's concomitant medications were not reported. The patient did not receive any other prior vaccinations. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0187, Pfizer NTEC), via an unspecified route of administration on 17May2021 as 1st dose, single for covid-19 immunization The reporter stated this was the second dose, the first dose, he did not get sick. On 15Jun2021 10:00 patient was not feeling well, nausea, patient wife took his temperature he was running a fever and so he was having like chills and muscle pain and joint pain. The reporter seriousness for the events was unspecified. It was further stated that, he took some Tylenol at work that morning, two Tylenol, he only had two dosage, he got some Tylenol at work and he haven't had any since then. The pharmacy said that continue taking Tylenol and liquids and fluids. The clinical outcome for the events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Amino acid level, Blood magnesium, Blood test, Full blood count, Haemoglobin
Clinical narrative: I have side effects where my face has been swollen, may be one to two weeks after that; its feel swollen and it's not going down yet; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was unknown (reported as that EW69, she doesn't know it J or 35), and Expiration Date was not reported), via intramuscularly, administered in Arm Right on 04Apr2021 (at the age of 52-year-old) as a single for COVID-19 immunization. Medical history included dialysis and blood pressure high from an unknown date and unknown if ongoing. Concomitant medications included minoxidil, carvedilol, amlodipine, valsartan for Hypertension and ascorbic acid, biotin, cyanocobalamin, folic acid, nicotinamide, pantothenic acid, pyridoxine, riboflavin, thiamine, zinc (RENAPLEX) taken dialysis, start and stop date were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW7534, Expiration Date: Unknown), via intramuscularly, administered in Arm Right on 12Mar2021 as a single dose for COVID-19 immunization. On 04Apr2021, after the second shot, patient had side effects where her face has been swollen, may be one to two weeks after that and its feel swollen and it's not went down yet. Patient stated that no one had told her what was happening. Patient did not receive any treatment for adverse event. The patient underwent lab tests and procedures which included tyrosine Serum, magnesium Serum, Micro HLB, CBC Differential Platelets, Hemoglobin A13, Hepatitis B antibody, Hepatitis C, Micro Keratin Ratio and Metabolic Panel with unknown results on an unspecified date. The outcome of event was not recovered.  Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis B antibody, Hepatitis C antibody, Investigation, Metabolic function test, Swelling face
Clinical narrative: I have side effects where my face has been swollen, may be one to two weeks after that; its feel swollen and it's not going down yet; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was unknown (reported as that EW69, she doesn't know it J or 35), and Expiration Date was not reported), via intramuscularly, administered in Arm Right on 04Apr2021 (at the age of 52-year-old) as a single for COVID-19 immunization. Medical history included dialysis and blood pressure high from an unknown date and unknown if ongoing. Concomitant medications included minoxidil, carvedilol, amlodipine, valsartan for Hypertension and ascorbic acid, biotin, cyanocobalamin, folic acid, nicotinamide, pantothenic acid, pyridoxine, riboflavin, thiamine, zinc (RENAPLEX) taken dialysis, start and stop date were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW7534, Expiration Date: Unknown), via intramuscularly, administered in Arm Right on 12Mar2021 as a single dose for COVID-19 immunization. On 04Apr2021, after the second shot, patient had side effects where her face has been swollen, may be one to two weeks after that and its feel swollen and it's not went down yet. Patient stated that no one had told her what was happening. Patient did not receive any treatment for adverse event. The patient underwent lab tests and procedures which included tyrosine Serum, magnesium Serum, Micro HLB, CBC Differential Platelets, Hemoglobin A13, Hepatitis B antibody, Hepatitis C, Micro Keratin Ratio and Metabolic Panel with unknown results on an unspecified date. The outcome of event was not recovered.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Dizziness, Lethargy, Pyrexia
Clinical narrative: stomach ache; lethargic; dizzy; 102 fever; This is a spontaneous report from a contactable consumer(parent). This consumer (parent) reported for 12-years-old female (daughter) patient who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Batch/Lot Number: ER8736) via intramuscular on 11Jun2021 at 03:15 in right arm as a single dose for Covid-19 immunization. Medical history was reported as none. The patient's concomitant medications, past drug history and known allergies were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID or any other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot number: EW0177) via intramuscular on 16May2021 at 12:00 in right arm for COVID-19 immunization. The patient experienced stomachache, 102 fever and she was lethargic and dizzy at 06:00 on 12Jun2021.The events were reported as non-serious. The patient did not receive any treatment. The patient underwent lab tests and procedures which included body temperature as 102 on 12Jun2021. The outcome of all events was resolved on an unspecified in Jun2021.