chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives all over; This is a spontaneous report received from a contactable consumer (patient's wife). A 38-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955, expiration date: 30Jun2021) via an unspecified route of administration in the arm right on 05Apr2021 11:16 AM as a single dose for covid-19 immunisation. Medical history included ongoing asthma since he was born and eye surgery from 05Mar2021. Concomitant medications included prednisolone acetate from 05Mar2021 after eye surgery. The patient previously received (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202, expiration date: Jun2021) on 15Mar2021 11:16 AM at 38 years old for covid-19 immunisation. The patient received his second Covid 19 vaccine on 05Apr2021 and the hives started on 08Apr2021. The patient had hives all over. The hives did get worse overnight. The patient had gotten hives when he was younger but it was a reaction to a plant. The hives he had currently have not gone away even with a shower or taking Benadryl. He took 2 25mg tablets of Benadryl within an hour of each other yesterday, 08Apr2021. Then about 9 hours later he took 2 more 25mg tablets. He was going to sleep so he thought the Benadryl (lot number: SEF004, expiry date: Dec2021) would help with that. The patient had no questions except if her husband needed to go to the doctor. The AEs did not required a visit to Emergency Room, no physician office. The patient had no Prior Vaccinations (within 4 weeks). Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Left side face swelling; This is a spontaneous report from a contactable consumer reported for herself. This 56-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) via an unspecified route of administration in the left arm (reported as "left shoulder") on 07Apr2021 13:00 as a single dose for covid-19 immunisation. Medical history included asthma diagnosed as a child. The patient stated it's not ongoing, it's more during seasonal allergies. She took Singulair to help. Concomitant medications were unknown. The patient had Pfizer covid19 vaccine on Wednesday 07Apr2021 and left side face swelling yesterday on 08Apr2021. It's on the left side of the face. It started around the eye and currently she can feel it running down the side of the face. Left side face swelling was reported as worsened. The patient asked if she would be okay to get the second vaccine. She stated she was not in pain, but was concerned that she won't be able to get the second vaccine. She had not treated the swelling yet, and was not sure if she should see her doctor. She was scheduled for the second dose of the vaccine. The patient had no prior Vaccinations (within 4 weeks). Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Diarrhoea, Fatigue, Nausea
Clinical narrative: temp to 100; weakness; fatigue; nausea; diarrhea; This is a spontaneous report from a contactable physician, the patient. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6206, second dose) solution for injection intramuscular in the left arm on 11Mar2021 at 08:20 (at the age of 76-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing blood pressure high from 2010, ongoing high lipid from 1980, and ongoing esophagitis from 1975. Concomitant medications included ongoing atenolol for blood pressure high from 2010, ongoing lisinopril for high blood pressure from 2010, ongoing atorvastatin for high lipids for greater than 10 years, ongoing fenofibrate for high lipid for greater than 10 years, and ongoing lansoprazole (PREVACID) for esophagitis for greater than 10 years. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162B2 (first dose, lot EL9266) for COVID-19 immunization on 18Feb2021 and experienced headache, nausea, diarrhea, weakness, fatigue, and 99.5 temp (fever). The patient experienced moderate weakness, fatigue, Temp to 100 F, Nausea + diarrhea x2 in Mar2021. Treatment for the event fever included liquid Rx-TYLENOL at 500 mg twice. The outcome of the events weakness, fatigue, Temp to 100, nausea, and diarrhea was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Fever cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: temp to 100; weakness; fatigue; nausea; diarrhea; This is a spontaneous report from a contactable physician, the patient. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6206, second dose) solution for injection intramuscular in the left arm on 11Mar2021 at 08:20 (at the age of 76-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing blood pressure high from 2010, ongoing high lipid from 1980, and ongoing esophagitis from 1975. Concomitant medications included ongoing atenolol for blood pressure high from 2010, ongoing lisinopril for high blood pressure from 2010, ongoing atorvastatin for high lipids for greater than 10 years, ongoing fenofibrate for high lipid for greater than 10 years, and ongoing lansoprazole (PREVACID) for esophagitis for greater than 10 years. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162B2 (first dose, lot EL9266) for COVID-19 immunization on 18Feb2021 and experienced headache, nausea, diarrhea, weakness, fatigue, and 99.5 temp (fever). The patient experienced moderate weakness, fatigue, Temp to 100 F, Nausea + diarrhea x2 in Mar2021. Treatment for the event fever included liquid Rx-TYLENOL at 500 mg twice. The outcome of the events weakness, fatigue, Temp to 100, nausea, and diarrhea was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Fever cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Neck pain
Clinical narrative: She had a back ache; Her neck and shoulder ached; Her neck and shoulder ached; This is a spontaneous report received from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 17Mar2021 14:30 as single dose for covid-19 immunisation. Medical history included covid from Nov2020, and lost there sense of taste and smell. The patient's concomitant medications were not reported. The patient experienced she had a back ache, and her neck and shoulder ached on 17Mar2021. The outcome of event back ache was unknown, while other events were recovered on 24Mar2021. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a contactable consumer. A 73 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on an unspecified date as single dose for covid-19 immunisation.  Medical history included high blood pressure. The patient was on high blood pressure medication but is not sure what the name of it was.  The patient experienced soreness at injection site on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient wasn't feeling well on 07Apr2021.  The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration, Neck pain
Clinical narrative: Ulcers in the back of my mouth; Severe neck pain; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 25Mar2021 at 13:45 (batch/lot number: EN6208) as a single dose for COVID-19 immunisation. Medical history included hidradenitis suppurativa from 2019 and ongoing (stated it has been about 2 years ago when she was diagnosed), anti-synthetase syndrome from 2020 and ongoing (diagnosed about a year ago, tested positive for an antibody of it), she was disabled from an unknown date and blood pressure (abnormal) from an unknown date. Family history was reported as none. Concomitant medication included mycophenolate mofetil hydrochloride (CELLCEPT) taken for anti-synthetase syndrome from an unspecified start date and ongoing - her rheumatoid doctor told her to get it, she suffered from anti-synthetase syndrome, this was an immune suppressant, she started taking this a few months ago (4-5 months ago), she was on another immune suppressant, but switched to this one. The patient stated she takes other medication for blood pressure, but it was not relevant. No further details provided. The patient received the Pfizer Covid vaccine and wanted to report side effects. She has an autoimmune disease. The symptoms started with severe pain in her neck on 03Apr2021. After that subsided, the back of her mouth broke out into ulcers on 06Apr2021, and it has been there for about 8 days. She was scheduled for the second dose this Wednesday, 14Apr2021. Stated she will get the second dose because she has a severe autoimmune disease. She went to her nose and throat doctor and got medicine for her mouth ulcers. The event mouth ulcers required a visit to the physician's office. Stated she will go for her second vaccine. She wanted to report side effects, and asked should she receive the second vaccine. Vaccination facility type was sports club center. Vaccine administered at military facility reported as no. No prior vaccinations (within 4 weeks). Relevant tests were reported as none. The outcome was recovered on 06Apr2021 for the event "severe neck pain" and not recovered for the event "ulcers in the back of my mouth".
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Burning sensation, Hypoaesthesia
Clinical narrative: Felt like a sunburn or wind burn on head, cheeks, both sides, and upper arms/Face on the right side felt like a sunburn or windburn; face on the right side became numb-like and it went to the other side; right breast was swollen; This is a spontaneous report received from a contactable consumer reported for self. A 69-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in Arm Right on 19Mar2021 (Lot Number: EN620P) as single dose for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. Prior vaccinations (within 4 weeks) was none. Medical history included Diabetic from 1995 and ongoing, blood pressure high from 1995 and ongoing (just took her usual medications); eczema from 2014. Family medical history relevant to AEs was none. The patient's concomitant medications were none. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration, administered in Arm Right on 26Feb2021 (Lot Number: EX9266) for COVID-19 immunisation; took the shingles shot and broke out they claimed that she had topical eczema. She thinks it was from the shot. That was in 2014. After the second or third day, her face on the right side became numb-like and it went to the other side on 22Mar2021. And now, on her head and on her body, it felt like a sun burn or wind burn. She took Benadryl and it is not going away. She didn't know if it was from the shot. It started 3 days after she had it on 19Mar2021. It started on the third day in her face and seemed to work its way down. Her right breast was swollen on Mar2021, and her daughter took the shot and got deathly sick, her right side was swollen to 3 times its size on her breast. She didn't swell that much and hers has gone down now. Her arms are really tender like sunburn or wind burn. As long as she is sitting still it doesn't bother her but if her clothes hit it or anything it is annoying. She didn't know if other people have complained about that. The patient stated it hurt on her head, like a sunburn. She said there was no numbness, it was more like a sunburn. It doesn't hurt unless touched, like her bra rubbing against it and agitating it. She didn't have this until she had the shot. She got the shot on 19Mar2021, and about 22Mar2021 it started with her face first. It worked its way down her body. It was about a week later that it spread to other parts of her body. She waited about calling because every day she thought it would be getting better. but it hasn't. she took Benadryl for a sunburn-type feeling on her body and it hasn't helped. She had not received any other treatment. There no AEs require a visit to emergency room or physician office. She had a physical done in between her first and second dose. She had routine bloodwork. Outcome of the event right breast was swollen was recovered, of the other events was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program.   A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Mar2021, the patient had his first dose of the vaccine and he was scheduled to go back 13Apr2021 for his second dose. Yesterday, 10Apr2021 (also reported as 11Apr2021, he had a COVID test that was positive. He knows he will probably have to quarantine but doesn't know if he can go back and get the second dose? He is going to have to miss his second dose and doesn't know what to do about getting it. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 10Apr2021. The outcome of the events was unknown. The events were considered as serious (medically significant).  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site soreness; This is a spontaneous report from a contactable consumer. This is 2 of 3 report. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), single dose in upper right arm via an unspecified route of administration on an unknown date for COVID-19 immunisation. Medical history included diabetic. . The patient's concomitant medications were not reported. Reporter was a consumer reporting she knew a person who had the Pfizer Covid 19 Vaccine and said they only had injection site soreness. Reporter stated all these people caller reports had soreness at injection site after receiving Pfizer Covid Vaccine didn't have anything other than injection site pain, Reporter would assume this would be all she had also. Reports these said persons were on various prescription medications and the caller was not. Reports they were all about the same age group. Reporter was surprised she would have all the reactions reported and the said persons did not. Caller did not know if any rhyme or reason but was trying to find out. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Eyelid oedema, Face oedema
Clinical narrative: woke up in the morning with edema on chin and lower eyelids; woke up in the morning with edema on chin and lower eyelids; This is a spontaneous report based on information received by Pfizer from Abbvie Pharmacovigilance via product quality complaint received by a contactable other HCP reported for self. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced woke up in the morning with edema on chin and lower eyelids. The event clinical course was as follows: the patient was injected with 1ml Voluma in temples, 3 ml Voluma cheeks, 1 ml Volift midface, 1 ml Volbella tear trough and 3 ml Volux in chin. 2 months later patient also received 0.5 ml non-Allergan dermal filler in lips and a small correction of 0.1 ml in the left tear trough. Following month, patient received a COVID 19 vaccine. Next morning, patient woke up in the morning with edema on chin and lower eyelids. Outcome of the events was resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Poor quality product administered, Product quality issue, Tenderness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received second dose of BNT162B2 (COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151; Expiration Date: Jul2021), via an unspecified route of administration at left arm on 12Apr2021 at 13:15 as single dose for covid-19 immunisation. Patient had historical vaccine first dose of BNT162B2 (at 62-year-old) lot number: ER8727, Expiration date: Jul2021 at left arm on 22Mar2021 for covid-19 immunisation showed tenderness in left shoulder. There was no patient medical history. There was no family history. There were no additional vaccines administered on same date of the COVID suspect. There were no prior vaccinations (within 4 weeks). No AE following prior vaccinations. The patient did not take concomitant medications. Patient experienced his arm is a little tender now on an unspecified date and received second dose that was clear on 12Apr2021. He received the first vaccination 3 weeks ago and this morning got the second vaccination. When he arrived, there was 30 minute delay. He saw the vaccines that were administered were transparent. It seems like it is not according to COVID standards. The person giving it said when it is diluted, it becomes transparent. He took it and is worried that it is not effective. The first dose was off white a little bit. It was not transparent and was exactly as described by the company. But now, it is transparent. He said that maybe they kept it too long outside, but they said it was correct. This same transparent one was given to several people before him. He did not provide any information on any others that had it. He wanted to know if that means it is not effective. They are doing it all the time. He later stated maybe the first one wasn't effective either. He just doesn't know. He later stated with the first dose, they knew what they were doing. He said he got the vaccine at pharmacy, does not have sample and didn't take photo. He thinks pharmacy did not dilute the vial correctly that's why it was clear, or they left it out too long. The pharmacy RPh told him they did it correctly. He doesn't believe it since the product is supposed to be off white after diluting. He did not see them do the actual diluting or shaking, just saw the vial sitting there. Site and PQM aware. He stated his arm is a little tender now and his temp is 98.4, it usually runs lower than that. He said he asked the company if he should get a third vaccine, he said they could not answer that. He said if anyone should know, its the company. Advised him to discuss his concerns with his doctor. No ER or physician's office visit required. The patient underwent lab tests and procedures which included body temperature was 98.4. Report not related to a study or program. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: covid test result Positive; covid test result Positive; The lymph node under my left arms was swollen a few days after the 2nd vaccines. It was about the size of a golf ball. It hard to touch and rolling. It went away in one week; This is a spontaneous report from a contactable Pharmacist. This (Age: 47; Unit: Unknown) female Pharmacist reported that the patient received second dose of BNT162B2 ( Lot number: EL 3249) via intramuscularly in left arm on 14Jan2021 15:00 and the patient received first dose of BNT162B2 (Lot number: EL 1284) via intramuscularly in left arm on 28Dec2021 15:00 both as a single dose for covid 19 immunization. The patient has not received any other vaccine within four weeks and no any other medication within two weeks. The patient's concomitant medication and medical history was not reported. No known allergies reported. Patient had no covid prior vaccination and tested to covid post vaccination. On 16Jan2021 the patient's lymph node under her left arms was swollen a few days after the 2nd dose vaccine,It was about the size of a golf ball, It was hard to touch and rolling, and It went away in one week. On 02Feb2021, the patient was tested NAA, RT-PCR (nasal swab) and tested positive for covid 19. No treatment was received. The outcome this event was reported as resolved.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the eve and the suspect vaccineBNT162B2
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: Sore Arms; This is a spontaneous report from a contactable consumer (patient). This 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unknown route on 06Apr2021 at 08:00 (at the age of 22-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history included, and concomitant medications not provided. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks and other medication in two weeks. On 18Jan2021, the patient nasal swab COVID test result was positive. On 06Apr2021,after vaccination at 16:00, the patient had sore arms. The patient did not receive any treatment. The outcome of the event sore arms was recovered.   Information on Lot/Batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Chills, Headache
Clinical narrative: lips starting to swell like a balloon (angioedema); headache; chills; This is a spontaneous report from a contactable other hcp (patient).   A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, at age of 39 years old, administered in Arm Left on 10Apr2021 13:30 (Lot Number: ER8729) at single dose for covid-19 immunization.  Patient is not pregnant at the time of vaccination. The patient medical history was not reported. Known allergies was None.  The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Mar2021 (age of 39 years old)(Lot Number: EN6208) at single dose for covid-19 immunization. The patient had 2nd vaccine on 10Apr2021 at 01:30 PM, woke up 11Apr2021 11:00 AM with headache and chills, then around 11 noticed lips starting to swell like a balloon (angioedema). No hives. Events resulted in Doctor or other healthcare professional office/clinic visit. Outcome for events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the angioedema.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: moderate body aches; fatigue; headache; This is a spontaneous report from a contactable consumer. A 59-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in arm left on 12Apr2021 at 10:30 as a single dose for COVID-19 immunization. Medical history included high blood pressure management. Concomitant medications included atenolol taken for an unspecified indication. Historical vaccine included first dose BNT162B2 on 22Mar2021 at 04:00PM. On 12Apr2021 at 18:00 patient experienced moderate body aches, fatigue and headache. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: experiencing fever 101.3; This is a spontaneous report from a contactable consumer (patient wife). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date for covid-19 immunization. The reporter stated that patient received the second dose of the Pfizer vaccine and experiencing fever 101.3 (body temperature). The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a contactable consumer (patient herself) and via report from a Pfizer-sponsored program. A 78-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: Not probed, Expiry Date: Unknown), via an unspecified route of administration on 12Apr2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (BNT162B2). She stated that she has a UTI and was given an antibiotic, Macrobid, and wanted to make sure it was not going to interact with the vaccine before she took it. She is on antibiotics now for her urinary tract infection. Consumer states that she gets a UTI about every other month. She would like to know if she can take her antibiotics or any other medication after the Covid-19 vaccine. On an unspecified date, the patient experienced UTI. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Lymphadenopathy, Pain in extremity
Clinical narrative: swollen lymph nodes under her right arm; chills/Cold Chills; sore back/Back was hurting; sore arm/arm was sore and really hurting; This is a spontaneous report received from a contactable consumer(patient). A 53-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Formulation: solution for injection, Lot Number: EW0161, Expiry date: unknown), via an unspecified route of administration on 10Apr2021 at 09:00, as single dose for covid-19 immunisation. The patient medical history included first dose of bnt162b2 (Lot number: ER2613) received on 20Mar2021. On 20Mar2021, the patient Arm hurt bad, like really achy. The event recovered on 22Mar2021. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. Prior Vaccinations (within 4 weeks), Patient has had both doses of the Pfizer Covid Vaccine. On 11Apr2021, the patient experienced chills/cold chills, sore back/back was hurting, sore arm/arm was sore and really hurting, swollen lymph nodes under her right arm on 12Apr2021. She wanted to know if that was a side effect, what should she take, how long will that last, and is this normal. Caller clarifies that with the first one, her arm hurt bad, like achy. She never checked her lymph nodes then. The events were considered as non-serious. The outcome of the event was chills/cold chills reported as recovered on 12Apr2021 and other events were reported as recovering.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Memory impairment
Clinical narrative: mild confusion; memory issues; This is a spontaneous report from a contactable consumer (patient's daughter). A 96-year-old male patient received first dose of (BNT162B2) PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection) (Lot Number: Unknown) via intramuscularly on Left arm on 25Mar2021 16:00 (at age 96-year-old) as single dose for COVID-19 Immunization. Patient medical history and concomitant medications were unknown.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination.Patient experienced mild confusion, memory issues on unspecified date in Mar2021. He received the first dose of the vaccine three weeks ago at the hospital. Two-three days later after receiving the vaccine he had symptoms. He developed mild confusion that has not passed. This was very unusual for her father. It continues today. It was very sudden and abrupt. He had been waking up the last three weeks asking what the hell was he doing. Caller calls her father every morning to say good morning, He forgets that she had called and then he will call her. He had never done anything like this in the ten years of them living together. He had been confused 11-12 times in the past 19 days. He forgot about a big business that he had when he was younger. These were changes or memory issues that her farther has not had in his entire life. Caller stated that her father was scheduled to receive the second dose on Thursday. Caller was hesitant to have her father receive the second dose. Caller was asking what the maximum time for her father was to get the second dose as he has received it 3 weeks ago and experienced an unsolicited side effect. Treatment given to these events were unknown. Outcome of event mild confusion was not recovered and memory issues was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling hot, Gait disturbance, Pain in extremity
Clinical narrative: Minimal arm pain; chills; face and body on fire; extreme exhaustion; Slight fever; 90 yo gma in a walker could have passed me heading to the bathroom; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient previously received first dose of BNT162B2 on an unspecified date as SINGLE DOSE for covid-19 immunisation. The 2nd dose was in different arm than 1st. The patient experienced minimal arm pain. It was stated that "Today was a roller coaster of chills, then face and body on fire, accompanied by extreme exhaustion. Slight fever. 90 yo gma in a walker could have passed me heading to the bathroom. Hour 28, I feel like I am turning a corner. Temp down, and feel like I could now beat the 90 yo, but probably not a 75 yo." The outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Minimal arm pain; chills; face and body on fire; extreme exhaustion; Slight fever; 90 yo gma in a walker could have passed me heading to the bathroom; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient previously received first dose of BNT162B2 on an unspecified date as SINGLE DOSE for covid-19 immunisation. The 2nd dose was in different arm than 1st. The patient experienced minimal arm pain. It was stated that "Today was a roller coaster of chills, then face and body on fire, accompanied by extreme exhaustion. Slight fever. 90 yo gma in a walker could have passed me heading to the bathroom. Hour 28, I feel like I am turning a corner. Temp down, and feel like I could now beat the 90 yo, but probably not a 75 yo." The outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Influenza virus test, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever spike to 101.5.; This is a spontaneous report from a contactable consumer(patient).   A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, at age of 50 years old, administered in Arm Left on 05Apr2021 08:30 am (Lot Number: ER8727) at single dose for covid-19 immunisation.  Medical history included allergies: Sulfa Based.  There were no concomitant medications in two weeks.  The patient got Vaccine on 05Apr2021 started having fever 09Apr2021 03:00 PM. Fever spike to 101.5. Had Fever on 10Apr2021 and 11Apr2021. Body temperature returned to normal on 12Apr2021. Event resulted in Doctor or other healthcare professionaoffice/clinic visit. No treatment received for event. Patient had negative Covid test(Nasal Swab) on 11Apr2021 and negative Flu test on 12Apr2021. The patient was not diagnosed with COVID-19 prior to vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome for the event was recovering.   No follow-up attempts possible. No further information expected
Sex: M
Vaccine: COVID19
Symptoms: Gingivitis
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Apr2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient experienced a gum infection and asked if he can take amoxicillin in Apr 2021. The outcome was unknown. No follow up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches; This is a spontaneous report from contactable consumer(patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient experienced body aches on an unspecified date with outcome of unknown  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: arm sore; chills; she felt tired and weak; she felt tired and weak; headache; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Mar2021 as SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient received her 1st dose on 28Mar2021. She also mentioned that she felt arm sore, headache and chills for a few days now. Also, she felt tired and weak. The outcome was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Dyspnoea, Headache
Clinical narrative: Fever of 102, 101, 100; chills; body aches; headache; severe cough; Sore arm at injection; shortness of breath; This is a spontaneous report from a contactable consumer reporting for herself. A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EP7533/expiration date: not provided), via an unspecified route of administration, on 09Apr2021 at 09:45 (at the age of 63 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6204/expiration date: not provided), via an unspecified route of administration, on 12Mar2021 at 09:30 (at the age of 63 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included hypertension and hypothyroidism. The patient had known allergies to hydromorphone (DILAUDID). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was taking unspecified concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Apr2021 at 18:00, the patient experienced fever of 102, 101, 100, chills, body aches, headache, severe cough, sore arm at injection and shortness of breath. The patient did not receive treatment for the events and did not require hospitalization or a physician's visit. The outcome of the events fever of 102, 101, 100, chills, body aches, headache, severe cough, sore arm at injection and shortness of breath was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever of 102, 101, 100; chills; body aches; headache; severe cough; Sore arm at injection; shortness of breath; This is a spontaneous report from a contactable consumer reporting for herself. A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EP7533/expiration date: not provided), via an unspecified route of administration, on 09Apr2021 at 09:45 (at the age of 63 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6204/expiration date: not provided), via an unspecified route of administration, on 12Mar2021 at 09:30 (at the age of 63 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included hypertension and hypothyroidism. The patient had known allergies to hydromorphone (DILAUDID). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was taking unspecified concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Apr2021 at 18:00, the patient experienced fever of 102, 101, 100, chills, body aches, headache, severe cough, sore arm at injection and shortness of breath. The patient did not receive treatment for the events and did not require hospitalization or a physician's visit. The outcome of the events fever of 102, 101, 100, chills, body aches, headache, severe cough, sore arm at injection and shortness of breath was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Muscle aches; Headache; This is a spontaneous report received from a contactable consumer. This consumer reported for a patient of unspecified age and gender who received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported of fever, chills, muscle aches and headache. It was reported that events took place after use of the product. Outcome was unknown for all the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Ophthalmological examination, Pain in extremity
Clinical narrative: No other side effect apart from soreness in the arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable Health Care Professional and a contactable consumer (wife). A 68 years old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history included ocular hypertension (eye exam, performed on an unspecified date, showed increased eye pressure) and rheumatoid arthritis. Concomitant medications included oral tofacitinib citrate (XELJANZ) from Mar2020 and ongoing, 5 mg twice daily, for rheumatoid arthritis. On an unspecified date, after the vaccination, the patient experienced "no other side effect apart from soreness in the arm". Outcome of the event was unknown. No other information or dates provided.  No follow-up attempts are needed, information about lot number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test (nasal swab PCR): positive; covid test (nasal swab PCR): positive; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 02Feb2021 14:15 (Batch/Lot Number: EL3248) as single dose, and dose 1 intramuscular, administered in arm left on Jan2021 (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. On 09Apr2021, the patient had stuffy nose that worsened with cough and fatigue. On 10Apr2021, patient underwent covid test (nasal swab PCR): positive. Outcome of the events was recovering. Patient was not diagnosed with covid prior to vaccination.; Sender's Comments: Based on the information currently available, vaccination failure of the suspected vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a non-contactable consumer and a contactable nurse. A 41-year-old male patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), dose 1 intramuscular on 26Jan2021 at 06:15 AM (Lot Number: EL3248) as single dose, dose 2 intramuscular, administered in arm right on 16Feb2021 at 05:45 PM (Lot Number: EL3248) as single dose, both for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not have COVID-19 prior to vaccination. The patient experienced COVID-19 virus test positive (medically significant) on 05Apr2021 with outcome of recovering. Patient became ill on 04Apr2021 with symptoms of runny nose, sore throat, cough. The patient underwent lab tests and procedures which included COVID-19 PRC test (nasal swab): positive on 05Apr2021. The event required physician office visit. It was unknown if treatment was administered.  Follow-up attempts completed. No further information expected.; Sender's Comments: A causal relationship to the suspect drug cannot be excluded in the development of event drug ineffective. The event COVID 19 is assessed as unrelated to the suspect product. The general population is at increased risk for acquiring this infection in light of the current global pandemic, and provides the more likely explanation.