chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 03Feb2021 (at the age of 78-year-old) as a single dose for out of an abundance of caution/COVID-19 immunisation. The patient's medical history included muscle relaxer. Concomitant medication included methocarbamol (Strength: 500 mg) at 250 mg, as needed for muscle relaxer. The methocarbamol medicine was 500 mg, and she takes half which was 250 mg as needed, she took 250 mg the night of 03Feb2021. She has been using this medication for a couple of years now. Reporter was calling because she received the first dose of the vaccine about 22 hours ago and she was concerned about a side effect and she wanted to ask if this was a normal side, that side effect was dizziness, it just started about an hour ago on 04Feb2021. No investigation assessment. The outcome of the event was not resolved.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: Really high blood pressure after the second dose. When he exercised for 30min, he checked his blood pressure and it was 191/94; This is a spontaneous report from a contactable consumer (patient himself) via a medical information team. An 85-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation and experienced elevated blood pressure after the first dose. Patient to report that he experienced really high blood pressure after the second dose. Patient mentioned that he was on medications now. He also mentioned that when he exercised for 30 min, he checked his blood pressure, and it was 191/94. The event was considered as non-serious by the consumer. On an unspecified date, the patient underwent lab tests and procedures which included blood pressure: Really high blood pressure after the second dose, blood pressure: 191/94 (he also mentioned that when he exercised for 30 min, he checked his blood pressure, and it was 191/94). The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea really bad; This is a spontaneous report from a contactable consumer (patient's wife). A 95-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Consumer called on behalf of her husband who got the Pfizer COVID-19 Vaccine 2 days ago and now he has got diarrhea really bad. She was wondering was that really very normal to have diarrhea like that after the vaccine. He had diarrhea terribly bad all day yesterday until about midnight or 1-further clarification of timeline including '1' not able to be provided. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Rash
Clinical narrative: I have a rash on the sides of my arms and my legs and on parts of torso so it like raised bumps, red bumps; I have a rash on the sides of my arms and my legs and on parts of torso so it like raised bumps, red bumps; it was like dry skin and then the previous day it was the worst; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EL3248 and Expiration date: UNKNOWN), via an unspecified route of administration on 24Jan2021 as unknown, single dose for COVID-19 immunization (55 years old when vaccinated). Medical history of the patient included thyroid disorder. The concomitant medications included thyroid (ARMOUR THYROID) taken for thyroid disorder. The reporter stated that she had the vaccine on 24Jan2021 and everything was fine until the two couple of days, still persisting, she initially thought it was like dry skin and then the previous day it was the worst and it felt the same that morning. It was reported that the patient had a rash on the sides of arms and legs and on parts of torso so it like raised bumps, red bumps on 02Feb2021. Therapeutic measures were taken as a result of rash on the sides of my arms and my legs and on parts of torso so it like raised bumps, red bumps which included Allegra, allergy medication. The reporter stated she tried to get with Dermatologist, Allegra its Fexofenadine. The outcome of the event i have a rash on the sides of my arms and my legs and on parts of torso so it like raised bumps, red bumps was reported as not resolved and the outcome of the event it was like dry skin and then the previous day it was the worst was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: I got really sick, I threw up, I was vomiting and I was wondering if it is side effect; I got really sick, I threw up, I was vomiting and I was wondering if it is side effect; This is a spontaneous report received from a contactable consumer or other non hcp. A 70-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EI9264, Expiry Date: unknown) via an unspecified route of administration on 02Feb2021 as single dose for covid-19 immunisation. Medical history included High blood pressure  from an unknown date and unknown if ongoing and Diabetic from an unknown date. Upon probe, the patient confirmed that she received the first dose of the vaccine. The patient's concomitant medications were not reported. The patient experienced she received the vaccine (unspecified vaccine) on Tuesday the 2nd (Feb2021) and everything was fine but last night she got really sick, she threw up, she was vomiting, and she was wondering if it is one of the side effects, so what was going on. The patient did not received any treatment for the events. The clinical outcome of the event was unknown.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer. A 35-year-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EL1283; expiration date: 30Apr2021), via an unspecified route of administration, administered in Arm Left on 21Jan2021 at 14:00 as 1ST single dose for covid-19 immunization (at the age of 35-years-old). The patient had no medical history including any illness at time of vaccination and there were no concomitant medications. It was reported that after receiving the first dose of vaccine on 22Jan2021 the patient experienced sore arm for a couple of days. She did not have any pain the first day. Mentions her daughter only had a sore arm for a couple of days. The outcome of the event was recovered on 23Jan2021.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Nausea, Nervousness
Clinical narrative: weak; Dizziness; very nauseous; Nervous; This is a spontaneous report from a contactable .  A patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL3248, Expiration date: unknown), via intramuscular, administered in top of left arm on 23Jan2021 around 09:30am  as 1st dose, single for COVID-19 immunization. Second dose was due on 11Feb2021. The patient medical history and concomitant medications were not reported. On 02Feb2021, 9 days and 14 hours after the vaccination, the patient experienced very nauseous, weak, nervous, dizziness. The events are assessed as non-serious.  Mostly she feels weak and very strong nausea. Now and then she has dizziness, but it is mostly strong nausea and weakness. She thought it was an anxiety attack and she realized today it was probably a reaction to the vaccine. Patient declines any treatment taken. The outcome of the events was recovered in 2021.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: The person who gave me the injection said that there was just a drop of blood; I started to see a bruise around the area like a 2 inch bruise like sort of a purplish black and red; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration on 03Feb2021 (not clarified) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. At the time of vaccination, the patient had nothing on where the injection was, and it felt fine. The person who gave the injection said that there was just a drop of blood and was told to put a band aid. Patient saw nothing that evening and yesterday (on an unspecified date in Feb2021) started to see a bruise around the area like a 2 inch bruise like sort of a purplish black and red. This just came over yesterday. Patient enquired that something to worry about, something from the injection, the vaccine. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Laboratory test, Pain
Clinical narrative: Chills; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9261, NDC number, UPC and expiry date unknown), via an unspecified route of administration on 22Jan2021 (at the age of 51-year-old) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included hyperthyroidism, thyroid disorder both from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for thyroid disorder; esomeprazole magnesium (NEXIUM MUPS) taken for an unspecified indication and multivitamins taken for an unspecified indication, all start and stop date were not reported. It was reported that last night (on 04Feb2021), the patient got chills and body aches, she was just wondering if that was something that happened, after 2 weeks just wondering. Patient took some Tylenol for the events. The patient underwent unspecified lab test in Dec2020 with unknown results, but she did not have anything wrong with her. Events resolved in Feb2021. Investigation assessment was performed.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Full blood count, Investigation, Metabolic function test, Mononucleosis heterophile test
Clinical narrative: She might have had a tiny scratch in her throat a couple of days before onset of Fatigue/a tiny scratch or tickle in her throat; she may have gotten a little bit of her Rhinovirus; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL1283), via an unspecified route of administration, administered in Arm Left on 11Jan2021 as (at the age of 41-years-old) as a single dose for covid-19 immunisation at hospital. The patient had no medical history. Concomitant medications included ongoing metoprolol 12.5 mg, once daily for an unspecified indication (Been on it for years never had any trouble). The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. There was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. There were no adverse events following prior vaccinations. No family medical history relevant to adverse event. It was reported that patient might had a tiny scratch in her throat a couple of days before onset of Fatigue; but it was very minor. Pertinent Details: Her daughter had a little runny nose, so she was tested and was positive for Rhinovirus; not COVID; caller assumed that she may have gotten a little bit of her Rhinovirus, but she did not even develop stuffy nose; just a tiny scratch or tickle in her throat. The patient underwent lab tests and procedures which included on 04Feb2021 Chest X- ray: showed nothing; full blood count (CBC): all normal and Basic Metabolic Panel-test, Result: normal; Mono: negative; tested for any respiratory illnesses in her nose: none, all normal. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinovirus infection, Throat irritation
Clinical narrative: She might have had a tiny scratch in her throat a couple of days before onset of Fatigue/a tiny scratch or tickle in her throat; she may have gotten a little bit of her Rhinovirus; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL1283), via an unspecified route of administration, administered in Arm Left on 11Jan2021 as (at the age of 41-years-old) as a single dose for covid-19 immunisation at hospital. The patient had no medical history. Concomitant medications included ongoing metoprolol 12.5 mg, once daily for an unspecified indication (Been on it for years never had any trouble). The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. There was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. There were no adverse events following prior vaccinations. No family medical history relevant to adverse event. It was reported that patient might had a tiny scratch in her throat a couple of days before onset of Fatigue; but it was very minor. Pertinent Details: Her daughter had a little runny nose, so she was tested and was positive for Rhinovirus; not COVID; caller assumed that she may have gotten a little bit of her Rhinovirus, but she did not even develop stuffy nose; just a tiny scratch or tickle in her throat. The patient underwent lab tests and procedures which included on 04Feb2021 Chest X- ray: showed nothing; full blood count (CBC): all normal and Basic Metabolic Panel-test, Result: normal; Mono: negative; tested for any respiratory illnesses in her nose: none, all normal. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A little bit of a sore arm; This is a spontaneous report from a contactable consumer (Patient). This is the master case and one of the two reports.   A 69-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9263, expiration date reported as 202021), via an unspecified route of administration, administered in arm on 02Feb2021 (at the age of 69-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included a very inflamed sciatic nerve for which patient was taking ibuprofen and Tylenol and stopped prior vaccination. The patient concomitant medications were not reported. On an unspecified date, the patient experienced a little bit of a sore arm. The patient was having a very inflamed sciatic nerve and was taking Ibuprofen and Tylenol for it but read that patient needed to stop that prior and after the vaccination. So, patient did that because it interferes with something with immune system. Patient questioned when it was appropriate to resume taking those drugs (Tylenol or Ibuprofen) again. Patient was taking both of those drugs prior to the vaccination but stopped taking them because all advise said not to take them prior or after the vaccination because it would interfere with the vaccination to work, so now patient was trying to find out how long patient need to wait after the vaccination before resuming Tylenol. When asked to confirm the two drug Ibuprofen and Tylenol query, consumer stated as yes (Ibuprofen and Tylenol), Tylenol was an Aspirin medication another name for (Tylenol). Consumer was informed about Pfizer Medical Information Department. When asked if have any problems with vaccine, consumer stated absolutely none. The outcome for event little bit of a sore arm was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Sleep disorder
Clinical narrative: After the 2nd shot, she felt chills, her arm is nowhere near as sore, she felt tired but could not sleep all night long; After the 2nd shot, she felt chills, her arm is nowhere near as sore, she felt tired but could not sleep all night long; After the 2nd shot, she felt chills, her arm is nowhere near as sore, she felt tired but could not sleep all night long; her arm is nowhere near as sore; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age (Age:76, Unit: unknown) received BNT162B2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date 2nd dose, single for covid-19 immunization. Patient previously received BNT162B2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: unknown, Expiration date: unknown), via unspecified route on unspecified date at a 1ST DOSE, SINGLE, for COVID-19 immunization and after the 1st shot her arm got really sore, could not sleep that night. Medical history included insomnia from an unknown date and unknown if ongoing. The patients concomitant medications were not reported. On an unspecified date patient experienced events after the 2nd shot, she felt chills, her arm was nowhere near as sore, she felt tired but could not sleep all night long. She tried treatment with Melatonin and Benadryl but it 'worked backwards' on her. Reporter would like to know if the covid vaccine is known to keep one from sleeping and would like to know if her not being able to sleep would prevent the covid vaccine from working. Reporter would like to know if her side effects would prevent the covid vaccine from working. Outcome of all events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore; This is a spontaneous report from a contactable consumer (patient). 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), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history concomitant medications were not reported. On an unknown date, patient experienced arm was sore. The outcome of the event was unknown.   Follow-up attempts are completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Arthralgia, Chills, Confusional state, Flank pain
Clinical narrative: Recent memory loss; Slight confusion; Pain in the hip and right flank; chills; Difficult for her husband to walk; Pain in the hip and right flank; This is a spontaneous report from a contactable nurse (patient's wife). A 87-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported.The reporter stated that, patient have received the vaccine last Friday and reported that patient experienced symptoms as chills, pain in the hip and right flank, slight confusion (which was new), and recent memory loss. She stated that it was difficult for her husband to walk and was still experiencing pain in his hip, but his movement had improved a little today. The patient did not had these symptoms before the vaccine and wanted to know if their symptoms are related to the vaccine. The outcome of the events difficult for her husband to walk was recovering and the outcome of other events were unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: Recent memory loss; Slight confusion; Pain in the hip and right flank; chills; Difficult for her husband to walk; Pain in the hip and right flank; This is a spontaneous report from a contactable nurse (patient's wife). A 87-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported.The reporter stated that, patient have received the vaccine last Friday and reported that patient experienced symptoms as chills, pain in the hip and right flank, slight confusion (which was new), and recent memory loss. She stated that it was difficult for her husband to walk and was still experiencing pain in his hip, but his movement had improved a little today. The patient did not had these symptoms before the vaccine and wanted to know if their symptoms are related to the vaccine. The outcome of the events difficult for her husband to walk was recovering and the outcome of other events were unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Both of them had an immediate reaction which is "a little arm pain"; Red blotch below the injection site/ red blotch is 4-5 inches long, and 3 inches wide. It is warm to  the touch; Red blotch below the injection site/ red blotch is 4-5 inches long, and 3 inches wide. It is warm to  the touch; This is a spontaneous report from a contactable consumer. This consumer reported for a Female patient (Mother).   A 93-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 29Jan2021, as a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy, allergies: Neosporin, and allergic to sulfa. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization and they both doses had an immediate reaction which was "a little arm pain" and it's already gone, and they weren't concerned about it already. A couple of days after (no date specified), the patient developed a red blotch below the injection site. The red blotch was 4-5 inches long, and 3 inches wide. It was warm to the touch. It has been a week now, and they said it was not going away. The patient concerned about the blotch on her arm. It was a couple of inches below the injection site. The patient said the blotch didn't hurt. She would just like to get over to medical information to ask them. She didn't feel like it was a life-or-death situation so she would just like more information. She said that it was raised and didn't hurt but warm to the touch. She wanted to know if there a have been reports about this in the clinical trials. She wanted to know if it was in the Pfizer vaccine. Outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash to the tops of her hands, the inside of her wrists, tops of her feet, and a big splotch on her ankle; This is a spontaneous report from a contactable consumer or other non hcp.    A 49-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Right on 01Feb2021 11:00 as 1ST dose, single for covid-19 immunisation. Medical history included osteoarthritis from 2019 to an unknown date, major depression from 2000 to an unknown date, arthritis. Concomitant medication(s) included prednisone (PREDNISONE) taken for arthritis. Consumer stated she had her first dose of the Pfizer COVID-19 vaccine on Monday morning, and this morning she had a rash to the tops of her hands, the inside of her wrists, tops of her feet, and a big splotch on her ankle and also having any difficulty in breathing, but she is wondering if she can take an antihistamine and monitor the rash. but sometimes she took Prednisone 10mg for inflammation of arthritis, and she was taking it before she got the vaccine then discontinued for two days after the vaccine, then resumed. The outcome of the event was unknown.   Follow-up attempts are completed. No further information Is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on body; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL3246; Expiration Date: Apr2021), dose 1 via unspecified route of administration in the Left Arm on 26Jan2021 at 09:00 (at the age of 57 years old) as a 1ST DOSE, SINGLE DOSE for COVID-19 immunization (does not want to get covid, as reported) Pharmacy/Drug Store. The patient medical history was none. Patient did not have other Products. Patient was unable to provide the NDC or dose of Covid-19 vaccine given. No other vaccines given the same day or 4 weeks prior. Patient also never had a problem with vaccines in past. On Unspecified date in Feb2021 the patient experienced about 4-5 days later (On Feb2021) she developed a rash on her body and went to see the doctor. Was told to call and report this and gave the lot number. She guesses she can't get the next vaccine. Stated provider did not recommend her getting the second one. Since she was concerned about Covid she wanted to know if she can even take other shots again with this vaccine. It was reported that, Still has rash (date unspecified) but it is going away and almost gone. Event did not require a visit to Emergency Room but visited Physician Office. No relevant tests were performed. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever; chills; headache; body aches; This is a spontaneous report from a contactable consumer or other non-health care professional. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got first Pfizer vaccine in morning and was told by the person giving her the vaccine, she should not take any Tylenol. Reporter states she took a Tylenol earlier that morning, around 8:30. Now she was worried about the effectiveness of the vaccine she received and asked whether it was ok to take Tylenol. The patient experienced fever, chills, headache, and body aches on an unspecified date. Reporter was asking if she should assume if she was not getting symptoms after the vaccine it was not working on her and whether everyone have some side effects after the vaccine. What about the variants that are showing up, whether the Pfizer vaccine work on those also. The outcome of the events was unknown. Information on Lot/Batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Nausea
Clinical narrative: body aches; Dizziness; Nausea; loss of appetite; chills; fatigue; itching; This is a spontaneous report from a contactable consumer or other non hcp. A 22-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: unknown; Expiration Date: unknown), via an unspecified route of administration, administered in Arm Right on 28Jan2021 (22-year-old at the time of vaccination), as a single dose for covid-19 immunization. The patient's medical history included non-sustained ventricular tachycardia diagnosed at birth, pacemaker and defibrillator. The reporter stated that her son has a serious heart condition, pacemaker/defibrillator- first was in 6th grade, currently on his fourth and drug hypersensitivity states they monitored them both longer than the 15 minutes because they have a history of serious allergic reactions to ACE inhibitors. The patient's concomitant medications were not reported. The patient continues taking his low dose aspirin prior to the vaccine but did not take any Tylenol. On 28Jan2021, the patient experienced dizziness, nausea, loss of appetite, chills, body aches, fatigue, and itching. The outcome of all the events was recovered on 29Jan2021.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: body aches; Dizziness; Nausea; loss of appetite; chills; fatigue; itching; This is a spontaneous report from a contactable consumer or other non hcp. A 22-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: unknown; Expiration Date: unknown), via an unspecified route of administration, administered in Arm Right on 28Jan2021 (22-year-old at the time of vaccination), as a single dose for covid-19 immunization. The patient's medical history included non-sustained ventricular tachycardia diagnosed at birth, pacemaker and defibrillator. The reporter stated that her son has a serious heart condition, pacemaker/defibrillator- first was in 6th grade, currently on his fourth and drug hypersensitivity states they monitored them both longer than the 15 minutes because they have a history of serious allergic reactions to ACE inhibitors. The patient's concomitant medications were not reported. The patient continues taking his low dose aspirin prior to the vaccine but did not take any Tylenol. On 28Jan2021, the patient experienced dizziness, nausea, loss of appetite, chills, body aches, fatigue, and itching. The outcome of all the events was recovered on 29Jan2021.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: he (and his wife) only experience sore arm; This is a spontaneous report from a contactable consumer (reporter's wife).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 23Jan2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced he (and his wife) only experience sore arm on an unspecified date with. Reporter had antibody test done after 1st dose and results are negative.  He was asking for information about antibody testing and if he should be concerned the vaccine is not working properly since he read after 1st dose of vaccine, he should have approximately 50 percent protection. Caller mentions that his mother who is in her 70's received Moderna vaccine and experienced fatigue, achy all over the place. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia oral, Swollen tongue
Clinical narrative: Tingling tongue; Numbness of circle all over my mouth; Numbness is medically up my jaw line/Numbness went like from my chin to top of my head; My tongue like swelling; Tingling back in the tongue; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247 and expiration date was reported) second dose via an unspecified route of administration on 27Jan2021 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number was not reported and expiration date was30Apr2021) first dose via an unspecified route of administration on unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. On 27Jan2021 evening Patient got a tingling in the tongue, numbness of circle all over my mouth which then it went up my jawline. Patient took a Benadryl but it subsides still there and ended up going to urgent care because of tongue like swelling. And doctor advised to continue with the Benadryl. And that was on Saturday. Further patient added Now yesterday continue Benadryl last Saturday to Monday of this week through February first. And side effects subside, yesterday all sudden I got a tingling back in the tongue. And numbness went like from my chin to top of my head. While patient further questioned what he was supposed to do with side effects.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Weight
Clinical narrative: her friend has been freezing since receiving her second COVID-19 Vaccine dose/cold; stated her friend experienced terrible chills after receiving her second COVID-19 Vaccine dose; This is a spontaneous report from a contactable consumer reported for a female patient (friend).  A female patient of unspecified age received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number& Expiry date not reported) via unspecified route of administration on 03Feb2021 as single dose for COVID-19 Immunization. Patient medical history and concomitant medications not reported. Historical vaccine included, Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number& Expiry date not reported) via unspecified route of administration on Jan2021 as single dose for COVID-19 Immunization. On 03Feb2021, Patient had been freezing and experienced terrible chills since receiving her second COVID-19 Vaccine dose. The patient reported freezing since receiving their second COVID-19 Vaccine dose. The reporter reported that her friend experienced terrible chills and cold, but no nausea. Patient underwent lab test and procedures include weight about 160-165 lbs. The reporter stated that she lost a lot of weight recently. The outcome of events were unknown.  Information about lot/batch number has been requested.  Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Investigation, Lymphadenopathy, Mammogram, Neck injury
Clinical narrative: swollen and enlarged lymph nodes; she is having some trouble swallowing and her throat feels "kind of swollen"; she is having some trouble swallowing and her throat feels "kind of swollen"; she noticed a bump on her neck/bump got larger, more painful; she noticed a bump on her neck/bump got larger, more painful; This is a spontaneous report from a contactable reporter (patient) other hcp via Medical Information Team  A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Left arm on 26Jan2021 as DOSE 2 for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. On Jan2021 the patient experienced swollen and enlarged lymph nodes specifically on the left supraclavicular side, just above left clavicle,  patient noticed bump on her neck, in which the side effects became worse bump got larger, more painful, and red, she was having some trouble swallowing and her throat feels kind of swollen.The patient underwent lab tests and procedures which included investigation: two lymph nodes in neck level 5b were found, two lymph nodes in neck level 5B were found. These lymph nodes appear rounded, hypoechoic, largest 1.2cm. Additional smaller node with some internal debris measuring up to 4 mm in level 5B was found as well, mammogram three large lymph nodes under arm in axilla, but the largest was measured at 20 x 17 mm on the left side.Caller stated that she had the diagnostic ultrasound for preexisting lymph nodes that were small but appeared to have increased in size when examined. Caller states prominent lymph nodes in left axilla measuring up to 7 mm. Caller reports from the mammogram results, a complicated cyst measuring at 7x3x3 mm at the 2 o'clock position on the left breast, as well as a cluster of cysts measuring 6x2x6 mm at the 3 o'clock position on the left breast. Caller states that results indicate 3 large probably benign, nodes. She was instructed to follow up in 3 months but believes she will follow up sooner due to the pain she was experiencing. Outcome of events was unknown.    Information about lot/batch has been requested  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Rash papular
Clinical narrative: swollen and enlarged lymph nodes; she is having some trouble swallowing and her throat feels "kind of swollen"; she is having some trouble swallowing and her throat feels "kind of swollen"; she noticed a bump on her neck/bump got larger, more painful; she noticed a bump on her neck/bump got larger, more painful; This is a spontaneous report from a contactable reporter (patient) other hcp via Medical Information Team  A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Left arm on 26Jan2021 as DOSE 2 for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. On Jan2021 the patient experienced swollen and enlarged lymph nodes specifically on the left supraclavicular side, just above left clavicle,  patient noticed bump on her neck, in which the side effects became worse bump got larger, more painful, and red, she was having some trouble swallowing and her throat feels kind of swollen.The patient underwent lab tests and procedures which included investigation: two lymph nodes in neck level 5b were found, two lymph nodes in neck level 5B were found. These lymph nodes appear rounded, hypoechoic, largest 1.2cm. Additional smaller node with some internal debris measuring up to 4 mm in level 5B was found as well, mammogram three large lymph nodes under arm in axilla, but the largest was measured at 20 x 17 mm on the left side.Caller stated that she had the diagnostic ultrasound for preexisting lymph nodes that were small but appeared to have increased in size when examined. Caller states prominent lymph nodes in left axilla measuring up to 7 mm. Caller reports from the mammogram results, a complicated cyst measuring at 7x3x3 mm at the 2 o'clock position on the left breast, as well as a cluster of cysts measuring 6x2x6 mm at the 3 o'clock position on the left breast. Caller states that results indicate 3 large probably benign, nodes. She was instructed to follow up in 3 months but believes she will follow up sooner due to the pain she was experiencing. Outcome of events was unknown.    Information about lot/batch has been requested  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Diarrhoea, Dizziness
Clinical narrative: join pain; Difficulty breathing; fast heartbeat; dizziness; weakness; chills; diarrhea; nausea; vomit; tiredness; headaches; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 66-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 27Jan2021 12:30 as 1st dose, single (age at vaccination 66-years) for COVID-19 immunization. Medical history included depression and parkinsons disease from an unknown date and unknown if ongoing. Concomitant medications included donepezil hcl 5mg, sertraline hcl 50mg, and carbidopa taken for an unspecified indication, start and stop date were not reported (medications in two weeks before vaccination). The patient was not had Covid prior vaccination, and the test was not performed post vaccination. The patient did not take any other vaccine in four weeks. Patient stated that 4 days after her first dose (31Jan2021 12:00am) she felt tiredness and headaches. The next day (01Feb2021), patient had chills, diarrhea, nausea and vomit a lot until was dehydrated. On 04Feb2021 12:00am, the patient had difficulty breathing, a fast heartbeat, dizziness, weakness and joint pain. Patient thought she was going to die and she did not go to the emergency room because she really do not want to get die there. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The treatment was received for the adverse events. Adverse event treatment given with pedialyte to get hydrated. The patient underwent lab tests and procedures which included heart rate increased: fast on 04Feb2021. The vaccination facility type was reported as hospital. . The clinical outcome of the events was reported as recovering.  Information about lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Heart rate increased, Nausea
Clinical narrative: join pain; Difficulty breathing; fast heartbeat; dizziness; weakness; chills; diarrhea; nausea; vomit; tiredness; headaches; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 66-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 27Jan2021 12:30 as 1st dose, single (age at vaccination 66-years) for COVID-19 immunization. Medical history included depression and parkinsons disease from an unknown date and unknown if ongoing. Concomitant medications included donepezil hcl 5mg, sertraline hcl 50mg, and carbidopa taken for an unspecified indication, start and stop date were not reported (medications in two weeks before vaccination). The patient was not had Covid prior vaccination, and the test was not performed post vaccination. The patient did not take any other vaccine in four weeks. Patient stated that 4 days after her first dose (31Jan2021 12:00am) she felt tiredness and headaches. The next day (01Feb2021), patient had chills, diarrhea, nausea and vomit a lot until was dehydrated. On 04Feb2021 12:00am, the patient had difficulty breathing, a fast heartbeat, dizziness, weakness and joint pain. Patient thought she was going to die and she did not go to the emergency room because she really do not want to get die there. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The treatment was received for the adverse events. Adverse event treatment given with pedialyte to get hydrated. The patient underwent lab tests and procedures which included heart rate increased: fast on 04Feb2021. The vaccination facility type was reported as hospital. . The clinical outcome of the events was reported as recovering.  Information about lot/batch number has been requested.