chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: After the first shot I had very mild symptoms, minor injection site soreness; a little tired/fatigue; This is a spontaneous report from a contactable consumer. A male patient of an unknown age received bnt162b2 (BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unknown date for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient stated that he'd gotten the second Pfizer covid vaccine yesterday. Per the patient, "I didn't feel anything more than a mosquito bite sensation when I got the second shot. After the first shot I had very mild symptoms, minor injection site soreness and a little tired. I've had the shingles and flu vaccines and with those I had mild to no symptoms. He got the first vaccine and just had mild symptoms such as injection site soreness and fatigue the following day a little bit. On the second day, he also had this and that was about it. On second shot that he got two days ago, it was pleasant. The injection was like a mosquito bite. He told the nurse that gave it that she was very good. He was at home yesterday expecting to feel something and he has not had any side effects. Outcome of the events was unknown.  Information on batch/lot number was requested. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This is a spontaneous report from a non-contactable consumer (patient). This adult male patient reported that received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number:), via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: Unknown) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination. It was unknown if patient COVID tested post vaccination. On an unspecified date, the patient experienced chills and headache. It was unknown if the patient received any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number could not be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Pain
Clinical narrative: she didn't feel well; woke up with aches and pains; she is also a little tired; she began having a headache; This is a spontaneous report from a contactable consumer and via Regulatory Authority. This 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Feb2021 (at the age of 73-year-old) at dose 2, single for COVID-19 vaccination. Medical history included migraines. Concomitant medication was not reported. It was reported that she received her second dose of the covid vaccine yesterday. She was experiencing a headache this morning (12Feb2021) and took 15 mg of Ibuprofen. The consumer said that she is generally healthy adult on no medications other than for occasional migraines. She says she walk 4-5 miles every day but did not today because she didn't feel well. She says she got her second dose of the COVID-19 vaccine yesterday on the 11th and today (12Feb2021), she woke up with aches and pains. She is a migraine person, and her doctor told her she could take Advil and Imitrex after it, which she has only took Advil, but she wanted to hear from the company that she could take Imitrex. She clarifies that she took two Ibuprofen at 06:00 AM today for her aches and pains which worked great, but she still has a headache and she is worried about it escalating into a migraine. She says that she is also a little tired. Caller says after her first dose of the vaccine she had no reaction whatsoever. The therapeutic measures were taken in response to the events aches and pains and headache. Outcome of the event headache was not recovered and for other events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: The past weekend I had a gout/Gout attack; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable 76-year-old male physician (patient) reported that he received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 22Jan2021 (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications were not reported. The patient was retired orthodontist stated, "I've had both doses of the Pfizer vaccine, my last dose was Wednesday 10Feb2021 (22Jan2021 was my first dose). He had his second dose of the covid vaccine on Wed 10Feb2021. His first dose was on 22Jan2021. The past weekend I had a gout attack. On Monday 08Feb2021 gout attack, I took 3 tablets of indomethacin 50mg during the days three times a day an anti-inflammatory and states it depresses t cells. He took no medicine on Tues, Wed, or Thurs. He was asking if there is a diminished response or efficacy to the vaccine if taking indomethacin. He was asking if he can he take more indomethacin. He was an orthodontist. On Tuesday, Wednesday, Thursday the patient took no medicine. Indomethacin was an anti-inflammatory and suppresses T-Cells, what was the interactions and the vaccine? The patient was able to take the indomethacin at this time, gout was attacking up a little bit. I want the ability to take it if it's gets worse? How long would it take generally for 2nd dose antibody titer to show up? What testing was available if it would be appropriate?" The patient stated on 08Feb2021 he took Indomethacin 3 - 50mg tabs, on 10Feb2021 received his second dose of the covid-19 vaccine, wondering if he can take the medication today, caller states he has not taken that medication in about 4 years. Therapeutic measures were taken as a result of the event. The outcome of the event was unknown.   Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Thoracic outlet syndrome
Clinical narrative: Thoracic Outlet Syndrome; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable other healthcare professional reported that a 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on an unknown date as DOSE 2, SINGLE for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route on an unknown date as dose number unknown, single for an unknown indication. Patient received the second dose of Covid 19 vaccine and she said she has thoracic outlet syndrome, she was receiving Botox injection in her shoulder and lower back. Asking if there is any amount of time before receiving the Botox and after receiving the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Super painful / burning hot Diarrhea. It's almost as if I ate a massive bowl of habanero chili peppers.; This is a spontaneous report from a contactable consumer (patient). This 30-year-old male patient reported that he received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 at 09:00 (Lot Number: EM9809, Age at vaccination: 30-years) as dose 1, single for COVID-19 immunisation. Medical history included obesity and smoking. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. On 12Feb2021 at 12:00 PM, the patient experienced super painful / burning hot Diarrhea. It's almost as if I ate a massive bowl of habanero chili peppers. No treatment received for the adverse event (AE). The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.  Follow-up (15Apr2021): Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: soreness in arm and a little achy; slight headache; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a 77-year-old male patient (husband). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247; Expiration Date: 31May2021), dose 1 via an unspecified route of administration, administered in arm left on 23Jan2021 (at the age of 77 years), as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included 10-year lung cancer survivor, in remission/cancer (the patient had many complications from that, he was not released from the hospital in Nov2019; After surgery he had been just a mess, just sits on couch. But taking ADVIL does help) from an unknown date and unknown if ongoing, open heart surgery in Jul2019 (prior to the lockdown) to an unknown date, high blood pressure from an unknown date and unknown if ongoing, diabetes from an unknown date and unknown if ongoing, shingles from an unknown date and unknown if ongoing (all before the vaccination). Concomitant medications included ibuprofen (ADVIL) and oxycodone hydrochloride, paracetamol (PERCOCET); taken both for pain from chemo (takes ADVIL daily/due to his condition, because he suffered from pain from chemo, his "PCP tells him he can take up to 6 ADVIL a day when needed and up to 4 PERCOCET a day as needed"), start and stop date were not reported. Reportedly, the patient had minimal side effect post the first injection with the PFIZER-BIONTECH COVID-19 VACCINE. Reporter stated her husband attempted to limit his PERCOCET intake to one a day while using the ADVIL to compensate (tried to not take PERCOCET because he tried not to take narcotics and relies heavily on ADVIL per doctor) and it was mentioned that he can take ADVIL. She mentioned her mother who received the MODERNA COVID-19 vaccine was told "not to take TYLENOL and ADVIL before and after vaccination". She said her husband was due for his second dose of the Pfizer-BioNTech vaccine unspecified date (tomorrow). The patient had minimal side effects from 1st dose, had soreness in arm and a little achy; and had slight headache on unspecified date. Reporter expressed her concern on a potential interaction between the vaccine and the pain medication and asked if her husband could take ADVIL and asked if he stops the pain medication tomorrow, "will it reduce the potential lowered response to the vaccine". Reporter explained that she was unable to reach primary health care provider (PCP) and needed an answer as to whether her husband should stop or continue his medication and asked was it worst for her husband to stop his pain medication today and tomorrow and be in pain". Reported serious was none. The clinical outcome of the events was unknown at the time of report. Follow-up attempts are completed. No further information is expected.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Polyuria
Clinical narrative: excessive urination since then.; This is a spontaneous report from a contactable consumer (patient daughter). A 90-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration on 09Feb2021 (Age at vaccination: 90-years-old) as dose 1, single for covid-19 immunization. Medical history included legs swell up (She said he started it many years ago), heart surgery (probably 3-4 years ago, She clarified her father said it was 10 years ago). Concomitant medication included ongoing furosemide taken for an unspecified indication from an unspecified start date and He was on water pills she did not know if that counts. He was taking 5 different pills per day. It was reported that patient received the first dose of the Pfizer Covid vaccine on 09Feb2021 and has been experiencing excessive urination since then. She wants to know if that was associated with the vaccine. It was reported that patient daughter stated as soon as he got the shot he peed 3 times immediately, as soon as he got home. It was still ongoing he has been on the toilet since around 10 am and he has not moved from getting off the toilet. She was not sure whether to call an ambulance. She called his doctor and he said to go to an urgent care center but she cannot get him there. She says it seems to be getting less. It was reported that Furosemide: His doctor prescribed it she does not know why, his legs swell up. She said he started it many years ago after his heart surgery probably 3-4 years ago. She clarified her father said it was 10 years ago and he has been taking it daily ever since. The patient has a second dose scheduled for 06Mar2021. The outcome for the event was reported as not resolved at the time of this report.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Feeling abnormal, Hypertension, Influenza like illness
Clinical narrative: Feeling a little bad; Palpitations; Blood pressure elevated; Just felt weak; Flu-like symptoms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 11Feb2021 15:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Pacemaker (She mentioned she has a pacemaker). The patient's concomitant medications were not reported. Patient received the Pfizer-BioNTech COVID-19 Vaccine first dose on 11Feb2021. She reported she did not have any problems 11Feb2021 or this morning (12Feb2021), mentioned she had a pacemaker, " She reported feeling a little bad; palpitations; blood pressure elevated; just felt weak " at around 2 o'clock today (12Feb2021 14:00). She was wondering if those events were side effects of the Pfizer COVID-19 Vaccine or just flu-like symptoms. The patient underwent lab tests and procedures which included blood pressure: elevated on 12Feb2021. The clinical outcome of the events was not recovered at the time of report.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Feeling a little bad; Palpitations; Blood pressure elevated; Just felt weak; Flu-like symptoms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 11Feb2021 15:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Pacemaker (She mentioned she has a pacemaker). The patient's concomitant medications were not reported. Patient received the Pfizer-BioNTech COVID-19 Vaccine first dose on 11Feb2021. She reported she did not have any problems 11Feb2021 or this morning (12Feb2021), mentioned she had a pacemaker, " She reported feeling a little bad; palpitations; blood pressure elevated; just felt weak " at around 2 o'clock today (12Feb2021 14:00). She was wondering if those events were side effects of the Pfizer COVID-19 Vaccine or just flu-like symptoms. The patient underwent lab tests and procedures which included blood pressure: elevated on 12Feb2021. The clinical outcome of the events was not recovered at the time of report.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Weight
Clinical narrative: my arm was sore.; 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 COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 16:00 as dose 1, single (age at vaccination 73-year-old) for covid-19 immunization. Medical history included none. There were no concomitant medications. The patient did not take prior Vaccinations (within 4 weeks). On04Feb2021, the patient experienced my arm was sore. It was reported that, "They gave me the shot, 15 minutes later I went to the car and my arm was sore. That night the pain went down to my elbow, it is tender down there, during the night when I was asleep my whole arm hurts, I cannot lift, cannot make twist motion, anything. It's just painful." They had the shot for Pfizer's COVID 19 vaccine and his wife has had trouble with her arm since the shot last Thursday, she can't pick up anything or pull without hurting. Patient stayed for 15 minutes fine, her arm didn't hurt, she left and got in the car, that day, she couldn't say what time, her arm started hurting, to lift, she thought it was no big deal, and it seems to be getting worse. She sleeps and rolls over and goes to lift her arm and it wakes her. It's just, she would probably think it was the weather, if not for when it started, it's really cold now, but it's not the weather. States it didn't hurt at all. She felt it going in and when it started and the 15 minutes until the timer went off, she was fine. She has not been to the doctor in quite a while and is fine. This has been a long time, she thought it would stop, it is not getting better, it's more annoying, it does hurt, only when she moves or lifts her purse or something or goes to pull up her pants. The patient was scheduled for second dose 24Feb2021. The patient underwent lab tests and procedures which included weight: 117-120 lbs on an unknown date. The outcome for event was not recovered.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Still swollen, painful glands/lymph; Still swollen, painful glands/lymph; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient non-pregnant of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 06Feb2021 16:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took sulfa drugs and experienced allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 15Jan2021 04:30 PM (Batch/Lot Number: was not reported) for covid-19 immunisation. On 06Feb2021 20:00 the patient experienced Still swollen, painful glands/lymph nodes, a week after vaccination. The clinical outcome of the events was not recovered at the time of vaccination.  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: Fatigue
Clinical narrative: Tiredness; This is a spontaneous report from a non-contactable consumer. This female consumer reported that.  An unspecified age adult female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Feb2021 as single dose, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. It was Unknown if patient received other vaccine in four weeks and Other medications in two weeks. It was reported that it was unknown if patient was pregnant at the time of vaccination. The patient experienced tiredness on Feb2021. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/Batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: tiredness; headache; Fever of 100.5f approx; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EN5318), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 09:45 as DOSE 2, SINGLE for covid-19 immunisation (Age at vaccination 48 years). Medical history included food allergy (red meat allergy (alpha-gal). The patient's concomitant medications were not reported. Historical vaccine includes dose 1 bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number not reported) on 27Jan2021. No covid prior vaccination. No covid tested post vaccination. On 16Feb2021 16:00 (6 hours after vaccination) patient experienced tiredness, headache, fever of 100.5f approx. persists 24 hours after vaccination. The patient underwent lab tests and procedures which included body temperature: 100.5 fahrenheit on 16Feb2021. No treatment was received as result of event. Could you kindly confirm the first awareness date of adverse events since discrepant information provided? It was filled that AE start date is 16Feb2021, while PRD was 17Feb2021. Response: Date confirmed. Complete recovery as of 19Feb2021. The outcome of all event was recovering.  Follow-up (24Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding awareness date. The response included:  Follow-up (03Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding awareness date of adverse events. The response included:  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Rib fracture
Clinical narrative: tripped over a speed bump and was taken to ER and given Naproxen for a broken rib; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of an unspecified age received bnt162b2 (BNT162B2, Pfizer-BioNTech COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient was walking into the hospital for her 2nd dose of the COVID vaccine and tripped over a speed bump and was taken to Emergency room and given Naproxen for a broken rib. Caller then went and took her 2nd dose and is now hearing that Naproxin could decrease the efficacy of the Covid vaccine. Relayed information and transferred. Faxing to Pfizer for AE that she tripped after getting first covid shot from Support CEP 159558. The outcome for event rib fracture was unknown. Treatment was received as result of AE includes emergency room visit and treated with Naproxen. The outcome for event rib fracture was unknown.  Information on the lot/ batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain, Pruritus
Clinical narrative: I had a large raised red bump on my arm at the injection site. Bump was sore and a little bit itchy; I had a large raised red bump on my arm at the injection site. Bump was sore and a little bit itchy; I had a large raised red bump on my arm at the injection site. Bump was sore and a little bit itchy; This is a spontaneous report from a contactable consumer (patient, self-reported). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on an unspecified date in Jan2021 at 09:00 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history was not reported. Concomitant medications included ethinylestradiol, norethisterone (ALYACEN) and venlafaxine. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not received any other vaccine in four weeks. On 04Feb2021 at 09:00 PM, about a week after vaccination I had a large raised red bump on my arm at the injection site. Bump was sore and a little bit itchy. Went away after a few days. She noticed the reaction on 04Feb2021 but at the time she thought she had just been bitten by something since it had been a week since her injection. She didn't realize it was related to her vaccine until she saw an article about "covid arm" on 17Feb2021 and realized that's what it was on that date. The patient did not received any treatment for the events. Outcome of the events was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Choking sensation, Pharyngeal swelling
Clinical narrative: choking sensation in her throat; throat was swollen; This is a spontaneous report from a contactable consumer (patient herself). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EM9810; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 11Feb2021 12:00 (at age of 74-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included hypertension, diabetes mellitus; diagnosed 7 years ago and asthma; diagnosed several years ago from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had not history and other products. Family medical history was none. AE following prior to vaccinations was none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as no previous. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, patient had received her first injection of the Pfizer-BioNTech vaccine on 11Feb2021. Later that night on 11Feb2021 she experienced a choking sensation in her throat. An Emergency Medical Technician told her to take Benadryl, which she did for two days, but the Benadryl did not work. The consumer then went to her doctor who determined her throat was swollen. The doctor prescribed a steroid for her to take. However, the consumer was continuing to experience the choking sensation. The consumer reported a history of receiving allergy shots and if she receives them undiluted, she experiences a choking sensation as well, but treatment with Benadryl has helped that in the past. The doctor said she was not choking but she has a sensation there like something was caught in her throat. She did not have a dose, lot or expiration for Benadryl. She did not have a name of the steroid, manufacturer, dose, lot or expiration. Therapeutic measures were taken as a result of adverse events as patient had receive benadryl and steroid injection. No relevant test was reported. The outcome of both events was unknown.  Follow up (15Mar2021): This follow up contains no new medically significant information.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: headache; got tickle in her throat, then turned into cough with congestion; got tickle in her throat, then turned into cough with congestion; tickle in throat; This is a spontaneous report from a contactable consumer or other non hcp. A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration in Arm Left on 12Feb2021 (age at vaccination 55years old) as single dose for covid-19 immunisation. Medical history reported none. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not re-ported) via an unspecified route of administration on unspecified date (age at vaccination 55years old) as single dose for covid-19 immunisation. There were no concomitant medications. On 16Feb2021 the patient experienced headache and got tickle in her throat, then turned into cough with congestion on 15Feb2021. The clinical course was reported as she got the second dose of Pfizer Covid vaccine on 12Feb2021, 15Feb2021, got tickle in her throat, then turned into cough with congestion, yesterday evening got a slight headache. Wants to know if these are normal side effects after the second dose. She had no issues with her first dose of the vaccine. The clinical out-come of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Chills, Headache, Malaise
Clinical narrative: chills; She said her fever was as high as 104 degrees on Saturday; Nausea; Headache; said she got very ill; Dry heaves; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9263, NDC number, expiry date was reported as unknown) via an unspecified route of administration on 22Jan2021 at approximately 14:00 (at the age of 69-years-old) in left arm as a single dose for covid-19 immunization. Medical history (including any illness at time of vaccination) included thyroid disorder and gastroesophageal reflux disease for years from an unknown date and unknown if ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, prior vaccinations (within 4 weeks), adverse events following prior vaccinations were reported as none. Family medical history relevant to adverse events was not reported. Concomitant medications included thyroid and acid reflux medication for years, start date and stop date were not reported. The patient received her first Pfizer covid-19 vaccine on 22Jan2021 at approximately 14:00, she got very ill that night. She said she woke up at 4:00 on 23Jan2021, with chills, fever as high as 104 degrees, nausea, and headache. She had read to take a Tylenol and drink a lot of water if side effects are experienced after the covid-19 vaccine. She got dry heaves after she took Tylenol and 2 glasses of water. Her mouth immediately got wet, and she ran to bathroom with dry heaves. She thought dry heaves were because she drank so much water after taking the Tylenol. The events were reported as non-serious. The events did not require emergency room or physician office visit. Her fever broke on Sunday (24Jan2021), and she felt better. All her side effects had resolved by Sunday, 24Jan2021. She was scheduled to receive her second Pfizer covid-19 vaccine on Friday (19Feb2021). She asked if there was anything, she can do ahead of getting her second covid-19 vaccine that will help with side effects, since she got so ill after the first covid-19 vaccine shot. She asked if she would get as ill with the second covid-19 vaccine shot as she did with the first covid-19 vaccine shot. She was advised that she would be transferred to Pfizer medical information for further assistance with her question. The patient was treated with extra strength Tylenol (NDC number: unknown, lot number: P120060, and expiration date: Apr2022) 500mg tablet on 23Jan2021. The patient underwent lab tests and procedures which included body temperature: 104 on 23Jan2021 and annual physical with blood work in Dec2020 and everything was fine. The outcome of the events dry heaves and nausea was recovered on 23Jan2021 and all other events were resolved on 24Jan2021.  Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Retching
Clinical narrative: chills; She said her fever was as high as 104 degrees on Saturday; Nausea; Headache; said she got very ill; Dry heaves; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9263, NDC number, expiry date was reported as unknown) via an unspecified route of administration on 22Jan2021 at approximately 14:00 (at the age of 69-years-old) in left arm as a single dose for covid-19 immunization. Medical history (including any illness at time of vaccination) included thyroid disorder and gastroesophageal reflux disease for years from an unknown date and unknown if ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, prior vaccinations (within 4 weeks), adverse events following prior vaccinations were reported as none. Family medical history relevant to adverse events was not reported. Concomitant medications included thyroid and acid reflux medication for years, start date and stop date were not reported. The patient received her first Pfizer covid-19 vaccine on 22Jan2021 at approximately 14:00, she got very ill that night. She said she woke up at 4:00 on 23Jan2021, with chills, fever as high as 104 degrees, nausea, and headache. She had read to take a Tylenol and drink a lot of water if side effects are experienced after the covid-19 vaccine. She got dry heaves after she took Tylenol and 2 glasses of water. Her mouth immediately got wet, and she ran to bathroom with dry heaves. She thought dry heaves were because she drank so much water after taking the Tylenol. The events were reported as non-serious. The events did not require emergency room or physician office visit. Her fever broke on Sunday (24Jan2021), and she felt better. All her side effects had resolved by Sunday, 24Jan2021. She was scheduled to receive her second Pfizer covid-19 vaccine on Friday (19Feb2021). She asked if there was anything, she can do ahead of getting her second covid-19 vaccine that will help with side effects, since she got so ill after the first covid-19 vaccine shot. She asked if she would get as ill with the second covid-19 vaccine shot as she did with the first covid-19 vaccine shot. She was advised that she would be transferred to Pfizer medical information for further assistance with her question. The patient was treated with extra strength Tylenol (NDC number: unknown, lot number: P120060, and expiration date: Apr2022) 500mg tablet on 23Jan2021. The patient underwent lab tests and procedures which included body temperature: 104 on 23Jan2021 and annual physical with blood work in Dec2020 and everything was fine. The outcome of the events dry heaves and nausea was recovered on 23Jan2021 and all other events were resolved on 24Jan2021.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Headache, Rash
Clinical narrative: rash on bilateral arms near the crest by his elbows & bilateral legs near the crest on the back on 16Feb2021; headache; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9266) intramuscularly in upper left arm on Sunday, 14Feb2021 at noon (at the age of 67-year-old) as single dose for COVID-19 immunization. Medical history included Polycythemia vera, excess red blood cells. Patient had no family history. Concomitant medication included dabigatran etexilate mesilate [PRADAXA] 150mg twice a day taken for Polycythemia vera, has excess red blood cells. Patient was a medic in the Air Force 30 years ago and was in respiratory therapist school. Patient previously received all the Hepatitis shots and had the shingles shot last year, had regular Flu shot a month and a half to two months ago and had no adverse events following prior vaccinations. Patient did not administer any other vaccine on same date of suspect or within four weeks. On 14Feb2021, patient experienced headache at night and on 16Feb2021, yesterday evening patient started breaking out in a rash on his bilateral arms near the crest by his elbows and bilateral legs above the knees and in the crease in the back of his knees. Relevant tests included: blood work done at VA a month ago on an unspecified date in 2021. Outcome of the events were unknown.  Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 28Jan2021 (at the age of 78-year-old) as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On 16Feb2021, patient experienced shoulder pain and went to the doctor. Patient was scheduled for her second dose on 18Feb2021. She never mentioned that she was supposed to get second dose tomorrow. Her doctor gave her a cortisone injection (anti-inflammatory shot) yesterday, 16Feb2021. Patient asked if it would be okay to proceed with the second vaccine dose tomorrow or she will need to postpone it and have it rescheduled. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash on her chest/rash on her neck and shoulder coming down the arm; itching on her chest; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration, administered in left arm on 16Feb2021 at 15:15 hours as dose 1, single (at the age of 65-years-old) for COVID-19 immunisation. Patient had no medical history. Patient had a sister, and she had the Moderna vaccine and had no reaction. There were no concomitant medications. Patient had no prior vaccinations (within 4 weeks). No relevant tests were performed. On 16Feb2021, patient had rash started about 17:00 or 18:00 hours that evening, patient noticed that it was itching on her chest and when she looked at it saw the rash on her chest/rash on her neck and shoulder coming down the arm. It had gotten better at this point with the use of hydrocortisone and Benadryl as treatment. Patient had no emergency room and physician office visit, but she did call, and they just gave her the COVID hotline but got no answer. Patient wanted to know if this is going to happen with the second shot, what should she expect with the second dose. The outcome of the events was recovering.   Follow-up attempts completed. No further information expected. Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Nausea, Pyrexia
Clinical narrative: chills; Fever; today is the first day he has had an appetite; nausea; headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 85-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration as dose 1, single for covid-19 immunisation. Medical history included asthma and COPD from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date Feb2021, the patient experienced Extreme chills, nausea, headache, and loss of appetite. It was reported that, first dose of the Pfizer Covid 19 vaccine 10 days ago and he developed the following symptoms: Extreme chills, nausea, headache, and loss of appetite.  The patient reported that a day or two after the first dose, he started developing chills and a fever. The patient said his symptoms went on from days and were getting increasingly worse. He said a day or two later, he started developing chills and a fever. He said his symptoms went on from days 2, 3, 4, 5, 6 and 7, getting increasingly worse. He said on day 7 he started taking Tylenol because he didn't know what else to do. He said he took Extra Strength Tylenol 500mg. He said the took 5 Extra Strength Tylenol 500mg a day (or 5 Extra Strength Tylenol 500mg within a 24-hour period). He said today is the first day he has had an appetite. The patient stated that he had suffered for the last 10 days and today is the first day he has had an appetite. The patient said he was going through all the COVID-19 Vaccine literature, and none of the symptoms are supposed to occur until the second COVID-19 Vaccine dose. The patient said since he experienced symptoms with the first COVID-19 Vaccine dose, he was concerned about what he would experience with the second COVID-19 Vaccine dose. The patient said on the plus side, the Extra Strength Tylenol 500mg lessened his symptoms. The patient said he has been drinking juices, but today was the first day he had a little bit of food. The patient said his health being what it is with the COPD and asthma, he was wondering if that contributed to more of the symptoms he experienced with the first COVID-19 Vaccine dose. The caller asked if Pfizer has heard of any other cases like his with people have symptoms after receiving the first COVID-19 Vaccine dose. The Reporter asked if Pfizer could provide him with an answer as to if he was taking the proper dose of Tylenol to treat his symptoms. The outcome of the event appetite impaired was recovering and other events were unknown.   Information about lot and batch number was requested.   Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pyrexia
Clinical narrative: chills; headache; chills; headache; nausea; sneezing; mother has a fever/she has now fever 100.9 Celsius; This is a follow-up spontaneous report from Pfizer-sponsored program  Support. A contactable nurse (daughter) reported for her mother that a 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown, Expiry date, NDC number: unknown), via an unspecified route of administration in arm on 10Feb2021 (age at vaccination was 78 years) at around 3 pm as dose 1, single for COVID-19 immunisation. Medical history was not reported. concomitant medications were none. On 12Feb2021 the patient experienced chills, headache; On 15Feb2021, experienced nausea, chills, headache; On an unspecified date in Feb2021, had fever and sneezing. Additional Context received as, the reporter reporting for her mom on the COVID vaccine who received the first shot on 10Feb2021 and afterward on Friday patient had the normal symptoms, chills and headache. The patient got better on Sunday but on Monday she had chills, headache, and nausea. Is it normal to have the delayed response. The patient knows it was normal to have a reaction 1-3 days after getting the shot but patient got better and then the symptoms returned; chills, headache, a fever of 100.9, and nausea. It was confirmed the shot was given on 10Feb2021. The symptoms of chills and headache started that following Friday, 12Feb2021. They resolved on 14Feb2021. But then on Monday, 15Feb2021 her mom experienced nausea, chills, and headache. It was explained that her temperature was checked on 16Feb2021, that was when patient noticed the fever of 100.8. The patient also reported having sneezing during this time but was not congested. The patient was wondering if her mom might just be getting sick. No treatment other than Tylenol. The events were no happened at emergency room and physician office. The report was non-serious. Outcome of the initially had events chills and headache recovered on 14Feb2021 and the reoccurred events nausea, chills, headache, fever and sneezing were not recovered.  Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: chills; headache; chills; headache; nausea; sneezing; mother has a fever/she has now fever 100.9 Celsius; This is a follow-up spontaneous report from Pfizer-sponsored program  Support. A contactable nurse (daughter) reported for her mother that a 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown, Expiry date, NDC number: unknown), via an unspecified route of administration in arm on 10Feb2021 (age at vaccination was 78 years) at around 3 pm as dose 1, single for COVID-19 immunisation. Medical history was not reported. concomitant medications were none. On 12Feb2021 the patient experienced chills, headache; On 15Feb2021, experienced nausea, chills, headache; On an unspecified date in Feb2021, had fever and sneezing. Additional Context received as, the reporter reporting for her mom on the COVID vaccine who received the first shot on 10Feb2021 and afterward on Friday patient had the normal symptoms, chills and headache. The patient got better on Sunday but on Monday she had chills, headache, and nausea. Is it normal to have the delayed response. The patient knows it was normal to have a reaction 1-3 days after getting the shot but patient got better and then the symptoms returned; chills, headache, a fever of 100.9, and nausea. It was confirmed the shot was given on 10Feb2021. The symptoms of chills and headache started that following Friday, 12Feb2021. They resolved on 14Feb2021. But then on Monday, 15Feb2021 her mom experienced nausea, chills, and headache. It was explained that her temperature was checked on 16Feb2021, that was when patient noticed the fever of 100.8. The patient also reported having sneezing during this time but was not congested. The patient was wondering if her mom might just be getting sick. No treatment other than Tylenol. The events were no happened at emergency room and physician office. The report was non-serious. Outcome of the initially had events chills and headache recovered on 14Feb2021 and the reoccurred events nausea, chills, headache, fever and sneezing were not recovered.  Follow-up attempts completed. No further information expected.