chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Erythema, Pruritus
Clinical narrative: Redness and itching of head and forehead; Redness and itching of head and forehead; hypertension; This is a spontaneous report from a contactable Pharmacist. A 49-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL3302, expiry date: May2021, NDC number: 59267100001) intramuscularly in deltoid right on 20Jan2021 at 0.3 ml single for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporting pharmacist works with a group of five pharmacists. Colleague administered Covid-19 Vaccine to the patient an hour ago. Patient presented with side effects. Pharmacist clarified adverse event as itching of the head and forehead. Forehead looked pretty red and as if there were pimples, but patient was scratching hard. Occurred 15-20 minutes after vaccination (20Jan2021). Pharmacist checked patient for other symptoms of breathing and swelling. Patient stated he was ok in that aspect. Pharmacist gave patient two 25 mg tablets of Benadryl. Pharmacist states patient is healthy and just has hypertension (20Jan2021). Patient is still at the clinic and is going to check back in with caller about how he is doing. Doesn't have exact time of vaccination. Seriousness: At least medically significant. Patient was able to go back to the kitchen and do his job. Pharmacist asked how would he know that is not an allergic reaction and if the second dose should be given. Sticker states NDC is 5926710001, but pharmacist believes NDC is 59267100001. Vaccination Facility Type was Nursing home. Additional Vaccines Administered On Same Date Of Pfizer Suspect was No. Pharmacist makes sure other vaccinations are separated by two weeks. All events required Physician Office Visit. Prior Vaccinations Within 4 Weeks was Unknown. AES Follow Prior Vaccinations was Unknown. Relevant Tests was None. Benadryl allergy tablet, 25 mg NDC: 50580- 226-51 Lot: SFF084 Exp: Feb2022. Pharmacist asked if second dose should be submitted. The outcome of the events was unknown.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events pruritus, erythema and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dysphonia, Hypoaesthesia oral
Clinical narrative: Lip and mouth numbness; hoarseness; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse.   A 46-year-old nurse reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose in the Left arm on 15Jan2021 at 11:30 am for COVID-19 immunization.Medical history included allergy to latex.  The patient's concomitant medications were not reported.  On 15Jan2021 at 12:00 am the patient experienced lip and mouth numbness, hoarseness, chest pressure and lightheadedness. Since the vaccination, the patient has not been tested for COVID. No treatment was received. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Nausea, Vomiting
Clinical narrative: About 20 minutes after the vaccine was administered I felt a wave of nausea and felt like I was going to vomit; then I felt dizzy; About 20 minutes after the vaccine was administered I felt a wave of nausea and felt like I was going to vomit; diarrhea; This is a spontaneous report from a contactable consumer (patient)  A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL324) on 14Jan2021 at 10:00 at single dose via an unspecified route of administration  on arm left for COVID-19 immunization. Relevant medical history included GERD, disc disease, meningioma, diverticulitis, panic attack and allergy to Macrodantin, Levaquin and Bactrim. Concomitant medications included metoprolol, atorvastatin, omeprazole and alprazolam. On 14Jan2021 about 20 minutes after the vaccine was administered patient felt a wave of nausea and felt like she was going to vomit, then she felt dizzy. Patient waited another 30 minutes before driving home hoping it would subside. Patient informed she have been nauseated, dizzy and had diarrhea on and off for 9 days. She didn't called her doctor yet or notified anyone at the site hoping it would pass, as she knew that nausea was one of the side effects. The patient was not treated for the events. At the time of the reporting the patient had not yet recovered from the event.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A male patient of unspecified age (Age: 63; Unit: Unknown) received the first dose and second dose of BNT162B2, via unspecified routes of administration on unspecified dates at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. After receiving both vaccines, patient still got pneumonia and he had seen many elderly died from pneumonia even after receiving the vaccine. Outcome of the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: headache; arm soreness near the site of injection; This is a spontaneous report from a contactable consumer, the patient. This 5-decade-old female patient (reported as in her late 40's) received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: UNKNOWN), first dose, unspecified route of administration on an unspecified date in Jan2021 as a single dose for COVID-19 vaccination. The patient's medical history included psoriasis from an unknown date an unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced a headache immediately following the first injection of the vaccine. Several hours later, the patient experienced arm soreness near the site of injection in the arm that received the injection. The clinical outcome of the headache and arm soreness near the site of injection was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Decreased appetite, Fatigue, Hypersomnia
Clinical narrative: she may have already had COVID 19 with the symptoms she has now; she may have already had COVID 19 with the symptoms she has now; was feeling bad; she lost her taste and her smell; she lost her taste and her smell; tired; sleeping all the time; she is sick; She still hasn't eaten a whole meal since Friday; not able to eat; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL0142, exp date not reported), intramuscular (by injection once left arm, below shoulder blade in muscle) on 13Jan2021 for COVID-19 immunization (because of job). Medical history included two stroked from 1998 and 2005. Concomitant medication included oral donepezil started taking 3 months ago (Oct2020) for something having to do with muscles because of stroke. She takes a blood thinner, as she had 2 strokes; and takes muscle relaxers too. By 15Jan2021 (Friday morning) the patient was feeling bad, she couldn't go to work, she lost her taste and her smell, part of smell. Part of taste was back at the time of reporting, but she was tired and sleeping all the time (onset date reported as 15Jan2021). She saw her neurologist because she had 2 strokes, they referred her to Pfizer, as they said she may have already had COVID 19 with the symptoms she has, but as far as she knows, she didn't have it, she took a test with the center a month before giving the vaccine, she took the vaccine because of her job, because of the kind of job she has, and they wanted her to let Pfizer know she was sick. She doesn't know if she wanted to get the other dose, as she was not feeling well at all. She was laying down sleeping every day. Her doctor said to tell Pfizer what was going on. She still doesn't feel good the day of reporting. She still hasn't eaten a whole meal since 15Jan2021. She thinks she was probably getting better, but was getting better slowly, she has no taste, she was not able to eat, no smell at all, which was really not a good thing. She can't tell the outcome of no smell she thinks. She can't smell nothing at all. She can't smell what she was cooking. It was the same as taste, she thought that is probably why she can't eat, she can't taste what she was eating. Taste was improved, but not well enough for her, it is hard to explain, you know how you enjoy food, like how it tastes, and if you can't taste, you can't eat. She sleeps all day, she was up now, but is probably going to go to sleep, she feels tired and needs to lay down. She told her doctor she will call and see what Pfizer says, they will go from there. She doesn't know if she will have to go see if she has COVID 19, or what was going on.  No further investigation assessment was performed. The patient took a test a month before (results unknown). No taste was recovering (ongoing at the time of reporting) while outcome of other events was not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Malaise, SARS-CoV-2 test
Clinical narrative: she may have already had COVID 19 with the symptoms she has now; she may have already had COVID 19 with the symptoms she has now; was feeling bad; she lost her taste and her smell; she lost her taste and her smell; tired; sleeping all the time; she is sick; She still hasn't eaten a whole meal since Friday; not able to eat; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL0142, exp date not reported), intramuscular (by injection once left arm, below shoulder blade in muscle) on 13Jan2021 for COVID-19 immunization (because of job). Medical history included two stroked from 1998 and 2005. Concomitant medication included oral donepezil started taking 3 months ago (Oct2020) for something having to do with muscles because of stroke. She takes a blood thinner, as she had 2 strokes; and takes muscle relaxers too. By 15Jan2021 (Friday morning) the patient was feeling bad, she couldn't go to work, she lost her taste and her smell, part of smell. Part of taste was back at the time of reporting, but she was tired and sleeping all the time (onset date reported as 15Jan2021). She saw her neurologist because she had 2 strokes, they referred her to Pfizer, as they said she may have already had COVID 19 with the symptoms she has, but as far as she knows, she didn't have it, she took a test with the center a month before giving the vaccine, she took the vaccine because of her job, because of the kind of job she has, and they wanted her to let Pfizer know she was sick. She doesn't know if she wanted to get the other dose, as she was not feeling well at all. She was laying down sleeping every day. Her doctor said to tell Pfizer what was going on. She still doesn't feel good the day of reporting. She still hasn't eaten a whole meal since 15Jan2021. She thinks she was probably getting better, but was getting better slowly, she has no taste, she was not able to eat, no smell at all, which was really not a good thing. She can't tell the outcome of no smell she thinks. She can't smell nothing at all. She can't smell what she was cooking. It was the same as taste, she thought that is probably why she can't eat, she can't taste what she was eating. Taste was improved, but not well enough for her, it is hard to explain, you know how you enjoy food, like how it tastes, and if you can't taste, you can't eat. She sleeps all day, she was up now, but is probably going to go to sleep, she feels tired and needs to lay down. She told her doctor she will call and see what Pfizer says, they will go from there. She doesn't know if she will have to go see if she has COVID 19, or what was going on.  No further investigation assessment was performed. The patient took a test a month before (results unknown). No taste was recovering (ongoing at the time of reporting) while outcome of other events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19 after getting the vaccine; tested positive for Covid-19 after getting the vaccine; This is a spontaneous report from a contactable consumer via the Pfizer Sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date was not reported), via an unspecified route of administration on 11Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid-19 after getting the vaccine on 14Jan2021. The reporter and his wife both took a rapid test on 08Jan2021 and it was negative. On 11Jan2021, they both got their first dose of the vaccine. The patient had a swab test done on 14Jan2021; she is asymptomatic, but her test was also positive. They wanted to know if it's ok to get the 2nd dose of vaccine. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045686 Same reporter, drug, and event with different patients
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from contactable consumer (patient) from a Pfizer-sponsored program Pfizer First Connect.  A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/lot number: EK9231), via an unspecified route of administration in the left arm on 03Jan2021 at single dose for covid-19 immunisation. Medical history was none.  There were no concomitant medications. The patient tested positive for covid on 10Jan2021 with outcome of not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: woke up at 3 am with itching to her chest and arms; This is a spontaneous report from a contactable other health professional.  A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EK9231), via an unspecified route of administration in the left arm on 18Jan2021 17:45 at SINGLE DOSE for COVID-19 immunization. Medical history included "hypothyroid", HTN (hypertension) and allergy to contrast dyes.  The patient has been diagnosed with COVID-19 on an unspecified date prior vaccination. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included thyroid (ARMOUR THYROID), silybum marianum (MILK THISTLE), magnesium chloride and unspecified BP medications. The patient previously took tetanus toxoid and experienced allergies.  On 19Jan2021, the patient woke up at 3 am with itching to her chest and arms. Patient took generic Zyrtec as treatment to the event. Outcome of event was recovering. The events were considered as non-serious.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Flushing, Hypotension, Paraesthesia
Clinical narrative: Blood Pressure dropped very low; Tingling; Flushed; This is a spontaneous report from a contactable consumer reporting for his cousin. A male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 20Jan2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included the patient previously received the meningitis vaccine on an unknown date. Concomitant medication were not provided. The patient did not have any known allergies. On Jan2021, the patient experienced blood pressure dropped very low, tingling and flushed. He has reported similar reaction to the meningitis vaccine when he received it. The outcome of the events blood pressure dropped very low, tingling and flushed was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: came down with COVID in a week; came down with COVID in a week; This is a spontaneous report from a contactable physician. This physician reported similar events for 4 patients. This is third of four reports. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 immunisation. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient came down with COVID in a week of vaccination. The outcome of the event came down with COVID in a week was unknown. The reporting physician stated that he doesn't think that them getting the vaccine and having COVID is related, he thinks it is a coincidence.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021064977 as same reporter/drug/AE/different patients.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid a week later; Tested positive for Covid a week later; This is a spontaneous report from a contactable other hcp (patient). A 30-year-old non-pregnant female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 04Jan2021 08:45, and 1st dose on an unspecified date via an unspecified route of administration; both at single doses for COVID-19 immunization. There were no medical history and concomitant medications. The patient has no known allergies. On 12Jan2021, the patient tested positive for COVID a week later from 2nd dose. Outcome of the events was reported as recovering. No treatment was given for the events. The patient underwent lab tests and procedures which included Nasal Swab: positive on 13Jan2021. The patient was not diagnosed with COVID prior vaccination.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "tested positive for Covid a week later".
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Impaired driving ability, Vaccination site erythema, Vaccination site pain
Clinical narrative: pain at the site of injection; redness radiating from the injection site; chills; fatigue; difficulty driving; This is a spontaneous report from a contactable consumer, the patient, via a Pfizer sales representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown) solution for injection intramuscular (at an unknown age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (Pfizer) for COVID-19 vaccination, first dose on an unknown date. The patient recently received both doses of the Pfizer vaccine for Covid. On an unknown date, the patient experienced many side effects with the second dose such as pain at the site of injection, redness radiating from the injection site by about 6 inches, chills, fatigue, and difficulty driving. The outcome of the events pain at the site of injection, redness radiating from the injection site, chills, fatigue, and difficulty driving was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Diagnosed with COVID after first vaccine; Diagnosed with COVID after first vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was diagnosed with COVID after first vaccine and wanted to know if the patient could take the second dose afterwards. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19  and suspected LOE  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Ocular hyperaemia, Pruritus, Vaccination site pain
Clinical narrative: sporadic itching mostly on chest and some on legs and arms; slight sore at the Injection site.; itchy eyes; slight redness in the corner of her eyeballs.; This is a spontaneous report from a contactable consumer or other non hcp. A 73-year-old female patient started to receive BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: Unknown), via an unspecified route of administration on 13Jan2021 at 10:00 (at the age of 73-years-old) as a single dose for Covid-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 15Jan2021, the patient experienced itchy eyes, slight redness in the corner of her eyeballs, sporadic itching mostly on chest and some on legs and arms and slightly sore at the injection site. The clinical outcome of the events itchy eyes, slight redness in the corner of her eyeballs, sporadic itching mostly on chest and some on legs and arms and slightly sore at the injection site was resolved on 17Jan2021.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Paraesthesia
Clinical narrative: Right Leg tingling; Strange Feeling; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 via an unspecified route of administration on 20Jan2021 10:00 AM at a single dose as COVID vaccine. There were no medical history and no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). The patient had no known allergies. The patient experienced right leg tingling and strange feeling on unspecified dates. Treatment was not received for the events. He had no COVID prior to vaccination. He did not have COVID tested post vaccination. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: got the first dose of COVID vaccine and afterwards he tested positive for COVID; got the first dose of COVID vaccine and afterwards he tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored Program, Pfizer First Connect, received from a contactable nurse. A male patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient received first dose of COVID vaccine and afterwards he tested positive for COVID. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: Massive headache; Severe chills; Couldn't get warm all day even with multiple layers of clothing; Dizziness/lightheaded; Feverish; Going from freezing cold to sweating profusely; Right arm is really itchy; Place on right arm started out as a red blotch the size of a nickel, but today is as big around as a grapefruit; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 16Jan2021 (17:30) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on 30Dec2020 (when the patient was 55 years old) on the left arm for COVID-19 immunization. The patient had no issues with the first dose of vaccination. On 17Jan2021, the morning after the second dose of vaccination, the patient woke up with a massive headache; developed severe chills; could not get warm all day long even with multiple layers of clothing; was dizzy and lightheaded; feverish; was freezing cold one minute, and then sweating profusely the next; right arm was really itchy; and had red blotch that was as big as a nickel, then as big around as a grapefruit at the time of reporting. The outcome of the events was recovered on 19Jan2021 for 'massive headache', 'could not get warm all day long even with multiple layers of clothing' and 'dizziness/lightheaded'; was recovering for 'severe chills', 'feverish' and 'freezing cold one minute, and then sweating profusely the next'; was not recovered for 'right arm was really itchy' and 'red blotch that was as big as a nickel, then as big around as a grapefruit'.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash macular, Vaccination site pruritus
Clinical narrative: Massive headache; Severe chills; Couldn't get warm all day even with multiple layers of clothing; Dizziness/lightheaded; Feverish; Going from freezing cold to sweating profusely; Right arm is really itchy; Place on right arm started out as a red blotch the size of a nickel, but today is as big around as a grapefruit; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 16Jan2021 (17:30) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on 30Dec2020 (when the patient was 55 years old) on the left arm for COVID-19 immunization. The patient had no issues with the first dose of vaccination. On 17Jan2021, the morning after the second dose of vaccination, the patient woke up with a massive headache; developed severe chills; could not get warm all day long even with multiple layers of clothing; was dizzy and lightheaded; feverish; was freezing cold one minute, and then sweating profusely the next; right arm was really itchy; and had red blotch that was as big as a nickel, then as big around as a grapefruit at the time of reporting. The outcome of the events was recovered on 19Jan2021 for 'massive headache', 'could not get warm all day long even with multiple layers of clothing' and 'dizziness/lightheaded'; was recovering for 'severe chills', 'feverish' and 'freezing cold one minute, and then sweating profusely the next'; was not recovered for 'right arm was really itchy' and 'red blotch that was as big as a nickel, then as big around as a grapefruit'.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: all got the first dose, and they all came down with COVID in a week; all got the first dose, and they all came down with COVID in a week; This is Spontaneous report from a contactable Physician. This physician reported similar events for four patients. This is the fourth of four reports.  A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 immunisation. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient came down with COVID in a week of vaccination. The outcome of the event came down with COVID in a week was unknown. The reporting physician stated that he doesn't think that them getting the vaccine and having COVID is related, he thinks it is a coincidence.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021064977 same reporter/drug/event, different patient.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Feeling cold, Malaise
Clinical narrative: Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaking really hard; feeling unwell; still cold; Just like when one catches the flu, all the symptoms came at one time; It was so stiff one time; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EK01231), via intramuscular route on the left arm on 19Jan2021 12:11 as a single dose for COVID-19 immunization. Medical history included stomach issues, two stents, pacemaker, asthma that turned into bronchitis. Historical vaccine data included the pneumococcal 13-valent conjugate vaccine (PREVNAR 13) first dose in "September" and the second Pneumonia shot on 11Jan2021, second dose, on the right arm within 4 weeks prior to the COVID vaccine. Concomitant medication included ongoing prasugrel for blood thinner.  On 20Jan2021 03:00, the patient experienced really heavy chills, she was shaking really hard, she had muscle pain like the flu, joint pain, fever that started at 100.6 degrees Fahrenheit and worsened to 101.6 degrees Fahrenheit, nauseated, feeling unwell. The caller clarifies that all of the symptoms came on at once, around 3am. Just like when one catches the flu, all the symptoms came at one time. The patient reported that it felt like she had the virus (not specified) all over again. The chills had calmed down, but she was still cold. Where the injection was given it was real sore. She had been doing arm circles and such to keep her muscles loosened up. It was so stiff at one time last night (20Jan2021) that she thought, she could not move it. The clinical outcome of events chills was recovering; muscle pain, fever, nauseated, still cold was not recovered; joint pain, shaking really hard, feeling unwell, vaccination site pain, stiff, flu like symptoms was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Pyrexia, Tremor
Clinical narrative: Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaking really hard; feeling unwell; still cold; Just like when one catches the flu, all the symptoms came at one time; It was so stiff one time; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EK01231), via intramuscular route on the left arm on 19Jan2021 12:11 as a single dose for COVID-19 immunization. Medical history included stomach issues, two stents, pacemaker, asthma that turned into bronchitis. Historical vaccine data included the pneumococcal 13-valent conjugate vaccine (PREVNAR 13) first dose in "September" and the second Pneumonia shot on 11Jan2021, second dose, on the right arm within 4 weeks prior to the COVID vaccine. Concomitant medication included ongoing prasugrel for blood thinner.  On 20Jan2021 03:00, the patient experienced really heavy chills, she was shaking really hard, she had muscle pain like the flu, joint pain, fever that started at 100.6 degrees Fahrenheit and worsened to 101.6 degrees Fahrenheit, nauseated, feeling unwell. The caller clarifies that all of the symptoms came on at once, around 3am. Just like when one catches the flu, all the symptoms came at one time. The patient reported that it felt like she had the virus (not specified) all over again. The chills had calmed down, but she was still cold. Where the injection was given it was real sore. She had been doing arm circles and such to keep her muscles loosened up. It was so stiff at one time last night (20Jan2021) that she thought, she could not move it. The clinical outcome of events chills was recovering; muscle pain, fever, nauseated, still cold was not recovered; joint pain, shaking really hard, feeling unwell, vaccination site pain, stiff, flu like symptoms was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaking really hard; feeling unwell; still cold; Just like when one catches the flu, all the symptoms came at one time; It was so stiff one time; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EK01231), via intramuscular route on the left arm on 19Jan2021 12:11 as a single dose for COVID-19 immunization. Medical history included stomach issues, two stents, pacemaker, asthma that turned into bronchitis. Historical vaccine data included the pneumococcal 13-valent conjugate vaccine (PREVNAR 13) first dose in "September" and the second Pneumonia shot on 11Jan2021, second dose, on the right arm within 4 weeks prior to the COVID vaccine. Concomitant medication included ongoing prasugrel for blood thinner.  On 20Jan2021 03:00, the patient experienced really heavy chills, she was shaking really hard, she had muscle pain like the flu, joint pain, fever that started at 100.6 degrees Fahrenheit and worsened to 101.6 degrees Fahrenheit, nauseated, feeling unwell. The caller clarifies that all of the symptoms came on at once, around 3am. Just like when one catches the flu, all the symptoms came at one time. The patient reported that it felt like she had the virus (not specified) all over again. The chills had calmed down, but she was still cold. Where the injection was given it was real sore. She had been doing arm circles and such to keep her muscles loosened up. It was so stiff at one time last night (20Jan2021) that she thought, she could not move it. The clinical outcome of events chills was recovering; muscle pain, fever, nauseated, still cold was not recovered; joint pain, shaking really hard, feeling unwell, vaccination site pain, stiff, flu like symptoms was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pyrexia, Upper respiratory tract infection
Clinical narrative: cough; started to feel chills; Fever; Upper respiratory infection; This is a spontaneous report. A contactable physician reported that a 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 15Jan2021 at SINGLE DOSE for covid-19 immunization. Patient does not have other relevant medical history. There were no concomitant medications. On 17Jan2021 21:00, the patient experienced upper respiratory infection. She experienced fever and started to feel chills on 18Jan2021. Then on an unspecified date, paient experienced cough. The outcome of events upper respiratory infection and fever was recovering whereas events cough and started to feel chills was unknown.   Follow-up attempts are completed. The following information on the batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal discomfort
Clinical narrative: a "significant discomfort" on her lower back also described as being "pretty painful"; a "significant discomfort" on her lower back also described as being "pretty painful"; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on Jan2021 (at the age of 65-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no previous back injuries. On an unspecified date in Jan2021, the patient experienced a significant discomfort to her lower back also described as being "pretty painful" during the first two days post vaccination. The clinical outcome of a "significant discomfort" on her lower back also described as being "pretty painful" was resolving, reported as "much better today" and "almost" gone.  Information on lot/batch number has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Oxygen saturation low/ checked his oxygen level and it was 78 and then after a few minutes it was 86 and 88; Fever of 102 F for 4 days; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration (Unknown if  given intramuscularly) on 15Jan2021 09:30 at a single dose on left arm below shoulder for COVID-19 immunization. Medical history included none. There were no concomitant medications. The patient experienced fever of 102 for 4 days on 16Jan2021 14:00 and oxygen saturation low on 20Jan2021 12:00 (reported as "12:00 - 12:30"). He received first dose 15Jan2021. He has not had a cough, but had 102 degree Fahrenheit fever for 4 days, so he had to stay home from work. He  had to get a COVID test and it was negative today (unspecified date). While he was there, they checked his oxygen level and it was 78 and then after a few minutes it was 86 and 88. There was no prescriber. He received it at a healthcare facility. He is supposed to go back to get second dose on 05Feb2021. It is unknown if it was given intramuscularly. The outcome of the events was not recovered. NO ER or physician's office required.  He is to follow up with his general practitioner, but he has not gone yet. No prior vaccinations (within 4 weeks) and no adverse event following prior vaccinations. No additional vaccines administered on same date of the Pfizer Suspect. Vaccination facility type was Hospital. Family medical history includes, Father is Diabetic and mother has colon cancer.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hot flush, Migraine, Neck pain
Clinical narrative: Hot flashes; Chills; Body aches; Migraine; Neck pain; Fatigue; This is a spontaneous report from a non-contactable Nurse.  A non-pregnant 22-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3246), intramuscular in the right arm on 11Jan2021 at 11:30 AM (at the age of 22-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported.  The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK5730), intramuscular, right arm  on 21Dec2020 for COVID-19 immunization. On 11Jan2021 at 23:30 PM, the patient experienced hot flashes, chills, body aches, migraine, neck pain, and fatigue. The patient did not receive any treatment for the events. The clinical outcome of the events hot flashes, chills, body aches, migraine, neck pain, and fatigue was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Hot flashes; Chills; Body aches; Migraine; Neck pain; Fatigue; This is a spontaneous report from a non-contactable Nurse.  A non-pregnant 22-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3246), intramuscular in the right arm on 11Jan2021 at 11:30 AM (at the age of 22-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported.  The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK5730), intramuscular, right arm  on 21Dec2020 for COVID-19 immunization. On 11Jan2021 at 23:30 PM, the patient experienced hot flashes, chills, body aches, migraine, neck pain, and fatigue. The patient did not receive any treatment for the events. The clinical outcome of the events hot flashes, chills, body aches, migraine, neck pain, and fatigue was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little arm soreness; This is a spontaneous report from a contactable consumer (patient). This female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: unknown), via unknown route of administration, on 19Jan2021 as a single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown.  On Jan2021, the patient reported that she took the 1st vaccine yesterday.  She did not have any problems other than a little arm soreness. The outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was sore and hurting; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284 /expiration date: not provided), via intramuscular route of administration, on 29Dec2020 10:15 AM (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was none. Concomitant medication was not provided. On an unknown date, the patient experienced her arm was sore and hurting. The outcome of the event her arm was sore and hurting was unknown.