chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: An itch on the left side of his abdomen; A single 'hive'; This is a spontaneous report from a contactable pharmacist. An 86-year-old male patient started to received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3247), via intramuscular route in the right arm from on 21Jan2021 08:00 (at the age of 86-years) as a single dose for COVID-19 immunization. Medical history included hypercholesterolaemia, hypertension, hypothyroidism. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medication included acetylsalicylic acid (ASPIRIN LOW), atorvastatin calcium (ATORVASTIN), metoprolol, levothyroxine sodium (SYNTHROID). On 21Jan2021 at 09:45, the patient developed an itch on the left side of his abdomen that became a single hive approximately 5 -10 mm. The patient was treated for itch and hive with levocetirizine 5 mg. The clinical outcome of the event itch and hive was recovered in Jan2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Myalgia, Pain, Sensitive skin
Clinical narrative: Swollen lymph nodes; sensitive skin; body aches; muscle aches and pain; prolonged headache (excess of 7 days); This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration in the left arm on 14Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient had no known allergies. Concomitant medication included levothyroxine sodium (LEVOXYL), liothyronine, and sertraline. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE on 28Dec2020 (lot number: EJ1685) at 09:30 AM, in the left arm for COVID-19 immunization when the patient was 43-year-old. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior to vaccination nor was she tested since the vaccination. The patient experienced swollen lymph nodes, sensitive skin, body aches, muscle aches and pain, prolonged headache (excess of 7 days), all on 14Jan2021 at 03:00 PM with outcome of not recovered. There was no treatment received for the events. The events were reported as non-serious.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Cough, Diarrhoea
Clinical narrative: not feeling too good; not able to sleep at night; loose stools; chills; nausea; low grade temperature; sinus issues, like drippage causing him to swallow the mucus all through the night; sinus issues, like drippage causing him to swallow the mucus all through the night; like a tickle in throat and he was coughing; like a tickle in throat and he was coughing; joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area.; joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area.; Slight headache; A little fever; Bowel movement soft; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date not reported), intramuscular at the left arm on 20Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history was not reported. The patient was vaccinated at a clinic. Concomitant medications included clopidogrel bisulfate (PLAVIX), losartan, hydrochlorothiazide, amlodipine, metoprolol; all were ongoing.  The patient previously took a flu shot (INFLUENZA VACCINE) on 18Dec2020. On an unspecified date, the patient was not feeling too good, was not able to sleep at night, loose stools, chills, nausea and low grade temperature. On 20Jan2021, the patient experienced sinus issues, like drippage causing him to swallow the mucus all through the night and had like a tickle in throat and he was coughing, had  joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area, slight headache, a little fever, and bowel movement soft. Clinical outcome of cough, slight headache and little fever was recovering, while for the other events was unknown.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Faeces soft, Headache, Insomnia, Malaise, Nausea
Clinical narrative: not feeling too good; not able to sleep at night; loose stools; chills; nausea; low grade temperature; sinus issues, like drippage causing him to swallow the mucus all through the night; sinus issues, like drippage causing him to swallow the mucus all through the night; like a tickle in throat and he was coughing; like a tickle in throat and he was coughing; joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area.; joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area.; Slight headache; A little fever; Bowel movement soft; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date not reported), intramuscular at the left arm on 20Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history was not reported. The patient was vaccinated at a clinic. Concomitant medications included clopidogrel bisulfate (PLAVIX), losartan, hydrochlorothiazide, amlodipine, metoprolol; all were ongoing.  The patient previously took a flu shot (INFLUENZA VACCINE) on 18Dec2020. On an unspecified date, the patient was not feeling too good, was not able to sleep at night, loose stools, chills, nausea and low grade temperature. On 20Jan2021, the patient experienced sinus issues, like drippage causing him to swallow the mucus all through the night and had like a tickle in throat and he was coughing, had  joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area, slight headache, a little fever, and bowel movement soft. Clinical outcome of cough, slight headache and little fever was recovering, while for the other events was unknown.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Sinus disorder, Throat irritation
Clinical narrative: not feeling too good; not able to sleep at night; loose stools; chills; nausea; low grade temperature; sinus issues, like drippage causing him to swallow the mucus all through the night; sinus issues, like drippage causing him to swallow the mucus all through the night; like a tickle in throat and he was coughing; like a tickle in throat and he was coughing; joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area.; joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area.; Slight headache; A little fever; Bowel movement soft; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date not reported), intramuscular at the left arm on 20Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history was not reported. The patient was vaccinated at a clinic. Concomitant medications included clopidogrel bisulfate (PLAVIX), losartan, hydrochlorothiazide, amlodipine, metoprolol; all were ongoing.  The patient previously took a flu shot (INFLUENZA VACCINE) on 18Dec2020. On an unspecified date, the patient was not feeling too good, was not able to sleep at night, loose stools, chills, nausea and low grade temperature. On 20Jan2021, the patient experienced sinus issues, like drippage causing him to swallow the mucus all through the night and had like a tickle in throat and he was coughing, had  joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area, slight headache, a little fever, and bowel movement soft. Clinical outcome of cough, slight headache and little fever was recovering, while for the other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging abnormal, Mobility decreased, Muscle spasms, Pain, Sciatica
Clinical narrative: muscle spasms from his lower back to his toes on the right side; sciatica; pain; This is Spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is a first of second reports. This consumer reported for a male patient (Husband, Age: 71) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unknown route of administation on 12Jan2021 at single dose on Arm Left for covid-19 immunisation. Medical history and concomitant medications were unknown. The consumer wanted to report an AE to the first dose of the covid 19 vaccine. The consumer states her husband experienced a twinge in his ham string 2 days before the vaccine but continues to play (caller motioned her husband is athletic) . Husband received the first dose of the vaccine on 12Jan2021, played on the 13th and could not play on the 14th two days after vaccine he experienced muscle spasms from his lower back to his toes on the right side and could not get out of bed.( shot was in the left arm) Husband went to the hospital on the 16th and they discharged him and he went back on the 17th and did a mri and diagnosed with sciatica and gave him oxycodone 10mg 1 mg 1 four times a day as needed, cyclobenzaprine 10 mg 1 every 8 hours, and  gabapentin 100 mg 2 three times a day and a prednisone 6 pack. Reported not getting any better so took him to pain management and ride over there was hell, could not get comfortable and screamed the whole way over which was 20 minute ride and went in the office in a wheelchair. They gave him a steroid and told him to wait 1/2 hour. When leaving he experienced the worst spasm ever and they gave him toradol and then additional steroid injections. Husband was able to walk out with a walker. The consumer can only lay down, can not sit up and is bedridden. Spasms have stopped at the time of the phone call but still in pain. Having PT come for consult. Husband insists on getting second dose and caller asked agent "what do I think?". Husband was told at the hospital that another patient his age came in with the same symptoms as his after a dose of the covid 19 vaccine. The consumer stated her husband insisted on getting the second dose of the covid 19 vaccine and asked the agent "what do I think?". The outcome of the event muscle spasms from his lower back to his toes on the right side was recovering. The outcome of the other events was unknown.   Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021078548 same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Screaming
Clinical narrative: muscle spasms from his lower back to his toes on the right side; sciatica; pain; This is Spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is a first of second reports. This consumer reported for a male patient (Husband, Age: 71) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unknown route of administation on 12Jan2021 at single dose on Arm Left for covid-19 immunisation. Medical history and concomitant medications were unknown. The consumer wanted to report an AE to the first dose of the covid 19 vaccine. The consumer states her husband experienced a twinge in his ham string 2 days before the vaccine but continues to play (caller motioned her husband is athletic) . Husband received the first dose of the vaccine on 12Jan2021, played on the 13th and could not play on the 14th two days after vaccine he experienced muscle spasms from his lower back to his toes on the right side and could not get out of bed.( shot was in the left arm) Husband went to the hospital on the 16th and they discharged him and he went back on the 17th and did a mri and diagnosed with sciatica and gave him oxycodone 10mg 1 mg 1 four times a day as needed, cyclobenzaprine 10 mg 1 every 8 hours, and  gabapentin 100 mg 2 three times a day and a prednisone 6 pack. Reported not getting any better so took him to pain management and ride over there was hell, could not get comfortable and screamed the whole way over which was 20 minute ride and went in the office in a wheelchair. They gave him a steroid and told him to wait 1/2 hour. When leaving he experienced the worst spasm ever and they gave him toradol and then additional steroid injections. Husband was able to walk out with a walker. The consumer can only lay down, can not sit up and is bedridden. Spasms have stopped at the time of the phone call but still in pain. Having PT come for consult. Husband insists on getting second dose and caller asked agent "what do I think?". Husband was told at the hospital that another patient his age came in with the same symptoms as his after a dose of the covid 19 vaccine. The consumer stated her husband insisted on getting the second dose of the covid 19 vaccine and asked the agent "what do I think?". The outcome of the event muscle spasms from his lower back to his toes on the right side was recovering. The outcome of the other events was unknown.   Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021078548 same reporter/drug/event, different patient
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate irregular, Hypertension
Clinical narrative: she did not feel totally right; some high blood pressure; she has an irregular heart beat; This is a spontaneous report from a contactable consumer (patient). The 77-years-old female patient received first dose of BNT162b2 (BNT162B2, lot number: EL3248), via an unspecified route of administration on 18Jan2021at SINGLE DOSE for covid-19 immunisation. Medical history included diagnosis of irregular heart rate prior to the vaccine, about 4-5 years ago, allergy, Cholesterol. The patient experienced some high blood pressure on Jan2021, she has an irregular heart beat on Jan2021. "I developed some high blood pressure after getting the vaccine." she has developed a very high blood pressure reading and that is unusual for her, states she went to a walk in clinic on Tuesday and then to the doctor today. Caller states that it really concerns her that someone who is medically savvy as she could have a serious problem. stated that she did not feel totally right while she was waiting afterwards, states that she came home and laid around and the next morning, she can tell when it is high because she is chronically low. Caller states the next morning the top number of her blood pressure was 166, states bottom number is never out of sync (AS REPORTED). Caller states she could feel it really bad yesterday, really bad states she took the pressure once and it was 182/94 and a little later it was 192/84 and that is when she went to the walk in clinic. Caller states she has an irregular heart beat and she takes a blood pressure medication to treat that, takes 25mg once a day at night time. Yesterday morning she took another one before she went to the walk in clinic to help treat the high blood pressure, so she had 50 mg in 12 hours; when she got there they checked it and it was 178/72.  She also takes an allergy medication and something for cholesterol that she has been taking for years. She called on 21Jan2021 around 5pm regarding the Pfizer covid vaccine. She called because she was having blood pressure issues and two different doctors thought it was covid vaccine related. It has taken since then till today to get a reasonable blood pressure. Her thoughts are not to get the second dose. She is asking if she will have any protection if she does not get the vaccine and if there will be any adverse effects if she goes not get the second vaccine. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1283; Expiration Date: Apr2021), via an unspecified route of administration in left arm, on 19Jan2021 (Tuesday) at 13:45 (around 01:45 PM), at a single dose, for COVID-19 immunization. The patient's medical history included thyroid. The patient's concomitant medication included unspecified thyroid medication. The patient previously took the first dose of BNT162B2 (Lot Number: EH9899) on 29Dec2020 (in left arm) for COVID-19 immunization. The patient had no other recent vaccinations. The patient's work scheduled the vaccine for them through a third-party provider. The patient received her second dose of the vaccine on Tuesday and has a fever on Wednesday (20Jan2021) afternoon (about 12:00 PM) which continues to spike. For treatment, the patient took two of ibuprofen 200 mg, and didn't exceed 6 in a day; she took it every 8 hours or so by mouth. The patient didn't know if there were signs to be looking for. The patient's temperature from this this morning (21Jan2021) was 101 degrees Fahrenheit, which dropped to 99.6 degrees Fahrenheit, and is now 101.7 degrees Fahrenheit. The patient would like to know when she should be concerned and if there was a specific temperature to reach after which Pfizer advises to seek help. The patient had not recovered from the event.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain
Clinical narrative: Headache; body aches; joint pain; chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el0142), via an unspecified route of administration on left arm on 20Jan2021 at single dose for Covid-19 immunization. The patient medical history was not reported. Concomitant medication included solifenacin succinate (VESICARE), dl-alpha tocopheryl acetate (VITAMIN E), omeprazole and Multivitamin. The patient previously received her firs dose of BNT162B2 at 11:00 AM on 02Jan2021 intramuscularly on left arm for Covid-19 immunization. The patient experienced headache, body aches, joint pain, chills and fatigue on 21Jan2021 05:00 AM. The events were reported as non-serious. The patient did not receive any treatment from events. The outcome of events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Blood pressure increased, Blood pressure measurement, Feeling jittery, Restlessness
Clinical narrative: getting jittery; tense; antsy; keyed up; blood pressure:  154/85; This is a spontaneous report from a contactable pharmacist, reporting for herself.  A 47-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via an unspecified route of administration on 14Jan2021 at 16:30 (at the age of 47 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included Stage IV endometriosis, AVNRT/SVT cardiac arrhythmia, survivor of clear cell renal cell carcinoma (treated 2010),  allergies: Lupron (rash), environmental allergies (grasses, trees, weeds, molds, animal dander), all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Drospirenone, ethinyl estradiol, betadex clathrate (YAZ), levonorgestrel (MIRENA), cetirizine hydrochloride (ZYRTEC), metoprolol succinate (TOPROL XL), and unspecified multivitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021 at 21:30, the patient starting getting jittery, tense, antsy, "keyed up".  She took her blood pressure and it was 154/85. One hour later it was 148/89.  Two hours later it was 158/88.  The next day, on 20Jan2021 (day 6 post-vaccine), the blood pressure reading in the morning upon arising was 154/86.  At 5 pm, it was 166/91. She doubled up on metoprolol succinate (TOPROL XL) dose, which didn't seem to alter the blood pressure at all, based on the home monitor readings.  On day 7 post-vaccine (21Jan2021) it is as if the preceding day with the elevated blood pressure never happened; she felt perfectly fine and normal.  Day 7 post vaccine, blood pressure resumed normal levels (115-120/70-80). The patient did not receive treatment for the events. The clinical outcome of getting jittery, tense, antsy, "keyed up", and blood pressure:  154/85 was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tension
Clinical narrative: getting jittery; tense; antsy; keyed up; blood pressure:  154/85; This is a spontaneous report from a contactable pharmacist, reporting for herself.  A 47-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via an unspecified route of administration on 14Jan2021 at 16:30 (at the age of 47 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included Stage IV endometriosis, AVNRT/SVT cardiac arrhythmia, survivor of clear cell renal cell carcinoma (treated 2010),  allergies: Lupron (rash), environmental allergies (grasses, trees, weeds, molds, animal dander), all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Drospirenone, ethinyl estradiol, betadex clathrate (YAZ), levonorgestrel (MIRENA), cetirizine hydrochloride (ZYRTEC), metoprolol succinate (TOPROL XL), and unspecified multivitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021 at 21:30, the patient starting getting jittery, tense, antsy, "keyed up".  She took her blood pressure and it was 154/85. One hour later it was 148/89.  Two hours later it was 158/88.  The next day, on 20Jan2021 (day 6 post-vaccine), the blood pressure reading in the morning upon arising was 154/86.  At 5 pm, it was 166/91. She doubled up on metoprolol succinate (TOPROL XL) dose, which didn't seem to alter the blood pressure at all, based on the home monitor readings.  On day 7 post-vaccine (21Jan2021) it is as if the preceding day with the elevated blood pressure never happened; she felt perfectly fine and normal.  Day 7 post vaccine, blood pressure resumed normal levels (115-120/70-80). The patient did not receive treatment for the events. The clinical outcome of getting jittery, tense, antsy, "keyed up", and blood pressure:  154/85 was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: Elevated heart rate that is almost like in her throat; Low grade fever; weakness that comes and goes/Very weak; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EH9899), via an unspecified route of administration on 20Jan2021 at a single dose for covid-19 immunization. The patient has no medical history and concomitant medications. On 20Jan2021, the patient experienced weakness that comes and goes/very weak. The patient reported that it started an hour and a half after the COVID-19 Vaccine. Comes in waves. At the time of the report, the patient stated that it was starting to subside, but after a while it will come back again. The patient added that she trying to fight through the weakness, but it was stopping her from doing things. The patient also experienced low grade fever on 20Jan2021 that was fluctuating. In the evening of 21Jan2021, the patient experienced elevated heart rate that was almost like in her throat. Heart rate was normally between 75-80, but it continues to jump over 100. The outcome of the events was not recovered.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Headache, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: fever; Headache; Chills; First dose: it was 3 weeks ago from 20Jan2021/ her son thinks it was 05Jan2021; pain under the arm; This is a spontaneous report from a contactable consumer (patient's mother). A 23-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 20Jan2021 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient previously received first dose of BNT162B2 (3 weeks ago, thinks it was 05Jan2021) for COVID-19 immunization. The reporter stated that her son worked in a doctor's office and got the second COVID 19 vaccine on 20Jan2021. Her son has a fever (started about 4PM) and she wanted to know if her son was contagious because he has a fever. He was experiencing quite a few side effects: headache and fever on 21Jan2021; and on 20Jan2021 chills and he started last night with pain under the arm. Outcome of the events pain under the arm and headache was not recovered, fever and chills were recovering.   Information on the Lot/Batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased
Clinical narrative: some lightheadedness for 1-2 hours after administration; some elevated heartrate in first 15 minutes after administration; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration at left arm on 20Jan2021 13:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin and experienced allergies. On 20Jan2021, the patient experienced some lightheadedness for 1-2 hours after administration and some elevated heartrate in first 15 minutes after administration. There was no treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: feeling dizzy/dizziness; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program, Pfizer First Connect. An 88-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at 09:45 at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. This evening or later this afternoon of 21Jan2021, the patient started feeling dizzy. She took something for the dizziness and then went to sleep. The reporter wanted to ask if that be something they need to worry about. They were wondering if this could come from the shot since it came on later. Outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Dysgeusia, Facial paralysis, Feeling abnormal, Hypoaesthesia
Clinical narrative: it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left tongue felt numb and fat as though I got injected at the dentist; Then medicine taste in my mouth and some slurring; Then medicine taste in my mouth and some slurring; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received first dose of BNT162B2 (Lot number and expiry date not available), via an unspecified route of administration on 21Jan2021 10:45 at single dose in the left arm for COVID-19 immunization. Medical history included Hypo thyroid (medication not needed at this time). The patient had no known allergies. Concomitant medication included cefixime (FLEXERIL) and ibuprofen (IBU). On 21Jan2021 11:00, after 15 minutes of getting the vaccine, the patient felt nauseated. Then it continued to get worse from there left side of face numb, mental fog, left tongue felt numb and fat as though she got injected at the dentist. Then medicine taste in her mouth and some slurring. Stated that her boss which is doctor side it looks and sounds like she has Bell palsy. She was prescribed Methylprednisolone and she feel somewhat better. Still waiting to feel completely myself. It's been now about 8 hours since her vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all the events which included methylprednisolone. The outcome of the events was recovering.  Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2  to the onset of reported events Bell palsy and mental fog occurred 15 minutes after getting the vaccine cannot be completely excluded. The case will be reevaluated should additional information become 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Nausea, Swollen tongue
Clinical narrative: it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left tongue felt numb and fat as though I got injected at the dentist; Then medicine taste in my mouth and some slurring; Then medicine taste in my mouth and some slurring; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received first dose of BNT162B2 (Lot number and expiry date not available), via an unspecified route of administration on 21Jan2021 10:45 at single dose in the left arm for COVID-19 immunization. Medical history included Hypo thyroid (medication not needed at this time). The patient had no known allergies. Concomitant medication included cefixime (FLEXERIL) and ibuprofen (IBU). On 21Jan2021 11:00, after 15 minutes of getting the vaccine, the patient felt nauseated. Then it continued to get worse from there left side of face numb, mental fog, left tongue felt numb and fat as though she got injected at the dentist. Then medicine taste in her mouth and some slurring. Stated that her boss which is doctor side it looks and sounds like she has Bell palsy. She was prescribed Methylprednisolone and she feel somewhat better. Still waiting to feel completely myself. It's been now about 8 hours since her vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all the events which included methylprednisolone. The outcome of the events was recovering.  Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2  to the onset of reported events Bell palsy and mental fog occurred 15 minutes after getting the vaccine cannot be completely excluded. The case will be reevaluated should additional information become 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen arm; sore arm; tiredness and some fatigue feeling in my upper back; tiredness and some fatigue feeling in my upper back; This is a spontaneous report from a contactable consumer reported for self. This 36-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL9262) at single dose in right arm on 20Jan2021 at 03:15 PM for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient experienced swollen arm, sore arm, tiredness and some fatigue feeling in her upper back on 21Jan2021. There was no treatment received for the adverse events. Serious was no: not results in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating and not congenital anomaly/birth defect. The outcome of events was resolving.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: itchiness; Injection site reaction of firmness beneath skin; Injection site reaction of swelling; Injection site reaction of redness; Injection site reaction of warmth; Injection site reaction of soreness; This is a spontaneous report from a non-contactable pharmacist (the patient). A 26-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), via an unknown route of administration in the left arm on 19Jan2021 at 16:30 (at the age of 26-years-old) as a single dose for Covid-19 immunization. Medical history included skin of upper arm is affected by mild eczema/atopic dermatitis, keratosis pilaris, hypertrophic scarring all from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was allergic to latex which causes a rash/ swelling. The patient's concomitant medications were not reported (did have other medications in two weeks, unspecified). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 20Jan2021 reported as for first day, the patient experienced Injection site reaction of firmness beneath skin, swelling, redness, warmth, soreness and on the second day also experienced itchiness. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site induration, vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pain was not recovered; pruritus was unknown. 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: itchiness; Injection site reaction of firmness beneath skin; Injection site reaction of swelling; Injection site reaction of redness; Injection site reaction of warmth; Injection site reaction of soreness; This is a spontaneous report from a non-contactable pharmacist (the patient). A 26-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), via an unknown route of administration in the left arm on 19Jan2021 at 16:30 (at the age of 26-years-old) as a single dose for Covid-19 immunization. Medical history included skin of upper arm is affected by mild eczema/atopic dermatitis, keratosis pilaris, hypertrophic scarring all from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was allergic to latex which causes a rash/ swelling. The patient's concomitant medications were not reported (did have other medications in two weeks, unspecified). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 20Jan2021 reported as for first day, the patient experienced Injection site reaction of firmness beneath skin, swelling, redness, warmth, soreness and on the second day also experienced itchiness. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site induration, vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pain was not recovered; pruritus was unknown. 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: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea, Upper-airway cough syndrome
Clinical narrative: Sore throat; post-nasal drainage/rhinorrhea; post-nasal drainage/rhinorrhea; This is a spontaneous report from a contactable healthcare professional. This 46- year-old male patient received the first dose of BNT162B2 on 29Dec2020  6:30 PM (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EL1284), via intramuscular route of administration, (at the age of 46-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a Hospital and anatomically located on the left arm. Allergies to medications, food, or other products: Lactose intolerance.  The medical history included: Heart/Double Lung Tx, Bronchiolitis obliterans. Concomitant medications included: Tacrolimus, Sirolimus, Enalapril, Prednisone, Bactrim, Zithromax, Prenatal vit, Citrical +D. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 18Jan2021, he experienced Sore throat, post-nasal drainage, and rhinorrhea. The patient did not receive treatment for the events. The clinical outcome of the events Sore throat, post-nasal drainage, and rhinorrhea was not recovered without treatment. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient received second dose BNT162B2 on 19Jan2021 at 06:30 pm (lot number: EL8982),Intramuscular, anatomically located on the left arm.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Gingival erythema, Gingival swelling, Immediate post-injection reaction
Clinical narrative: Had covid after 19 days got the vaccine; Had covid after 19 days got the vaccine; immediately lightheaded dizzy; body aches; severe sore throat; gums swollen and red; gums swollen and red; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 15:15 at single dose for COVID-19 immunisation. Medical history included covid-19 (covid prior vaccination: Yes). No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID). No other vaccine in four weeks. The patient experienced side effects immediately lightheaded dizzy , body aches, severe sore throat, gums swollen and red on 15Jan2021, had covid after 19 days (as reported) got the vaccine. The events resulted in emergency room/department or urgent care. Events treatment included steroids and fluids. The outcome of events was not recovered. No covid tested post vaccination. The patient was not pregnant.  Information about Lot/Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported covid  based on the known safety profile.  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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: Had covid after 19 days got the vaccine; Had covid after 19 days got the vaccine; immediately lightheaded dizzy; body aches; severe sore throat; gums swollen and red; gums swollen and red; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 15:15 at single dose for COVID-19 immunisation. Medical history included covid-19 (covid prior vaccination: Yes). No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID). No other vaccine in four weeks. The patient experienced side effects immediately lightheaded dizzy , body aches, severe sore throat, gums swollen and red on 15Jan2021, had covid after 19 days (as reported) got the vaccine. The events resulted in emergency room/department or urgent care. Events treatment included steroids and fluids. The outcome of events was not recovered. No covid tested post vaccination. The patient was not pregnant.  Information about Lot/Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported covid  based on the known safety profile.  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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; headache; This is a spontaneous report from a non-contactable consumer. A 50-year-old female patient received received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular at single dose into the left arm on 20Jan2021 for COVID-19 immunization. Medical history and concomitant drugs were unknown. On 20Jan2021 the patient experienced sore arm and headache. No treatment for the events was received.  At the time of reporting the patient was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body aches; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; solution for injection; lot number: EJ1685; expiration date: unknown), intramuscular left arm on 30Dec2020 08:00 AM at a single dose for covid-19 immunization. Medical history included crohn's disease, asthma and has known allergies. The patient was not diagnosed with COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but had received other medications within 2 weeks of vaccination. The patient reported that approximately 12 hours (30Dec2020 08:00 PM) later after the first injection, she had some body aches. The outcome of the event was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3247) on left arm on 21Jan2021 10:00 AM at a single dose for COVID-19 immunization. Medical history included Penicillin allergy. Patient was not pregnant. Concomitant medications were not reported. No other vaccine administered in four weeks. No other medications administered in two weeks. Patient experienced sore arm on 21Jan2021 10:30 AM with outcome not recovered. No treatment was received. No COVID prior vaccination. No COVID tested post vaccination.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She had a tiny bit of soreness if she touched the vaccine injection site, but did not experience any soreness if she moved or lifted her arm; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 16Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had her first dose of the Pfizer COVID-19 Vaccine on Saturday, 16Jan2021, with no side effects. The patient stated that she had read in the past that taking 1 ibuprofen before and after the flu vaccine was recommended. She said she also had medical people tell her the same. She recently read a study where it is recommended a person shouldn't take ibuprofen before or after receiving the COVID-19 Vaccine because the ibuprofen might interfere with the vaccine's effectiveness. She said she is now in a bit of a quandary moving forward, as to if she should take any kind of analgesic, or Ibuprofen, or anything of that nature before getting her second COVID-19 Vaccine dose. She took 1 Advil prior to receiving her first dose of the COVID-19 Vaccine. She wanted to know if she should not take any ibuprofen before her second COVID-19 Vaccine dose. The patient reported further that on 16Jan2021, she had a tiny bit of soreness in her arm, only if she touched the COVID-19 Vaccine injection site. She does not experience any soreness if she moved or lift her arm. Outcome of the event was unknown.  Information on the batch/lot number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness and exhaustion after the vaccination; This is a spontaneous report received from a contactable consumer. A 37-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date: unknown), via an unspecified route of administration, on 21Jan2021, at single dose, for COVID-19 immunization, at the hospital. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 21Jan2021, the patient experienced tiredness and exhaustion after the vaccination. No treatment for the event was given. The outcome of the event was not recovered. The event was assessed as non-serious.