chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness and mild swelling at injection site; redness and mild swelling at injection site; sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5730), via intramuscular route of administration on the left arm on 18Dec2020 17:15, then the second dose via an unspecified route of administration on the left arm on  07Jan2021, both at single dose for COVID-19 immunization administered at hospital facility. Medical history included asthma, anxiety, vitamin d deficiency, eczema and rosacea, and known allergies: nickel and latex. Concomitant medications included influenza vaccine (FLU) on 11Nov2020 received within 4 weeks prior to the COVID vaccine; minocycline, cetirizine hydrochloride (ZYRTEC), ethinylestradiol, norgestrel (CRYSELLE), colecalciferol (VITAMIN D) , calcium, and vitamin b complex received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced redness and mild swelling at injection site, sore arm on 19Dec2020. The events were reported as non-serious and no treatment was given. The patient underwent COVID test/ nasal swab: negative on 24Nov2020. The outcome of the events was  recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Rash, SARS-CoV-2 test negative
Clinical narrative: rash developed on 50% of her body; vomiting; nausea; headache; severe muscle aches; This is a spontaneous report from a contactable nurse reported for herself. This 39-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via Intramuscular at left arm on 16Dec2020 at 01:00 PM at single dose (lot number: EK5730) for COVID-19 immunisation. Medical history was unknown. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), zolpidem tartrate (AMBIEN) and vitamins. The patient previously took dicycloverine hydrochloride (BENTYL), amlodipine and azithromycin (ZITHROMAX), all experiencing allergies. The patient experienced rash developed on 50% of her body, vomiting, nausea, headache, severe muscle aches 24 hours post vaccination on 17Dec2020 10:45 AM. The patient was treated with Benadryl, Tylenol, IM Solumedrol. The patient had Covid test post vaccination by Nasal Swab on 28Dec2020 and on 04Jan2021, both with negative results. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of all events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the rash and other reported events  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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: rash developed on 50% of her body; vomiting; nausea; headache; severe muscle aches; This is a spontaneous report from a contactable nurse reported for herself. This 39-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via Intramuscular at left arm on 16Dec2020 at 01:00 PM at single dose (lot number: EK5730) for COVID-19 immunisation. Medical history was unknown. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), zolpidem tartrate (AMBIEN) and vitamins. The patient previously took dicycloverine hydrochloride (BENTYL), amlodipine and azithromycin (ZITHROMAX), all experiencing allergies. The patient experienced rash developed on 50% of her body, vomiting, nausea, headache, severe muscle aches 24 hours post vaccination on 17Dec2020 10:45 AM. The patient was treated with Benadryl, Tylenol, IM Solumedrol. The patient had Covid test post vaccination by Nasal Swab on 28Dec2020 and on 04Jan2021, both with negative results. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of all events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the rash and other reported events  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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling in side of tongue at 10 minutes after vaccine/ tingling on right side of cheek at 45 minutes/ tingling on tongue & cheek; tingling on toes on right side of feet only/ tingling on foot; This is a spontaneous report from a contactable nurse (patient). A 39-year-old non-pregnant female nurse (patient) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular route of administration on the left arm on 29Dec2020 10:00 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no known allergies. Concomitant medications included multivitamins, ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), vitamin B complex, zinc, and curcuma longa (TURMERIC), all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient experienced tingling in side of tongue at 10 minutes after vaccine, tingling on right side of cheek at 45 minutes & tingling on toes on right side of feet only on 29Dec2020 10:15. The tingling on tongue & cheek went away, but she was still getting tingling on foot at times. This never happened to her before the vaccine. No treatment was given and events were reported as non-serious. The outcome of the event tingling on tongue & cheek was recovered on an unspecified date and of tingling on foot was not recovered. The patient had not been tested for COVID-19 since the vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Diarrhoea, Dizziness, Headache, Pain
Clinical narrative: tactile overstimulation?(having clothing or a blanket hurt and irritated my skin); Extreme headache; blurred vision at long distances; lightheadedness; occasional off balance; diarrhea; low grade fever; body aches; This is a spontaneous report from a contactable Nurse. This 33-year-old female Nurse (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), intramuscular on 05Jan2021 06:45 AM at single dose on left arm for COVID-19 immunisation. Medical history included hypertension (HTN), depression and anxiety. No known allergies. Concomitant medication included quetiapine fumarate (SEROQUEL), metoprolol, hydrochlorothiazide, lithium, alprazolam (XANAX), lamotrigine (LAMICTAL), folic acid / iron (PRENATAL), multivitamins [vitamins nos] (MULTIVITAMINS), melatonin, ibuprofen, paracetamol (TYLENOL). The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: Eh9899), intramuscular on 15Dec2020 07:30 AM on left arm for COVID-19 immunisation. The patient extreme headache with blurred vision at long distances (blurred vision resolved after 24 hours) lightheaded ness/occasional off balance, diarrhea, low grade fever, body aches, tactile overstimulation (having clothing or a blanket hurt and irritated her skin) on 06Jan2021 01:00 AM. No treatment was received for the events. The outcome of the event blurred vision at long distances was recovered in Jan2021. The outcome of other event was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin irritation, Vision blurred
Clinical narrative: tactile overstimulation?(having clothing or a blanket hurt and irritated my skin); Extreme headache; blurred vision at long distances; lightheadedness; occasional off balance; diarrhea; low grade fever; body aches; This is a spontaneous report from a contactable Nurse. This 33-year-old female Nurse (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), intramuscular on 05Jan2021 06:45 AM at single dose on left arm for COVID-19 immunisation. Medical history included hypertension (HTN), depression and anxiety. No known allergies. Concomitant medication included quetiapine fumarate (SEROQUEL), metoprolol, hydrochlorothiazide, lithium, alprazolam (XANAX), lamotrigine (LAMICTAL), folic acid / iron (PRENATAL), multivitamins [vitamins nos] (MULTIVITAMINS), melatonin, ibuprofen, paracetamol (TYLENOL). The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: Eh9899), intramuscular on 15Dec2020 07:30 AM on left arm for COVID-19 immunisation. The patient extreme headache with blurred vision at long distances (blurred vision resolved after 24 hours) lightheaded ness/occasional off balance, diarrhea, low grade fever, body aches, tactile overstimulation (having clothing or a blanket hurt and irritated her skin) on 06Jan2021 01:00 AM. No treatment was received for the events. The outcome of the event blurred vision at long distances was recovered in Jan2021. The outcome of other event was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dizziness, Feeling abnormal, Myalgia
Clinical narrative: Muscle pain; Dizzy; face swelling; Dry heaving; Neck swelling; hip pain, soreness, and his back and shoulders are sore as well, joint achiness; hip pain, soreness, and his back and shoulders are sore as well; hip pain, soreness, and his back and shoulders are sore as well.; brachial plexus origin there was a sharp stabbing pain shooting down; rash was all over his body, but mostly on his back; drowsy; injection sight swelling in his arm; he did kind of feel like something was sitting on his chest; This is a spontaneous report from a contactable consumer. This 36-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. Medical history included pre-existing back injury that caused neuropathy, damaged nerves, and chronic sciatica, all in 2009. There were no concomitant medications. On 05Jan2021, the consumer experienced muscle pain, joint achiness which got painful. He was dizzy. His girlfriend noticed a rash on his body. It was welted, but not itchy. His face and neck swelled up. He was dry heaving and couldn't throw up. He was given diphenhydramine hydrochloride (BENADRYL) and steroid shots in the ER. About 4.5 hours after the vaccine, the same day was when it all came on. At 8 o'clock, it got worse. The consumer had hip pain, soreness, and his back and shoulders are sore as well. He was dizzy and drowsy. At 11pm that night, his face was swollen and his neck was swollen. The rash was all over his body, but mostly on his back. He had injection sight swelling in his arm. At his brachial plexus origin there was a sharp stabbing pain shooting down his arm. It did go away. He recovered completely. That stabbing pain lasted from the 5th-6th. He has hip pain, soreness, and his back and shoulders were sore as well. They are ongoing, but improving. He has taken diphenhydramine hydrochloride (BENADRYL) and ibuprofen (MOTRIN). He has not had a fever. His neck still has a little swelling. He didn't have difficulty breathing. But he did kind of feel like something was sitting on his chest. He received a steroid. The consumer had to go to the ER visit. He was there over night from 05Jan2021 to 06Jan2021. The consumer went to get a free COVID test, and they had the vaccine available. The outcome of the event dizzy, face swelling, dry heaving, brachial plexus origin there was a sharp stabbing pain shooting down his arm was recovered on 06Jan2021. The outcome of muscle pain, neck swelling, hip pain, soreness, and his back and shoulders are sore as well, joint achiness was recovering. The outcome of other events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Rash, Retching, SARS-CoV-2 test
Clinical narrative: Muscle pain; Dizzy; face swelling; Dry heaving; Neck swelling; hip pain, soreness, and his back and shoulders are sore as well, joint achiness; hip pain, soreness, and his back and shoulders are sore as well; hip pain, soreness, and his back and shoulders are sore as well.; brachial plexus origin there was a sharp stabbing pain shooting down; rash was all over his body, but mostly on his back; drowsy; injection sight swelling in his arm; he did kind of feel like something was sitting on his chest; This is a spontaneous report from a contactable consumer. This 36-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. Medical history included pre-existing back injury that caused neuropathy, damaged nerves, and chronic sciatica, all in 2009. There were no concomitant medications. On 05Jan2021, the consumer experienced muscle pain, joint achiness which got painful. He was dizzy. His girlfriend noticed a rash on his body. It was welted, but not itchy. His face and neck swelled up. He was dry heaving and couldn't throw up. He was given diphenhydramine hydrochloride (BENADRYL) and steroid shots in the ER. About 4.5 hours after the vaccine, the same day was when it all came on. At 8 o'clock, it got worse. The consumer had hip pain, soreness, and his back and shoulders are sore as well. He was dizzy and drowsy. At 11pm that night, his face was swollen and his neck was swollen. The rash was all over his body, but mostly on his back. He had injection sight swelling in his arm. At his brachial plexus origin there was a sharp stabbing pain shooting down his arm. It did go away. He recovered completely. That stabbing pain lasted from the 5th-6th. He has hip pain, soreness, and his back and shoulders were sore as well. They are ongoing, but improving. He has taken diphenhydramine hydrochloride (BENADRYL) and ibuprofen (MOTRIN). He has not had a fever. His neck still has a little swelling. He didn't have difficulty breathing. But he did kind of feel like something was sitting on his chest. He received a steroid. The consumer had to go to the ER visit. He was there over night from 05Jan2021 to 06Jan2021. The consumer went to get a free COVID test, and they had the vaccine available. The outcome of the event dizzy, face swelling, dry heaving, brachial plexus origin there was a sharp stabbing pain shooting down his arm was recovered on 06Jan2021. The outcome of muscle pain, neck swelling, hip pain, soreness, and his back and shoulders are sore as well, joint achiness was recovering. The outcome of other events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Swelling, Swelling face, Vaccination site swelling
Clinical narrative: Muscle pain; Dizzy; face swelling; Dry heaving; Neck swelling; hip pain, soreness, and his back and shoulders are sore as well, joint achiness; hip pain, soreness, and his back and shoulders are sore as well; hip pain, soreness, and his back and shoulders are sore as well.; brachial plexus origin there was a sharp stabbing pain shooting down; rash was all over his body, but mostly on his back; drowsy; injection sight swelling in his arm; he did kind of feel like something was sitting on his chest; This is a spontaneous report from a contactable consumer. This 36-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. Medical history included pre-existing back injury that caused neuropathy, damaged nerves, and chronic sciatica, all in 2009. There were no concomitant medications. On 05Jan2021, the consumer experienced muscle pain, joint achiness which got painful. He was dizzy. His girlfriend noticed a rash on his body. It was welted, but not itchy. His face and neck swelled up. He was dry heaving and couldn't throw up. He was given diphenhydramine hydrochloride (BENADRYL) and steroid shots in the ER. About 4.5 hours after the vaccine, the same day was when it all came on. At 8 o'clock, it got worse. The consumer had hip pain, soreness, and his back and shoulders are sore as well. He was dizzy and drowsy. At 11pm that night, his face was swollen and his neck was swollen. The rash was all over his body, but mostly on his back. He had injection sight swelling in his arm. At his brachial plexus origin there was a sharp stabbing pain shooting down his arm. It did go away. He recovered completely. That stabbing pain lasted from the 5th-6th. He has hip pain, soreness, and his back and shoulders were sore as well. They are ongoing, but improving. He has taken diphenhydramine hydrochloride (BENADRYL) and ibuprofen (MOTRIN). He has not had a fever. His neck still has a little swelling. He didn't have difficulty breathing. But he did kind of feel like something was sitting on his chest. He received a steroid. The consumer had to go to the ER visit. He was there over night from 05Jan2021 to 06Jan2021. The consumer went to get a free COVID test, and they had the vaccine available. The outcome of the event dizzy, face swelling, dry heaving, brachial plexus origin there was a sharp stabbing pain shooting down his arm was recovered on 06Jan2021. The outcome of muscle pain, neck swelling, hip pain, soreness, and his back and shoulders are sore as well, joint achiness was recovering. The outcome of other events was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Pain in extremity, Pain in jaw, Vaccination site hypoaesthesia
Clinical narrative: felt numbness at the injection site; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; Throughout the day (Dated) it became increasingly difficult to turn my head in any direction and is very painful to move it to the left; This is a spontaneous report from a contactable other healthcare professional (patient).  A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration from 06Jan2021 14:15 (reported as "02:15 PM") at single dose on the left arm as COVID vaccine. The COVID-19 vaccine was administered in a workplace clinic. Medical history included gastrooesophageal reflux disease (GERD), Acid Reflux Disease, Pseudo Tumor and known allergies reported as "Known allergies: Sulfate Drug, Pertussis".  The patient's concomitant medications were not reported.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient reported that directly after the shot, she felt numbness at the injection site and stated "I realize this is normal and the shot was given properly and painlessly in the upper left arm) at approximately 2 am (12 hours after receiving the vaccine)". Patient woke up with moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line. Throughout the day on 07Jan2021, it became increasingly difficult to turn her head in any direction and was very painful to move it to the left. The events occurred on 07Jan2021 -2:00 AM. Events were assessed as non-serious. No treatment was received for the events. No Covid prior vaccination. The patient was not tested for COVID after/post vaccination. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Fever. T 101 F; The flu like symptoms lasted about 36 hours; headache; chills; Tiredness; Went to sleep early; This is a spontaneous report from a contactable Nurse.  A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 05Jan2021 14:00 for the 2nd dose at single dose, intramuscular on 18Dec2020 11:00 for the 1st dose at single dose for covid-19 immunisation.  Medical history included I am allergic to pollen, dust mite.  The patient experienced Four hours after 2nd shot, headache, chills. Tiredness. Went to sleep early. The next day still tiredness, headache , chills and fever. T 101 F. The flu like symptoms lasted about 36 hours. All events were non serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. 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 resolved.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Fever. T 101 F; The flu like symptoms lasted about 36 hours; headache; chills; Tiredness; Went to sleep early; This is a spontaneous report from a contactable Nurse.  A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 05Jan2021 14:00 for the 2nd dose at single dose, intramuscular on 18Dec2020 11:00 for the 1st dose at single dose for covid-19 immunisation.  Medical history included I am allergic to pollen, dust mite.  The patient experienced Four hours after 2nd shot, headache, chills. Tiredness. Went to sleep early. The next day still tiredness, headache , chills and fever. T 101 F. The flu like symptoms lasted about 36 hours. All events were non serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. 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 resolved.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Circumstance or information capable of leading to medication error, Feeling cold, Headache, Pyrexia
Clinical narrative: having pain in her ovaries; fever at 100.8°F; she is a little chilly; first dose on 20Dec2020/second dose on 09Jan2020; a little headache/got a headache again; This is a spontaneous report from a contactable Consumer (patient's husband). A 69-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced having pain in her ovaries on an unspecified date with outcome of not recovered, a little headache/got a headache again on 27Dec2020, fever at 100.8°F and she is a little chilly on an unspecified date, all with outcome of unknown.  The patient got the first dose of COVID-19 vaccine on 20Dec2020, and she was supposed to get the second dose on 09Jan2020. On the 7th day after the patient got the vaccine, she got a little headache and then two or three days ago, she got a headache again, and she is a little chilly. The patient had a mild fever of 100.8°F. The patient was also having pain in her ovaries and she still had that pain at this time. The patient rated the pain as varying from a 7 to a 5 to a 3 on a pain scale. Because of this ovarian pain, the patient may have another type of infection but they are not sure. The patient no longer had a period, she was after menopause. The reporter asked for recommendations on receiving the second dose if symptoms are still present, and if positive to a COVID-19 test. The patient would get tested at the hospital where they work.   Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching, moderate itching, no rash, mostly on torso and legs /started on right leg and has worsened and spread; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686), intramuscular on 05Jan2021 10:30 at single dose on left upper arm as Covid vaccine. Medical history included hypertension from an unknown date and unknown if ongoing.  There were no concomitant medications.  The patient stated that she was inoculated on 05Jan2021 with the COVID-19 vaccine at 10:30 AM in left upper arm. On 07Jan2021 (this morning), she was having a side effect that was not listed on information provided to her.  She was itching, moderate itching, no rash, mostly on torso and legs and has taken some hydroxyzine 50mg to see if that would help stop the issues. Patient had a call with PCP today as well, started on right leg and has worsened and spread. Patient works in human resources for one of the hospitals. which is why she was able to get the vaccine. Patient had no pain at injection site or any other issues. Outcome of the event was not recovered (reported as "itching was reported as worsened"; ongoing).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Pain, Pyrexia
Clinical narrative: body ache; High grade fever (102); rigors; malaise; This is a spontaneous report from a Non-contactable Physician. A 34 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 05Jan2021 12:00 at the second single dose (lot number EL0142), via an unspecified route of administration on 15Dec2020 17:00 at the first single dose (lot number EK5730) for covid-19 immunisation.  Vaccination location was Left arm. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced body ache, high grade fever (102), rigors, malaise on 05Jan2021 18:00. The patient did not receive any treatment for the events. The outcome of events was recovered in Jan2021.    No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Severe, intractable daily migraine headaches that escalate throughout the day; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received bnt162b2 (BNT162B2) lot no: RH 9899, via an unspecified route of administration in left arm on 16Dec2020 at a single dose for Covid-19 immunization in hospital. The patient had no relevant medical history. The patient was not pregnant at the time of vaccination. Concomitant medication included vilazodone hydrochloride (VIIBRYD), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), lamotrigine (LAMICTAL), trazodone, and lorazepam (ATIVAN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 17Dec2020 06:00, the patient experienced severe, intractable daily migraine headaches that escalate throughout the day and do not respond to any treatment, medicinal or non medicinal (unspecified).  The event was reported as non-serious. The event resulted in doctor or other healthcare professional office/clinic visit. The patient had not recovered from the event. The patient received another bnt162b2 dose (lot no: EK 4176) on 06Jan2021 in left arm.  Information on the batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Body aches; Fever; Chills; Nausea; This is a spontaneous report from a contactable healthcare professional (HCP), the patient. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the left arm on 06Jan2021 at 09:15 (at the age of 37-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included IBS (irritable bowel syndrome) and known allergies possibly penicillin related drugs. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Jan2021 at 21:00, the patient experienced body aches, fever, chills, and nausea. No treatment was provided for the events body aches, fever, chills, and nausea. The outcome of the events body aches, fever, chills, and nausea was recovering. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; Headache; Sinus congestion; This is a spontaneous report from a contactable consumer reported for himself. A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9899 and expiration date unknown), via intramuscular on left arm on 22Dec2020 at single dose for COVID-19 prophylaxis. The patient medical history reported as none. Concomitant medications reported as none. The patient is a radiology technician that reported that he got the Pfizer vaccine on the 22Dec2020. He said that he got a positive Covid test on 04Jan2021. The patient had the Covid symptoms as of last Monday night on 04Jan2021. He stated that he developed a headaches and sinus congestion on the 04Jan2021. Stated that he has not had a fever. He said that there was no adverse reaction from the vaccine itself. He said that he was due for the second dose on the 11Jan2021 and he is currently quarantined so he will not be getting the second dose. The outcome of the events was unknown.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Oropharyngeal pain, Pain
Clinical narrative: Chills; body ache; malaise; headache; sore throat; This is a spontaneous report from a non-contactable other hcp (patient). A 25-year-old female patient received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 06Jan2021 15:30 at single dose for covid-19 immunization. Medical history was none. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), escitalopram oxalate (LEXAPRO). The patient experienced Chills, body ache, malaise, headache, sore throat on 07Jan2021. Patient was not received treatment for the adverse event. Patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: two staff members who tested positive for covid after receiving the first dose.; two staff members who tested positive for covid after receiving the first dose.; This is a spontaneous report from the Pfizer Sponsored Program called 'Pfizer First Connect' received by a contactable pharmacist. This pharmacist reported similar events for 2 staff members. This is 2nd of 2 reports.   A patient (demographics unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, in Dec2020 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On unknown date, after first shot of vaccine, COVID test resulted positive. The reporting pharmacist is asking about the recommendation regarding taking the second shot. The outcome of the event was unknown.  Information about Batch/Lot number has been requested.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded. ,Linked Report(s) : US-PFIZER INC-2021010495 Same reporter/ drug/ event for different patients.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hot flush, Pain, Pruritus, Pyrexia
Clinical narrative: Fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on side of injection with no rash; fatigue; This is a spontaneous report from a contactable other hcp (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1284) intramuscularly at right arm on 06Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included known allergies to opiate derivatives and penicillin. Concomitant medication included clopidogrel, sertraline, simvastatin. The patient previously received first dose of bnt162b2 (lot number: ELC5730) intramuscularly at right arm on 18Dec2020 13:00 at single dose for COVID-19 immunization. The patient experienced fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on side of injection with no rash; fatigue, all on 07Jan2021 01:30. No treatment received. This is a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pain
Clinical narrative: Severe body aches; headache; nausea; diarrhea; exhaustion; This is a spontaneous report from a contactable nurse. A 49-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 06Jan2021 16:30 at the first single dose for covid-19 immunisation.  Medical history included ongoing hypertension , ongoing hypothyroidism , ongoing blood cholesterol increased , Known allergies: Sulfa.  The patient's concomitant medications were not reported.  The patient experienced severe body aches, headache, nausea, diarrhea, exhaustion on 07Jan2021 03:00.  The patient did not receive any treatment for the events. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient reported arm pain post vaccine.; This is a spontaneous report from a non-contactable consumer. An adult female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiration date were not reported), intramuscularly on an unspecified date at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient reported arm pain post vaccine. The event was considered non-serious by the consumer. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Lymphadenopathy
Clinical narrative: swollen lymph nodes; feeling of fullness in ears; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899 and expiry date unknown) intramuscular at the right arm on 21Dec2020 14:30 at single dose for Covid-19 immunization in a hospital. The patient's medical history was not reported. The patient has no COVID prior vaccination. Concomitant medication included paracetamol (TYLENOL), ibuprofen, famotidine (PEPCID [FAMOTIDINE]) and ethinylestradiol, norgestimate (TRI FEMYNOR); all from unspecified date for unspecified indication. The patient has no other vaccine in four weeks. On 21Dec2020 15:45, the patient experienced swollen lymph nodes and feeling of fullness in ears. The patient was not COVID tested post vaccination. The patient did not received treatment for the events. The outcome of the events swollen lymph nodes and feeling of fullness in ears was recovering. The reporter considered the event non-serious; which did not result in death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating and no congenital anomaly/birth defect.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Insomnia, Myalgia, Pyrexia
Clinical narrative: mild muscle aches; Injection site soreness; feverish; headache; insomnia; restlessness; This is a spontaneous report from a contactable Physician reporting for herself. A 32-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231) via an unspecified route of administration, in left arm, on 07Jan2021 at 11:15 at single dose for COVID-19 immunisation. Age at vaccination was 32 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685) was received via an unspecified route of administration on 21Dec2020 at 09:00 in left arm at single dose. Medical history included major depression, and generalised anxiety. The patient had no known allergies to medications, food, or other products. Concomitant medications included escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN) and daily fusion multivitamin. On 08Jan2021 at 01:00 AM the patient experienced injection site soreness, feverish, headache, insomnia, restlessness, mild muscle aches. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The outcome of the events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, Vaccination site pain
Clinical narrative: mild muscle aches; Injection site soreness; feverish; headache; insomnia; restlessness; This is a spontaneous report from a contactable Physician reporting for herself. A 32-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231) via an unspecified route of administration, in left arm, on 07Jan2021 at 11:15 at single dose for COVID-19 immunisation. Age at vaccination was 32 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685) was received via an unspecified route of administration on 21Dec2020 at 09:00 in left arm at single dose. Medical history included major depression, and generalised anxiety. The patient had no known allergies to medications, food, or other products. Concomitant medications included escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN) and daily fusion multivitamin. On 08Jan2021 at 01:00 AM the patient experienced injection site soreness, feverish, headache, insomnia, restlessness, mild muscle aches. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The outcome of the events was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Malaise, Nausea, SARS-CoV-2 test
Clinical narrative: not feeling well overall; nausea; diarrhea; chills; This is a spontaneous report from a contactable Pharmacist (patient).  This 41-Year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL0140), via an unspecified route of administration, on 06Jan2021 at 01:30 PM at single dose for COVID-19 immunisation. Vaccine location was Left arm. The patient was vaccinated at hospital, age at vaccination was 41-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included sambucus nigra (ELDERBERRY), colecalciferol (VITAMIN D), camellia sinensis (GREEN TEA). On 08Jan2021 at 12:00 AM, the patient experienced nausea, diarrhea, chills, not feeling well overall. The events were reported as non-serious. The patient was tested for Covid post vaccination however it was also reported that she was not tested (to be clarified). Outcome was recovering. No treatment was received for the events.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Pain in extremity
Clinical narrative: Sore arm; increase in temperature; This is a spontaneous report from a non-contactable other healthcare professional (reported for herself). This 69- year-old female patient (reported for herself) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EK423), via an unspecified route of administration, on 05Jan2021 at 10:30 AM (at the age of 69-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. The patient did not have any allergies to medications, food, or other products. The patient does not have any medical history. The patient was not taking any concomitant medications. The patient did not receive any medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jan2021 at 04:00 AM, she experienced a sore arm and an increase in temperature. The patient did not receive treatment for the events. The clinical outcome of the events sore arm and an increase in temperature was recovered. Patient was not tested for COVID-19 since having the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever 100; injection site pain; Moderate body aches; Chills; This is a spontaneous report from a contactable nurse (patient). A 31-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 07Jan2021 10:30 at single dose in left arm for covid-19 immunization. Medical history included asthma and depression. The patient had no allergies to medications, food, or other products. Concomitant medications the patient received within 2 weeks of vaccination included celecoxib (CELEXA) and bupropion. The patient previously received her first dose of bnt162b2 on 18Dec2020 15:00 at the age of 31-years in her left arm for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced moderate injection site pain, moderate body aches, chills and fever 100 on 07Jan2021 22:00. The patient was not received any treatments for the adverse events. The outcome of the events was not recovered.   Information about lot/batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: Towards 3:00 pm I noticed I had a fever of 100.0; I started to feel body aches and fatigue around 2:00 am the next day; I started to feel body aches and fatigue around 2:00 am the next day; This is a spontaneous report from a contactable Other Health Professional (patient). A 34-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EK9231, via an unspecified route of administration in the left arm on 05Jan2021 at a single dose for an  COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient had no known allergies. The patient's historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE (lot number: EH9899) administered on 18Dec2020 12:00 PM, via intramuscular in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He was not diagnosed with COVID-19 prior to vaccination. He has not been tested for COVID-19 since the vaccination. The patient did not feel anything after receiving the vaccine on 05Jan2021. He started to feel body aches and fatigue around 2:00 am the next day (06Jan2021). Towards 3:00 pm, he noticed that he had a fever of 100.0 (unspecified unit). He took some TYLENOL and slept most of the day. He woke up Thursday morning feeling great. The patient recovered from 'body aches and fatigue' and 'fever of 100.0' on an unknown date in Jan2021. The events were reported as non-serious. Therapeutic measures were taken as a result of the events.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Pyrexia
Clinical narrative: chills; fever up to 102; diarrhea; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: ek5730, expiration date: unknown), intramuscularly on the right arm on 18Dec2020 at 16:15 at a single dose for COVID-19 immunization administered at the hospital. The patient's medical history and concomitant medications were not reported. The patient previously took codeine, for which she had known allergies. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Dec2020 at 19:00, the patient experienced chills, fever up to 102, and diarrhea. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of chills, fever up to 102, and diarrhea as she talked to her family physician. The patient recovered from all the events on an unspecified date.