chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hyperventilation, Malaise, Rash macular
Clinical narrative: Abdominal discomfort; Abdominal pain; Lightheaded/Dizzy; Having trouble taking deep breaths/couldn't breath; Sweating; Hyperventilating; Developed blotchy skin; Shaking; Headache; Vomited; A spontaneous report (United States) was received from a health care professional concerning a 50-year-old, female patient who received Moderna's COVID-19 vaccine and experienced abdominal discomfort, abdominal pain, lightheaded/dizzy, having trouble taking deep breaths/couldn't breathe, sweating, hyperventilating, developed blotchy skin, shaking, headache, and vomited.   The patient's medical history included current conditions of mild osteopenia, gastroesophageal reflux disease, anemia, and allergic reaction (anaphylaxis) to metoclopramide. Concomitant products known to have been used by the patient, within two weeks prior to the event, included cefixime, ibuprofen, omeprazole, estradiol, and hydrocodone bitartrate, paracetamol.     On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) in their left arm for prophylaxis of COVID-19 infection.   On 22 Dec 2020, the patient told a medical assistant in the waiting area that she felt ill to her stomach and she was having trouble taking deep breaths. The patient was found in a nearby bathroom sitting on the floor. She had vomited, reported she was lightheaded, couldn't breath, was shaking, had abdominal discomfort, and was sweating. It was attempted to move the patient to a wheelchair, but she did not respond well to the transfer. The patient reported the symptoms worsening: headache, abdominal pain, and developed blotch skin, hyperventilating, and was dizzy. A code blue was called and the patient was given a 0.5mg Epinephrine injection. The patient was sent to the emergency room. Treatment for the event included 0.5mg Epinepherine injection, famotidine, ondansetron HCl, prednisone 60mg, and lorazepam 1mg intravenously.   Action taken with mRNA-1273 in response to the events was not provided.  The events abdominal discomfort, abdominal pain, lightheaded/dizzy, having trouble taking deep breaths/couldn't breathe, sweating, hyperventilating, developed blotchy skin, shaking, headache, and vomited were considered not resolved.; Reporter's Comments: This case concerns a 50 year old female patient with medical history of mild osteopenia, gastroesophageal reflux disease, anemia, and allergic reaction (anaphylaxis) to metoclopramide, who experienced events of Abdominal discomfort, Abdominal pain, Dizziness, Dyspnoea, Hyperhidrosis, Hyperventilation, Rash macular, Tremor, Headache, and Vomiting following their first of two planned doses of mRNA-1273 (Lot number: 011J20A). The patient was found ill in the waiting room after leaving clinic prior to completing 15 minute observation time. Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Abdominal discomfort; Abdominal pain; Lightheaded/Dizzy; Having trouble taking deep breaths/couldn't breath; Sweating; Hyperventilating; Developed blotchy skin; Shaking; Headache; Vomited; A spontaneous report (United States) was received from a health care professional concerning a 50-year-old, female patient who received Moderna's COVID-19 vaccine and experienced abdominal discomfort, abdominal pain, lightheaded/dizzy, having trouble taking deep breaths/couldn't breathe, sweating, hyperventilating, developed blotchy skin, shaking, headache, and vomited.   The patient's medical history included current conditions of mild osteopenia, gastroesophageal reflux disease, anemia, and allergic reaction (anaphylaxis) to metoclopramide. Concomitant products known to have been used by the patient, within two weeks prior to the event, included cefixime, ibuprofen, omeprazole, estradiol, and hydrocodone bitartrate, paracetamol.     On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) in their left arm for prophylaxis of COVID-19 infection.   On 22 Dec 2020, the patient told a medical assistant in the waiting area that she felt ill to her stomach and she was having trouble taking deep breaths. The patient was found in a nearby bathroom sitting on the floor. She had vomited, reported she was lightheaded, couldn't breath, was shaking, had abdominal discomfort, and was sweating. It was attempted to move the patient to a wheelchair, but she did not respond well to the transfer. The patient reported the symptoms worsening: headache, abdominal pain, and developed blotch skin, hyperventilating, and was dizzy. A code blue was called and the patient was given a 0.5mg Epinephrine injection. The patient was sent to the emergency room. Treatment for the event included 0.5mg Epinepherine injection, famotidine, ondansetron HCl, prednisone 60mg, and lorazepam 1mg intravenously.   Action taken with mRNA-1273 in response to the events was not provided.  The events abdominal discomfort, abdominal pain, lightheaded/dizzy, having trouble taking deep breaths/couldn't breathe, sweating, hyperventilating, developed blotchy skin, shaking, headache, and vomited were considered not resolved.; Reporter's Comments: This case concerns a 50 year old female patient with medical history of mild osteopenia, gastroesophageal reflux disease, anemia, and allergic reaction (anaphylaxis) to metoclopramide, who experienced events of Abdominal discomfort, Abdominal pain, Dizziness, Dyspnoea, Hyperhidrosis, Hyperventilation, Rash macular, Tremor, Headache, and Vomiting following their first of two planned doses of mRNA-1273 (Lot number: 011J20A). The patient was found ill in the waiting room after leaving clinic prior to completing 15 minute observation time. Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Incorrect product administered; A spontaneous report was received from a Moderna employee concerning a patient who received Regeneron's COVID-19 monoclonal antibody treatment instead of Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, product administration error.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received Regeneron's COVID-19 monoclonal antibody treatment intramuscularly instead of Moderna's COVID-19 vaccine (mRNA-1273).  No treatment information was provided.   There was no change planned to the dosing schedule of mRNA-1273 in response to the event. The patient would receive priority access to the first dose of mRNA-1273.   The event, product administration error, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of Product administration error (incorrect product administered) for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of Product administration error (incorrect product administered).
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Anaphylactoid reaction, COVID-19, Dyspnoea, Heart rate increased
Clinical narrative: Like an anaphylactic reaction; Tested positive for Covid 19; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced the events, tested positive for COVID-19 and like an anaphylactic reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the next day following vaccine administration, the patient began to experience increased pulse, acceleration in her heart beat, difficulty breathing, and other symptoms like an anaphylactic reaction. The patient also tested positive for COVID-19, although she was asymptomatic prior to receiving the mRNA-1273 vaccine. Treatment for the event included intramuscular Benadryl.   Action taken with mRNA-1273 in response to the events was not reported.  The events, tested positive for COVID-19 and like an anaphylactic reaction, were unknown.; Reporter's Comments: This case concerns a female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot unknown),  and who experienced the serious unlisted event of Anaphylactic reaction and the non-serious unlisted event of SARS-CoV-2 test positive. Very limited information regarding this event of anaphylactic reaction has been provided at this time.  Based on improvement of symptoms after treatment with Benadryl and temporal association between the use of the product and the start date of the event on the day following vaccination, a causal relationship cannot be excluded making the event of anaphylactic reaction possibly related to the vaccine.  Based on the latency of infection with SARS-CoV-2 prior to testing positive for the virus, the temporal association between the use of the product and the start date of the event tested positive for COVID-19 on the day following vaccination, the event is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test positive, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Like an anaphylactic reaction; Tested positive for Covid 19; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced the events, tested positive for COVID-19 and like an anaphylactic reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the next day following vaccine administration, the patient began to experience increased pulse, acceleration in her heart beat, difficulty breathing, and other symptoms like an anaphylactic reaction. The patient also tested positive for COVID-19, although she was asymptomatic prior to receiving the mRNA-1273 vaccine. Treatment for the event included intramuscular Benadryl.   Action taken with mRNA-1273 in response to the events was not reported.  The events, tested positive for COVID-19 and like an anaphylactic reaction, were unknown.; Reporter's Comments: This case concerns a female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot unknown),  and who experienced the serious unlisted event of Anaphylactic reaction and the non-serious unlisted event of SARS-CoV-2 test positive. Very limited information regarding this event of anaphylactic reaction has been provided at this time.  Based on improvement of symptoms after treatment with Benadryl and temporal association between the use of the product and the start date of the event on the day following vaccination, a causal relationship cannot be excluded making the event of anaphylactic reaction possibly related to the vaccine.  Based on the latency of infection with SARS-CoV-2 prior to testing positive for the virus, the temporal association between the use of the product and the start date of the event tested positive for COVID-19 on the day following vaccination, the event is assessed as unlikely related to mRNA-1273.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Hypersensitivity, Rash
Clinical narrative: Allergic reaction; Rash on the left side of face; A spontaneous report was received from a consumer, who was a 56-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, allergic reaction and rash on the left side of face.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included hydroxychloroquine.  On 02 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 02 Jan 2021, within a few minutes of vaccine administration, the patient developed an allergic reaction. She had a rash on the left side of her face that was still ongoing. Treatment for the event included 50mg diphenhydramine.     Action taken with mRNA-1273 in response to the events was unknown. The patient inquired whether she should get the second dose or not, since she was scheduled for second dose on 30 Jan 2021.  The outcome of the events, allergic reaction and rash on the left side of face, was considered not resolved.; Reporter's Comments: Company comment: This case concerns a 56-year-old female patient, who experienced unexpected events of allergic reaction and rash on the left side of her face. The event occurred on the same day within a few minutes after the administration of the first dose of the Moderna COVID-19 vaccine administered.  De-challenge and re-challenge were not applicable. Based on the strong temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Muscle spasms, Myalgia
Clinical narrative: Muscle pain, from lower back down.; I had no feeling at all below the waist; fatigue; Muscles would feel like they were seizing up and clenching throughout the night; This is a spontaneous report from a contactable nurse. A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , via an unspecified route of administration in left arm on 07Jan2021 18:30 at a single dose for COVID-19 immunization. The vaccine was administered in a hospital. Medical history included Von Willebrand's disease. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included ibuprofen. On 07Jan2021 23:00, the patient experienced muscle pain, from lower back down, Muscles would feel like they were seizing up and clenching throughout the night, for a short time she had no feeling at all below the waist and incredible fatigue. The outcome of the events was not recovered. The patient was not tested for COVID-19 post vaccination. The events was assessed as non-serious by the nurse. The patient did not received any treatment for the events.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Malaise, Nasopharyngitis
Clinical narrative: Cold- sore throat; Cold- sore throat; Sick/ She is sick as a dog; This is a spontaneous report from a contactable consumer (patient).  This female patient with unspecified age received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on 06Jan2021 (age was unknown at the time of vaccine) as single dose, for immunization. Medical history included she is in between major surgeries (unspecified) and ongoing, and when she took the vaccine she was already coming down with a cold - sore throat.  Concomitant medications were reported.  On Jan2021 patient feels 'more sick/sick as a dog' following vaccination. She knew she probably shouldn't have taken the vaccine given she felt a cold coming on but she took it anyway.  She believes it is only a cold as her husband came down with a cold as well and tested negative for Covid.  She states she doesn't believe the vaccine has anything to do with her cold. She was asking if she took an 'antibx' (if prescribed by her hcp) would it interfere with vaccine at all. The outcome of events Cold was unknown, for sore throat was unknown, and for Sick/ She is sick as a dog was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Cold - sore throat worsened is not related to the vaccine use but represents the progression of the pre-existing medical condition.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Headache, Myalgia
Clinical narrative: mild headache/splitting headache; soreness; soreness/progressive muscle soreness in the posterior chain (shoulder, back, traps); soreness/progressive muscle soreness in the posterior chain (shoulder, back, traps); lack of energy; soreness/progressive muscle soreness in the posterior chain (shoulder, back, traps); This is a spontaneous report from a contactable other healthcare professional (patient). A male patient of an unspecified age (28, unit unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first dose of the Covid vaccine on 23Dec2020, initial symptoms include mild headache and soreness. In the next 5 days symptoms got worse, including progressive muscle soreness in the posterior chain (shoulder, back, traps), splitting headache, lack of energy. Got better in the following 5 days. Outcome of events was recovering. This report is considered as non-serious.   Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: mild headache/splitting headache; soreness; soreness/progressive muscle soreness in the posterior chain (shoulder, back, traps); soreness/progressive muscle soreness in the posterior chain (shoulder, back, traps); lack of energy; soreness/progressive muscle soreness in the posterior chain (shoulder, back, traps); This is a spontaneous report from a contactable other healthcare professional (patient). A male patient of an unspecified age (28, unit unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first dose of the Covid vaccine on 23Dec2020, initial symptoms include mild headache and soreness. In the next 5 days symptoms got worse, including progressive muscle soreness in the posterior chain (shoulder, back, traps), splitting headache, lack of energy. Got better in the following 5 days. Outcome of events was recovering. This report is considered as non-serious.   Information about batch/lot number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; body aches; severe nausea; This is a spontaneous report from a contactable healthcare professional reporting for self.  A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 02Jan2021 at 12:00 PM (Dose 1) as a single dose in the left arm  (age at vaccination: 45 years old) for COVID-19 immunization.  There was no relevant medical history.  She did not have COVID prior to vaccination. There were no allergies to medications, food, or other products. The patient's concomitant medications were not reported; there were no other medications taken in the 2 weeks prior.  The patient received the COVID vaccine at 12:00 PM on 02Jan2021. Exactly 12 hours later, on 03Jan2021 at 12:00 AM, she began having a fever, body aches, and severe nausea. This had continued all week. The patient was COVID tested post-vaccination on 04Jan2021 via nasal swab with a negative result. "Yesterday" (as of 08Jan2021) she went to immediate care (physician office)  and the doctor said that she had a bad reaction to the vaccine and shouldn't be having fevers every day and if they continue she may need to go to the emergency room. She was tested for other illnesses and everything was negative. Therapeutic measures were taken as a result of severe nausea and included ondansetron (ZOFRAN). The outcome of the events fever, body aches, and severe nausea was recovering. She reported the events as non-serious and confirmed there was no hospitalization.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tension headache
Clinical narrative: headaches; headache was not that bad, it was kind of a tension headache; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 08Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for Covid-19 immunization. The patient received her second dose of the Covid vaccine and was told not to take Tylenol. She was not told anything of what not to take on the first dose. She was currently having headaches and wanted to know what she can take since she was told not to take Tylenol. The patient informed that her headache was not that bad, it was kind of a tension headache. The patient did not think it was involved with the vaccine. Her headache was not that bad and she can live with it. The patient just wanted to know if it was not recommended to take Tylenol. The patient was advised to contact healthcare professional. The events was considered non-serious.  Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Based on the information provided, the possible contribution of suspect BNT162B2 to the events headache and tension headache cannot be totally excluded.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Occupational exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose on 23Dec2020 and was subsequently exposed at work to the virus and became symptomatic and tested positive on 31Dec2020. Her next scheduled dose is on Sunday, they may have to reschedule. The patient queried on how long should they delay the next dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31Dec2020. The outcome of the events was unknown.  Information about Lot/Batch number is requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of suspected Covid-19 infection and suspected LOE due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: intense headache; achiness; fever; This is a spontaneous report from a contactable consumer. A 33-year-old male patient started to receive bnt162b2, via an unspecified route of administration in the right arm from 06Jan2021 13:00 at a SINGLE DOSE for covid-19 immunization. Patient has no relevant medical history. Historical vaccine included bnt162b2 on16Dec2020 for covid-19 immunization (1st dose).  The patient's concomitant medications were not reported.  About 12 hours after 2nd dose on 07Jan2021, intense headache, achiness, and fever which lasted acutely for another 24 hours, and continues to persist moderately. Resulted in needing to take day off of work. The outcome of events was recovering. No treatment received due to events.  Information about Lot/batch number is requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Nausea, Palpitations, Tinnitus
Clinical narrative: Ringing in ears; Nausea; Heart palpitations; heart rate elevated to 163; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the right arm on 07Jan2021 12:30 at single dose for COVID-19 immunisation. Medical history included asthma. The patient was not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT), levothyroxine sodium (SYNTHROID), montelukast sodium (SINGULAIR), and paracetamol (TYLENOL). The patient previously took first dose of bnt162b2 (lot number: EH9899, expiry date not reported) in the left arm on 17Dec2020 at 12:30 at single dose for COVID-19 immunisation. The patient previously took amoxicillin and experienced allergies. On 07Jan2021 16:45, the patient experienced ringing in ears, nausea, heart palpitations, and heart rate elevated to 163. Clinical outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: fainting spell; almost passed out; dizzy spells; weak; This is a spontaneous report from a contactable consumer (patient herself). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), via an unspecified route of administration on 07Jan2021 in right upper arm shoulder area at single dose for prevent covid. Medical history included ongoing acne. Concomitant medication included doxycycline from 2020 (taking it 6 months ago) and ongoing for acne. Patient stated that she got the Covid vaccine yesterday 07Jan2021 and almost passed out in her kitchen after a couple hours. Patient stated got in shower had dizzy spells and was weak 07Jan2021, she felt better now. Patient stated that she was a small girl of 105 pounds and the dose could have made her sick. She wanted to make sure she did not need to go and be seen. Patent had another spell in shower this morning and stated that the fainting spell and feeling weak started at 9:00 yesterday evening on 07Jan2021. Outcome of dizzy spells was recovering, and outcome of other events were unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Fatigue, Mucosal disorder, Myalgia
Clinical narrative: Body chills; fever that went up to 100.4 degrees F.; fatigue; excess mucus; bone pain 10/10; muscle pain 8/10; other vaccine same date vaccine date 05Jan2021; This is a spontaneous report from a contactable other health professional (patient). A 66-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. Medical history included DM type 2, hypertension (HTN), fibromyalgia, chronic asthma, Covid prior vaccination, No Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered at Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other vaccine same date included other vaccine same date product was Pfizer, other vaccine same date vaccine date 05Jan2021. On 06Jan2021, the patient experienced Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus. No treatment received for the adverse events Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus. The events were non-serious per the reporter. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus was recovering.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bone and muscle pain cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body chills; fever that went up to 100.4 degrees F.; fatigue; excess mucus; bone pain 10/10; muscle pain 8/10; other vaccine same date vaccine date 05Jan2021; This is a spontaneous report from a contactable other health professional (patient). A 66-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. Medical history included DM type 2, hypertension (HTN), fibromyalgia, chronic asthma, Covid prior vaccination, No Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered at Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other vaccine same date included other vaccine same date product was Pfizer, other vaccine same date vaccine date 05Jan2021. On 06Jan2021, the patient experienced Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus. No treatment received for the adverse events Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus. The events were non-serious per the reporter. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus was recovering.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bone and muscle pain cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: done in his left arm, and it was a little sore; slight headache; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiration date were not reported) via an unspecified route of administration on the left arm on 04Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies: dust, pollen, grass, and trees. The patient's concomitant medications were not reported. He received first shot on 04Jan2021, 5 days ago. He has had no bad reactions. He was happy to report. He then stated it was done in his left arm, and it was a little sore. He also had a slight headache that first evening which was unusual for him. So far so good. He was due for his regular allergy shot which he generally gets every 2-3 weeks for dust, pollen, grass, and trees. He lived in (City) and has pretty good allergies. It is said on the allergy shot not to have a flu shot within 72 hours of getting the allergy shot, so he was just wondering if it will be safe for him to have the allergy shot within approximately 120 hours of receiving the Pfizer COVID vaccine. "Is it safe or advisable to have his allergy shot done today when it has only been 5 days since getting the COVID vaccine? Is he putting himself at any kind of risk?" He did not have the name of the allergy shot to provide. He said it is just an injection of a little bit of the allergen. He is not a health provider. He was on the early receiving end of the vaccine because he was a hospital volunteer and works in PACU. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Lymphadenopathy, Nausea, Off label use
Clinical narrative: Joint pain; Low grade fever; Nausea; Redness at injection site; Pain at injection site; Warmth at injection site; Mild swelling in distal hand of injection; Moldy swollen axillary lymph nodes; received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021; received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021; This is a spontaneous report from a contactable Nurse(patient). A 35-year-old female patient received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021 16:00 at the 35 years old at single dose for COVID-19 immunization.  The medical history included PCOS, depression. The patient was not Allergies to medications, food, or other products. The concomitant medications were bupropion and venlafaxine. The patient previously took first dose BNT162B2 (lot number EK5730) on 21Dec2020 at 35 years old at Left arm for COVID-19 immunization. On 08Jan2021 08:00 the patient experienced Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes.  There was no treatment received for the adverse events Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes was not recovered.  The information on the batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Joint pain; Low grade fever; Nausea; Redness at injection site; Pain at injection site; Warmth at injection site; Mild swelling in distal hand of injection; Moldy swollen axillary lymph nodes; received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021; received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021; This is a spontaneous report from a contactable Nurse(patient). A 35-year-old female patient received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021 16:00 at the 35 years old at single dose for COVID-19 immunization.  The medical history included PCOS, depression. The patient was not Allergies to medications, food, or other products. The concomitant medications were bupropion and venlafaxine. The patient previously took first dose BNT162B2 (lot number EK5730) on 21Dec2020 at 35 years old at Left arm for COVID-19 immunization. On 08Jan2021 08:00 the patient experienced Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes.  There was no treatment received for the adverse events Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes was not recovered.  The information on the batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pain
Clinical narrative: Chills; aches; lethargy; This is a spontaneous report from a contactable other healthcare professional. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EL0142 ), intramuscular in the left arm on 07Jan2021 18:15 at a single dose for covid-19 immunization. The patient had no medical history included. Patient has no allergies to medications, food, or other products. There were no concomitant medications. On 08Jan2021, the patient experienced chills, aches and lethargy. The outcome of the events was recovering on 08Jan2021 at 11:00. The patient was vaccinated in a hospital. Patient has no other medications received within 2 weeks of vaccination. Patient has not been diagnosed with COVID-19 prior to vaccination and has not been been tested for COVID-19 since vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Feeling cold, Headache, Pyrexia
Clinical narrative: cough; headache; feel cold; fever; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller said he should get the second dose tomorrow 09Jan2021, asked if the date was correct. Caller said he received the 1st dose on 19Dec2020.At the end of the call he mentioned he "had symptoms", had a "headache, feel cold and fever". Caller confirmed he no longer had these side effects "but have cough".  The outcome of the event cough was not recovered on an unspecified date. The outcome of the other events was recovered on an unspecified date.    No follow-up attempts are possible; information about batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder, Throat tightness
Clinical narrative: During her 15 minute waiting period after the injection, the patient began to experience throat tightness and sinus drainage; During her 15 minute waiting period after the injection, the patient began to experience throat tightness and sinus drainage; This is a spontaneous report from a non-contactable healthcare professional. A 45-year-old female patient received bnt162b2  (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of bnt162b2 on an unknown date at a single dose for covid-19 immunization. On an unknown date, during her 15 minute waiting period after the injection, the patient began to experience throat tightness and sinus drainage. The he denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient received antihistamines as treatment for the event until stable to go home and follow up with. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Fatigue, SARS-CoV-2 test
Clinical narrative: Large erythematous area over site of injection 7cm x 5cm; Large erythematous area over site of injection 7cm x 5cm, blanching; Large erythematous area over site of injection 7cm x 5cm, Pruritic; Large erythematous area over site of injection 7cm x 5cm, Tenderness (mild)/Area painful for first 24 hours after injection; Large erythematous area over site of injection 7cm x 5cm, Induration (mild); Generalized fatigue; Joint pain; Slight increased temperature 99.3F for about 12 hours; This is a spontaneous report from a contactable physician (patient). A 56-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via intramuscular on 05Jan2021 08:45 at single dose in left arm for covid-19 immunisation. Medical history included asthma, diabetes. Concomitant medication included metformin, rosuvastatin, empagliflozin (JARDIANCE), omeprazole, vitamin c (ascorbic acid), ergocalciferol (VITAMIN D), paracetamol (TYLENOL), ibuprofen (MOTRIN), naproxen (NAPROSYN) and Multivitamin. The patient had known allergies to sulfamethoxazole, trimethoprim (BACTRIM) and experienced rash; raltegravir potassium (ISENTRESS) and experienced rash; emtricitabine, tenofovir disoproxil fumarate (TRUVADA) and experienced rash. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular on 15Dec2020 13:30 at single dose in right arm for covid-19 immunisation. It was reported that on 07Jan2021 the patient experienced large erythematous area over site of injection 7cm x 5cm, blanching, pruritic, + tenderness (mild), + induration (mild). Area painful for first 24 hours after injection, that has gotten better, area of erythema is slowly getting larger, pruritus started 1 day ago and is slightly worsening (also starting to have slight generalized pruritus). After injection on 05Jan2021, the next morning (on 06Jan2021) had slight increased temperature 99.3F for about 12 hours with generalized fatigue and joint pain for about 24 hours on 07Jan2021.  The area in question started to get red and indurated after that time period. The fatigue and joint pain have resolved completely. The patient received treatment for events included topical 1% hydrocortisone ointment, diphenhydramine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had been tested for COVID-19, included nasal swab and SARS-COV-2 RNA PCR on 22Dec2020 with negative result. The outcome of the events area painful for first 24 hours after injection was recovering, the outcome of the events fatigue and joint pain were recovered on 08Jan2021, the outcome of the event slight increased temperature 99.3F was unknown, the outcome of the rest events was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pallor, Vaccination site pruritus
Clinical narrative: Large erythematous area over site of injection 7cm x 5cm; Large erythematous area over site of injection 7cm x 5cm, blanching; Large erythematous area over site of injection 7cm x 5cm, Pruritic; Large erythematous area over site of injection 7cm x 5cm, Tenderness (mild)/Area painful for first 24 hours after injection; Large erythematous area over site of injection 7cm x 5cm, Induration (mild); Generalized fatigue; Joint pain; Slight increased temperature 99.3F for about 12 hours; This is a spontaneous report from a contactable physician (patient). A 56-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via intramuscular on 05Jan2021 08:45 at single dose in left arm for covid-19 immunisation. Medical history included asthma, diabetes. Concomitant medication included metformin, rosuvastatin, empagliflozin (JARDIANCE), omeprazole, vitamin c (ascorbic acid), ergocalciferol (VITAMIN D), paracetamol (TYLENOL), ibuprofen (MOTRIN), naproxen (NAPROSYN) and Multivitamin. The patient had known allergies to sulfamethoxazole, trimethoprim (BACTRIM) and experienced rash; raltegravir potassium (ISENTRESS) and experienced rash; emtricitabine, tenofovir disoproxil fumarate (TRUVADA) and experienced rash. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular on 15Dec2020 13:30 at single dose in right arm for covid-19 immunisation. It was reported that on 07Jan2021 the patient experienced large erythematous area over site of injection 7cm x 5cm, blanching, pruritic, + tenderness (mild), + induration (mild). Area painful for first 24 hours after injection, that has gotten better, area of erythema is slowly getting larger, pruritus started 1 day ago and is slightly worsening (also starting to have slight generalized pruritus). After injection on 05Jan2021, the next morning (on 06Jan2021) had slight increased temperature 99.3F for about 12 hours with generalized fatigue and joint pain for about 24 hours on 07Jan2021.  The area in question started to get red and indurated after that time period. The fatigue and joint pain have resolved completely. The patient received treatment for events included topical 1% hydrocortisone ointment, diphenhydramine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had been tested for COVID-19, included nasal swab and SARS-COV-2 RNA PCR on 22Dec2020 with negative result. The outcome of the events area painful for first 24 hours after injection was recovering, the outcome of the events fatigue and joint pain were recovered on 08Jan2021, the outcome of the event slight increased temperature 99.3F was unknown, the outcome of the rest events was not recovered.