chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Atrial fibrillation, Diarrhoea, Gait disturbance, Headache
Clinical narrative: atrial fibrillation episodes; can't walk very well (limping) due to stiffness; unable to move her hands; muscles are stiff; ongoing watery diarrhea; terrible arthritis throughout her whole body; swollen armpit with a growth; sore left arm; headaches; A spontaneous report was received from a consumer who was a 73-year-old, female patient who received Moderna's covid-19 vaccine (mRNA-1273) and experienced sore left arm (vaccination site pain), headache, terrible arthritis throughout her whole body (arthralgia), unable to move her hands, muscles are stiff, ongoing watery diarrhea, a swollen armpit with a growth (vaccination site lymphadenopathy), she can't walk very well (limping) due to stiffness and atrial fibrillation episodes.  The patient's medical history includes cancer of the bowels five years ago, heart problems and arthritis.  Concomitant medications reported as amlodipine besylate (2.5 mg daily), rivaroxaban (20 mg daily), Preservision, organic whole food multi-vitamins, and marijuana.  On 27-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of Covid-19 infection.   On 27-JAN-2021, the patient reported that her left arm was sore and that she had headaches that started six hours after the injection and lasted for seven or eight days.  Additionally, the patient reported several other symptoms for which the start date was unknown including arthritis throughout her entire body, the inability to move her hands, stiff muscles, watery diarrhea and a swollen armpit with a growth.  She also reported that she was limping due to stiffness and was having atrial fibrillation episodes.  No additional data regarding the atrial fibrillation episodes was provided.   Laboratory details were not provided.   Treatment for the events included paracetamol and naproxen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, headaches, was considered recovered/resolved.  The outcomes of the events, sore left arm (vaccination site pain), terrible arthritis throughout her whole body (arthralgia), unable to move her hands, muscles are stiff, ongoing watery diarrhea, a swollen armpit with a growth (vaccination site lymphadenopathy), she can't walk very well (limping) due to stiffness and atrial fibrillation episodes, were considered unknown.; Reporter's Comments: This case concerns a 73 Y/O F with serious unexpected atrial fibrillation and NS unexpected diarrhea, muscular weakness, gait disturbance, musculoskeletal stiffness and NS expected arthralgia, vaccination site pain, vaccination site lymphadenopathy, headache.  Event onset the same day as first dose mRNA-1273. Outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal stiffness, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: atrial fibrillation episodes; can't walk very well (limping) due to stiffness; unable to move her hands; muscles are stiff; ongoing watery diarrhea; terrible arthritis throughout her whole body; swollen armpit with a growth; sore left arm; headaches; A spontaneous report was received from a consumer who was a 73-year-old, female patient who received Moderna's covid-19 vaccine (mRNA-1273) and experienced sore left arm (vaccination site pain), headache, terrible arthritis throughout her whole body (arthralgia), unable to move her hands, muscles are stiff, ongoing watery diarrhea, a swollen armpit with a growth (vaccination site lymphadenopathy), she can't walk very well (limping) due to stiffness and atrial fibrillation episodes.  The patient's medical history includes cancer of the bowels five years ago, heart problems and arthritis.  Concomitant medications reported as amlodipine besylate (2.5 mg daily), rivaroxaban (20 mg daily), Preservision, organic whole food multi-vitamins, and marijuana.  On 27-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of Covid-19 infection.   On 27-JAN-2021, the patient reported that her left arm was sore and that she had headaches that started six hours after the injection and lasted for seven or eight days.  Additionally, the patient reported several other symptoms for which the start date was unknown including arthritis throughout her entire body, the inability to move her hands, stiff muscles, watery diarrhea and a swollen armpit with a growth.  She also reported that she was limping due to stiffness and was having atrial fibrillation episodes.  No additional data regarding the atrial fibrillation episodes was provided.   Laboratory details were not provided.   Treatment for the events included paracetamol and naproxen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, headaches, was considered recovered/resolved.  The outcomes of the events, sore left arm (vaccination site pain), terrible arthritis throughout her whole body (arthralgia), unable to move her hands, muscles are stiff, ongoing watery diarrhea, a swollen armpit with a growth (vaccination site lymphadenopathy), she can't walk very well (limping) due to stiffness and atrial fibrillation episodes, were considered unknown.; Reporter's Comments: This case concerns a 73 Y/O F with serious unexpected atrial fibrillation and NS unexpected diarrhea, muscular weakness, gait disturbance, musculoskeletal stiffness and NS expected arthralgia, vaccination site pain, vaccination site lymphadenopathy, headache.  Event onset the same day as first dose mRNA-1273. Outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Coronavirus test positive, Cough, Diarrhoea
Clinical narrative: Tested positive for Covid; Flu like symptoms; Cough; Viral rash; Chills; Fever; Sore throat; Vomiting; Vaccine was administered in the side of her arm and not in her deltoid muscle; Abdominal cramps; Diarrhea; Pain/body ache; A spontaneous report was received from a Healthcare Professional concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events abdominal cramps, pain, diarrhea, flu like symptoms, viral rash, fever, chills, cough, sore throat, body aches, vomiting, tested positive for covid.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot batch: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27JAN2021 the patient received the 2nd dose of the Moderna vaccine in her left arm and reported that the vaccine was administered in the side of her arm and not in her deltoid muscle. On the same day the patient reported nausea, headache, injection site swelling, redness 2 inches below the injection site and pain. Nausea ended on 28JAN2021 and the other symptoms are ongoing  On 11 Jan 2021, the patient experienced the events abdominal cramps. pain, diarrhea.   On 12 Jan 2021, the patient experienced the events flu like symptoms. viral rash, fever, chills, cough, sore throat, body aches, vomiting.   On 13 Jan 2021, the patient experienced the events tested positive for covid.   Treatment details included Claritin and Ibuprofen  Action taken with mRNA-1273 in response to the events was not reported.   On 22 Jan 2021, the patient was completely recovered from abdominal cramps. pain, diarrhea, flu like symptoms. viral rash, fever, chills, cough, sore throat, body aches, vomiting and coronavirus test positive.   The outcome of all events was recovered/resolved.; Reporter's Comments: This case concerns a 64 Y/O M with NS unexpected COVID-19, influenza-like symptoms, abdominal cramps, diarrhea, viral rash, sore throat, cough, and NS expected fever, chills, vomiting, pain. Onset 13 days after first dose mRNA-1273. Events resolved. Second dose mRNA-1273 with nausea, headache, injection site swelling, redness, pain. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Oropharyngeal pain, Pain, Product administered at inappropriate site, Pyrexia
Clinical narrative: Tested positive for Covid; Flu like symptoms; Cough; Viral rash; Chills; Fever; Sore throat; Vomiting; Vaccine was administered in the side of her arm and not in her deltoid muscle; Abdominal cramps; Diarrhea; Pain/body ache; A spontaneous report was received from a Healthcare Professional concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events abdominal cramps, pain, diarrhea, flu like symptoms, viral rash, fever, chills, cough, sore throat, body aches, vomiting, tested positive for covid.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot batch: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27JAN2021 the patient received the 2nd dose of the Moderna vaccine in her left arm and reported that the vaccine was administered in the side of her arm and not in her deltoid muscle. On the same day the patient reported nausea, headache, injection site swelling, redness 2 inches below the injection site and pain. Nausea ended on 28JAN2021 and the other symptoms are ongoing  On 11 Jan 2021, the patient experienced the events abdominal cramps. pain, diarrhea.   On 12 Jan 2021, the patient experienced the events flu like symptoms. viral rash, fever, chills, cough, sore throat, body aches, vomiting.   On 13 Jan 2021, the patient experienced the events tested positive for covid.   Treatment details included Claritin and Ibuprofen  Action taken with mRNA-1273 in response to the events was not reported.   On 22 Jan 2021, the patient was completely recovered from abdominal cramps. pain, diarrhea, flu like symptoms. viral rash, fever, chills, cough, sore throat, body aches, vomiting and coronavirus test positive.   The outcome of all events was recovered/resolved.; Reporter's Comments: This case concerns a 64 Y/O M with NS unexpected COVID-19, influenza-like symptoms, abdominal cramps, diarrhea, viral rash, sore throat, cough, and NS expected fever, chills, vomiting, pain. Onset 13 days after first dose mRNA-1273. Events resolved. Second dose mRNA-1273 with nausea, headache, injection site swelling, redness, pain. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Viral rash, Vomiting
Clinical narrative: Tested positive for Covid; Flu like symptoms; Cough; Viral rash; Chills; Fever; Sore throat; Vomiting; Vaccine was administered in the side of her arm and not in her deltoid muscle; Abdominal cramps; Diarrhea; Pain/body ache; A spontaneous report was received from a Healthcare Professional concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events abdominal cramps, pain, diarrhea, flu like symptoms, viral rash, fever, chills, cough, sore throat, body aches, vomiting, tested positive for covid.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot batch: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27JAN2021 the patient received the 2nd dose of the Moderna vaccine in her left arm and reported that the vaccine was administered in the side of her arm and not in her deltoid muscle. On the same day the patient reported nausea, headache, injection site swelling, redness 2 inches below the injection site and pain. Nausea ended on 28JAN2021 and the other symptoms are ongoing  On 11 Jan 2021, the patient experienced the events abdominal cramps. pain, diarrhea.   On 12 Jan 2021, the patient experienced the events flu like symptoms. viral rash, fever, chills, cough, sore throat, body aches, vomiting.   On 13 Jan 2021, the patient experienced the events tested positive for covid.   Treatment details included Claritin and Ibuprofen  Action taken with mRNA-1273 in response to the events was not reported.   On 22 Jan 2021, the patient was completely recovered from abdominal cramps. pain, diarrhea, flu like symptoms. viral rash, fever, chills, cough, sore throat, body aches, vomiting and coronavirus test positive.   The outcome of all events was recovered/resolved.; Reporter's Comments: This case concerns a 64 Y/O M with NS unexpected COVID-19, influenza-like symptoms, abdominal cramps, diarrhea, viral rash, sore throat, cough, and NS expected fever, chills, vomiting, pain. Onset 13 days after first dose mRNA-1273. Events resolved. Second dose mRNA-1273 with nausea, headache, injection site swelling, redness, pain. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIzziness; A spontaneous report was received from a consumer concerning a 69 year old, female patient who received their first of two planned doses of mRNA-1273 and experienced dizziness.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 03 Feb 2021, priorto the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, at night the patient complained of dizziness to her daughter. On 04 Feb 2021 the patient was admitted in hospital.   Treatment for the event included Tylenol.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. Further information has been requested.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site induration, Vaccination site swelling
Clinical narrative: Injection site area was hard; Injection site area was swollen (left arm); Vaccine not given in the deltoid muscle correctly; A spontaneous report was received from a consumer (patient), an 84 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced injection site area was hard (vaccination site induration), injection site area was swollen (left arm) (vaccination site swelling), and vaccine not given in the deltoid muscle correctly (incorrect route of product administration).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 09 Feb 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 031L20A), intramuscular in the left arm for the prophylaxis of COVID-19 infection.   The patient was concerned that they did not give him the vaccine correctly in the deltoid muscle on 09 Feb 2021. On 10 FEB 2021, the patient experienced that the injection site area was hard like a rock and swollen, approximately five inches below the actual injection location. No further information was provided. Treatment information was unknown.  Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The outcome for the events, injection site area was hard, injection site area was swollen was considered as unknown, that of event they did not give him the vaccine in the deltoid muscle correctly was considered recovered on 09 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,  a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Heart rate
Clinical narrative: Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme weakness; rapid heartrate; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration in the left arm on 29Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy, coronary artery disease (CAD), hypertension (HTN), pulmonary hypertension, sick sinus syndrome, hypothyroidism, hyperlipidemia, osteoporosis, chronic kidney disease (CKD), and diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included alprazolam (XANAX), venlafaxine hydrochloride (EFFEXOR), quetiapine fumarate (SEROQUEL), sertraline hydrochloride (ZOLOFT), isosorbide mononitrate (IMDUR), and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 02:15, the patient experienced extreme soreness in left upper arm, chills, headache, tiredness, feeling like she had the flu, extreme weakness, and rapid heartrate. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Influenza like illness, Pain in extremity
Clinical narrative: Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme weakness; rapid heartrate; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration in the left arm on 29Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy, coronary artery disease (CAD), hypertension (HTN), pulmonary hypertension, sick sinus syndrome, hypothyroidism, hyperlipidemia, osteoporosis, chronic kidney disease (CKD), and diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included alprazolam (XANAX), venlafaxine hydrochloride (EFFEXOR), quetiapine fumarate (SEROQUEL), sertraline hydrochloride (ZOLOFT), isosorbide mononitrate (IMDUR), and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 02:15, the patient experienced extreme soreness in left upper arm, chills, headache, tiredness, feeling like she had the flu, extreme weakness, and rapid heartrate. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Limb injury
Clinical narrative: Fallen; an injury to his arm / hurt his arm; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, 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's wife reported that she and her husband (patient) was due for their second Covid19 vaccine tomorrow (03Feb2021). However, her husband received a tetanus shot last Friday, 29Jan2021, after an injury to his arm. He had fallen and hurt his arm on an unknown date and needed one. She was asking about the dosing interval between vaccines. Outcome of the events was unknown.  Information about lot/batch number is requested.
Sex: M
Vaccine: COVID19
Symptoms: Haemoptysis, Oesophageal rupture
Clinical narrative: he was hospitalized because ripped something in his esophagus; started coughing blood; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number no reported, via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. Patient reported that he received the 2nd dose of the Pfizer COVID-19 vaccine last 27Jan2021. On Friday 29Jan2021, he was hospitalized because ripped something in his esophagus and started coughing blood. He knows that this is not related to the vaccine but is trying to find out any effects of his prescribed medications with the efficacy of the vaccine. He was prescribed methylprednisolone and Z-pak (Azithromycin) 4mg. He's heard that methylprednisolone can lower the efficacy of the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The reported events ripped something in his esophagus and coughing blood were likely due to diet, and unrelated to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itchy, sensitive at site of injection; sensitive at site of injection; Size of half a raisin -slightly raised and slightly swollen; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient (also the age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available at the time of the report), via an unspecified route of administration at the left arm (reported as left shoulder) on 31Jan2021 at SINGLE DOSE for covid-19 immunization. The patient had no allergies to medications, food, or other products and no other medical history. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19, since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included finasteride (reported as Generic form for Propecia: other medications the patient received within 2 weeks of vaccination). It was reported that itchy, sensitive at site of injection - started 24H after (reported onset on 01Feb2021) and still sensitive 48H after. Size of half a raisin -slightly raised and slightly swollen. Case/ events were considered non-serious. The outcome of the events was not recovered. No treatment was received.   Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Gait disturbance, Myalgia, Pelvic inflammatory disease, Pelvic pain
Clinical narrative: Muscle soreness of bilateral legs and hip joints/ got worse; pelvic pain; Couldn't walk; Drag showed inflamed pelvic girdle; This is a spontaneous report from a contactable healthcare professional.  A non-pregnant 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. Solution for injection, lot number: 42 (as reported)), via an unspecified route of administration on the right arm on 15Jan2021 08:30 at single dose for COVID-19 immunisation.  The patient medical history was not reported.  Concomitant medication included metoprolol, fish oil, calcium and monascus purpureus (RED YEAST RICE).  The patient had known allergies: DILAUDID.  The patient experienced muscle soreness of bilateral legs and hip joints on 22Jan2021 and it got worse. Patient also experienced deep pelvic pain on an unspecified date in Jan2021 and went to physician on 24Jan2021. The patient couldn't walk in Jan2021. Cat scan showed no apparent reason, drag showed inflamed pelvic girdle on Jan2021. The outcome of the events was not recovered.; Sender's Comments: Case serious due to Pelvic inflammatory disease, classified Medically Significant and always serious event, per List Critical Term. Other reported events were non-serious. Based on available information, the Company considered that all reported events were possibly associated to BNT162B2 injection, due to a plausible chronological relation. 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Swelling face, Tinnitus
Clinical narrative: Thumping in ears; swelling in face; straight mouth unable to move; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 29Jan2021 09:00 at a single dose for COVID-19 immunisation. The patient has no medical history. Concomitant medication included acetylsalicylic acid (ASPIRIN BAYER) and vitamin D [vitamin D nos]. The patient experienced thumping in ears while in observation room and had swelling in face with a straight mouth unable to move on 30Jan2021 23:30. Outcome of events was unknown. The adverse events resulted in emergency room/department or urgent care. No treatment was given for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: arm hurt worse than ever; extremely exhausted; headache; controllable chills; fever of 101; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 02Feb2021 10:30, at single dose, for COVID-19 immunization, at a school or student health clinic. Medical history included COVID-19 (prior to vaccination) and arm hurt, both on an unknown date. The patient was not pregnant at the time of vaccination and has no allergy to medications, food, or other products. Concomitant medication included ibuprofen and vitamins. It was reported that on 02Feb2021 at 14:30, about 4 hours after getting the vaccine, the patient's arm hurt worse than ever and she was extremely exhausted. On 02Feb2021, in the middle of the night, the patient experienced headache, controllable chills and had a fever of 101. No treatment was given for the events. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was not resolved. The reporter assessed the events as non-serious.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: arm hurt worse than ever; extremely exhausted; headache; controllable chills; fever of 101; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 02Feb2021 10:30, at single dose, for COVID-19 immunization, at a school or student health clinic. Medical history included COVID-19 (prior to vaccination) and arm hurt, both on an unknown date. The patient was not pregnant at the time of vaccination and has no allergy to medications, food, or other products. Concomitant medication included ibuprofen and vitamins. It was reported that on 02Feb2021 at 14:30, about 4 hours after getting the vaccine, the patient's arm hurt worse than ever and she was extremely exhausted. On 02Feb2021, in the middle of the night, the patient experienced headache, controllable chills and had a fever of 101. No treatment was given for the events. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was not resolved. The reporter assessed the events as non-serious.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling hot, Pain in extremity, SARS-CoV-2 test
Clinical narrative: fatigue; warming feeling; sore arm; joints sore; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: el3248 and expiry date: unknown), via an unspecified route of administration on the left arm, on 02Feb2021 11:00 at a single dose for COVID-19 immunization. The first dose was received on 12Jan2021 11:00 on the right arm (lot number: ej1656). Medical history included cancer. Patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and no other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue, warming feeling, sore arm, joints sore on 02Feb2021 15:00. No treatment was received for the events. Outcome of the events was not recovered. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination. Covid test was on 03Feb2021 with unknown results. The reporter considered the events non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Palatal swelling
Clinical narrative: Swelling in soft pallet and oral mucosal membranes; Swelling in soft pallet and oral mucosal membranes; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318) on right arm, via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS), tachycardia, epilepsy, allergies to penicillin, cherry and apple. The patient was not pregnant at the time of vaccination. Concomitant medications included spironolactone (ALDACTONE), celecoxib (CELEXA) and naproxen sodium (ALEVE). The patient experienced swelling in soft pallet and oral mucosal membranes on 02Feb2021. She took 2 doses of 25 mg diphenhydramine hcl (BENADRYL). One at onset and one at recurrence a few hours later. 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. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. Therapeutic measures were taken as a result of swelling in soft pallet and oral mucosal membranes which included self-administered diphenhydramine hcl. The outcome of the events was recovering.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Nausea
Clinical narrative: headache; 9.5hrs after 2nd vaccine dose a fever set in and climbed to 101.2/fever; chills; muscle aches; nausea; This is a spontaneous report from a contactable Other Health Professional reported for herself (patient). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302; expiration date not provided), intramuscular (left arm) on 02Feb2021 13:30 at SINGLE DOSE for covid-19 immunisation. Patient's medical history and concomitant medications were not reported.  The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Patient is not pregnant. The patient has no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140; expiration date not provided), intramuscular (left arm) on 13Jan2021 for COVID-19 immunisation. The patient experienced headache, '9.5hrs after the 2nd vaccine dose a fever set in', chills, muscle aches, and nausea all on 02Feb2021 at 23:00. Patient's clinical course is as follows: 9.5hrs after 2nd vaccine dose a fever set in and climbed to 101.2. To accompany the fever were chills, muscle aches, nausea, and a headache. After taking a fever reducer, the nausea stayed and the fever returned approximately 8hrs as did the chills, muscle aches, and headache. It was reported that patient took a fever reducer again and now waiting to see if that helps again. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included body temperature with result of '101.2 (9.5hrs after 2nd vaccine dose a fever set in, and climbed to 101.2)' on 02Feb2021. The patient has not received treatment for headache, chills, muscle aches, and nausea. Facility where the most recent COVID-19 vaccine was administered was reported as 'Workplace clinic'. Outcome of the events was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; 9.5hrs after 2nd vaccine dose a fever set in and climbed to 101.2/fever; chills; muscle aches; nausea; This is a spontaneous report from a contactable Other Health Professional reported for herself (patient). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302; expiration date not provided), intramuscular (left arm) on 02Feb2021 13:30 at SINGLE DOSE for covid-19 immunisation. Patient's medical history and concomitant medications were not reported.  The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Patient is not pregnant. The patient has no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140; expiration date not provided), intramuscular (left arm) on 13Jan2021 for COVID-19 immunisation. The patient experienced headache, '9.5hrs after the 2nd vaccine dose a fever set in', chills, muscle aches, and nausea all on 02Feb2021 at 23:00. Patient's clinical course is as follows: 9.5hrs after 2nd vaccine dose a fever set in and climbed to 101.2. To accompany the fever were chills, muscle aches, nausea, and a headache. After taking a fever reducer, the nausea stayed and the fever returned approximately 8hrs as did the chills, muscle aches, and headache. It was reported that patient took a fever reducer again and now waiting to see if that helps again. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included body temperature with result of '101.2 (9.5hrs after 2nd vaccine dose a fever set in, and climbed to 101.2)' on 02Feb2021. The patient has not received treatment for headache, chills, muscle aches, and nausea. Facility where the most recent COVID-19 vaccine was administered was reported as 'Workplace clinic'. Outcome of the events was not recovered.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: muscle pain in arm and back; Soreness/Tenderness in arm as expected; Headache; fever; chills; This is a spontaneous report from a contactable consumer (patient herself). A 23-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3248), via an unspecified route of administration on the left arm, on 02Feb2021 08:15 at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 20:00, the patient experienced soreness/tenderness in arm as expected. At around 8pm (12 hours after injection), patient started feeling muscle pain in arm and back. About an hour later, patient started to run a fever and had chills. Headache came on after and lasted through the night and into the next morning. Since the vaccination, the patient has not  been tested for COVID-19. The outcome of the event was recovered on an unspecified date. Case was reported as non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Hyperacusis
Clinical narrative: felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Similar to a migraine; tired; slept for a long time; light and sound was very painful; light and sound was very painful; This is a spontaneous report from a contactable consumer (reported for herself).  A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration from 28Jan2021 10:00 at a single dose in the right arm for COVID-19 immunization. Medical history included chronic sinus infections. Patient was not pregnant at the time of vaccination and the report. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included trazodone, xylometazoline hydrochloride (SUDAFED), cetirizine hydrochloride (ZYRTEC), and fluticasone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took clarithromycin (BIAXIN) and experienced allergies (reported as know allergies). About an hour after the injection, on 28Jan2021 11:00 AM, patient felt lightheaded, had a low grade fever, chills and sweating, light and sound was very painful - similar to a migraine even though patient have never had one previously, and patient was very tired and slept for a long time.  These lasted for 5 days. The events required doctor or other healthcare professional office/clinic visit in response to the events. Patient received treatment for the adverse events and was reported as unknown. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events reported was recovering.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypersomnia, Migraine, Photophobia, Pyrexia
Clinical narrative: felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Similar to a migraine; tired; slept for a long time; light and sound was very painful; light and sound was very painful; This is a spontaneous report from a contactable consumer (reported for herself).  A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration from 28Jan2021 10:00 at a single dose in the right arm for COVID-19 immunization. Medical history included chronic sinus infections. Patient was not pregnant at the time of vaccination and the report. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included trazodone, xylometazoline hydrochloride (SUDAFED), cetirizine hydrochloride (ZYRTEC), and fluticasone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took clarithromycin (BIAXIN) and experienced allergies (reported as know allergies). About an hour after the injection, on 28Jan2021 11:00 AM, patient felt lightheaded, had a low grade fever, chills and sweating, light and sound was very painful - similar to a migraine even though patient have never had one previously, and patient was very tired and slept for a long time.  These lasted for 5 days. The events required doctor or other healthcare professional office/clinic visit in response to the events. Patient received treatment for the adverse events and was reported as unknown. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events reported was recovering.   Information on the lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Muscle aches; Low back and hip pain; Low back and hip pain; Severe headache; This is a spontaneous report from a contactable consumer reported for himself. A 69-year-old male patient received the first dose of BNT162B2 (lot number: EL 9264), via an unspecified route of administration in the left arm on 02Feb2021 07:00 (at the age of 69-years-old) at single dose for COVID-19 immunization. Medical history included COVID-19 on 23Nov2020, heart bypass, high cholesterol and triglyceride. Concomitant medication included clopidogrel bisulfate (PLAVIX), lisinopril, metoprolol, fenofibrate and atorvastatin calcium (ATORVAST).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 03Feb2021 at 12:00 AM, the patient experienced fever, muscle aches, low back and hip pain and severe headache. He stated that its like he has COVID all over again. The outcome of the events was not recovered. It was unknown if the patient received treatment for the events.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Body temperature decreased, Cold sweat, Diarrhoea
Clinical narrative: Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; sweating profusely; very low body temp; rapid pulse; shaking; This is a spontaneous report from a contactable consumer who reported for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 02Feb2021 04:00 PM at a single dose for covid-19 immunisation. Medical history included obesity. Patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 02Feb2021 at 10:00 PM (6 hours after vaccine was given),  the patient experienced severe stomach cramping, diarrhea, dizzy, nausea, cold clammy pale skin, sweating profusely, very low body temp, rapid pulse, and shaking. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Hyperhidrosis, Nausea
Clinical narrative: Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; sweating profusely; very low body temp; rapid pulse; shaking; This is a spontaneous report from a contactable consumer who reported for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 02Feb2021 04:00 PM at a single dose for covid-19 immunisation. Medical history included obesity. Patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 02Feb2021 at 10:00 PM (6 hours after vaccine was given),  the patient experienced severe stomach cramping, diarrhea, dizzy, nausea, cold clammy pale skin, sweating profusely, very low body temp, rapid pulse, and shaking. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Tremor
Clinical narrative: Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; sweating profusely; very low body temp; rapid pulse; shaking; This is a spontaneous report from a contactable consumer who reported for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 02Feb2021 04:00 PM at a single dose for covid-19 immunisation. Medical history included obesity. Patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 02Feb2021 at 10:00 PM (6 hours after vaccine was given),  the patient experienced severe stomach cramping, diarrhea, dizzy, nausea, cold clammy pale skin, sweating profusely, very low body temp, rapid pulse, and shaking. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.