chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Myalgia, Vaccination site erythema
Clinical narrative: Stomach pain; It was almost like diarrhea; Sore muscle pain; Redness in injection site on Left arm; This is a spontaneous report received from a non-contactable consumer (patient).  A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A couple hours after first shot the patient had rather sore muscle pain and redness in injection site on Left arm on 13Apr2021 (Tuesday and Thursday). On 14Apr2021 (Wednesday) the patient also had some stomach pain (and it wasn't), it was almost like diarrhea not quite. The patient recovered from the event diarrhea on 16Apr2021 while outcome of the events muscle pain, vaccination site erythema, stomach pain was unknown.  No follow up attempts needed. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: minor soreness in my arm; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0150) via an unspecified route of administration in the right arm on 02Apr2021 at 16:30 (at the age 35-years-old) as a single dose for COVID-19 immunisation. Medical history included blood clot from an unknown date and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included apixaban (ELIQUIS) from an unknown date for blood clot. The patient reported experiencing minor soreness in her arm with the first shot on an unspecified date. The patient received the second dose of BNT162B2 (lot number EW0170) in Apr2021. The clinical outcome of minor soreness in arm was unknown. It was also reported that since vaccination the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This is a spontaneous report from a contactable consumer (patient). This 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported he was scheduled to receive his second dose of BNT162B2 "this past Friday," although Thursday night the patient ended up with a sore throat which he attributed to pollen and doing yard work and not the vaccine. He saw a physician assistant (PA) on Friday morning and was also given a triamcinolone acetonide (KENALOG) shot. He went to the health clinic vaccination site on Friday and was told he had to wait two weeks after receiving the steroid shot to receive the second dose and reported he was seeing he regular doctor the following day. The patient inquired if his culture results came back positive and he had to take an antibiotic, would that prevent him from receiving the second dose and whether the side effects would be worse with the second dose because the triamcinolone acetonide would be affecting his immune system. He inquired if it would be less effective or at least as effective as an other-company vaccine and if it would help keep him out of the hospital or from having a severe case. He also asked for the 6-month topline analysis results of the BNT162B2 vaccine and if the triamcinolone acetonide shot decreased the efficacy of the vaccine and how long he should wait after the steroid to receive the second dose. The patient also asked if his immune response wasn't as effective after the triamcinolone acetonide would the booster dose get him where he needed to be and whether Pfizer has provided a statement on the need for a booster dose or if Pfizer was investigating the need for a booster dose. The clinical outcome of sore throat was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information, the event Sore throat  is most likely related to pollen and doing yard work which is not related to the suspected drug.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Taste disorder
Clinical narrative: taste was affected for several hours; blood pressure has been high and yesterday it was 166/78; This is a spontaneous report from a contactable consumer (patient) reported an 89-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included high blood pressure, lymphoma, and allergic to aspirin. Concomitant medications were not reported. On an unspecified date after the first dose of the vaccine the patient experienced taste was affected for several hours then subsided. Her blood pressure had been high and yesterday (24Apr2021) it was 166/78 but she did not recall what her pulse was. The patient had a history of high blood pressure and lymphoma so the high blood pressure was not new and she did not think it was related to the vaccine. The outcome of taste was affected was recovered. The outcome of blood pressure had been high was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information, the event Blood pressure high is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Medical history of high blood pressure may provide an explanation for the event.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Fatigue, Headache, Lethargy
Clinical narrative: Fever (101); Body aches; Fatigue; Lethargy; Headache; Minor shortness of breathe; This is a spontaneous report received from a contactable consumer (patient) via COVAES. This 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0161) via an unspecified route of administration in the left arm on 21Apr2021 at 12:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included back injury and arthritis, both from unknown dates and unknown if ongoing. The patient had no known allergies and was not diagnosed with COVID-19 prior to vaccination. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number EP7533) on 31Mar2021 at 12:15 (at the age of 56-years-old) for COVID-19 immunisation. On 22Apr2021 at 06:00 the patient experienced fever reported as 101, body aches, fatigue, lethargy, headache and minor shortness of breath. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of fever reported as 101, body aches, fatigue, lethargy, headache and minor shortness of breath were recovered in Apr2021. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever (101); Body aches; Fatigue; Lethargy; Headache; Minor shortness of breathe; This is a spontaneous report received from a contactable consumer (patient) via COVAES. This 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0161) via an unspecified route of administration in the left arm on 21Apr2021 at 12:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included back injury and arthritis, both from unknown dates and unknown if ongoing. The patient had no known allergies and was not diagnosed with COVID-19 prior to vaccination. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number EP7533) on 31Mar2021 at 12:15 (at the age of 56-years-old) for COVID-19 immunisation. On 22Apr2021 at 06:00 the patient experienced fever reported as 101, body aches, fatigue, lethargy, headache and minor shortness of breath. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of fever reported as 101, body aches, fatigue, lethargy, headache and minor shortness of breath were recovered in Apr2021. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: Very fatigued; muscle pain; arm pain; This is spontaneous report from a contactable consumer (patient). A 21-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EWO171) via an unspecified route of administration on 22Apr2021 at 14:15 (at the age of 21-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included migraines and anxiety. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was diagnosed with COVID-19 prior to the vaccine. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), propranolol, fexofenadine hydrochloride (ALLEGRA), and birth control from unknown dates for unspecified indications. On 22Apr2021 at 21:00 the patient experienced very fatigued, muscle pain, and arm pain. The patient did not receive any treatment for the events. The outcomes of very fatigued, muscle pain, and arm pain were recovered with lasting effects. It was also reported that since the vaccine, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Conjunctivitis, Fatigue, Nausea, Pyrexia
Clinical narrative: pinkeye in both eyes; nausea; mild fever; joint pain; fatigue; sciatica; This is spontaneous report from a contactable consumer (patient). A 33-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0169) via an unspecified route of administration on 24Apr2021 at 14:15 (at the age of 33-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included anxiety, irritable bowel syndrome (IBS), and penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole, sertraline, hydroxyzine hcl, and buspirone hydrochloride (BUSPAR) from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EW0150) on 03Apr2021 at 10:00 as a single dose in the right arm for COVID-19 immunization. ON 25Apr2021 at 03:30 the patient woke up with pinkeye in both eyes. She also experienced nausea, mild fever joint pain, fatigue, and sciatica. The events were reported as non-serious. The patient was not hospitalized as a result of the events. The patient was treated with pinkeye drops: polymyxin B and trimethoprim. The outcomes of nausea, mild fever, joint pain, fatigue, sciatica, and pinkeye were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: pinkeye in both eyes; nausea; mild fever; joint pain; fatigue; sciatica; This is spontaneous report from a contactable consumer (patient). A 33-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0169) via an unspecified route of administration on 24Apr2021 at 14:15 (at the age of 33-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included anxiety, irritable bowel syndrome (IBS), and penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole, sertraline, hydroxyzine hcl, and buspirone hydrochloride (BUSPAR) from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EW0150) on 03Apr2021 at 10:00 as a single dose in the right arm for COVID-19 immunization. ON 25Apr2021 at 03:30 the patient woke up with pinkeye in both eyes. She also experienced nausea, mild fever joint pain, fatigue, and sciatica. The events were reported as non-serious. The patient was not hospitalized as a result of the events. The patient was treated with pinkeye drops: polymyxin B and trimethoprim. The outcomes of nausea, mild fever, joint pain, fatigue, sciatica, and pinkeye were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: off balance; This is a spontaneous report from contactable consumer (wife). A male patient of unspecified age received bnt162b2 (BNT162B2, Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on 18Mar2021 as a single dose for covid-19 immunisation. The patient's medical history included Covid positive in Oct 2019. The patient's concomitant medications were not reported. On 18Mar2021, on the day of vaccination, the reporter stated that her husband had an off balance. The reporter wanted to know if it was ok to take the second dose. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received BNT162B2 (COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at the age of 26-years-old as single dose, dose 2 via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) at the age of 26-years-old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She already got the 2 doses of the covid vaccine, being the second dose administered on 22Apr2021. She said that after getting the first dose she got her period a couple hours after it was administered and that was strange for her since she is very regular and the same happened after getting the second dose. She wanted to know if this something normal from the vaccine. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Dysmenorrhoea, Fatigue, Headache
Clinical narrative: Late menstrual period by 2 weeks and extreme heavy period (thin, clotty) with lots of cramps; Late menstrual period by 2 weeks and extreme heavy period (thin, clotty) with lots of cramps; Late menstrual period by 2 weeks and extreme heavy period (thin, clotty) with lots of cramps; Fever; chills; nausea; headache; muscle heaviness; metal taste in mouth; sinus swelling; sneezing; extreme fatigue; This is a spontaneous report received from contactable consumers (one of them is the patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8737) via an unspecified route of administration, administered in right arm on 22Apr2021 13:00 (at the age of 45-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included high blood pressure and allergy to sulfa drug. Patient was not pregnant. The patient's concomitant medications were not reported. On 23Apr2021 11:45, patient experienced fever, chills, nausea, headache, muscle heaviness, metal taste in mouth, sinus swelling, sneezing and extreme fatigue. On 03May2021 03:00, patient had late menstrual period by 2 weeks and extreme heavy period (thin, clotty) with lots of cramps on an unspecified date when it did came. The patient did not receive treatment for the events reported. Outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation delayed, Muscle discomfort, Nausea, Pyrexia
Clinical narrative: Late menstrual period by 2 weeks and extreme heavy period (thin, clotty) with lots of cramps; Late menstrual period by 2 weeks and extreme heavy period (thin, clotty) with lots of cramps; Late menstrual period by 2 weeks and extreme heavy period (thin, clotty) with lots of cramps; Fever; chills; nausea; headache; muscle heaviness; metal taste in mouth; sinus swelling; sneezing; extreme fatigue; This is a spontaneous report received from contactable consumers (one of them is the patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8737) via an unspecified route of administration, administered in right arm on 22Apr2021 13:00 (at the age of 45-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included high blood pressure and allergy to sulfa drug. Patient was not pregnant. The patient's concomitant medications were not reported. On 23Apr2021 11:45, patient experienced fever, chills, nausea, headache, muscle heaviness, metal taste in mouth, sinus swelling, sneezing and extreme fatigue. On 03May2021 03:00, patient had late menstrual period by 2 weeks and extreme heavy period (thin, clotty) with lots of cramps on an unspecified date when it did came. The patient did not receive treatment for the events reported. Outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder, Sneezing
Clinical narrative: Late menstrual period by 2 weeks and extreme heavy period (thin, clotty) with lots of cramps; Late menstrual period by 2 weeks and extreme heavy period (thin, clotty) with lots of cramps; Late menstrual period by 2 weeks and extreme heavy period (thin, clotty) with lots of cramps; Fever; chills; nausea; headache; muscle heaviness; metal taste in mouth; sinus swelling; sneezing; extreme fatigue; This is a spontaneous report received from contactable consumers (one of them is the patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8737) via an unspecified route of administration, administered in right arm on 22Apr2021 13:00 (at the age of 45-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included high blood pressure and allergy to sulfa drug. Patient was not pregnant. The patient's concomitant medications were not reported. On 23Apr2021 11:45, patient experienced fever, chills, nausea, headache, muscle heaviness, metal taste in mouth, sinus swelling, sneezing and extreme fatigue. On 03May2021 03:00, patient had late menstrual period by 2 weeks and extreme heavy period (thin, clotty) with lots of cramps on an unspecified date when it did came. The patient did not receive treatment for the events reported. Outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Menstrual disorder, Rash
Clinical narrative: was feeling as though as she was going to faint; Her heart was beating fast soon; She also developed a rash to her arm and elbow.; was normally on time with cycle, and it had been off; This is a spontaneous report from a contactable consumer (patient's mother). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 26 years old, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Mother was calling on behalf of her 26 years old daughter who had received both doses of the Pfizer Covid vaccine. A couple of weeks after the vaccine her daughter while in the shower, was feeling as though as she was going to faint, she was normally on time with cycle, and it had been off, her heart was beating fast soon after she got the vaccine, but it went away. she also developed a rash to her arm and elbow. The reporter asked if an abnormal cycle which has never had was part of the Pfizer Covid vaccine and what about infertility if there were any reports on whether the vaccine would cause infertility. The outcome of the event "Her heart was beating fast soon" was recovered on an unspecified date, of the other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Menstrual disorder, Pruritus, Rash papular, Vaccination site pain
Clinical narrative: period symtems; itching is around her waist with small red bumps like shingles; itching is around her waist with small red bumps like shingles; itching is around her waist with small red bumps like shingles; she has some pain also at the site.; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A 59-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included shingles. There were no concomitant medications.  The patient received the Pfizer vaccine on 06Apr2021, the 1st dose. She was scheduled to receive the 2nd dose on 27Apr2021. In Apr2021, the patient had developed issues, it felt like period symtems and sometimes similar to the feeling she had when she had shingles in the past. She had recently read of possible side effects that include the vaccine possibly stimulating previous auto immune issues. She asked if she should get the 2nd shot or visit with physician before receiving. The patient experienced itching from the first shot of pfizer covid vaccine. Itching was around her waist with small red bumps like shingles and she had some pain also at the site in Apr2021. The outcome of the events was unknown. The report was non-serious.  information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: unusual heavy menstrual bleeding; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced unusual heavy menstrual bleeding on an unspecified date. Outcome of event was unknown.   Information on lot/batch number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Headache, Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: headache; dizziness; heaviness; ringing in the ears; numbness; black spots; This is spontaneous report from contactable consumer (patient, self-reported). A 19-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8734 and expiration date was not reported), via unspecified route of administration in right arm on 05Apr2021 at 14:15 (at 19-years age) 1ST dose single for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient had received the other vaccine (not specified) same date 5Apr2021, 2 ND dose, batch no: EW0170, in Left arm. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications in 2 weeks prior to vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 27Apr2021 at 12:15 the patient had experienced headache, dizziness, heaviness, ringing in the ears, black spots and body numbness. The patient had underwent the lab COVID-19 test negative (nasal swab). The patient did not received any treatment for the adverse events. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up (PRD 28Apr2021): This is a follow up-spontaneous report from a contactable consumer, added the suspect drug details, added the events, added the lab data.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Skin hyperpigmentation, Tinnitus
Clinical narrative: headache; dizziness; heaviness; ringing in the ears; numbness; black spots; This is spontaneous report from contactable consumer (patient, self-reported). A 19-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8734 and expiration date was not reported), via unspecified route of administration in right arm on 05Apr2021 at 14:15 (at 19-years age) 1ST dose single for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient had received the other vaccine (not specified) same date 5Apr2021, 2 ND dose, batch no: EW0170, in Left arm. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications in 2 weeks prior to vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 27Apr2021 at 12:15 the patient had experienced headache, dizziness, heaviness, ringing in the ears, black spots and body numbness. The patient had underwent the lab COVID-19 test negative (nasal swab). The patient did not received any treatment for the adverse events. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up (PRD 28Apr2021): This is a follow up-spontaneous report from a contactable consumer, added the suspect drug details, added the events, added the lab data.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: anxiety; This is a spontaneous report received from a contactable consumer (patient) by a Pfizer sponsored program.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient got the second dose and she felt very anxious after. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Pain, Pain in extremity
Clinical narrative: he is experiencing sore arm; severe headache; stomach pain; overall body pain; This is a spontaneous report from a contactable consumer (patient) by Pfizer- sponsored program COVAX US Support.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 23Apr2021 morning (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm, severe headache, stomach pain and overall body pain all in Apr2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Menstrual disorder, Palpitations
Clinical narrative: Episode of heart  pounding; Felt dizzy; Her Menstrual cycle went off track; This is a spontaneous report received from Pfizer sponsored program COVAX US Support from a contactable consumer reported for her daughter. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The reporter stated her Daughter got pfizer covax series and 2.5 months later had an episode of heart pounding and felt dizzy. She also had her menstrual cycle went off track and she was always on time. She had not seen her HCP because she stated they moved and she needed to get one. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Nervousness
Clinical narrative: Weakness; Feeling shaky; This is a spontaneous report received from a contactable consumer (the patient) from a female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 16Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the COVID-19 vaccine on 16Apr2021, and she has been experiencing weakness and feeling shaky (from an unspecified date). The outcome of the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: 36 weeks pregnant with her first pregnancy and she received the first dose of the Pfizer Covid vaccine; Soreness of the arm; This is a spontaneous report from a contactable nurse (parent) via a Pfizer-sponsored program. A 29-year-old female patient (the patient was 36 weeks pregnant at the onset of the event) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at the age of 29-year-old on an unspecified date (pregnant at time of vaccination) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The nurse stated her daughter was 36 weeks pregnant with her first pregnancy and she received the first dose of the Pfizer Covid vaccine. She just had soreness of the arm on an unknown date. Her doctor recommended she get the vaccine.  The events outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: headache; body aches; chills; This is a spontaneous report from a contactable consumer (patient).  A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 23Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history was none. There were no concomitant medications. The evening of 23Apr2021 the patient begun to experience chills; he woke up on 24Apr2021 (Saturday morning) with very bad body aches and headache that lasted all day. Sunday he continued to experience a headache. Outcome of the event headache was not recovered while outcome of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headache; Pulsing pain; This is a spontaneous report from a contactable consumer (patient).  A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 22Apr2021 09:45 (Batch/Lot number was not reported), age at vaccination of 50-years-old, as single dose, for covid-19 immunisation. Medical history was none; the patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. Concomitant medications were not reported. The patient experienced headache traveling down the center of cranium on 23Apr2021 10:00 AM and pulsing pain on 23Apr2021 10:00 AM. No treatments for the events were given. The patient recovered from the events on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: chills; body aches; headache; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was and  concomitant medications were not reported. The patient experienced chills, body aches and headache 15 hours after receiving 2nd dose of BNT162B2. Outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: severe vertigo; This is a spontaneous report from a contactable consumer (Pfizer colleague).   A 7-decade-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe vertigo  on an unspecified date after his 2nd dose. Outcome of the event was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea; lightheadedness; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient experienced nausea and lightheadedness on an unspecified date at the time of first vaccination. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: bruising; This is a spontaneous report received from a non-contactable consumer from Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was bruising after the COVID vaccine. The outcome of bruising was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Menstruation delayed, Menstruation irregular, Pregnancy test, SARS-CoV-2 test
Clinical narrative: I noticed that like my periods got weird that I have not had a period; I noticed that like my periods got weird that I have not had a period; This is a spontaneous report from a contactable consumer reported for herself. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left, at the age of 35 years, on 02Apr2021 (Batch/Lot Number: ER8735) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included allergies to sweet potato and banana from an unknown date and unknown if ongoing. Concomitant medications included polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported and vitamins. The patient previously took wellbutrin, methocarbamol and ceclor and experienced drug hypersensitivity. On 21Apr2021, the patient stated, "So, I think I need to report something that isn't the first effect and the other thing I don't know if it is not, so I got my first Covid Vaccine the Pfizer on 02Apr2021 and I noticed that like my periods got weird that I have not had a period and I am normally, completely regular then I got my 2nd Vaccine that past Saturday and I got it on my left side of my body and my lip swelled up on left side and then I got a rash but the rash is going away and swelling going down but I thought I need to report that." The patient underwent lab tests and procedures which included body height: 5 foot 8 inches, pregnancy test: not pregnant, sars-cov-2 test: negative and weight: it must be between 180-185; all on unspecified dates. The outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: I noticed that like my periods got weird that I have not had a period; I noticed that like my periods got weird that I have not had a period; This is a spontaneous report from a contactable consumer reported for herself. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left, at the age of 35 years, on 02Apr2021 (Batch/Lot Number: ER8735) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included allergies to sweet potato and banana from an unknown date and unknown if ongoing. Concomitant medications included polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported and vitamins. The patient previously took wellbutrin, methocarbamol and ceclor and experienced drug hypersensitivity. On 21Apr2021, the patient stated, "So, I think I need to report something that isn't the first effect and the other thing I don't know if it is not, so I got my first Covid Vaccine the Pfizer on 02Apr2021 and I noticed that like my periods got weird that I have not had a period and I am normally, completely regular then I got my 2nd Vaccine that past Saturday and I got it on my left side of my body and my lip swelled up on left side and then I got a rash but the rash is going away and swelling going down but I thought I need to report that." The patient underwent lab tests and procedures which included body height: 5 foot 8 inches, pregnancy test: not pregnant, sars-cov-2 test: negative and weight: it must be between 180-185; all on unspecified dates. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature abnormal, Chills, Feeling cold
Clinical narrative: has been sick since; freezing; temperature of 100°F; chills; muscle aches; joint pain; nauseous; headache; her feet are wobbly when walking; This is a spontaneous report from a contactable consumer (patient). A A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history included poor immunization of her lungs and post covid syndrome. Lab test included COVID-19 in December 2020 and temperature of 100°F. The patient's concomitant medications were not reported. Patient stated she received the first dose of the Pfizer COVID vaccine yesterday and she has been sick ever since she received the first vaccine dose and was wondering how long the symptoms would last. Patient stated that she felt as if she had COVID-19 all over again. Patient also stated that she has been freezing, temperature of 100°F with Tylenol, chills, muscle aches and joint pain, nauseous, headache and her feet were wobbly when walking. Patient would like to know if these are possible side effects from the vaccine and what should she do about them and since she is having these side effects with the first dose will she have the same side effects with the second dose. She received two doses of the convalescent antibodies and Remdesivir. She also had post-Covid syndrome so she was afraid of how the side effects with the first and second dose will affect her. She was instructed by her physician that she should receive a covid vaccine since she may have a lower response to the vaccine so she doesn't want to be enduring these symptoms for nothing. Patient would like to know if it is necessary for her to receive the second dose to which the response was "she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Illness, Myalgia, Nausea
Clinical narrative: has been sick since; freezing; temperature of 100°F; chills; muscle aches; joint pain; nauseous; headache; her feet are wobbly when walking; This is a spontaneous report from a contactable consumer (patient). A A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history included poor immunization of her lungs and post covid syndrome. Lab test included COVID-19 in December 2020 and temperature of 100°F. The patient's concomitant medications were not reported. Patient stated she received the first dose of the Pfizer COVID vaccine yesterday and she has been sick ever since she received the first vaccine dose and was wondering how long the symptoms would last. Patient stated that she felt as if she had COVID-19 all over again. Patient also stated that she has been freezing, temperature of 100°F with Tylenol, chills, muscle aches and joint pain, nauseous, headache and her feet were wobbly when walking. Patient would like to know if these are possible side effects from the vaccine and what should she do about them and since she is having these side effects with the first dose will she have the same side effects with the second dose. She received two doses of the convalescent antibodies and Remdesivir. She also had post-Covid syndrome so she was afraid of how the side effects with the first and second dose will affect her. She was instructed by her physician that she should receive a covid vaccine since she may have a lower response to the vaccine so she doesn't want to be enduring these symptoms for nothing. Patient would like to know if it is necessary for her to receive the second dose to which the response was "she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: has been sick since; freezing; temperature of 100°F; chills; muscle aches; joint pain; nauseous; headache; her feet are wobbly when walking; This is a spontaneous report from a contactable consumer (patient). A A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history included poor immunization of her lungs and post covid syndrome. Lab test included COVID-19 in December 2020 and temperature of 100°F. The patient's concomitant medications were not reported. Patient stated she received the first dose of the Pfizer COVID vaccine yesterday and she has been sick ever since she received the first vaccine dose and was wondering how long the symptoms would last. Patient stated that she felt as if she had COVID-19 all over again. Patient also stated that she has been freezing, temperature of 100°F with Tylenol, chills, muscle aches and joint pain, nauseous, headache and her feet were wobbly when walking. Patient would like to know if these are possible side effects from the vaccine and what should she do about them and since she is having these side effects with the first dose will she have the same side effects with the second dose. She received two doses of the convalescent antibodies and Remdesivir. She also had post-Covid syndrome so she was afraid of how the side effects with the first and second dose will affect her. She was instructed by her physician that she should receive a covid vaccine since she may have a lower response to the vaccine so she doesn't want to be enduring these symptoms for nothing. Patient would like to know if it is necessary for her to receive the second dose to which the response was "she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.