chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Vaccination site pain
Clinical narrative: patient says that she was in bed for about a day after each Moderna Covid-19 vaccine; sore injection site arm; felt tired after receiving each Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (patient says that she was in bed for about a day after each Moderna Covid-19 vaccine), VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired after receiving each Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (patient says that she was in bed for about a day after each Moderna Covid-19 vaccine), VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired after receiving each Moderna Covid-19 vaccine). At the time of the report, ASTHENIA (patient says that she was in bed for about a day after each Moderna Covid-19 vaccine), VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired after receiving each Moderna Covid-19 vaccine) was resolving.            No concomitant medications were reported.  The patient was in bed for about a day after each Moderna Covid-19 vaccine. Patient drank a lot of water and felt better.  No  treatment medications were reported.   This case was linked to MOD-2022-482710 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2022: Follow-up was received and contains no new information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 2010, Ocular hypertension (Pressure on eyes), Penicillin allergy and Drug allergy (Darvon allergy). Concomitant products included LEVOTHYROXINE for Hypothyroidism, BIMATOPROST (LUMIGAN) for Ocular hypertension.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ALOPECIA (Hair loss). At the time of the report, ALOPECIA (Hair loss) had not resolved.            Patient took her booster shot on 26-Oct-2021 with the batch number 939905 and patient received probably Flu vaccine on Sep-2021.  Patient's dermatologist stated that the hair loss could be due to her immune system was attacking her hair and the that had been worsened and also stated that she would go to take some lab analyses and patient did not had ever COVID positive test or diagnosis.  No treatment had been given for hair loss.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second dose after 21 days/almost 22 days after the first dose/Second dose 48 hours before the recommended time frame; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose after 21 days/almost 22 days after the first dose/Second dose 48 hours before the recommended time frame) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose after 21 days/almost 22 days after the first dose/Second dose 48 hours before the recommended time frame). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose after 21 days/almost 22 days after the first dose/Second dose 48 hours before the recommended time frame) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant use were reported No Treatment were reported
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Headache, Malaise, SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: vaginal bleeding/a lot of bleeding; Anemic; Health is being affected; worsening headaches; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal bleeding/a lot of bleeding), ANAEMIA (Anemic), MALAISE (Health is being affected) and HEADACHE (worsening headaches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Started when patient was much younger), Drug allergy (Allergic to Benadryl) and Menopause (Patient went into menopause approximately two years ago).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding/a lot of bleeding), ANAEMIA (Anemic), MALAISE (Health is being affected) and HEADACHE (worsening headaches). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, VAGINAL HAEMORRHAGE (vaginal bleeding/a lot of bleeding), ANAEMIA (Anemic), MALAISE (Health is being affected) and HEADACHE (worsening headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) never tested positive.         No concomitant medications were reported.  The date of administration for the Booster dose was two to three weeks ago from the time of report. The events started occurring a couple of days after she received the Moderna booster dose. Patient had gone into menopause approximately two years ago and the reporter stated that the Moderna booster dose brought the patient out of menopause and her health was being affected by the vaccine. The health was being affected and it was worsened after booster dose. Vaginal bleeding had not improved or worsened. Patient may have to undergo a surgery - hysterectomy. The patient has been exposed to COVID-19 in the past but never tested positive. It was reported that the patient was under duress when she received the Moderna COVID-19 vaccine and stated that she was made to get the Moderna vaccine by her employer or she would be at risk of losing her job.   Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Mobility decreased, Somnolence
Clinical narrative: I felt a little slow; sleepy; It felt like someone slugged me really hard in the arm for 3-4 days; kind of tired; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (I felt a little slow), SOMNOLENCE (sleepy), FEELING ABNORMAL (It felt like someone slugged me really hard in the arm for 3-4 days) and FATIGUE (kind of tired) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced MOBILITY DECREASED (I felt a little slow), SOMNOLENCE (sleepy), FEELING ABNORMAL (It felt like someone slugged me really hard in the arm for 3-4 days) and FATIGUE (kind of tired). In January 2021, FEELING ABNORMAL (It felt like someone slugged me really hard in the arm for 3-4 days) had resolved. At the time of the report, MOBILITY DECREASED (I felt a little slow), SOMNOLENCE (sleepy) and FATIGUE (kind of tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that dose was full dose Total, patient had taken 4 full doses of Moderna COVID-19 vaccine. AE had not caused patient to seek medical care office visit, Urgent care, ER or hospitalized  No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2022-482921, MOD-2022-482916 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Head discomfort, Nasopharyngitis, Somnolence
Clinical narrative: It felt like a mild punch in my arm; A little sluggish in the head; Like a little head cold; Felt sleepy for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (It felt like a mild punch in my arm), HEAD DISCOMFORT (A little sluggish in the head), NASOPHARYNGITIS (Like a little head cold) and SOMNOLENCE (Felt sleepy for 1 day) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced FEELING ABNORMAL (It felt like a mild punch in my arm), HEAD DISCOMFORT (A little sluggish in the head), NASOPHARYNGITIS (Like a little head cold) and SOMNOLENCE (Felt sleepy for 1 day). On 12-Feb-2021, SOMNOLENCE (Felt sleepy for 1 day) had resolved. At the time of the report, FEELING ABNORMAL (It felt like a mild punch in my arm), HEAD DISCOMFORT (A little sluggish in the head) and NASOPHARYNGITIS (Like a little head cold) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-482921, MOD-2022-482874 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Pain in extremity, SARS-CoV-2 test
Clinical narrative: I've gotten 4 full dose Moderna Covid-19 shots.; my arm was sore; I was tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm was sore), FATIGUE (I was tired) and EXTRA DOSE ADMINISTERED (I've gotten 4 full dose Moderna Covid-19 shots.) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 021C21A, 025L20A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 07-Jan-2022.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2022, the patient experienced PAIN IN EXTREMITY (my arm was sore) and FATIGUE (I was tired). On 14-Feb-2022, the patient experienced EXTRA DOSE ADMINISTERED (I've gotten 4 full dose Moderna Covid-19 shots.). At the time of the report, PAIN IN EXTREMITY (my arm was sore) and FATIGUE (I was tired) had resolved and EXTRA DOSE ADMINISTERED (I've gotten 4 full dose Moderna Covid-19 shots.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications was provided by the reporter. No treatment was provided by the reporter. It was reported that believe got COVID, got chills, lasted longer than it normally does. Got Chills for 1 night, it turned into bronchitis.   This case was linked to MOD-2022-482874, MOD-2022-482916 (Patient Link).
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Mobility decreased, Vaccination site pain
Clinical narrative: difficulty moving; Mild insomnia the evening after the shot (difficulty both falling asleep and staying asleep).; Adverse event is pain at the site of injection from ~5 hr post injection (right arm, same location as previous doses); This spontaneous case was reported by an other health care professional and describes the occurrence of MOBILITY DECREASED (difficulty moving), INSOMNIA (Mild insomnia the evening after the shot (difficulty both falling asleep and staying asleep).) and VACCINATION SITE PAIN (Adverse event is pain at the site of injection from ~5 hr post injection (right arm, same location as previous doses)) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J221A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (EL 9262) on 24-Jan-2021, pfizer (EL 9261) on 14-Feb-2021 and pfizer (FD 8448) on 05-Sep-2021. Past adverse reactions to the above products included No adverse reaction with Pfizer, pfizer and pfizer.    On 13-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced MOBILITY DECREASED (difficulty moving), INSOMNIA (Mild insomnia the evening after the shot (difficulty both falling asleep and staying asleep).) and VACCINATION SITE PAIN (Adverse event is pain at the site of injection from ~5 hr post injection (right arm, same location as previous doses)). At the time of the report, MOBILITY DECREASED (difficulty moving), INSOMNIA (Mild insomnia the evening after the shot (difficulty both falling asleep and staying asleep).) and VACCINATION SITE PAIN (Adverse event is pain at the site of injection from ~5 hr post injection (right arm, same location as previous doses)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: giving low doses of Moderna injections; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (giving low doses of Moderna injections) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (giving low doses of Moderna injections). At the time of the report, UNDERDOSE (giving low doses of Moderna injections) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication details was provided. No treatment medication details was provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: losing clumps of her hair on Saturday; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (losing clumps of her hair on Saturday) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21A and 084J21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 11-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2022, the patient experienced ALOPECIA (losing clumps of her hair on Saturday). At the time of the report, ALOPECIA (losing clumps of her hair on Saturday) outcome was unknown.            No medical history was provided by the reporter. Weight of the patient was reported as 210. No treatment medication was reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received beyond 36 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received beyond 36 days after 1st dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J2121A and 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received beyond 36 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received beyond 36 days after 1st dose) outcome was unknown.            No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Pyrexia, Rash
Clinical narrative: Vaccine exposure via breastmilk; had a fever for a couple of days; a topical rash; This is a spontaneous report from a contactable consumer or other non-HCP (patient's father). A 7-months-old male patient (infant) while breastfeeding received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), 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. On an unspecified date 2021, the patient experienced Vaccine exposure via breastmilk, had a fever for a couple of days, and a topical rash. Caller stated, should mother get her second dose because of the infant's reaction. The outcome of the events was recovered on an unspecified date 2021.  Additional information: Caller states that after the mother received the first dose of the vaccine the seven month old breast fed male infant "a couple of days later he developed a fever and he had a full body rash it was like a topical rash so when you stretched the skin it would kind of disappear and he had that for a while".   Caller declines to complete a report. No further details captured, reported, or documented at this time.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (30Jul2021): This is a follow-up Spontaneous report from a contactable consumer. This consumer reported for a male patient which included: missed AE details.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100976062 Mother/baby case
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: He was very tired.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date Feb2021 (Lot number: en6202) at the age of 18 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "very mild von Wilderbrand" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "He was very tired.".  Additional information: The administration time of vaccination as reported as 14:00. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no know allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, SARS-CoV-2 test
Clinical narrative: Aches and headache; Aches and headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 13:00 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy: Penicillin allergy" (unspecified if ongoing); "pituitary tumor" (unspecified if ongoing); "Brain aneurysm rupture with coiling" (unspecified if ongoing); "I did have COVID", start date: 02Nov2020 (unspecified if ongoing), notes: symptoms included fatigue, loss of taste and smell, and a headache and pain. There were no concomitant medications. Past drug history included: Erithromycin, reaction(s): "Known allergies: Erithromycin". The following information was reported: PAIN (non-serious), HEADACHE (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Aches and headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, headache.  Additional information: Patient felt like the virus attacked her weakest parts of  body (for instance). head hurt on her left side, as if she was punched. It lasted two days. That seems to be where her pain was from COVID. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient did not received any other medications within 2 weeks of vaccination.no treatment received for the adverse event. patient was diagnosed with COVID-19 Prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. patient was Allergies to Penicillin, Erythromycin. Vaccine Facility information was available. Facility where the most recent COVID-19 vaccine was administered was at Hospital. Ethnicity information is available. Race information is available.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021419276 Same patient, different drug, different event (split)
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Pain, Pain in extremity
Clinical narrative: pain in my arm; body hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Feb2021 12:15 (Lot number: EL-9809) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Zithromax, reaction(s): "Allergies to medications, food, or other products:Zithomax"; Sulpha antibiotic, reaction(s): "Drug Allergy". Vaccination history included: Bnt162b2, administration date: Jan2021, when the patient was 45 years old, for Covid-19 immunization, reaction(s): "headache", "high my blood pressure 160/90 and later 180/90", "felt on my period", "small rash". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in my arm"; PAIN (non-serious), outcome "unknown", described as "body hurts". The events "pain in my arm" and "body hurts" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not take any other medications the patient received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 Since the vaccination. Patient received treatment for high blood pressure medication for two days. COVID-19 vaccine was administered at other facility.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: hafter 2nd injection bodyaches continued in hip, tehn moved to right hip, bilateral feet and ankles, thighs, shoulders, neck etc and have not subsided, have goteen worse; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "seasonal asthma," (unspecified if ongoing); "anxiety d/2 COVID" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN XL. Past drug history included: Allergies: lidocaine, reaction(s): "allergies lidocaine". Vaccination history included: Bnt162b2 (Lot number: EK5730, Intramuscular, dose number 1), administration date: 19Dec2020, for COVID-19 immunization, reaction(s): "bodyaches in injection site BUT also in left hip"; Bnt162b2 (Lot number: EK5730, Intramuscular, dose number 1), for COVID-19 immunization, reaction(s): "bodyaches in injection site BUT also in left hip". The following information was reported: PAIN (non-serious), outcome "unknown", described as "hafter 2nd injection bodyaches continued in hip, tehn moved to right hip, bilateral feet and ankles, thighs, shoulders, neck etc and have not subsided, have goteen worse". Therapeutic measures were taken as a result of pain.  Additional information: AE (adverse event) treatment diagnosed with hashimotos disorder and on medication which has not taken away the pain. No COVID prior vaccination. No COVID tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Feeling abnormal, Headache, Loss of personal independence in daily activities
Clinical narrative: headaches worsened; headaches worsened; dizziness; Brain foggness has increased; Getting through the day to complete work or even basic tasks is very difficult.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 13:00 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: if covid prior vaccination- Yes; "known allergies: cilians" (unspecified if ongoing), notes: known allergies: cilians. The patient took concomitant medications. Vaccination history included: Bnt162b2 ({product=COVID 19, lot unknown=False,, dose number=1}]), for COVID-19 Immunization, reaction(s): "Dizziness", "Headache", "Migraine", "Pain", "Vomiting". The following information was reported: HEADACHE (non-serious), CONDITION AGGRAVATED (non-serious), outcome "not recovered" and all described as "headaches worsened"; DIZZINESS (non-serious), outcome "not recovered", described as "dizziness"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Brain foggness has increased"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "Getting through the day to complete work or even basic tasks is very difficult.". The events "headaches worsened", "headaches worsened", "dizziness", "brain foggness has increased" and "getting through the day to complete work or even basic tasks is very difficult." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, condition aggravated, dizziness, feeling abnormal, loss of personal independence in daily activities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: headaches worsened; headaches worsened; dizziness; Brain foggness has increased; Getting through the day to complete work or even basic tasks is very difficult.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 13:00 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: if covid prior vaccination- Yes; "known allergies: cilians" (unspecified if ongoing), notes: known allergies: cilians. The patient took concomitant medications. Vaccination history included: Bnt162b2 ({product=COVID 19, lot unknown=False,, dose number=1}]), for COVID-19 Immunization, reaction(s): "Dizziness", "Headache", "Migraine", "Pain", "Vomiting". The following information was reported: HEADACHE (non-serious), CONDITION AGGRAVATED (non-serious), outcome "not recovered" and all described as "headaches worsened"; DIZZINESS (non-serious), outcome "not recovered", described as "dizziness"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Brain foggness has increased"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "Getting through the day to complete work or even basic tasks is very difficult.". The events "headaches worsened", "headaches worsened", "dizziness", "brain foggness has increased" and "getting through the day to complete work or even basic tasks is very difficult." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, condition aggravated, dizziness, feeling abnormal, loss of personal independence in daily activities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body temperature, Pruritus, Pyrexia, Rash
Clinical narrative: broken out in a rash; itching that turned into a rash last night; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 17 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Sep2021 (Batch/Lot number: unknown) at the age of 17 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 05Sep2021, outcome "unknown", described as "broken out in a rash"; PYREXIA (non-serious) with onset 04Sep2021, outcome "unknown", described as "low grade fever"; PRURITUS (non-serious) with onset 05Sep2021, outcome "unknown", described as "itching that turned into a rash last night". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: NDC number and UPC number of the suspect were unknown. When the Reason for no lot number asked, it was reported that reporter did not had patients card at the time of report. Grandmother (reporter) was seeking guidance on behalf of her 17year old Granddaughter (patient) who had her first dose on 03Sep2021 of the Pfizer Covid-19 Vaccine. She had broken out in a rash. It started on Saturday with a low grade fever and yesterday, with itching that turned into a rash last night. The reporter was to take Granddaughter to the Emergency Department because it was the holiday today. Transferring agent stated that they already addressed that and do not provide treatment recommendation but advised to reach out to her grand daughter's pediatrician or Physician and she agreed to speak with them. Investigation Assessment was no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Blood test, Drug interaction, Dyskinesia, Feeling abnormal
Clinical narrative: had a drug interaction with pfizer covid-19; told that the drug interaction pfizer covid-19 affected her right hip.; she had debility with ambulation for 5 days; brain fog; pain; She was only capable of ambulating from bed to bathroom; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2020US100435_NS.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), administration date: 23Mar2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "she had debility with ambulation"; Bnt162b2 (first dose), administration date: 23Mar2021, for Covid-19 immunization, reaction(s): "pain", "brain fog". The following information was reported: ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "she had debility with ambulation for 5 days"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "brain fog"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain"; DYSKINESIA (non-serious) with onset 2021, outcome "unknown", described as "She was only capable of ambulating from bed to bathroom"; DRUG INTERACTION (non-serious), outcome "unknown", described as "had a drug interaction with pfizer covid-19"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "told that the drug interaction pfizer covid-19 affected her right hip.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported received 2 dose of Pfizer Vaccine, 1st dose on 23Mar2021 and 2nd Dose on 13Apr2021, Patient stated after first dose she had debility with ambulation, brain fog and pain for 2 days. with receiving 2nd dose, Patient reported Continuous brain fog, pain and of debility with ambulation for 5 days. She was only capable of ambulating from bed to bathroom. She had a drug interaction with pfizer covid-19, 2nd injection, which was admin 13Apr2021. Several mris and blood work was collected, and pt. was told that the drug interaction pfizer covid-19 affected her right hip.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Magnetic resonance imaging, Musculoskeletal discomfort, Pain
Clinical narrative: had a drug interaction with pfizer covid-19; told that the drug interaction pfizer covid-19 affected her right hip.; she had debility with ambulation for 5 days; brain fog; pain; She was only capable of ambulating from bed to bathroom; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2020US100435_NS.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), administration date: 23Mar2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "she had debility with ambulation"; Bnt162b2 (first dose), administration date: 23Mar2021, for Covid-19 immunization, reaction(s): "pain", "brain fog". The following information was reported: ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "she had debility with ambulation for 5 days"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "brain fog"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain"; DYSKINESIA (non-serious) with onset 2021, outcome "unknown", described as "She was only capable of ambulating from bed to bathroom"; DRUG INTERACTION (non-serious), outcome "unknown", described as "had a drug interaction with pfizer covid-19"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "told that the drug interaction pfizer covid-19 affected her right hip.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported received 2 dose of Pfizer Vaccine, 1st dose on 23Mar2021 and 2nd Dose on 13Apr2021, Patient stated after first dose she had debility with ambulation, brain fog and pain for 2 days. with receiving 2nd dose, Patient reported Continuous brain fog, pain and of debility with ambulation for 5 days. She was only capable of ambulating from bed to bathroom. She had a drug interaction with pfizer covid-19, 2nd injection, which was admin 13Apr2021. Several mris and blood work was collected, and pt. was told that the drug interaction pfizer covid-19 affected her right hip.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pigmentation disorder, Plantar fasciitis, Pruritus
Clinical narrative: foot started hurting really bad; I just got rid of planter fasciitis and may be it came back; I noticed a spot on my foot that coincided with a sting ray bite I had last summer; tendered and it was itchy; foot was swollen; tendered and it was itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old patient received bnt162b2 (BNT162B2), administration date 23Aug2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "planter fasciitis" (unspecified if ongoing), notes: I just got rid of planter fasciitis. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "foot started hurting really bad"; PLANTAR FASCIITIS (non-serious), outcome "unknown", described as "I just got rid of planter fasciitis and may be it came back"; PIGMENTATION DISORDER (non-serious), outcome "unknown", described as "I noticed a spot on my foot that coincided with a sting ray bite I had last summer"; TENDERNESS (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "tendered and it was itchy"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "foot was swollen".  Additional information: The patient had shots like two Mondays ago/ couple of weeks ago. The patient also reported that the second dose was on 23rd\ 23Aug. The patient noticed a spot on foot that coincided with a sting ray bite that the patient had last summer, and everything towards the sting ray bite my foot was swollen, it was tendered and it was itchy and the patient wondered why that happened as that was a really old bite. Patient height: was reported as 5,10 or 11. The patient took allergy medication, blood pressure medicine and cholesterol medicine (medication name not clarified further).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: foot started hurting really bad; I just got rid of planter fasciitis and may be it came back; I noticed a spot on my foot that coincided with a sting ray bite I had last summer; tendered and it was itchy; foot was swollen; tendered and it was itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old patient received bnt162b2 (BNT162B2), administration date 23Aug2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "planter fasciitis" (unspecified if ongoing), notes: I just got rid of planter fasciitis. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "foot started hurting really bad"; PLANTAR FASCIITIS (non-serious), outcome "unknown", described as "I just got rid of planter fasciitis and may be it came back"; PIGMENTATION DISORDER (non-serious), outcome "unknown", described as "I noticed a spot on my foot that coincided with a sting ray bite I had last summer"; TENDERNESS (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "tendered and it was itchy"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "foot was swollen".  Additional information: The patient had shots like two Mondays ago/ couple of weeks ago. The patient also reported that the second dose was on 23rd\ 23Aug. The patient noticed a spot on foot that coincided with a sting ray bite that the patient had last summer, and everything towards the sting ray bite my foot was swollen, it was tendered and it was itchy and the patient wondered why that happened as that was a really old bite. Patient height: was reported as 5,10 or 11. The patient took allergy medication, blood pressure medicine and cholesterol medicine (medication name not clarified further).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Incorrect dose administered, Pruritus
Clinical narrative: Burning; itching; redness bilateral feet; had dose 1 and dose 2 on 03Sep2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Sep2021 09:30 (Lot number: FC3182) at the age of 47 years as dose 1, single and administered in arm left, administration date 03Sep2021 09:30 (Lot number: FC3183) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADDERALL. Past drug history included: None. The following information was reported: BURNING SENSATION (non-serious) with onset 05Sep2021 23:00, outcome "not recovered", described as "Burning"; PRURITUS (non-serious) with onset 05Sep2021 23:00, outcome "not recovered", described as "itching"; ERYTHEMA (non-serious) with onset 05Sep2021 23:00, outcome "not recovered", described as "redness bilateral feet"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 03Sep2021 09:30, outcome "unknown", described as "had dose 1 and dose 2 on 03Sep2021". Therapeutic measures were not taken as a result of burning sensation, pruritus, erythema.  Additional information: Patient had no known allergies. Patient did not had any vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, post vaccination.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: deleted event 'overdose' and updated the event from 'inappropriate schedule of vaccine administered' to 'inappropriate dose of vaccine administered'.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: periods don't flow anymore, it literally stopped/doesn't come and flow like it should; spots black blood; menstrual irregularities; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 24 year-old female patient received bnt162b2 (BNT162B2), administration date 18Jul2021 (Batch/Lot number: unknown) at the age of 24 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), when the patient was 24 years old, for Covid-19 Immunization. The following information was reported: AMENORRHOEA (non-serious) with onset Aug2021, outcome "not recovered", described as "periods don't flow anymore, it literally stopped/doesn't come and flow like it should"; INTERMENSTRUAL BLEEDING (non-serious) with onset Aug2021, outcome "unknown", described as "spots black blood"; MENSTRUATION IRREGULAR (non-serious) with onset Aug2021, outcome "unknown", described as "menstrual irregularities".  Follow-up (09Sep2021): This is a follow-up spontaneous report from a contactable Nurse. This Nurse reported for a patient (Reporter's Daughter).It included: Patients details, Reaction(s)/Event(s) details,Drug(s) Information.  Additional Information:History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was only had her childhood vaccine.The patient did not visited Physician Office but she has an appointment next week with a gynaecologist. The patient did not received prior Vaccinations (within 4 weeks).The patient does not had AE(s) following prior vaccinations.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.  Follow-up (13Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.