chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: some spots of psoriasis in June/the end of year 2021 psoriasis getting worse and worse. He has 30% of his leg covered, and his arms. "It is growing hard, whole leg covered and arms.; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (some spots of psoriasis in June/the end of year 2021 psoriasis getting worse and worse. He has 30% of his leg covered, and his arms. "It is growing hard, whole leg covered and arms.) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis and Hypertension (more than 10 years in treatment). Concomitant products included OLMESARTAN MEDOXOMIL (FLUXOCOR [OLMESARTAN MEDOXOMIL]) for Hypertension.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PSORIASIS (some spots of psoriasis in June/the end of year 2021 psoriasis getting worse and worse. He has 30% of his leg covered, and his arms. "It is growing hard, whole leg covered and arms.). The patient was treated with BETAMETHASONE DIPROPIONATE, CALCIPOTRIOL (DAIVOBET [BETAMETHASONE DIPROPIONATE;CALCIPOTRIOL]) for Psoriasis, at an unspecified dose and frequency. At the time of the report, PSORIASIS (some spots of psoriasis in June/the end of year 2021 psoriasis getting worse and worse. He has 30% of his leg covered, and his arms. "It is growing hard, whole leg covered and arms.) had not resolved.            Patient stated in June 2021, he did his annual check up and also went to the dermatologist. At that point he had some spots of psoriasis and they went away with the usual treatment: an ointment. Patient has used this ointment to treat his psoriasis before the vaccine and it had always worked. Towards the end of the year 2021, that psoriasis is getting worse and worse. The treatment is not working. Patient says that the ointment, it usually lasts for a whole year before he buys another one. He states that the ointment he bought in June 2021 is already all used up, that is the extent of his psoriasis.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Vaccination site erythema
Clinical narrative: swollen lymphnodes under my armpit; headache; redness around injection site; spans about 2 mm; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPHADENOPATHY (swollen lymphnodes under my armpit), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness around injection site; spans about 2 mm) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymphnodes under my armpit), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness around injection site; spans about 2 mm). At the time of the report, LYMPHADENOPATHY (swollen lymphnodes under my armpit) and HEADACHE (headache) outcome was unknown and VACCINATION SITE ERYTHEMA (redness around injection site; spans about 2 mm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On Jan 2022 patient received booster dose of Moderna (two days ago). On Jan 2022 patient experienced swollen lymph nodes under armpit and headache(on first day). No concomitant medication were reported.   No treatment drug were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: wakes up with cramps like they are going to have a period; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (wakes up with cramps like they are going to have a period) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     The patient's past medical history included Menopausal in January 2011 and Surgery. Concurrent medical conditions included Bone disorder and Joint disorder.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (wakes up with cramps like they are going to have a period). At the time of the report, MUSCLE SPASMS (wakes up with cramps like they are going to have a period) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported. Patient did not take any medication to treat the side effects but thought about taking a rapid release Tylenol. Patient has comorbidities. Patient is not currently on any medications.   This case was linked to MOD-2022-446890, MOD-2022-446928 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelilng at the injection site; Pain at the injection site; Fever; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE SWELLING (Swelilng at the injection site), VACCINATION SITE PAIN (Pain at the injection site) and PYREXIA (Fever) 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 VACCINATION SITE SWELLING (Swelilng at the injection site), VACCINATION SITE PAIN (Pain at the injection site) and PYREXIA (Fever). At the time of the report, VACCINATION SITE SWELLING (Swelilng at the injection site), VACCINATION SITE PAIN (Pain at the injection site) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  No treatment medication was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-446727 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received first moderna vaccine and johnson and johnson vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first moderna vaccine and johnson and johnson vaccine) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) for an unknown indication.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient started COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (unknown route) at an unspecified dose. On 06-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first moderna vaccine and johnson and johnson vaccine). On 06-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first moderna vaccine and johnson and johnson vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Mild COVID Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Mild COVID Arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (Mild COVID Arm). On 01-May-2021, VACCINATION SITE REACTION (Mild COVID Arm) had resolved.            No concomitant medications were reported  No treatment information was provided  the patient had she had mild COVID Arm for 1 day   This case was linked to MOD-2022-447415, MOD-2022-447154 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Significant lymph node swelling on left side of body with significant pain; Significant lymph node swelling on left side of body with significant pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 15:00 (Lot number: FC3182) at the age of 27 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Mast Cellular Activation Disorder" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA; NEXPLANON; CALCIUM + MAGNESIUM; NEXIUM [ESOMEPRAZOLE SODIUM]; ORILISSA.  The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 22Sep2021 08:00, outcome "recovering" and all described as "Significant lymph node swelling on left side of body with significant pain". Therapeutic measures were taken as a result of lymphadenopathy, lymph node pain.  Additional information- Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The treatment for adverse event included Benadryl and Non steroidal anti inflammatory drugs (NSAID) for days until pain subsided. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, has the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: HCP stated that they have diluted the vaccine and stored at room temperature but it went up to 80F.; HCP stated that they have diluted the vaccine and stored at room temperature but it went up to 80F.; This case has been considered invalid as Unspecified number of patients.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) and all described as "HCP stated that they have diluted the vaccine and stored at room temperature but it went up to 80F." Additional information: HCP calling for temperature excursion of the Pfizer-BioNTech Covid19 Vaccine. HCP stated that they have diluted the vaccine and stored at room temperature but it went up to 80F. She is not sure about the duration of the excursion, she gave a estimated duration of 1 hour. HCP stated, "we gave it to them quickly within 1 to 2 hours we gave it, we were done". HCP is asking for viability information of the vaccine. She just wanted to make sure that she doesn't need to revaccinate them.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: case re-assessed to invalid.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: body aches starting 6 hours after injection lasting 4 hours; headache within 15 minutes of injection; Sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 28Feb2021 10:30 (Lot number: EN6201) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lung Sarcoidosis" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: HCTZ; FAMOTIDINE; VIT D [VITAMIN D NOS]. Past drug history included: Ibuprofen, reaction(s): "Allergy"; Atropine, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (administration time=10:30 AM, vaccine location=Left leg, dose number=1, event on 07Feb2021), administration date: 07Feb2021, when the patient was 67 years old, for covid-19 immunization, reaction(s): "headache within 15 min of injection", "body aches starting 6 hrs after injection lasting 8 hrs", "sore arm", "vaccine location Left leg". The following information was reported: HEADACHE (non-serious) with onset 28Feb2021 10:45, outcome "recovered" (2021), described as "headache within 15 minutes of injection"; PAIN (non-serious) with onset 28Feb2021 16:30, outcome "recovered" (28Feb2021), described as "body aches starting 6 hours after injection lasting 4 hours"; PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Sore arm". Therapeutic measures were not taken as a result of headache, pain, pain in extremity.  Additional information: Patient had no other vaccine within four weeks. Patient had no covid prior vaccination. Patient was not tested for covid post vaccination. Headache within 15 min of injection, body aches starting 6 hours after injection lasting 4 hours both doses: sore arm 24hour.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: i've had chest pains ever since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Sep2021 (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: CHEST PAIN (non-serious) with onset 2021, outcome "not recovered", described as "i've had chest pains ever since".  Clinical course: Patient received covid shots back in September and she had  had chest pains ever since. She was  going to the doctor soon to have an evaluation and if it comes back that  shot had anything to do with this she will sue the out of you.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Overdose
Clinical narrative: Gave one patient 6 full doses of vaccine; she developed persistent conjunctivitis in both eyes; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program (159558).  An adult female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 Immunization; Bnt162b2 (dose 2, single), for COVID-19 Immunization. The following information was reported: OVERDOSE (non-serious), outcome "unknown", described as "Gave one patient 6 full doses of vaccine"; CONJUNCTIVITIS (non-serious), outcome "not recovered", described as "she developed persistent conjunctivitis in both eyes".  Additional information: The age of the patient was reported to be around 50 to 60. Reporter confirms the medical assistant was administering a Covid booster and gave the patient 6 full doses. The patient was fine that day and laughed about it. The doctor's office checked on daily for a week and she had no reports of an adverse event. The medical assistant had never done a Pfizer vaccine before and pulled the whole vial undiluted. He was given instructions and didn't follow them. 6 doses is an odd number to have in a vial and makes it harder to remember. The patient's daughter brought her into the clinic because she developed persistent conjunctivitis in both eyes and blames the vaccine and they were very angry. The patient was vaccinated in doctor's office. The physician does not consider it related to the vaccine based on the literature he read.   Follow-up attempts have been completed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Swelling
Clinical narrative: Pain; this morning woke up with a swollen armpit; swollen arm pit on the left side of her body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Open heart surgery", start date: 31Aug2021, stop date: 07Sep2021, notes: (From: 31 Aug 2021 To: Unspecified), Dates when patient was in hospital for Open heart surgery: 26Aug2021 to 7Sep2021. Concomitant medication(s) included: WARFARIN [WARFARIN POTASSIUM], start date: 01Sep2021. Vaccination history included: Bnt162b2 (1st dose), administration date: 28Feb2021, when the patient was 57 years old, for Covid-19 Immunization; Bnt162b2 (2nd dose), administration date: 21Mar2021, when the patient was 57 years old, for Covid-19 Immunization. The following information was reported: SWELLING (non-serious) with onset 02Nov2021, outcome "not recovered", described as "swollen arm pit on the left side of her body"; PAIN (non-serious) with onset 03Nov2021, outcome "not recovered", described as "Pain"; PERIPHERAL SWELLING (non-serious) with onset 03Nov2021, outcome "not recovered", described as "this morning woke up with a swollen armpit".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Pain in extremity, Rhinorrhoea
Clinical narrative: fatigue; sore arm only on arm with injection; runny nose; slight sore throat; This is a spontaneous report received from a contactable consumer.  A 9 year-old female patient (not pregnant) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FK5127) in the left arm on 05Nov2021 at 16:45 at the age of 9 years as a single dose for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "sunscreen allergy" (unspecified if ongoing); "bug sprays allergy" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [LORATADINE]. The following information was reported: FATIGUE (non-serious) with onset 06Nov2021 at 08:30, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset 06Nov2021 at 08:30, outcome "unknown", described as "sore arm only on arm with injection"; RHINORRHOEA (non-serious) with onset 06Nov2021 at 08:30, outcome "unknown", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 06Nov2021 08:30, outcome "unknown", described as "slight sore throat". Therapeutic measures were not taken as a result of fatigue, pain in extremity, rhinorrhoea, oropharyngeal pain.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Rash
Clinical narrative: A rash or breakout on the face and neck; patient received BNT162B2 and influenza vaccine on the same day; patient received BNT162B2 and influenza vaccine on the same day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 5 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 11Nov2021 09:15 (Lot number: Fks127) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 11Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: paracetamol (TYLENOL); ibuprofen (MOTRIN). The following information was reported: RASH (non-serious) with onset 12Nov2021 16:00, outcome "not recovered", described as "A rash or breakout on the face and neck"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 11Nov2021, outcome "unknown" and all described as "patient received BNT162B2 and influenza vaccine on the same day". Therapeutic measures were not taken as a result of rash.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Overdose
Clinical narrative: received 10mcg each and the 7 y/o and 11 y/o received 20 mcg each; "she bled a lot", had a lot of cramping pain and vomited x2.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 11 year-old female 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: OVERDOSE (non-serious), outcome "unknown", described as "received 10mcg each and the 7 y/o and 11 y/o received 20 mcg each"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as ""she bled a lot", had a lot of cramping pain and vomited x2.".  No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Bloody nose 8 hours post vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10 year-old female patient (not pregnant) received BNT162B2 (COMIRNATY), administered in arm left, administration date 11Nov2021 19:45 (Lot number: FK5618) at the age of 10 years as dose 1 (tris), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: EPISTAXIS (non-serious) with onset 12Nov2021 03:30, outcome "recovered" (Nov2021), described as "Bloody nose 8 hours post vaccination". Therapeutic measures were not taken as a result of epistaxis.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. . The patient did not receive any other vaccines within four weeks prior to the vaccination. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Swelling
Clinical narrative: Some Swelling; 3-year-old patient went in for a flu shot and received BNT162B2 instead; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202101587674.  A 3 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) at the age of 3 years as dose 1 (tris), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "Some Swelling"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "3-year-old patient went in for a flu shot and received BNT162B2 instead".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after final vaccination. Patient was diagnosed of COVID Discharged home
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hypersensitivity, Overdose, Pain in extremity
Clinical narrative: Allergic Reaction; received possibly the whole undiluted vial of the vaccine / was possibly 90 - 120 mcg of vaccine given to the patient; Please provide the stage of medication error (e.g., prescribing, dispensing, preparation, and administration): preparpation and administration; received possibly the whole undiluted vial of the vaccine / was possibly 90 - 120 mcg of vaccine given to the patient; mild fever; chills; sore arm; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team.  A 58 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 16Nov2021 (Lot number: FH8030) as dose 2, single for covid-19 immunisation. Relevant medical history included hypertension (ongoing); osteoarthritis (ongoing); prediabetes (ongoing); Allergic reactions (ongoing); hypercholesterolemia (ongoing); High cholesterol (unspecified if ongoing); Allergy symptoms (unspecified if ongoing). Concomitant medication(s) included ATORVASTATIN taken for blood cholesterol increased (ongoing); ALLEGRA taken for hypersensitivity (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension (ongoing). Vaccination history included Bnt162b2 (Dose:01, Batch/Lot# 301558A, Time: 13:00, Site and Route of injection, Anatomical Site of injection: Left upper arm, Route of administration: Intramuscular, Batch/Lot number: 301558A / PAA173398), administration date 19Oct2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s) mild fever, chills. The following information was reported OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 16Nov2021, outcome unknown; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 16Nov2021, outcome unknown; PYREXIA (non-serious) with onset 16Nov2021, outcome recovered (2021); CHILLS (non-serious) with onset 16Nov2021, outcome recovered (2021); PAIN IN EXTREMITY (non-serious) with onset 16Nov2021, outcome recovered (2021); HYPERSENSITIVITY (non-serious) with onset 16Nov2021 21:00, outcome recovered (2021). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypersensitivity.  Phone out 3:40 pm  Reporter provided an update that the patient is still OK and doing fine.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product preparation error, Pyrexia
Clinical narrative: Allergic Reaction; received possibly the whole undiluted vial of the vaccine / was possibly 90 - 120 mcg of vaccine given to the patient; Please provide the stage of medication error (e.g., prescribing, dispensing, preparation, and administration): preparpation and administration; received possibly the whole undiluted vial of the vaccine / was possibly 90 - 120 mcg of vaccine given to the patient; mild fever; chills; sore arm; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team.  A 58 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 16Nov2021 (Lot number: FH8030) as dose 2, single for covid-19 immunisation. Relevant medical history included hypertension (ongoing); osteoarthritis (ongoing); prediabetes (ongoing); Allergic reactions (ongoing); hypercholesterolemia (ongoing); High cholesterol (unspecified if ongoing); Allergy symptoms (unspecified if ongoing). Concomitant medication(s) included ATORVASTATIN taken for blood cholesterol increased (ongoing); ALLEGRA taken for hypersensitivity (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension (ongoing). Vaccination history included Bnt162b2 (Dose:01, Batch/Lot# 301558A, Time: 13:00, Site and Route of injection, Anatomical Site of injection: Left upper arm, Route of administration: Intramuscular, Batch/Lot number: 301558A / PAA173398), administration date 19Oct2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s) mild fever, chills. The following information was reported OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 16Nov2021, outcome unknown; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 16Nov2021, outcome unknown; PYREXIA (non-serious) with onset 16Nov2021, outcome recovered (2021); CHILLS (non-serious) with onset 16Nov2021, outcome recovered (2021); PAIN IN EXTREMITY (non-serious) with onset 16Nov2021, outcome recovered (2021); HYPERSENSITIVITY (non-serious) with onset 16Nov2021 21:00, outcome recovered (2021). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypersensitivity.  Phone out 3:40 pm  Reporter provided an update that the patient is still OK and doing fine.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Gait disturbance
Clinical narrative: disqualibrium; unable to work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 13May2021 15:30 (Lot number: EWQ182) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic pain", start date: 1992 (ongoing); "COPD", start date: 1992 (ongoing); "High BP", start date: 1992 (ongoing); "Adrenalectomy", start date: 2005, stop date: 2005; "Cholesterol" (ongoing); "Reflux" (ongoing); "Prostate" (ongoing); "Heart" (ongoing). Concomitant medication(s) included: OXYCODONE taken for pain (ongoing); TAMSULOSIN taken for prostate infection (ongoing); LIPITOR taken for blood cholesterol (ongoing); PROSCAR taken for prostate cancer (ongoing); ALBUTEROL [SALBUTAMOL] taken for chronic obstructive pulmonary disease (ongoing); ESOMEPRAZOLE SODIUM taken for gastrooesophageal reflux disease (ongoing); BACLOFEN taken for pain (ongoing); COZAAR taken for cardiac disorder, hypertension (ongoing). Vaccination history included: Shingrix, administration date: 22Sep2020, for Allergic reaction; Shingrix. The following information was reported: BALANCE DISORDER (non-serious) with onset 2021, outcome "recovered" (2021), described as "disqualibrium"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "recovered" (2021), described as "unable to work".  Additional information: Family medical history relevant to AE: Patient had an allergic reaction following Shingres(2) on 22Sep2020. Treated with Xolair ending, 01Jul2211. Immediately following 1st Pfizer covid vaccine on 13May2021, I had prolonged disequilibrium /proprioception issues for 10-12 weeks. Following the 2nd Pfizer shot I did here initial mild fever and on 31Oct2021 started experiencing urticaria and angioedema again (some as in past) Have Since scheduled follow up 31Oct2021 with Allergist and resumption of Xolair treatment ASAP. Despite current treatment with Prednisone, Symptoms are worsening daily. No relevant tests or Specific Relevant tests were performed. Patient did not report reaction to first shot, but patient should have. Patient disequilibrium was severe and prolonged! Had to be careful to avoid falling and was founcing into walls was fearful to get 2nd shot. Had these issues become more severe, patient would not be able to walk. Not pleased about new allergic event. Resuming Xolair treatment was extremely costly and time consuming. Patient inquired why is not the public informed of the less severe allergic reactions like patient. Have significant discomfort.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lethargy
Clinical narrative: This is a spontaneous report received from contactable other-HCP, via a Pfizer-sponsored program (060820). A 66-year-old female patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), at the age of 66, on Nov 29, 2021, single dose, for COVID-19 immunisation. The patient's medical history not reported. Concomitant medication included ibrance taken for breast cancer, start date: Nov 17, 2021 (ongoing). Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (manufacturer unknown), for COVID-19 immunization. The following information experienced lethargy/became lethargic, onset Nov 29, 2021, with outcome of recovering. Additional information: Patient takes ibrance for 21 days on, 7 off. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information  expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Dyspnoea, Heart rate
Clinical narrative: intense chest pain; increase in blood pressure; increase in heart rate especially with exertion; shortness of breath; I'm not able to exercise like normal; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date 21Sep2021 (Lot number: FC3182) at the age of 27 years as dose 2, single and (Lot number: FF8839) as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid-19" (unspecified if ongoing), notes: Prior to vaccination. The patient's concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 01Sep2021, outcome "recovering", described as "intense chest pain"; BLOOD PRESSURE INCREASED (non-serious) with onset 01Sep2021, outcome "recovering", described as "increase in blood pressure"; HEART RATE INCREASED (non-serious) with onset 01Sep2021, outcome "recovering", described as "increase in heart rate especially with exertion"; DYSPNOEA (non-serious) with onset 01Sep2021, outcome "recovering", described as "shortness of breath"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 01Sep2021, outcome "recovering", described as "I'm not able to exercise like normal". The events "intense chest pain", "increase in blood pressure", "increase in heart rate especially with exertion", "shortness of breath" and "i'm not able to exercise like normal" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain, blood pressure increased, heart rate increased, dyspnoea, loss of personal independence in daily activities.  Additional information: After receiving the first and second vaccine, patient started having intense chest pain within 24 hours after the shot. In addition, she also had an increase in blood pressure and an increase in heart rate especially with exertion. Sometimes at rest her heart rate would spike for no reason into the 170s. The chest pain was associated with some shortness of breath. She have never had any cardiac issues prior to receiving these shots. 3 months out she was still having chest pain especially with exertion, elevated heart rate, and not able to exercise like normal. Prior to vaccination, patient diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Loss of personal independence in daily activities
Clinical narrative: intense chest pain; increase in blood pressure; increase in heart rate especially with exertion; shortness of breath; I'm not able to exercise like normal; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date 21Sep2021 (Lot number: FC3182) at the age of 27 years as dose 2, single and (Lot number: FF8839) as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid-19" (unspecified if ongoing), notes: Prior to vaccination. The patient's concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 01Sep2021, outcome "recovering", described as "intense chest pain"; BLOOD PRESSURE INCREASED (non-serious) with onset 01Sep2021, outcome "recovering", described as "increase in blood pressure"; HEART RATE INCREASED (non-serious) with onset 01Sep2021, outcome "recovering", described as "increase in heart rate especially with exertion"; DYSPNOEA (non-serious) with onset 01Sep2021, outcome "recovering", described as "shortness of breath"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 01Sep2021, outcome "recovering", described as "I'm not able to exercise like normal". The events "intense chest pain", "increase in blood pressure", "increase in heart rate especially with exertion", "shortness of breath" and "i'm not able to exercise like normal" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain, blood pressure increased, heart rate increased, dyspnoea, loss of personal independence in daily activities.  Additional information: After receiving the first and second vaccine, patient started having intense chest pain within 24 hours after the shot. In addition, she also had an increase in blood pressure and an increase in heart rate especially with exertion. Sometimes at rest her heart rate would spike for no reason into the 170s. The chest pain was associated with some shortness of breath. She have never had any cardiac issues prior to receiving these shots. 3 months out she was still having chest pain especially with exertion, elevated heart rate, and not able to exercise like normal. Prior to vaccination, patient diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm; feverish; achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "feverish"; PAIN (non-serious), outcome "unknown", described as "achy".  Additional information: This report for patient 1: Male, 70 years old. Caller stated "My wife and I experienced a sore arm, we felt feverish and achy with our two first doses of the Pfizer BioNTech COVID-19 vaccine. Caller is a consumer that was calling about the Pfizer Covid-19 vaccine adult dose. Caller mentions he has had all three doses and he is 70 years old. Him and his wife are fully boostered and they feel good.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: breakthrough bleeding / early menstruation; breakthrough bleeding / early menstruation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single and administered in arm left, administration date 09Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SERTRALINE. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUATION IRREGULAR (non-serious) all with onset Apr2021, outcome "unknown" and all described as "breakthrough bleeding / early menstruation". Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstruation irregular.  Additional information included: It was reported that after the last two shots, there was breakthrough bleeding / early menstruation. The patient was not due for her period and it came heavy that same evening. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Device Date: 04Dec2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: She and her daughter received the 1st dose on 03Sep2021 and the 2nd dose on 03Dec2021; I had a pain in my left side/ had pain on her upper left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (Batch/Lot number: unknown) 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), administration date: 03Sep2021, for COVID-19 Immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "She and her daughter received the 1st dose on 03Sep2021 and the 2nd dose on 03Dec2021"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "recovering", described as "I had a pain in my left side/ had pain on her upper left leg". Therapeutic measures were taken as a result of pain in extremity.  Additional information: Patient asked what is the efficacy of the two vaccines, since they were given further apart. Enquired about the booster shot. Asked about the efficacy of the second dose. Investigation Assessment was not provided. After her 2nd dose, she had a pain in her left side. She took Advil and felt better. Patient was advised to call her vaccination provider or healthcare provider if she had any questions about the safety or efficacy of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever (103.4(degree)F); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Aug2021 16:00 (Lot number: FC3180) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot/Batch number: FA7485, Route of administration : Intramuscular, Time of administration: 16:00, expiration Date: 01Oct2021), administration date: 26Jul2021, when the patient was 35 years old, for Covid-19 immunization, reaction(s): "Headache", "Nausea". The following information was reported: PYREXIA (non-serious) with onset 17Aug2021, outcome "recovered", described as "fever (103.4(degree)F)". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100958215 Same patient, same drug with different dose, similar AE