chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain, Spinal compression fracture
Clinical narrative: it caused her 2 spinal compression fractures to re flare up; in a great deal of pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: SPINAL COMPRESSION FRACTURE (medically significant), outcome "unknown", described as "it caused her 2 spinal compression fractures to re flare up"; PAIN (non-serious), outcome "unknown", described as "in a great deal of pain". Clinical course: I have a friend who had the latest Pfizer booster in late Nov2022 and claims it caused her 2 spinal compression fractures to re flare up and now is in a great deal of pain. Can the booster cause this kind of reaction? I just had it also and had no reaction this time. I realize everyone reacts differently.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy
Clinical narrative: lymph node under her left arm next to her breast swelled up/warm and red; Fatigue; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 4 (booster), single (Lot number: GJ6665) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing), notes: Medical History (MedDRA code): Blood pressure, Continuing: true, Comments: Blood pressure; "Cholesterol" (ongoing), notes: Medical History (MedDRA code): Cholesterol, Continuing: true, Comments: Cholesterol. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (3rd dose: , Date: 06Dec2021 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided), administration date: 06Dec2021, when the patient was 60-year-old, for Covid-19 Vaccination; BNT162b2 (1st dose: , Date: 20Mar2021 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided , Batch/Lot number: EN6206), administration date: 20Mar2021, when the patient was 59-year-old, for Covid-19 Vaccination; BNT162b2 (2nd dose: , Date: 10Apr2021 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided , Batch/Lot number: EW0151), administration date: 10Apr2021, when the patient was 59-year-old, for Covid-19 Vaccination. The following information was reported: CHILLS (non-serious) with onset 18Nov2022, outcome "recovered" (25Nov2022); FATIGUE (non-serious) with onset 18Nov2022, outcome "recovered" (25Nov2022); LYMPHADENOPATHY (non-serious) with onset 19Nov2022, outcome "recovered" (24Nov2022), described as "lymph node under her left arm next to her breast swelled up/warm and red".  Additional information: Vaccination Facility Type was Hospital. Vaccine was not Administered at Military Facility. Patient wanted to report she had a reaction to it or a side effect. Her lymph node under her left arm next to her breast swelled up the next day and stayed swollen for about 5 days, at one time into the third day, it was warm and red. States it was in the same arm that she got the shot in. She also reports she had fatigue and chills. Treatment: she did call the CDC and spoke to a nurse specialist on 21Nov2022 and was told to drink plenty of water. Prior Vaccinations (within 4 weeks) was none. Family Medical History Relevant to Adverse Events was none.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Aug2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: It was reported that patient got COVID 19 and for that Paxlovid treatment was given from 24Nov2022 to 29Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events drug ineffective and covid-19  and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2022 at 14:00 as dose 1, single (Lot number: EN6201), in left arm, on 31Mar2022 at 14:00 as dose 2, single (Lot number: ER8732), in right arm and on 09Nov2021 at 15:00 as dose 3 (booster), single (Lot number: EW0173), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Apr2022 at 16:00 as dose 4 (booster), single (Lot number: 049LCIA), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1; RA" (unspecified if ongoing), notes: Type 1; RA; Fibromyalgia. degenerative disc. under active thyroid; "Fibromyalgia" (unspecified if ongoing), notes: Type 1; RA; Fibromyalgia. degenerative disc. under active thyroid; "degenerative disc" (unspecified if ongoing), notes: Type 1; RA; Fibromyalgia. degenerative disc. under active thyroid; "under active thyroid" (unspecified if ongoing), notes: Type 1; RA; Fibromyalgia. degenerative disc. under active thyroid. Concomitant medication(s) included: ENBREL, start date: Mar2022, stop date: 25Nov2022; HUMALOG, start date: Jan1992; LEVOTHYROXINE, start date: Jan2011. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Apr2022 at 16:00, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was Adult (18-64 Years). Other medication in 2weeks was reported as yes. Patient received Paxlovid treatment from 01Dec2022 to 06Dec2022 for Covid-19.  Conclusion: The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6201, lot ER8732, lot EW0173 fill lot EN5333, lot EP8684, lot EP8725 and the formulated drug product lot EN5322, lot EP8571, lot EP8606. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: vaccine brand: Pfizer; Moderna; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Oct2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulpha" (unspecified if ongoing), notes: known allergies: Sulpha. Concomitant medication(s) included: TYLENOL, start date: 26Nov2022, stop date: 27Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Dec2022, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand: Pfizer; Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Nov2022) Negative, notes: I was tested negative on 29Nov2022; (06Dec2022) Positive, notes: I had a rebound and was tested positive again on 06Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment included Paxlovid from 26Nov2022 to 30Nov2022. Known allergies included Sulpha.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: vaccine brand: Pfizer; Moderna; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL; IBUPROFEN; SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]; MUCINEX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand: Pfizer; Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  Additional information: Anti-viral details: Product=COVID 19 Treatment: Paxlovid: Treatment start date=27Nov2022, Treatment stop date=01Dec2022 and Indication: Treatment of COVID-19. The patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain
Clinical narrative: He just feels like achy; Really achy; Chills; He does not feel good now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Dec2022 as dose number unknown, (booster) single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 07Dec2022, outcome "unknown"; MALAISE (non-serious) with onset 07Dec2022, outcome "unknown", described as "He does not feel good now"; PAIN (non-serious) with onset 07Dec2022, outcome "unknown", described as "He just feels like achy; Really achy".  Additional information: Reporter (wife) stated, her husband had the shot yesterday (on 06Dec2022) Bivalent and this morning he just felt like achy and he had chills but no fever just really achy. He did not feel good.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand: Pfizer; Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 19:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 56 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP7534), on 09Apr2021 as dose 2, single (Lot number: ER8731) and on 08Oct2021 as dose 3 (booster), single (Lot number: FE3590) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Apr2022 as dose 4 (booster), single (Lot number: 005M21A) for covid-19 immunisation. The patient's relevant medical history included: "slightly high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTIN, start date: 07Nov2022 (in two weeks of vaccination). The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Apr2022, outcome "unknown", described as "vaccine brand: Pfizer; Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.  Clinical course: Patient had no known allergies. Patient took Paxlovid (Lot number: Unknown) for 5 straight days (Sunday to Thursday: start date was 27Nov2022 and stop date was 01Dec2022). Patient was feeling somewhat better on Wednesday, 30Nov2022, and more better on 1Dec2022. Patient felt 90% better on Friday, and that state of health stayed the same through Sunday. On Monday, 5Dec2022, He felt dramatically worse, almost as bad as he did on Sunday, 27Nov2022, but the headache was less intense. Patient was recovering from symptoms. No treatment received for symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "no" (unspecified if ongoing), notes: known allergies: no, other medical history: no. Concomitant medication(s) included: PROBIOTICS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Anti-viral treatment with Paxlovid started on 26Nov2022 till 30Nov2022 (Lot#2692134).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 04Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "IBS" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "migraines" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative after 9 days of initial illness; Positive, notes: Then tested positive after 4 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had all 4 doses of the vaccine prescribed and took Paxlovid from 23Nov2022 to 27Nov2022, for treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood pressure measurement, Fall, Hypotension, Investigation
Clinical narrative: stomach bothering him; suddenly collapsed when he was going to the bathroom; blood pressure was low; The day after the booster, her husband woke up with a fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, The previous vaccines and booster shots they had were from Pfizer too.), for Covid-19 immunization; Bnt162b2 (Dose 2 , The previous vaccines and booster shots they had were from Pfizer too.), for Covid-19 immunization; Bnt162b2 (Dose 3 (Booster), He had no reaction with other boosters., The previous vaccines and booster shots they had were from Pfizer too.), for Covid-19 immunization. The following information was reported: PYREXIA (hospitalization) with onset Dec2022, outcome "unknown", described as "The day after the booster, her husband woke up with a fever"; HYPOTENSION (hospitalization) with onset Dec2022, outcome "unknown", described as "blood pressure was low"; ABDOMINAL DISCOMFORT (hospitalization) with onset Dec2022, outcome "unknown", described as "stomach bothering him"; FALL (hospitalization) with onset Dec2022, outcome "unknown", described as "suddenly collapsed when he was going to the bathroom". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: low; all kinds of tests: Unknown results, notes: they came up with nothing out of the ordinary. Clinical course: Caller called in regards to Pfizer Covid-19 Vaccine. She stated that her husband got hospitalized after getting the shot. Caller and her husband got their second booster, fourth shot, last Sunday. Her husband is hospitalized. The day after the booster, her husband woke up with a fever, stomach bothering him. He had no reaction with other boosters. Confirmed that this booster shot is Pfizer adult bivalent. The previous vaccines and booster shots they had were from Pfizer too. He slept and then "suddenly collapsed when he was going to the bathroom, called an ambulance, blood pressure was low. They kept him overnight for observation, running all kinds of tests to see if there was an infection. they came up with nothing out of the ordinary."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: stomach bothering him; suddenly collapsed when he was going to the bathroom; blood pressure was low; The day after the booster, her husband woke up with a fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, The previous vaccines and booster shots they had were from Pfizer too.), for Covid-19 immunization; Bnt162b2 (Dose 2 , The previous vaccines and booster shots they had were from Pfizer too.), for Covid-19 immunization; Bnt162b2 (Dose 3 (Booster), He had no reaction with other boosters., The previous vaccines and booster shots they had were from Pfizer too.), for Covid-19 immunization. The following information was reported: PYREXIA (hospitalization) with onset Dec2022, outcome "unknown", described as "The day after the booster, her husband woke up with a fever"; HYPOTENSION (hospitalization) with onset Dec2022, outcome "unknown", described as "blood pressure was low"; ABDOMINAL DISCOMFORT (hospitalization) with onset Dec2022, outcome "unknown", described as "stomach bothering him"; FALL (hospitalization) with onset Dec2022, outcome "unknown", described as "suddenly collapsed when he was going to the bathroom". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: low; all kinds of tests: Unknown results, notes: they came up with nothing out of the ordinary. Clinical course: Caller called in regards to Pfizer Covid-19 Vaccine. She stated that her husband got hospitalized after getting the shot. Caller and her husband got their second booster, fourth shot, last Sunday. Her husband is hospitalized. The day after the booster, her husband woke up with a fever, stomach bothering him. He had no reaction with other boosters. Confirmed that this booster shot is Pfizer adult bivalent. The previous vaccines and booster shots they had were from Pfizer too. He slept and then "suddenly collapsed when he was going to the bathroom, called an ambulance, blood pressure was low. They kept him overnight for observation, running all kinds of tests to see if there was an infection. they came up with nothing out of the ordinary."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: how painfully it was but when I took the Pfizer shot it wasn't as bad as others; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "how painfully it was but when I took the Pfizer shot it wasn't as bad as others".  Additional information: Patient have had many people talk about their shots and how painfully it was but when patient took the Pfizer shot it wasn't as bad as others. Age reported was 61.  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: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 06Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Grass" (unspecified if ongoing); "known allergies: cats" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: METFORMIN; LISINOPRIL; ALLOPURINOL; GEMFIBROZIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 26Nov2022 to 01Dec2022.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing). Patient  had no known allergies. Concomitant medication(s) included: SYNTHROID, start date: 05Jun2014, stop date: 08Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive covid test on day 8. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 23Nov2022 to 27Nov2022 for COVID 19 Treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 2, single (Lot number: ER8727) at the age of 71 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 29Nov2022 to 03Dec2022.   Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot ER8727 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot ER8727, fill lot EP8679, and the formulated drug product lot EP8566. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not have any known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 05Dec2022 to an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported COVID-19 after BNT162B2 immunization is considered drug ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: landed in the ER with one man having a BP around 220; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HYPERTENSION (medically significant), outcome "unknown", described as "landed in the ER with one man having a BP around 220". The event "landed in the er with one man having a bp around 220" required emergency room visit. Clinical Course: Reporter stated that after she got it in October, her blood pressure has not been right since. It fluctuates with the highest reading at 220 but will hang around 187 (146 was lowest she can get it), said she had called before and was referred to CDC. Caller asking can the shot affect blood pressure. States she talked to 2 other people who experienced the same thing. Reporter stated she has had all Pfizer covid 19 shots and date of last booster: 24Oct2022. Stated she has talked to many people about this; 2 other people she talked to landed in the ER with one man having a BP around 220. States she called Pfizer right after this happened. She can only find 2 other people that this happened to. All she knows about the two people that experienced this too was that one and the other was a female from but lives in. One of them went to the ER. Reporter does not have any further information to do reports on them.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201360920 Same reporter, same product, same event, different patient;US-PFIZER INC-202201361209 Same reporter, same product, same event, different patient;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 13:15 as dose 5 (booster), single (Lot number: BJ2524), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "M.E./C.F.S" (unspecified if ongoing), notes: M.E./C.F.S; "M.E./C.F.S" (unspecified if ongoing), notes: M.E./C.F.S; "Diverticulosis" (unspecified if ongoing); "IBS" (unspecified if ongoing), notes: IBS; "Cancer IDC and radiation induced sarcoma" (unspecified if ongoing), notes: Cancer IDC and radiation induced sarcoma; "Osteoarthritis" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Blepharitis" (unspecified if ongoing); "Lymphodema" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not received other medications within 2 weeks of starting COVID-19 treatment. The patient received paxlovid for COVID-19 treatment (lot number GE1627) from 03Dec2022 till 07Dec2022. The paxlovid seemed to help until day 3 at which time she felt it was doing nothing.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19; COVID 19; Dose: 5; Moderna vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9264), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 19Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Sep2022 as dose 5 (booster), single (Lot number: AS7144B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient took concomitant medications. Past drug history included: Macrodantin, reaction(s): "Known allergies: Macrodantin", notes: Known allergies: Macrodantin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "unknown", described as "Dose: 5; Moderna vaccine"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 29Nov2022 to 03Dec2022,  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: last night 07Dec2022 patient tested positive for COVID again; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 03Jul2021 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 07Dec2022, outcome "unknown", described as "last night 07Dec2022 patient tested positive for COVID again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: last night 07Dec2022 I tested positive for COVID again; (07Dec2022) Positive, notes: last night 07Dec2022 I tested positive for COVID again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid for COVID 19 treatment from 23Nov2022 to 27Nov2022. It was reported that 7 days after he completed taking Paxlovid he began to experience a lingering headache. It has been four days of having my head and last night 07Dec2022 patient tested positive for COVID again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing); "enlarged heart" (unspecified if ongoing), notes: enlarged heart; "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: Wheat and dairy" (unspecified if ongoing). Concomitant medication(s) included: STRATTERA; PROZAC. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures Paxlovid were taken from 08Dec2022 as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 42 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Lot number: EL0140), in right arm, on 20Jan2021 as dose 2, single (Lot number: EL9263), in right arm and on 04Oct2021 as dose 3 (booster), single (Lot number: FE3592), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive 3 days after testing negative with a return of symptoms; Negative, notes: Tested positive 3 days after testing negative with a return of symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Tested positive 3 days after testing negative with a return of symptoms. product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 29Nov2022, treatment stop date: 03Dec2022.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "vaccination failure", "COVID-19".
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Lot number: Es5372) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: En9581), in left arm, on 01Mar2021 as dose 2, single (Lot number: En6200), in right arm and on 22Nov2021 as dose 3 (booster), single (Lot number: Fd0809), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnoea" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN; IRBESARTAN. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 28Nov2022 to 02Dec2022 as treatment of COVID-19. The patient had no known allergies.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 to the Vaccination failure (LOE) and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Description of complaint: COVID-19 positive after receiving COVID-19 Vaccines. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: COVID-19 positive after receiving COVID-19 Vaccines and had boosters. Patient received Paxlovid as treatment for covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Inflammatory arthritis" (unspecified if ongoing); "Pernicious anemia" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was treated with Paxlovid from 29Nov2022 till 04Dec2022. Patient had other medications in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.