chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Lot number: FF2589) at the age of 38 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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Bleed after going through menopause; 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 67 year-old female patient received bnt162b2 (BNT162B2), administration date 31Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous immunization series complete, MANUFACTURER UNKNOWN), administration date: 2021, for COVID-19 Immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "Bleed after going through menopause".  Additional information: A 67-year-old female patient stated that she had the Pfizer COVID-19 vaccines last year and the Pfizer  COVID-19 booster on 31Oct2021. The patient was asking if it was a normal side effect for a woman to bleed after going through menopause after having the Pfizer COVID-19 vaccines, and could it be the vaccines that caused it.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: swelling of the left shoulder and pain; swelling of the left shoulder and pain; 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 79-year-old male patient received bnt162b2 (BNT162B2), administration date 01Apr2022 (Lot number: FK9895) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TESTOSTERONE CYPIONATE. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization; Bnt162b2 (Dose 2, single), for COVID-19 Immunization. The following information was reported: JOINT SWELLING (non-serious), ARTHRALGIA (non-serious) all with onset Apr2022, outcome "unknown" and all described as "swelling of the left shoulder and pain". Additional information: He just got his booster shot of the Pfizer BionTech Covid-19 vaccine (Gray cap per confirmation with Pfizer CS) last Friday and was curious if there was a potential interaction with testosterone injection and viagra. Consumer stated that there was no headache, no flu-like symptoms, and just experienced swelling of the left shoulder and pain. Consumer also stated that he did not experience flu-like symptoms during his initial series of the Pfizer BionTech covid-19 Vaccine shots. Consumer also stated that he takes Testosterone injection 1ML/every other week.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Chills, Headache
Clinical narrative: feel a pain in the middle of her upper stomach that felt "like a rock"; heart was beating fast; little bit weak; feel bad with chills; headache; joint pain; nausea/ Nauseous; 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 59 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2022 (Lot number: FK9895) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (1st dose, Lot:EN6205), for Covid-19 Immunization; Bnt162b2 (2nd dose, Lot:ER2613), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 02Apr2022, outcome "unknown", described as "feel bad with chills"; HEADACHE (non-serious) with onset 02Apr2022, outcome "unknown", described as "headache"; ARTHRALGIA (non-serious) with onset 02Apr2022, outcome "unknown", described as "joint pain"; NAUSEA (non-serious) with onset 02Apr2022, outcome "unknown", described as "nausea/ Nauseous"; ASTHENIA (non-serious) with onset 03Apr2022, outcome "unknown", described as "little bit weak"; ABDOMINAL PAIN UPPER (non-serious) with onset 03Apr2022 18:00, outcome "unknown", described as "feel a pain in the middle of her upper stomach that felt "like a rock""; HEART RATE INCREASED (non-serious) with onset 03Apr2022, outcome "unknown", described as "heart was beating fast". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, headache, arthralgia, nausea, asthenia, abdominal pain upper, heart rate increased. Additional information: on, Friday 01Apr2022. Caller notes this was her third dose of the Pfizer covid vaccine. Caller said she began to feel bad with chills, headache, joint pain, and nausea on Saturday. Caller said on Sunday she began to feel "much better" although a "little bit weak" but that around 18:00 begun to feel a pain in the middle of her upper stomach that felt "like a rock", nauseous, and that her heart was beating fast. Caller said she did not go into work today (Monday, 04Apr), that she started to feel better but then she began to feel the same sensations as Sunday evening this afternoon. Caller is asking if she should go to the hospital or contact her doctor? Consumer stated, "No, I didn't go to any doctor just take Tylenol." Prior vaccination (4 weeks): Consumer stated, "No. I had first dose and second dose, no reaction but this one the third one that's the one I had reaction. " No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Nausea
Clinical narrative: feel a pain in the middle of her upper stomach that felt "like a rock"; heart was beating fast; little bit weak; feel bad with chills; headache; joint pain; nausea/ Nauseous; 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 59 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2022 (Lot number: FK9895) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (1st dose, Lot:EN6205), for Covid-19 Immunization; Bnt162b2 (2nd dose, Lot:ER2613), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 02Apr2022, outcome "unknown", described as "feel bad with chills"; HEADACHE (non-serious) with onset 02Apr2022, outcome "unknown", described as "headache"; ARTHRALGIA (non-serious) with onset 02Apr2022, outcome "unknown", described as "joint pain"; NAUSEA (non-serious) with onset 02Apr2022, outcome "unknown", described as "nausea/ Nauseous"; ASTHENIA (non-serious) with onset 03Apr2022, outcome "unknown", described as "little bit weak"; ABDOMINAL PAIN UPPER (non-serious) with onset 03Apr2022 18:00, outcome "unknown", described as "feel a pain in the middle of her upper stomach that felt "like a rock""; HEART RATE INCREASED (non-serious) with onset 03Apr2022, outcome "unknown", described as "heart was beating fast". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, headache, arthralgia, nausea, asthenia, abdominal pain upper, heart rate increased. Additional information: on, Friday 01Apr2022. Caller notes this was her third dose of the Pfizer covid vaccine. Caller said she began to feel bad with chills, headache, joint pain, and nausea on Saturday. Caller said on Sunday she began to feel "much better" although a "little bit weak" but that around 18:00 begun to feel a pain in the middle of her upper stomach that felt "like a rock", nauseous, and that her heart was beating fast. Caller said she did not go into work today (Monday, 04Apr), that she started to feel better but then she began to feel the same sensations as Sunday evening this afternoon. Caller is asking if she should go to the hospital or contact her doctor? Consumer stated, "No, I didn't go to any doctor just take Tylenol." Prior vaccination (4 weeks): Consumer stated, "No. I had first dose and second dose, no reaction but this one the third one that's the one I had reaction. " No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Nasopharyngitis, Productive cough
Clinical narrative: head cold; Her temperature was 101.1 which was over 100; coughing; phlegm; cold; testing positive for Covid; testing positive for Covid; 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 72 year-old female patient received bnt162b2 (BNT162B2), administration date 20Jan2022 (Lot number: TJ1614) at the age of 72 years as dose 3 (booster), single, administration date 08Apr2021 (Lot number: EP7533) as dose 2, single and administration date 18Mar2021 (Lot number: 5N6204) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Apr2022, outcome "unknown" and all described as "testing positive for Covid"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "head cold"; PYREXIA (non-serious), outcome "unknown", described as "Her temperature was 101.1 which was over 100"; COUGH (non-serious), outcome "unknown", described as "coughing"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "phlegm"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) 101.1, notes: Her temperature was 101.1 which was over 100, which doesn't look good; sars-cov-2 test: (01Apr2022) positive, notes: Result: Covid positive;  Unit: Not Provided. Therapeutic measures were taken as a result of nasopharyngitis, pyrexia, cough, productive cough, nasopharyngitis. Clinical information: She usually did not had a fever of any kind and she states she had been checking her temperature. She stated she was fully vaccinated and she understands there was no guarantee or anything. The cold ran it's course and she didn't know if those were cold symptoms or the COVID. She states she had not taken the medication at first on Friday. Because of her cold and everything, the doctor said she could take some Vitamin C and Vitamin D and get some Mucinex or stuff like that for cold stuff. She states that she did take some Vitamin C and Vitamin D. She took a couple of aspirin, low dose, she thinks 81mg.   Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: head cold; Her temperature was 101.1 which was over 100; coughing; phlegm; cold; testing positive for Covid; testing positive for Covid; 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 72 year-old female patient received bnt162b2 (BNT162B2), administration date 20Jan2022 (Lot number: TJ1614) at the age of 72 years as dose 3 (booster), single, administration date 08Apr2021 (Lot number: EP7533) as dose 2, single and administration date 18Mar2021 (Lot number: 5N6204) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Apr2022, outcome "unknown" and all described as "testing positive for Covid"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "head cold"; PYREXIA (non-serious), outcome "unknown", described as "Her temperature was 101.1 which was over 100"; COUGH (non-serious), outcome "unknown", described as "coughing"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "phlegm"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) 101.1, notes: Her temperature was 101.1 which was over 100, which doesn't look good; sars-cov-2 test: (01Apr2022) positive, notes: Result: Covid positive;  Unit: Not Provided. Therapeutic measures were taken as a result of nasopharyngitis, pyrexia, cough, productive cough, nasopharyngitis. Clinical information: She usually did not had a fever of any kind and she states she had been checking her temperature. She stated she was fully vaccinated and she understands there was no guarantee or anything. The cold ran it's course and she didn't know if those were cold symptoms or the COVID. She states she had not taken the medication at first on Friday. Because of her cold and everything, the doctor said she could take some Vitamin C and Vitamin D and get some Mucinex or stuff like that for cold stuff. She states that she did take some Vitamin C and Vitamin D. She took a couple of aspirin, low dose, she thinks 81mg.   Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Rheumatoid arthritis
Clinical narrative: Increase in her rheumatoid arthritis symptoms; She probably felt things with the first two doses but just did not relate it to the vaccine; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4342179-00.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Apr2021 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single and intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "recovered" (2021), described as "Increase in her rheumatoid arthritis symptoms"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "She probably felt things with the first two doses but just did not relate it to the vaccine". The action taken for upadacitinib was unknown.  Clinical course: On unknown dates, the patient experienced bursitis, osteoarthritis and rheumatoid arthritis symptoms increased with Rinvoq (Upadacitinib). In 2021, the patient experienced inflammation with covid booster. On an unknown date, rheumatoid arthritis symptoms increased resolved. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. The patient experienced inflammation with the Covid booster and it also caused an increase in her rheumatoid arthritis symptoms which lasted for about eight weeks. She thought she probably felt things with the first two doses but just did not relate it to the vaccine. She had Osteoarthritis that affects many areas. She had been doing very well for about a week. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.   Causality for Rinvoq (Upadacitinib) The reporter's causality for the event(s) of rheumatoid arthritis symptoms increased was not provided.  Causality for Pfizer BioNTech Covid-19 Vaccine (Upadacitinib) Causality as per reporter (Drug/Vaccine): Probable  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between all the reported events Rheumatoid arthritis , Feeling abnormal and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 43.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Inflammation, Rheumatoid arthritis, SARS-CoV-2 test
Clinical narrative: headache; Inflammation; flare of Rheumatoid arthritis; MARKETING PROGRAM NAME NOT AVAILBALE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4341426-00.  A 43 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date May2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Route: Intramuscular), administration date: Apr2021, when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2022, outcome "recovering", described as "flare of Rheumatoid arthritis"; INFLAMMATION (non-serious) with onset Feb2022, outcome "recovering", described as "Inflammation"; HEADACHE (non-serious), outcome "unknown", described as "headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. The action taken for adalimumab was dosage permanently withdrawn. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of inflammation and flare rheumatoid arthritis with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event of headache was not provided.  Causality for Pfizer BioNTech COVID-19 vaccine (Tozinameran): The reporter's causality for the events of Inflammation, Rheumatoid arthritis flare up and Headache with Pfizer BioNTech COVID-19 vaccine was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided there is a reasonable possibility of causal association between the events with the suspect product bnt162b2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: put me down for 4 days feeling just awful; 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 83 year-old female patient received bnt162b2 (BNT162B2), administration date 31Mar2022 (Batch/Lot number: unknown) as dose 4 (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, reaction(s): "no problem"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "no problem"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "no problem". The following information was reported: FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "put me down for 4 days feeling just awful".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she got sick from the COVID 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 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: ILLNESS (non-serious), outcome "unknown", described as "she got sick from the COVID 19 vaccine".  Additional information: NDC number of COVID 19 vaccine was not provided. Investigations was not provided. Reason for no lot number of COVID 19 vaccine reported as reporter unwilling to complete the report. Expiry date of COVID 19 vaccine was not provided. Other Products was not provided. The reporter has been sick for 8 months and she saw her doctor today. He told her she should call Pfizer today, but she didn't ask why. He said Pfizer could help her. She got sick from the COVID 19 vaccine, and he thought maybe Pfizer was doing a study or could help her get better. She is not up to talking right now, and she would mostly want to talk to medical information to see what Pfizer can do for her. The patient asked can Pfizer help her. The patient stated she will call back when she feels like talking.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Chills, Diarrhoea
Clinical narrative: Chills; Bad diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Apr2022 13:00 (Lot number: Pfizer 9893) at the age of 78 years as dose 4 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PNEUMOCOCCAL VACCINE taken for immunisation, administration date 01Apr2022. Vaccination history included: Bnt162b2 (Vaccine Name: First Covid vaccine, Lot Number / Expiry Date: unknown/unknown/ NDC 59267-1000-1, Route, Anatomical Location: left arm , No. of Previous Doses: No, Date: 02Feb2021), administration date: 02Feb2021, when the patient was 78 years old, for COVID-19 immunization; Bnt162b2 (Vaccine Name: Second  Covid vaccine, Lot Number / Expiry Date: unknown/unknown, Route, Anatomical Location: left arm , No. of Previous Doses: one, Date: 24Feb2021), administration date: 24Feb2021, when the patient was 78 years old, for COVID-19 immunization; Bnt162b2 (Vaccine Name: First Covid booster, Lot Number / Expiry Date:  EW0196/unknown, Route, Anatomical Location: left arm, No. of Previous Doses: two , Date: 26Sep2021), administration date: 26Sep2021, when the patient was 79 years old, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 03Apr2022, outcome "not recovered", described as "Bad diarrhea"; CHILLS (non-serious) with onset 04Apr2022, outcome "not recovered", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that she got her second booster shot yesterday and was now having diarrhea. The patient stated that she was having bad diarrhea. The patient stated that she was having chills.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain all over her body from head to toe started the day after inoculation. She states it was horrible pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 84 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 31Mar2022 (Lot number: FL3209) at the age of 84 years as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Vaccine brand: Pfizer / BioNTech, Vaccine brand unknown: False, Vaccine administration date: 28Sep2021, Vaccine lot number: FF2557, Vaccine lot unknown: False, Vaccine dose number: 3, Vaccine dose number unknown: False, Vaccine location: Left arm), administration date: 28Sep2021, when the patient was 83 years old, for Covid-19 immunization; Bnt162b2 (Vaccine brand: Pfizer / BioNTech, Vaccine brand unknown: False, Vaccine administration date: 27Feb2021, Vaccine administration time: 09:45 AM, Vaccine lot number: EN6198, Vaccine lot unknown: False, Vaccine dose number: 2, Vaccine dose number unknown: False, Vaccine location: Left arm), administration date: 27Feb2021, when the patient was 83 years old, for Covid-19 immunization; Bnt162b2 (Vaccine brand: Pfizer / BioNTech, Vaccine brand unknown: False, Vaccine administration date: 06Feb2021, Vaccine administration time: 02:15 PM, Vaccine lot number: EM9180, Vaccine lot unknown: False, Vaccine dose number: 1, Vaccine dose number unknown: False, Vaccine location: Left arm), administration date: 06Feb2021, when the patient was 83 years old, for Covid-19 immunization.  The following information was reported: MYALGIA (non-serious) with onset 02Apr2022, outcome "recovering", described as "Muscle pain all over her body from head to toe started the day after inoculation. She states it was horrible pain". Therapeutic measures were not taken as a result of myalgia.  Additional Information: Adverse event: Muscle pain all over her body from head to toe started the day after inoculation. She states it was horrible pain. Today 05Apr2022 she is feeling a bit better.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain, Pruritus, Rash, Skin laceration
Clinical narrative: she's been very ill since then; It started as normal aches, but then it evolved into pain and vomiting; It started as normal aches, but then it evolved into pain and vomiting; She now has rash, itch, and her skin is ripped open; She now has rash, itch, and her skin is ripped open; She now has rash, itch, and her skin is ripped open; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 16 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary immunization series completed but unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Primary immunization series completed but unknown manufacturer), for Covid-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "she's been very ill since then"; PAIN (non-serious), VOMITING (non-serious), outcome "unknown" and all described as "It started as normal aches, but then it evolved into pain and vomiting"; RASH (non-serious), PRURITUS (non-serious), SKIN LACERATION (non-serious), outcome "unknown" and all described as "She now has rash, itch, and her skin is ripped open". The events "she's been very ill since then", "it started as normal aches, but then it evolved into pain and vomiting", "it started as normal aches, but then it evolved into pain and vomiting", "she now has rash, itch, and her skin is ripped open", "she now has rash, itch, and her skin is ripped open" and "she now has rash, itch, and her skin is ripped open" were evaluated at the emergency room visit. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: she's been very ill since then; It started as normal aches, but then it evolved into pain and vomiting; It started as normal aches, but then it evolved into pain and vomiting; She now has rash, itch, and her skin is ripped open; She now has rash, itch, and her skin is ripped open; She now has rash, itch, and her skin is ripped open; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 16 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary immunization series completed but unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Primary immunization series completed but unknown manufacturer), for Covid-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "she's been very ill since then"; PAIN (non-serious), VOMITING (non-serious), outcome "unknown" and all described as "It started as normal aches, but then it evolved into pain and vomiting"; RASH (non-serious), PRURITUS (non-serious), SKIN LACERATION (non-serious), outcome "unknown" and all described as "She now has rash, itch, and her skin is ripped open". The events "she's been very ill since then", "it started as normal aches, but then it evolved into pain and vomiting", "it started as normal aches, but then it evolved into pain and vomiting", "she now has rash, itch, and her skin is ripped open", "she now has rash, itch, and her skin is ripped open" and "she now has rash, itch, and her skin is ripped open" were evaluated at the emergency room visit. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash
Clinical narrative: Rash on back and legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). Other Case identifier(s): 2022SA015261. A female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 10Dec2021 (Batch/Lot number: unknown) as dose 1, single for immunisation; dupilumab (DUPIXENT), from 03Dec2021 (Batch/Lot number: unknown) to 03Dec2021 at 400 mg 1x/day. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 10Dec2021, outcome "unknown", described as "Rash on back and legs". The action taken for dupilumab was unknown. Additional information  Initial information received on 12Jan2022 regarding an unsolicited valid non-serious case. Pfizer BioNTech COVID-19 Vaccine, Suspect Generic Name: Tozinameran, with an unknown dosage regimen, route, strength, formulation and strength unknown. Dupixent, Substance Name: Dupilumab Suspect, Device constituent associated with drug Dupilumab pre-filled syringe, Formulation: Solution for injection, Strength: 200 mg, Combination product or not: Yes, Add constituent devices in case for assessment: No, Duration of administration: 1 day route and formulation for an unknown indication. The patients past medical history, medical history treatment(s), concomitant(s) and family history were not provided. The patient who had (rash on back and legs while being treated with Dupilumab (Dupixent) via unknown medical device and Tozinameran (Pfizer BioNTech COVID-19 Vaccine). On 10Dec2021 the patient developed a non-serious event rash on back and legs (rash) (latency: 7 days) following the first dose intake of Dupilumab and (latency: approximately 6 hours) following the first dose intake of Tozinameran. It was reported "received her first dose of 400mg of Dupixent on 03Dec. On 10Dec she got her first Covid shot and 5-6 hours later she developed a rash on her back and legs.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: I am experiencing shoulder pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05Apr2022 (Lot number: FK9893) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "I am experiencing shoulder pain".  Additional information: Primary Immunization series complete. Concern: Consumer stated, patient called because patient was experiencing shoulder pain after patient got shot this morning and was wondering if it will be safe to take either ibuprofen or Tylenol. Consumer stated, that the COVID-19 shot, the booster shot (Pfizer COVID-19 Vaccine). Consumer was informed about the Pfizer Medical Information department and telephone was shared as, option 3, 8 AM to 9 PM, Monday to Friday, as per EST. Consumer was informed about the role of Pfizer drug safety. Consumer hung up abruptly. Product details, Pharmacy details and other details could not be probed as consumer hung up abruptly. Hence further probing could not be done. Limited information available over the call.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: recurrence of a former heart condition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 32 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "heart condition" (unspecified if ongoing), notes: I experienced a recurrence of a former heart condition I had when I was 19 a few days. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Unknown Manufacturer), for Covid-19 immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "recurrence of a former heart condition".  Additional information: Customer Verbatim: Hi Team, I was wondering if someone from the Pfizer Team could give me a call and listen to my story regarding the second covid vaccine. I am a 32 year old healthy individual, and I believe I experienced a recurrence of a former heart condition I had when I was 19 a few days after taking the second Pfizer vaccine. I submitted a VAERS report several months ago but haven't heard anything from them. I've been working closely again with  Cardiology for my current health needs.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: he and his wife were diagnosed with COVID-19. Caller later mentioned being vaccinated and having a booster from the Pfizer CVOID-19 Vaccine; he and his wife were diagnosed with COVID-19. Caller later mentioned being vaccinated and having a booster from the Pfizer CVOID-19 Vaccine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient. Regulatory number: US-PFIZERINC-GRACE00614852.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "he and his wife were diagnosed with COVID-19. Caller later mentioned being vaccinated and having a booster from the Pfizer CVOID-19 Vaccine".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: F
Vaccine: DT
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 11-year-old female patient Outside Of The Recommended Age Range, was inadvertently administered intramuscularly the DT vaccine rather than the Td vaccine with no reported adverse event; Initial information received on 05-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 11 years old female patient who had reported that patient outside of the recommended age range, was inadvertently administered intramuscularly the dt vaccine rather than the td vaccine with no reported adverse event while receiving vaccine diphtheria-25/tetanus-5 adsorbed toxoids no preservative. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 05-Apr-2022, the patient received a 0.5 ml dose of suspect diphtheria-25/tetanus-5 adsorbed toxoids no preservative (strength, frequency, batch lot number, expiry number and formulation: unknown) via intramuscular route in unknown administration site for immunization. Batch lot number is requested.  On 05-APR-2022, the patient developed a non-serious event 11-year-old female patient outside of the recommended age range, was inadvertently administered intramuscularly the dt vaccine rather than the td vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) following the administration of diphtheria-25/tetanus-5 adsorbed toxoids no preservative.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (product administered to patient of inappropriate age).  At time of reporting, the outcome was Unknown for the event product administered to patient of inappropriate age.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Receiving expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) 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 medication reported. No treatment medication reported. Date the vial was initially stored in the refrigerator: 31-Aug-2021.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported; the caller said the ROTATEQ expired on 07-MAR-2022 and was administered on 09-MAR-2022; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 09-MAR-2022, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter orally for prophylaxis (strength and lot number were not reported, expiration date: 07-MAR-2022) (expired product administered). There were no prior temperature excursions. No additional adverse event/product quality complaint were reported. No additional information was provided.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: Caller is a nurse calling to report that an expired dose of ROTATEQ was administered to the patient; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies.  On 22-MAR-2022, the patient was vaccinated with an expired Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered at a dose of 2 milliliters (mL) (lot number reported and validated as 1707460, expiration date reported and stablished as 14-MAR-2022) (strength, route of administration and anatomical location and vaccination scheme were not provided) (expired product administered).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA008972: US-009507513-2203USA008707:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extra dose administered, Fatigue, Headache, Injection site pain
Clinical narrative: accidentally given a third dose of Shingrix; arm pain; swollen area on arm; Nausea; fatigue; HEADACHE; MUSCLE ACHE; red swollen area on arm, redness from the 3rd dose; This case was reported by a consumer and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of nausea (also experienced arm pain, headache, muscle ache and redness after receiving 1st dose in left arm on 12th October 2021, refer case US2022AMR060911). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   In March 2022, the patient received the 3rd dose of Shingrix. In March 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site swelling, nausea, fatigue, headache, muscle pain, erythema of extremities and extra dose administered. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site swelling, nausea, fatigue, headache, muscle pain and erythema of extremities were recovered/resolved and the outcome of the extra dose administered was unknown.   The reporter considered the injection site pain, injection site swelling, nausea, fatigue, headache, muscle pain and erythema of extremities to be related to Shingrix.     Linked case(s) involving the same patient: US2022AMR060910, US2022AMR060911   Additional Information: GSK Receipt Date: 02-Apr-2022 and 06-Apr-2022 Reporter's comment: The case was self-reported by the patient. In January 2022 (the patient thought around the 20th of month), the patient received 2nd dose in left arm and experienced nausea, arm pain, headache, muscle ache and redness which lasted about 2.5 days.  Last week from reporting date, the patient accidently given a third dose of Shingrix in left arm. The patient stated side effects from the Shingrix vaccine were rough compared to other vaccines. The patient had pretty significant side effects nausea, fatigue, headache, muscle ache, red swollen area on arm and arm pain. In addition, patient had redness from the third dose of Shingrix that went from the injection site travelling down and wrapping around her arm. The side effects from all three doses were similar, but side effects from third dose were more intense and lasted longer (about a week). The reporter consented to follow up with health care professional (pharmacy) Additional Supportive Information: The patient accidently given a third dose of Shingrix, which led to extra dose administered.  For tolerance of 2nd dose refer case US2022AMR060910. This case was 1 of 3 cases reported by same reporter for same patient for different dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR060910:same reporter US-GLAXOSMITHKLINE-US2022AMR060911:same reporter