chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: pain on the right side of my neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 at 00:45 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1st), for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd), for Covid-19 immunization; Covid-19 vaccine (Dose: 3rd), for Covid-19 immunization; Covid-19 vaccine (Dose: 4th), for Covid-19 immunization. The following information was reported: NECK PAIN (non-serious) with onset 26Sep2022 at 05:30, outcome "not recovered", described as "pain on the right side of my neck". Therapeutic measures were taken as a result of neck pain.  Additional information: Woke up the following morning after receiving shot with pain on the right side of neck, the same side patient received the injection. Took 2 Extra Strength Excedrin, which always help with pain. The pain Extra Strength Excedrin, which always help with pain. The pain continued throughout the day, sometimes throbbing. Patient tried to massage it, but could not locate a precise point where the pain was coming from. Patient is unable to turn head to the right, or look down, without causing pain. No covid prior vaccination. No covid tested post vaccination. No Known allergies.  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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: All over itching- no rash.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER.), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER.), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3, UNKNOWN MANUFACTURER.), for Covid-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset 18Sep2022 at 12:00, outcome "not recovered", described as "All over itching- no rash.". Therapeutic measures were not taken as a result of pruritus.   Additional information: the patient did not received other vaccine in four weeks or covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: testing positive for covid on 10Sep2022; testing positive for covid on 10Sep2022; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team and product quality group. The reporter is the patient.  An 87-year-old female patient received BNT162b2 (BNT162B2), on 17Jan2021 as dose 1, single (Lot number: EK9231), on 07Feb2021 as dose 2, single (Lot number: EL9261), on 28Sep2021 as dose 3 (booster), single (Lot number: 30135BA) and on 03Apr2022 as dose 4 (booster), single (Lot number: FK8985) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Sep2022, outcome "unknown" and all described as "testing positive for covid on 10Sep2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Sep2022) Positive.  Clinical course: Patient received the primary series and 2 boosters of Pfizer Covid vaccine and is now looking for timing on when patient can get the 5th vaccine, the bivalent booster due to testing positive for covid on 10Sep2022. Patient stated that experienced minimal symptoms and thought she had a cold. The patient is now off of isolation.   No follow-up attempts are possible. No further information is expected.; 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 to the Vaccination failure (LOE) and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: still or its still coming back for her facial paralysis, like part of her neck is still getting numb; facial paralysis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 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 following information was reported: FACIAL PARALYSIS (medically significant) with onset 2021, outcome "not recovered"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "still or its still coming back for her facial paralysis, like part of her neck is still getting numb". The event "facial paralysis" required physician office visit. Therapeutic measures were taken as a result of facial paralysis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: She got the booster dose but tested positive for COVID-19; She got the booster dose but tested positive for COVID-19; Primary series: Moderna / Booster: Pfizer BNT162b2; 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 47-year-old female patient received BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 47 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Jan2021 as dose 1, single (Lot number: 039K20-2A) and on 05Feb2021 as dose 2, single (Lot number: 012L20A) for covid-19 immunisation. The patient's relevant medical history included: "COVID exposure" (unspecified if ongoing), notes: Predisposing factor. Her husband, son, and daughter had it. Patient was the last to have it. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Nov2021, outcome "unknown", described as "Primary series: Moderna / Booster: Pfizer BNT162b2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Sep2022, outcome "unknown" and all described as "She got the booster dose but tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Negative, notes: She took the home test and they were all negative; (17Sep2022) Positive, notes: took PCR test on 17Sep2022 in the afternoon around 4PM and received the positive result on 18Sep2022. Patient had major symptoms until 22Sep2022. Still has a bit of a cough and felt tired, but that's it. Primary infection site was unknown (it felt like all over). Predisposing factors reported as: Her husband, son, and daughter had it. Patient was the last to have it. Her husband, son, and daughter had been vaccinated and had boosters that were Pfizer.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 27Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin, shellfish; "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Penicillin, shellfish. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Sep2022) Negative, notes: Tested negative on last day of Paxlovid treatment; (25Sep2022) Positive, notes: Tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: It is unknown if other medication taken in 2 weeks of starting COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pulmonary thrombosis, Thrombosis
Clinical narrative: She had the Moderna COVID-19 Vaccine and Pfizer Booster COVID-19 Vaccine; right after the Booster she got the blood clot in her lungs and on her leg; right after the Booster she got the blood clot in her lungs and on her leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Private).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: Moderna covid-19 vaccine (Dose number: Unknown), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "She had the Moderna COVID-19 Vaccine and Pfizer Booster COVID-19 Vaccine"; PULMONARY THROMBOSIS (medically significant), THROMBOSIS (medically significant), outcome "unknown" and all described as "right after the Booster she got the blood clot in her lungs and on her leg". The caller (reporter) is calling on behalf of her mom (consumer) actually. She said that her mother got the Pfizer Booster COVID-19 Vaccine and as a result her mother had a lungs blood clot and also on the leg." When paraphrased the concern, reporter stated, "She had the Moderna COVID-19 Vaccine and Pfizer Booster COVID-19 Vaccine and right after the Booster she got the blood clot in her lungs and on her leg. Yes she got the Moderna COVID-19 Vaccine and the Pfizer Booster COVID-19 Vaccine."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 at 11:00 as dose 1, single (Lot number: EN6206), in left arm, on 26Mar2021 at 10:30 as dose 2, single (Lot number: EP8730), in left arm, on 17Aug2021 at 11:00 as dose 3 (booster), single (Lot number: EC3132), in left arm and on 01Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "over weight" (unspecified if ongoing). Concomitant medication(s) included: L-THYROXINE [LEVOTHYROXINE SODIUM], start date: 30Jun2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (25Sep2022) Positive, notes: Rebound Covid positive on 25Sep2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Xeljanz Xr (From 14Aug2022 to 11Sep2022), Simvastatin (From 30Jun2022 to 11Sep2022).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: first 3 were Moderna COVID vaccine and his 4th was Pfizer COVID vaccine.; tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2022, outcome "unknown", described as "first 3 were Moderna COVID vaccine and his 4th was Pfizer COVID vaccine."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Her husband was positive on Saturday.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201188416 same reporter/vaccine, different patient, similar event.;
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL; LORATADINE; B12 [CYANOCOBALAMIN]; B COMPLEX [VITAMIN B COMPLEX]; CALCIUM WITH D3. Past drug history included: Erythromycin, reaction(s): "Known Allergies: Erythromycin"; Tetracycline, reaction(s): "Known allergies: tetracycline"; Ibuprofen, reaction(s): "Known allergies: ibuprofen"; Amoxicillin, reaction(s): "Known Allergies: amoxicillin"; Topamax, reaction(s): "Known Allergies: Topamax"; Prilosec, reaction(s): "Known allergies: prilosec"; Elavil, reaction(s): "Known allergies: elavil"; Pamelor, reaction(s): "Known allergies: pamelor"; Maxaq, reaction(s): "Known allergies: maxaq". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". 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.  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.
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) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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) and as dose 3 (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. No known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: Positive, notes: COVID 19 Treatment; Positive, notes: Rebound COVID with new symptoms and positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 15Sep2022 to 20Sep2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiomegaly
Clinical narrative: have 2 kids that enlarged heart from this vaccine now; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A patient (no qualifiers provided) 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: CARDIOMEGALY (non-serious), outcome "unknown", described as "have 2 kids that enlarged heart from this vaccine now".  Additional information:  The reporter had 2 kids that enlarged heart from this vaccine now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200071313 same reporter/drug/AE, different patients;
Age: 78.0
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 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2022 as dose 4 (booster), single (Lot number: FM069D) at the age of 78 years, 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergy: Sulf" (unspecified if ongoing), notes: known allergy: Sulf. Concomitant medication(s) included: ATORVASTATIN, start date: May2016, stop date: 13Sep2022. 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: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received vaccine. Yes, Other medication received in 2 weeks. Patient was treated with COVID-19 treatment from 13Sep2022 to 17Sep2022. Patient report about COVID treatment.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Covid positive/ It was instantly positive; Covid positive/ It was instantly positive; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022, outcome "unknown" and all described as "Covid positive/ It was instantly positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2022) Instantly positive; (10Jul2022) Negative; (15Jul2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Summary: Patient received the original Pfizer 2 shots, the first booster was Pfizer and second booster was Moderna. She did not have batch and lot numbers for these immunizations. She developed fever within 15 minutes on 04Jul around 8:00. She was certain that she was COVID positive, having been contaminated at the meeting. Being all alone at 5000 feet in the withheld mountains, with little supplies and no test kit was pretty worrisome. Her physician partner from withheld called withheld pharmacy in withheld just as soon as they opened, and she get the last box of Paxlovid (batch number unknown) there were no kits to be purchased in withheld. She had received Paxlovid treatment from 05Jul2022 to 09Jul2022. However, word went out on our mountain that she was needful and one was dropped off. It was instantly positive. She was waiting for the Tylenol to give a little relief, she drove the 25 miles to withheld.   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 available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test, Swelling
Clinical narrative: Swollen armpit; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high triglycerides" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; CYCLOBENZAPRINE; MELOXICAM; CHROMIUM PICOLINATE; CALCIUM; GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]; ACIDOPHILUS; ZINC. Past drug history included: Aspirin, reaction(s): "known allergies;aspirin". Vaccination history included: BNT162b2 (Dose Number: 1, Lot Number: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 23Feb2021, for covid-19 immunisation; BNT162b2 (Dose Number: 2, Lot Number: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Mar2021, for covid-19 immunisation; BNT162b2 (Dose Number: 3, Lot Number: 30135BA, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 08Dec2021, for covid-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset 23Sep2022 at 03:30, outcome "recovered" (25Sep2022 at 15:00), described as "Fever"; SWELLING (non-serious) with onset 23Sep2022 at 22:00, outcome "recovered" (26Sep2022 at 10:00), described as "Swollen armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling, pyrexia. Additional Information: The lot number was reported as (6 or G) 72528. The patient did not receive vaccine in four weeks and took Centrum in two weeks. Fever started Friday, Sep23 at 3:30 AM and ran through Saturday, Sep25 at 3:00 PM. Highest temp: 100.1 F. Swollen armpit start Friday, Sept 23 at 10 PM and continued to Monday, Sep26 at 10 AM. The patient has not been diagnosed with covid prior vaccination and has tested negative covid post vaccination.  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: 47.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Myalgia, Off label use, Pain in extremity, Product use issue
Clinical narrative: Moderate fatigue; Arm pain; Moderate to mild myalgia; other vaccine same date product: Influenza; other vaccine same date product: Influenza; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 17:00 as dose 4 (booster), single (Lot number: GJ6739) at the age of 47 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 24Sep2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization completed (Manufacturer Unknown)), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE (Manufacturer Unknown)), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 24Sep2022, outcome "unknown" and all described as "other vaccine same date product: Influenza"; PAIN IN EXTREMITY (non-serious) with onset 24Sep2022 at 22:00, outcome "not recovered", described as "Arm pain"; FATIGUE (non-serious) with onset 24Sep2022 at 22:00, outcome "not recovered", described as "Moderate fatigue"; MYALGIA (non-serious) with onset 24Sep2022 at 22:00, outcome "not recovered", described as "Moderate to mild myalgia". Therapeutic measures were not taken as a result of fatigue, pain in extremity, myalgia. Additional Information: The patient took over the counter and prescription medications in two weeks. The patient has not been diagnosed with covid prior vaccination and has not tested for covid post vaccination. The patient has no known allergies. The patient experienced arm pain very mild on day of vaccination, then moderate the date following vaccination; moderate to mild myalgia - mild day of vaccination and moderate day following vaccination and moderate fatigue. Based on previous experience with the vaccine recipients are likely to resolve within 48-72 hours post-dose.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngeal swab, Vaccination failure
Clinical narrative: Contracted COVID-19; Contracted COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group and a sales representative. The reporter is the patient.  An 86-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: PFI E19264), in left arm, on 22Feb2021 as dose 2, single (Lot number: EN6200), in left arm and on 09Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 85 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Heart failure" (unspecified if ongoing); "high BP" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Sep2022, outcome "recovering" and all described as "Contracted COVID-19". The event "contracted covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (21Sep2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: It was unknown if patient received any other vaccine in four weeks. The patient took other medication in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: fatigue; sore arm; aches; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 at 14:30 as dose 5 (booster), single (Lot number: GH9693) at the age of 63 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid prior vaccination" (unspecified if ongoing). There were no concomitant medications. 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; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 25Sep2022 at 23:45, outcome "recovered" (Sep2022), described as "aches"; FATIGUE (non-serious) with onset 25Sep2022 at 23:45, outcome "recovered" (Sep2022); PAIN IN EXTREMITY (non-serious) with onset 25Sep2022 at 23:45, outcome "recovered" (Sep2022), described as "sore arm ". Therapeutic measures were not taken as a result of fatigue, pain in extremity, pain.  Additional information: Patient had no other vaccine in four weeks and no other medications in two weeks. It was also reported sore arm 8 hours post-injection, aches and fatigue 12 hours post injection. Events did not result in emergency room visit and physician office visit. Patient did not have covid tested post vaccination, and no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
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) (Other HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies : Penicillin" (unspecified if ongoing), notes: Known allergies : Penicillin. The patient's 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: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti viral details Product was COVID 19. Treatment brand was Pfizer. Treatment start date on 26Sep2022. Indication treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Malaise, Pain in extremity, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: neomycin" (unspecified if ongoing); "digestive issues (food allergies)/sinusitis (food allergies)" (unspecified if ongoing); "sinusitis (food allergies)" (unspecified if ongoing); "eustacian tube inflammation" (unspecified if ongoing); "Uticaria from eye drops" (unspecified if ongoing), notes: other medical history: Uticaria from eye drops; "Known allergies: other antibiotics topical" (unspecified if ongoing); "digestive issues (food allergies)" (unspecified if ongoing); "Known allergies: additives in eye drops" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, prev dose lot number: EN6208, prev dose administration time: 11:45 AM, prev dose vaccine location: Right arm), administration date: 11Mar2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "Malaise", "Vaccination site pain", "Arthralgia", "Pain in extremity", "Headache", "Visual impairment"; BNT162b2 (DOSE 2, SINGLE, prev dose lot number: ER8737, prev dose vaccine location: Right arm), administration date: 01Apr2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "Malaise", "Vaccination site pain", "Arthralgia", "Pain in extremity", "Headache", "Visual impairment". The following information was reported: VISUAL IMPAIRMENT (non-serious), outcome "recovered", described as "intermittent visual focus disturbances 5-6 hours"; MALAISE (non-serious), outcome "recovered", described as "general malaise 6 hours"; VACCINATION SITE PAIN (non-serious), ARTHRALGIA (non-serious), outcome "recovered" and all described as "First 4 doses upon injection shooting pain down arm to wrist"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "pain in arm 4-5 hours/shooting pain, Down arm to wrist"; HEADACHE (non-serious), outcome "recovered", described as "pounding headache 3-4 hours". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of visual impairment, malaise, vaccination site pain, arthralgia, pain in extremity, headache. Additional information: Facility type vaccine was pharmacy or drug Store. No other vaccine in four weeks and no covid prior vaccination. First 4 doses upon injection shooting pain, down arm to wrist, continued pain in arm 4-5 Hours, pounding headache 3-4 hours, intermittent visual focus disturbances 5-6 Hours, general malaise 6 hours. No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Visual impairment
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: neomycin" (unspecified if ongoing); "digestive issues (food allergies)/sinusitis (food allergies)" (unspecified if ongoing); "sinusitis (food allergies)" (unspecified if ongoing); "eustacian tube inflammation" (unspecified if ongoing); "Uticaria from eye drops" (unspecified if ongoing), notes: other medical history: Uticaria from eye drops; "Known allergies: other antibiotics topical" (unspecified if ongoing); "digestive issues (food allergies)" (unspecified if ongoing); "Known allergies: additives in eye drops" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, prev dose lot number: EN6208, prev dose administration time: 11:45 AM, prev dose vaccine location: Right arm), administration date: 11Mar2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "Malaise", "Vaccination site pain", "Arthralgia", "Pain in extremity", "Headache", "Visual impairment"; BNT162b2 (DOSE 2, SINGLE, prev dose lot number: ER8737, prev dose vaccine location: Right arm), administration date: 01Apr2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "Malaise", "Vaccination site pain", "Arthralgia", "Pain in extremity", "Headache", "Visual impairment". The following information was reported: VISUAL IMPAIRMENT (non-serious), outcome "recovered", described as "intermittent visual focus disturbances 5-6 hours"; MALAISE (non-serious), outcome "recovered", described as "general malaise 6 hours"; VACCINATION SITE PAIN (non-serious), ARTHRALGIA (non-serious), outcome "recovered" and all described as "First 4 doses upon injection shooting pain down arm to wrist"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "pain in arm 4-5 hours/shooting pain, Down arm to wrist"; HEADACHE (non-serious), outcome "recovered", described as "pounding headache 3-4 hours". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of visual impairment, malaise, vaccination site pain, arthralgia, pain in extremity, headache. Additional information: Facility type vaccine was pharmacy or drug Store. No other vaccine in four weeks and no covid prior vaccination. First 4 doses upon injection shooting pain, down arm to wrist, continued pain in arm 4-5 Hours, pounding headache 3-4 hours, intermittent visual focus disturbances 5-6 Hours, general malaise 6 hours. No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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. An 81-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2022 as dose 4 (booster), single (Lot number: FK9825) at the age of 80 years, 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Prostate surgery", start date: 2017 (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral treatment included Paxlovid.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: 6N6208), on 31Mar2021 as dose 2, single (Lot number: ER8732), on 20Aug2021 as dose 3 (booster), single (Lot number: FC3180), in left arm and on 10Jun2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 58 years, in left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Patient medical history included Rheumatoid Arthritis and known allergies to Penicillin and Macrodantin. Concomitant medication(s) included: ADVIL 12 HORAS; METHOTREXATE; MUCINEX; ORENCIA; SUDAFED 12 HOUR; TYLENOL. Past drug history included: Macrodantin, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received the vaccine. Other medication in 2 weeks included Methotrexate, Orencia, Tylenol, Advil, Sudafed, Mucinex. Patient received Paxlovid (Lot number- 1919252A) from 13Sep2022 to 18Sep2022 for treatment of COVID-19.
Age: 75.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing), notes: Other medical history: Chronic lymphocytic leukemia. Concomitant medication(s) included: PAXIL [PIROXICAM]. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. 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: Positive, notes: Treatment of COVID-19. 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.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic Migraine" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Allergy: Penicillin. 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had received vaccine. Patient had not received any other medication in 2weeks. Patient received Paxlovid as COVID 19 Treatment from 14Sep2022 to 19Sep2022. It was reported that two weeks after onset of symptoms and one week after completion of Paxlovid treatment I have redevelopment a cough, nasal congestion, and ear fullness (I originally developed an ear infection with the onset of COVID).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: M
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 54-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years for COVID-19 immunization. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish. Concomitant medication(s) included: HUMALOG, start date: 31Mar2021; LISINOPRIL, start date: 01May2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Other medication in 2 weeks was reported as 'Yes'. Paxlovid was started on 21Sep2022 to 25Sep2022 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: Chills; Nausea; Fatigue; This is a spontaneous report received from a contactable healthcare professional.  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Heart conditions" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown".  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-PV202200071855 Same patient and product; different dose and event.