chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 Vaccine (030M20A First dose) on 17-Feb-2021, Moderna Covid-19 Vaccine (013A21A Second dose) on 17-Mar-2021 and Moderna Covid-19 Vaccine (04821A Third dose) on 22-Jan-2022. Past adverse reactions to the above products included No adverse event with Moderna Covid-19 Vaccine, Moderna Covid-19 Vaccine and Moderna Covid-19 Vaccine.    On 06-Jan-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had resolved.            No concomitant medication was reported.  No treatment information was reported.
Age: 82.0
Sex: F
Vaccine: COVID19, FLUX, RVX
Symptoms: Decreased appetite, Fatigue
Clinical narrative: She states that now, she feels very tired and has no appetite; She states that now, she feels very tired and has no appetite; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (She states that now, she feels very tired and has no appetite) and DECREASED APPETITE (She states that now, she feels very tired and has no appetite) in an 82-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect products included non-company products INFLUENZA VACCINE (INFLUENZA) for an unknown indication, RSV VACCINE for an unknown indication and METHOTREXATE for Rheumatoid arthritis.    Previously administered products included for COVID-19 prophylaxis: original moderna (dose 2) and original moderna (dose 1). Past adverse reactions to the above products included No adverse event with original moderna and original moderna. Concurrent medical conditions included Arthritis rheumatoid and Blood pressure high. Concomitant products included LOSARTAN and AMLODIPINE for Blood pressure high, FOLIC ACID and GOLIMUMAB (SIMPONI) for Rheumatoid arthritis.   In 2023, the patient received dose of INFLUENZA VACCINE (INFLUENZA) (unknown route) 1 dosage form and dose of RSV VACCINE (unknown route) 1 dosage form. In 2023, METHOTREXATE (unknown route) dosage was changed to at an unspecified dose. In October 2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient started METHOTREXATE (unknown route) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (She states that now, she feels very tired and has no appetite) and DECREASED APPETITE (She states that now, she feels very tired and has no appetite). At the time of the report, FATIGUE (She states that now, she feels very tired and has no appetite) and DECREASED APPETITE (She states that now, she feels very tired and has no appetite) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient had received Spikevax 12+ (2023-2024 formula) in early OCT-2023. It was reported that about 1 weeks prior to her Spikevax (2023-2024) shot, she stopped taking the Methotrexate. She had FLU and RSV vaccines 3 weeks after the Spikevax and restarted the Methotrexate 1 week after the FLU shot & RSV shots. She states that the Methotrexate was restarted 4 weeks after Spikevax (2023-2024) shot. No treatment medication was reported.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Headache, Peripheral swelling
Clinical narrative: Headaches, lt arm swollen, diarrhea
Age: 1.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Erythema, Product preparation error
Clinical narrative: Pt was here receiving the Covid19 vaccine. Was given the correct 0.3ml, however vaccine was not diluted prior to administration. Patient's mother states she had a red spot but has had that same reaction with other vaccines. She said she is doing well now otherwise.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain, Pain in extremity, Tenderness
Clinical narrative: I know it was a Pfizer Covid shot but I do not know anything about it. My shoulder became very hot and red. I put an ice pack on it, it helped with the redness.  Since then I get terrible pain sometimes down to the elbow. Certain movements sets off the pain. Ice or heat does not help at all. Often can't raise my arm up and the shooting pain is terrible. It feels like someone took their fist and hit me in the shoulder area hard. Sensitive area.
Age: 2.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Product preparation error
Clinical narrative: Patient was here to receive the Covid19 vaccine. Patient was given 0.3 ml dose, however vaccine was not reconstituted prior to administration. Pt's mother was notified and patient is doing well.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Neck pain, Pain, Syringe issue
Clinical narrative: Shingrix Vaccine was given on  left arm on 1/27/24 around 1130am.  Syringe failed to depress.  On 3rd try,  vaccine was received.  Patient called around  3:30pm complaining of radiating  pain from shoulder to neck on left side.  She had taken a tramadol  that she had for the pain and a cold compress was recommended and used.  Followed up with her the next day,  pain was better than day before, but still unable to lift arm.  Told her we will follow up with patient in a few days regarding the status of reaction.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: INJECTION SITE REACTION W/ EDEMA ON ENTIRE ARM, PRURITUS, AND PAIN.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Neck pain
Clinical narrative: Patient complains of pain from left elbow, shoulder and into the neck and upper back
Age: 42.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: Wrong vaccine given to patient - should have been Abrysvo and not Arexvy as pt is pregnant and not 60 y/o
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Vaccination site discolouration, Vaccination site hypoaesthesia
Clinical narrative: my arms numb for long time where I had the shots and darkness yellow skin; my arms numb for long time where I had the shots and darkness yellow skin; flu; This is a spontaneous report received from a Consumer or other non-HCP.  An adult female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as DOSE 1, SINGLE (batch/lot number: unknown), administered in the right arm for COVID-19 immunization. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (first dose (manufacturer unknown) via an unspecified route of administration, on an unspecified date (batch/lot number: unknown) as DOSE 1, SINGLE) for COVID-19 immunization; Covid-19 vaccine (second dose (manufacturer unknown) via an unspecified route of administration, on an unspecified date (batch/lot number: unknown) as DOSE 2, SINGLE) for COVID-19 immunization; Covid-19 vaccine (third dose (manufacturer unknown) via an unspecified route of administration, on an unspecified date (batch/lot number: unknown) as DOSE 3 (BOOSTER), SINGLE) for COVID-19 immunization. The following information was reported: VACCINATION SITE HYPOAESTHESIA (non-serious), VACCINATION SITE DISCOLOURATION (non-serious), outcome "unknown" and all described as "my arms numb for long time where I had the shots and darkness yellow skin"; INFLUENZA (non-serious), outcome "unknown" described as "flu." It was unknown if therapeutic measures were taken as a result of vaccination site hypoaesthesia, vaccination site discolouration, influenza.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient has been tested for COVID-19. Result of nasal swab test was positive. The patient reported "I want to complain about COVID vaccine. I had 3 shots and had COVID, then flu now cold. I had my arms numb for long time where I had the shots and darkness yellow skin, but I don't know if is associated with the shots.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400023581 same patient/vaccine, different events;
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: sore arm, having aches; sore arm, having aches; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. Other Case identifier(s): 02536561 (Merck).  A female patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Lot number: EN6203) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot no.: EN6200), administration date: 26Feb2021, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious), outcome "unknown" and all described as "sore arm, having aches".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400010949 same patient, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: sore arm, having aches; sore arm, having aches; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. Other Case identifier(s): 02536561 (Merck).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 4 (booster), single (Lot number: GJ6739) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single; Lot number: EN6200), administration date: 26Feb2021, for COVID-19 immunisation, reaction(s): "sore arm, having aches", "sore arm, having aches"; BNT162b2 (Dose 2, single; Lot number: EN6203), administration date: 19Mar2021, for COVID-19 immunisation, reaction(s): "sore arm, having aches", "sore arm, having aches"; BNT162b2 (Dose 3 (booster), single; Lot number: 33130BA), administration date: 03Dec2021, for COVID-19 immunisation, reaction(s): "sore arm, having aches", "sore arm, having aches". The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious), outcome "unknown" and all described as "sore arm, having aches".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400010949 Same patient and event, different dose number;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cognitive disorder, Drug ineffective, Malaise
Clinical narrative: PT (Patient) took the COVID Vaccine from Pfizer in the past/COVID after vaccine; PT (Patient) took the COVID Vaccine from Pfizer in the past/COVID after vaccine; Not feeling well; she can't think straight; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "PT (Patient) took the COVID Vaccine from Pfizer in the past/COVID after vaccine"; MALAISE (non-serious), outcome "unknown", described as "Not feeling well"; COGNITIVE DISORDER (non-serious), outcome "unknown", described as "she can't think straight". Therapeutic measures were taken as a result of covid-19, drug ineffective. Additional information: COVID after vaccine. Pt (patient) adv she's not feeling very well, she can't think straight. PT took the COVID Vaccine from Pfizer in the past and you just got her rsv shot from Pfizer as well.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2023 at 15:00 as dose 2 (booster), single (Lot number: GJ5342) at the age of 58 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Sep2023 at 15:00 as dose 3 (booster), single (Lot number: 3030371), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), 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), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid taken from 13Jan2024 to 17Jan2024.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Moderna/ Dose #4: Pfizer/ Dose #5 Moderna.; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP from product quality group.  A 24-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose number unknown, single (Lot number: GJ3277) at the age of 22 years, in left arm for covid-19 immunisation; elasomeran, imelasomeran (SPIKEVAX BIVALENT ORIGINAL / OMICRON), on 10Oct2023 at 14:30 as dose number unknown, single), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Jan2021 as dose 1, single (Lot number: 027L20A), in left arm, on 14Feb2021 as dose 2, single (Lot number: 024M20A), in left arm and on 11Nov2021 as dose number unknown, single (Lot number: 071F21), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Jan2024, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Moderna/ Dose #4: Pfizer/ Dose #5 Moderna.". Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive other Medication in 2 weeks. Patient did not received treatment for the adverse events. Patient did not have any Known allergies. Other medical history was none.; Sender's Comments: Considering the interchange of vaccine and based on the known information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound neck, Vaccination site swelling
Clinical narrative: arm is still swollen at injection site; ultrasound showed a partial blood clot in her neck; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 11Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset Sep2022, outcome "not recovered", described as "ultrasound showed a partial blood clot in her neck"; VACCINATION SITE SWELLING (non-serious), outcome "not recovered", described as "arm is still swollen at injection site". The events "ultrasound showed a partial blood clot in her neck" and "arm is still swollen at injection site" required physician office visit. The patient underwent the following laboratory tests and procedures: Ultrasound neck: (Sep2022) ultrasound showed a partial blood clot in her neck. Therapeutic measures were taken as a result of thrombosis. Additional information: reporter states she had her 3rd Pfizer covid 19 booster Jun2022. Reports her arm is still swollen at injection site. States she went to the doctor in July and Aug2022. It was thought it could be an abcess however when they did an ultrasound, the ultrasound showed a partial blood clot in her neck (diagnosed in Sep2022). States she has been on blood thinners ever since. Her hcp thinks it may have been attributed to Pfizer covid booster.  Caller is wondering how to reduce the swelling.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia
Clinical narrative: he had pain in his shoulder; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "he had pain in his shoulder".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Rash
Clinical narrative: rash on same side of body; This is a spontaneous report received from a Physician from a sales representative.  An adult female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient was 3 trimester pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (hospitalization), 6 days after the suspect product administration, outcome "unknown", described as "rash on same side of body". It was unknown if therapeutic measures were taken as a result of rash. Additional information: Provider stated the pregnant person 32-36 weeks received Abrysvo at a pharmacy. 6 days later the patient had rash on same side of body as vaccine was administered. Also, patient was hospitalized. Provider stated he did not feel vaccine caused either issue listed above.  The reporter considered "rash on same side of body" not related to rsv vaccine prot.subunit pref 2v.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on known disease pathophysiology, the event rash is assessed as not related to RSV VACCINE PROT.SUBUNIT PREF 2V, and more likely an intercurrent medical condition.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Investigation, Weight
Clinical narrative: Diagnosed with ALS; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 2, single (Lot number: EW0162) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. Vaccination history included: pfizer COVID vaccine (Dose 1, Single Lot EP7534, Exp: Unknown, Dose: unknown, administered in left arm), administration date: 22Mar2021, when the patient was 53-year-old, for Covid-19 immunization. The following information was reported: AMYOTROPHIC LATERAL SCLEROSIS (medically significant) with onset 24Jan2024, outcome "unknown", described as "Diagnosed with ALS". The patient underwent the following laboratory tests and procedures: but had other test: Unknown results; Weight: lost a lot of weight. Clinical course: He stated he just found a month ago his wife has ALS diagnosis due to the vaccines, clarified as the Covid Vaccine. He wanted to know what should do about his wife. Reporter stated he does not know if covid vaccine caused ALS for his wife. Yesterday, the doctor diagnosed wife with ALS and doctor said there has been a 20% increase in this since people have taken the vaccine. They all received the Pfizer Covid Vaccine. Official diagnosis occurred yesterday of ALS. However, things were happening earlier and suspected back in November (year unspecified), but had to have other test done.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400025172 same patient/reporter, different dose/events;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19, Weight
Clinical narrative: His wife has covid; His wife has covid; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Lot number: FJ8762), on 14Apr2021 as dose 2, single (Lot number: EW0162) and on 22Mar2021 as dose 1, single (Lot number: EP7534), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing), notes: Hypothyroidism. Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. The patient also took other concomitant therapy.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "His wife has covid". The patient underwent the following laboratory tests and procedures: Weight: Lost a lot of weight, notes: Lost a lot of weight,  Additional information: Reporter stated he just found a month ago his wife has ALS diagnosis due to the vaccines, clarified as the Covid Vaccine. This is his second time getting covid. His daughter had allergic to reaction due Covid Vaccine. His doctor does not know what was going on there has been 20% increase the ALS since covid. The doctor does not have any answers. He wants to know what was going on due to them all their getting covid Vaccine. He wants to know what should do about his wife. After transfer reporter stated he does not know if covid vaccine caused ALS for his wife. His wife has covid. He clarified, yesterday the doctor diagnosed wife with ALS and doctor said there has been a 20% increase in this since people have taken the vaccine.  He then added, his daughter also has covid. She works in a hospital. Confirmed she had an allergic reaction to the covid vaccine. Confirmed they all received the Pfizer Covid Vaccine. Official diagnosis occurred yesterday of ALS. However, things were happening earlier and suspected back in November, but had to have other test done. Clinical coordinator: ALS 24Jan2024, could have been early suspected back in November, but had other test.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Has covid; Has covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Has covid".  Clinical course: The patient works in a hospital.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400025159 same reporter/patient/drug, different event;
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Pharmacist.  A 44-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number 1, single, Manufacture unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number 2, single, Manufacture unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number 3, (BOOSTER), Manufacture unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number 4, (BOOSTER), Manufacture unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number 5, (BOOSTER), Manufacture unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number 6, (BOOSTER), Manufacture unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number 7, (BOOSTER), Manufacture unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors. However, a contributory role of BNT162b2 omi xbb.1.5  to the events Vaccination failure and Covid-19 cannot be ruled out.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Apr2023 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, 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), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 treated with Paxlovid from 15Jan2024 to 20Jan2024. Additional information: The patient has no known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left leg for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, 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), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid from 17Jan2024 to 21Jan2024 for COVID-19.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "adult onset Still's disease" (unspecified if ongoing), notes: In non medicated remission currently. Concomitant medication(s) included: VALSARTAN/HYDROCHLOORTHIAZIDE, start date: 01Jan2019; ONE A DAY WOMEN'S 50+ COMPLETE MULTIVITAMIN; ESTRADIOL, start date: 01Mar2023. The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (Dose 5 (Booster), Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 4 (Booster), Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (16Jan2024) 102, notes: fever. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information:  The patient had symptoms on 16Jan2024, runny nose, body aches, fever of 102. First dose of Paxlovid taken about noon 17Jan2024 for treatment of Covid-19. She took the final dose 9pm on 21Jan2024. Concomitant medication included Iwi heart omega 3 supplement.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lyme's" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 08Jan2024 to 12Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 4 (booster), single (Lot number: GJ6665) at the age of 75 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "R/A" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "chronic back" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "Known allergies: Cymbalta" (unspecified if ongoing). 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: after taking Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 06Jan2024 to 11Jan2024.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Known allergies: Sulfur" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jun2008. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12Jan2024 to 17Jan2024. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 29Sep2023 as dose 1 (toppac), single (Lot number: Hg4629) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tetracyclene, reaction(s): "allergies: Tetracyclene". Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (vaccine lot number: Gl2042, vaccine location: Left arm, vaccine dose number unknown), administration date: 12May2023, when the patient was 66-year-old, for Covid-19 Immunization; BNT162b2;BNT162b2 omi ba.4-5 (vaccine lot number: Gh9694, vaccine location: Left arm, vaccine dose number unknown), administration date: 09Oct2022, when the patient was 66-year-old, for Covid-19 Immunization; BNT162b2 (vaccine lot number: Fj9943, vaccine location: Left arm, vaccine dose number unknown), administration date: 15Apr2022, when the patient was 65-year-old, for Covid-19 Immunization; BNT162b2 (vaccine lot number: Fe3590, vaccine location: Left arm, vaccine dose number unknown), administration date: 08Oct2021, when the patient was 65-year-old, for Covid-19 Immunization; BNT162b2 (vaccine lot number: Ew0150, vaccine location: Left arm, vaccine dose number unknown), administration date: 07Apr2021, when the patient was 65-year-old, for Covid-19 Immunization; Bnt162b2 (vaccine lot number: En6024, vaccine dose number unknown), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jan2024 at 07:00, outcome "not recovered" and all described as "COVID 19 ". Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment of COVID-19 included nirmatrelvir, ritonavir (PAXLOVID) from 15Jan2024 to 20Jan2024.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Lot number: HG4680) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Small fiber polyneuropathy" (unspecified if ongoing), notes: Small fiber polyneuropathy; "Ehlers Danlos" (unspecified if ongoing), notes: Ehlers Danlos; "Asthma" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 1, SINGLE, Batch/Lot No: 029A21A, Location of injection: Arm Left), administration date: 20Mar2021, when the patient was 57-year-old, for COVID-19 immunization; moderna (DOSE 2, SINGLE, Batch/Lot No: 042B21A, Location of injection: Arm Left), administration date: 17Apr2021, when the patient was 57-year-old, for COVID-19 immunization; moderna (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: 018F21A, Location of injection: Arm Left), administration date: 17Nov2021, when the patient was 58-year-old, for COVID-19 immunization; moderna (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 18May2022, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: GJ3275, Location of injection: Arm Left), administration date: 10Nov2022, when the patient was 59-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid treatment from 17Jan2024 to 21Jan2024).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted COVID; contracted COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400012459 Same reporter/ drug/ event for different patients;
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine administration date=09Oct2023/Moderna/Vaccine administration date=10Oct2022/Pfizer / BioNTech; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose number unknown (booster), single at the age of 43 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Oct2023 at 12:00 as dose number unknown (booster), single), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "hashimito's" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 01Jul2009, stop date: 26Jan2024. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Oct2023 at 12:00, outcome "unknown", described as "Vaccine administration date=09Oct2023/Moderna/Vaccine administration date=10Oct2022/Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective, covid-19 included Paxlovid from 16Jan2024 to 20Jan2024.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "essential tremor" (unspecified if ongoing); "migraines" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Allergies: compazine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 18Jan2024 to 22Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Physician.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's 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; 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included: Paxlovid from 15Jan2024 to 19Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information available, a possible contributory role of the suspect vaccine BNT162b2 omi xbb.1.5  cannot be excluded for the reported event of the lack of efficacy of the vaccine
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 included Paxlovid from 07Jan2024 and 11Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: How long after Covid before getting Covid shot? Caller thinks 3 months.; How long after Covid before getting Covid shot? Caller thinks 3 months.; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), on 02Apr2021 as dose 2, single (Batch/Lot number: unknown), on 01Dec2021 as dose 3 (booster), single (Lot number: FF2587) and on 29Jul2022 as dose 4 (booster), single (Lot number: FL3198) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: caller provides she takes high blood pressure medication. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "How long after Covid before getting Covid shot? Caller thinks 3 months.". Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Claustrophobia, Dyspnoea, Feeling abnormal, Feeling hot, Nausea
Clinical narrative: How long after Covid before getting Covid shot? Caller thinks 3 months.; How long after Covid before getting Covid shot? Caller thinks 3 months.; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), on 02Apr2021 as dose 2, single (Batch/Lot number: unknown), on 01Dec2021 as dose 3 (booster), single (Lot number: FF2587) and on 29Jul2022 as dose 4 (booster), single (Lot number: FL3198) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: caller provides she takes high blood pressure medication. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "How long after Covid before getting Covid shot? Caller thinks 3 months.". Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.