chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: Multiple sclerosis; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2021 at 14:30 as dose 1, single (Lot number: EK5740) at the age of 24 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; LEXAPRO. The following information was reported: MULTIPLE SCLEROSIS (hospitalization, disability, medically significant) with onset 11Jan2021 at 12:00, outcome "not recovered". The patient was hospitalized for multiple sclerosis (hospitalization duration: 5 day(s)). The event "multiple sclerosis" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of multiple sclerosis.  Clinical course: If other vaccine in four weeks was no. Other medications in two weeks was Insulin, Lexapro. Almost immediately after getting the vaccine patient started getting numbness and tingling in my arms and chest then her trunk went and chest then my trunk went numb and began to have severe vertigo. Patient went to the emergency room where patient was diagnosed with Multiple sclerosis. Patient had never been diagnosed with MS prior and patient had never ever had these symptoms prior to the vaccination. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Ae treatment was IV steroids. If covid prior vaccination was No. If covid tested post vaccination was No. Known allergies was No; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-Multiple sclerosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic
Clinical narrative: Started as one bump similar to the look of chicken pox. Then 2 more appeared and 4 more and kept multiplying till he had hundreds of them. They would itch constantly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 at 08:15 as dose 2, single (Lot number: er8729) 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. Vaccination history included: BNT162b2 (DOSE 1, Lot number: en6204/06-2021, Administration time: 08:15 AM, Vaccine location: Left arm), administration date: 16Mar2021, when the patient was 66-year-old, for Covid-19 immunization. The following information was reported: RASH PRURITIC (non-serious) with onset 22May2021 at 08:00, outcome "unknown", described as "Started as one bump similar to the look of chicken pox. Then 2 more appeared and 4 more and kept multiplying till he had hundreds of them. They would itch constantly". The events "started as one bump similar to the look of chicken pox. then 2 more appeared and 4 more and kept multiplying till he had hundreds of them. they would itch constantly" required physician office visit. It was unknown if therapeutic measures were taken as a result of rash pruritic.  Additional information: The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior vaccination and had not been diagnosed with COVID-19 prior vaccination. Patient went to 1 doctor and 4 dermatologist and no one could figure what was causing this reaction. The last dermatologist thinks it is a reaction from the vaccine since it started shortly after getting it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201333410 Same reporter/patient/drug, different dose/event;
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Started as one bump similar to the look of chicken pox. Then 2 more appeared and 4 more and kept multiplying till he had hundreds of them. They would itch constantly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 at 08:15 as dose 2, single (Lot number: er8729) 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. Vaccination history included: BNT162b2 (DOSE 1, Lot number: en6204/06-2021, Administration time: 08:15 AM, Vaccine location: Left arm), administration date: 16Mar2021, when the patient was 66-year-old, for Covid-19 immunization. The following information was reported: RASH PRURITIC (non-serious) with onset 22May2021 at 08:00, outcome "unknown", described as "Started as one bump similar to the look of chicken pox. Then 2 more appeared and 4 more and kept multiplying till he had hundreds of them. They would itch constantly". The events "started as one bump similar to the look of chicken pox. then 2 more appeared and 4 more and kept multiplying till he had hundreds of them. they would itch constantly" required physician office visit. It was unknown if therapeutic measures were taken as a result of rash pruritic.  Additional information: The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior vaccination and had not been diagnosed with COVID-19 prior vaccination. Patient went to 1 doctor and 4 dermatologist and no one could figure what was causing this reaction. The last dermatologist thinks it is a reaction from the vaccine since it started shortly after getting it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201333410 Same reporter/patient/drug, different dose/event;
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 at 08:15 as dose 1, single (Lot number: er8729), in left arm and on 06Apr2021 at 08:15 as dose 2, single (Lot number: en6204) 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 18Jun2022, outcome "unknown" and all described as "COVID-19 confirmed by positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2022) Positive, notes: Nasal Swab.  Additional information: Facility type vaccine: Other. If other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: Yes. Known allergies: No. Other medical history: No.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201332845 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 at 08:15 as dose 1, single (Lot number: er8729), in left arm and on 06Apr2021 at 08:15 as dose 2, single (Lot number: en6204) 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 18Jun2022, outcome "unknown" and all described as "COVID-19 confirmed by positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2022) Positive, notes: Nasal Swab.  Additional information: Facility type vaccine: Other. If other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: Yes. Known allergies: No. Other medical history: No.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201332845 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I developed an acute onset of shingles; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 60 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 07Oct2022 as dose number unknown, single. Vaccination history included: Moderna (Dose 1), for COVID-19 immunization, reaction(s): "fatigue", "headache"; Moderna (Dose 2), for COVID-19 immunization, reaction(s): "fatigue", "headache"; Moderna (Dose 3 (Booster)), for COVID-19 immunization, reaction(s): "fatigue", "headache". The following information was reported: HERPES ZOSTER (non-serious) with onset 21Nov2022, outcome "recovering", described as "I developed an acute onset of shingles". The event "i developed an acute onset of shingles" required physician office visit. Therapeutic measures were taken as a result of herpes zoster. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. Initial covid vaccines and 1st booster were Moderna. Patient's employer only had the Pfizer for her 2nd booster. With Moderna, patient did have some issues after the injections with fatigue, headache, etc but had nothing initially after the Pfizer. On 21Nov2022, she developed an acute onset of shingles and have never before and see that there have been several reported cases of shingles with this booster. AE treatment: NSAID, calamine lotion, analgesics.
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Drug ineffective, Suspected COVID-19
Clinical narrative: Still got the virus four times / got worse after she took another booster.; Still got the virus four times / got worse after she took another booster.; Still got the virus four times / got worse after she took another booster.; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP).  A 92-year-old female patient received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine ((manufacturer unknown), via an unspecified route of administration, on an unspecified date (batch/lot number: unknown), as DOSE NUMBER UNKNOWN), for COVID-19 immunization, reaction: "COVID-19"; Covid-19 vaccine (manufacturer unknown), via an unspecified route of administration, on an unspecified date (batch/lot number: unknown) as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE) for COVID-19 immunization, reaction: "COVID-19." The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), DISEASE RECURRENCE (medically significant) all with onset 2022, outcome "not recovered" and all described as "Still got the virus four times / got worse after she took another booster." Per Comirnaty Testing, the reported stated her mother is 92 years old and she has had all the vaccines and boosters and she still got the virus four times and got worse after she took another booster. [Note: it was unknown what vaccine(s) this person received].  No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200111579 same patient and suspect vaccine; different dose number and events.;
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 08Sep2022 at 21:00 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years 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 Oct2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 with nirmatrelvir/ ritonavir (PAXLOVID) from 17Oct2022 to 21Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 15:30 as dose 4 (booster), single (Lot number: GJ3277) at the age of 44 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EW0150), in left arm, on 27Apr2021 as dose 2, single (Lot number: EW0174), in left arm and on 02Jan2022 as dose 3 (booster), single (Lot number: FJ1614), in left arm for covid-19 immunisation. The patient's relevant medical history included: "I am a smoker, which was why I was eligible for paxlovid" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Nov2022) Positive, notes: Tested Positive on 14Nov2022; (19Nov2022) Negative, notes: Completed the course of treatment on 19Nov2022 and tested negative the same day; (21Nov2022) Positive, notes: By noon on 21Nov2022, was sick again, and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Patient was treated with Paxlovid from 14Nov2022 to 19Nov2022 (lot number: GF6450) for COVID-19. Patient tested positive on 14Nov2022, started Paxlovid that evening and was symptom free by 17Nov2022. Completed the course of treatment on 19Nov2022and tested negative the same day. On 21Nov2022 started with sore throat, then stuffy nose, then a fever. By noon on 21Nov2022, patient was sick again and tested positive. On the day of this report, on 26Nov2022, patient is still sick, still have a fever. Not better or worse but just feels like all Paxlovid did was postpone the illness.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Weight
Clinical narrative: her arm hurts whole night; it is a big red circle around it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 14 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: PROZAC taken for anxiety. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Nov2022, outcome "unknown", described as "her arm hurts whole night"; VACCINATION SITE ERYTHEMA (non-serious) with onset Nov2022, outcome "unknown", described as "it is a big red circle around it". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, vaccination site erythema. Additional Information: Reporter stated, do not have a vaccination card from this last shot they did not even ask me to fill out a card. It was reported that mother and fourteen year daughter got Pfizer third shot on Tuesday (22Nov2022) afternoon. Patient mother was fine and never had reaction whatsoever, Patient was been telling her arm hurts whole night. Parent taught it was just normal and just looked at it, it is a big red circle around it.  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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Tongue dry
Clinical narrative: Dry mouth; Dry tongue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. 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 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DRY MOUTH (non-serious) with onset 15Nov2022, outcome "unknown"; TONGUE DRY (non-serious) with onset 15Nov2022, outcome "unknown", described as "Dry tongue". Therapeutic measures were not taken as a result of dry mouth, tongue dry.  Additional information: It was also reported that the patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201333363 Same patient, different drug/ AE;
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; dose number: 3 brand: Pfizer/ dose number:4/5 brand other:Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 54 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16May2022 as dose 4 (booster), single (Lot number: 059M21A), in left arm and on 27Sep2022 at 17:30 as dose 5 (booster), single (Lot number: AS7163B), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "known allergies: some antibiotics" (unspecified if ongoing), notes: Yes, some antibiotics, alcohol, apples, raw onions; "known allergies: alcohol" (unspecified if ongoing), notes: Yes, some antibiotics, alcohol, apples, raw onions; "known allergies: apples" (unspecified if ongoing), notes: Yes, some antibiotics, alcohol, apples, raw onions; "known allergies: raw onions" (unspecified if ongoing), notes: Yes, some antibiotics, alcohol, apples, raw onions. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16May2022, outcome "unknown", described as "dose number: 3 brand: Pfizer/ dose number:4/5 brand other:Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Nov2022) Positive, notes: Rebound COVID positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 04Feb2021 as dose 2, single (Lot number: EN5318), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19: the patient received treatment with Paxlovid from 17Nov2022 to 21Nov2022.  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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 16Apr2021 as dose 2, single (Lot number: ER8731), in left arm and on 03Jan2022 as dose 3 (booster), single (Lot number: FJ1611) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: DETROL, start date: 01Jan2020; COZAAR, start date: 15Jul2022; VITAMIN D2, start date: 30Nov2020; LIPITOR, start date: 01Jan2020, stop date: 22Nov2022; ZYDUS, start date: 01Jan2020, stop date: 22Nov2022; VITAMIN D3, start date: 01Jan2019; SPRING VALLEY B100 COMPLEX, start date: 01Jan2019; KRILL OIL, start date: 01Jan2020; CYMBALTA, start date: 01Jan2019; CLARITIN [LORATADINE], start date: 01Jan2018. Past drug history included: Codeine, reaction(s): "Drug Allergy"; Povidine, reaction(s): "Drug Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19: the patient received treatment with Paxlovid from 24Nov2022 to 25Nov2022 and she stated that she had already limited taste and smell from previous COVID (Sep2021) but after taking first am dose she had a terrible taste concentrating on the left posterior portion of her tongue that continued all day. After taking the second pm dose, the terrible taste heightened and her upper lip became puffy and numb. She immediately took liquid Benadryl to stop the reaction. She then had intestinal distress and flu like symptoms. Chills, sweats, super exhausted. Slept for 1.5hrs. Woke up feeling sluggish and not herself. The terrible taste lingered until 24hrs after first am dose. Started to dissipate 27hrs after onset. She didn't have any of those symptoms prior to taking this medication. She did not continue to take Paxlovid on day 2.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "Irratable bowl" (unspecified if ongoing); "Emphysema" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 18Nov2022 to 22Nov2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 20.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 20 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Shortly after taking the first dose (3 pills in the morning) she threw them up. Patient had uncontrollable coughing and despite trying not to throw up, she had to and she puked most of the medicine. My cough is much worse now than before she took the pills. She drank them with lots of water (almost a full 16 oz) but she don't think they sat well in my throat or stomach. She was still coughing after the throwing up episode whereas before she threw up she wasn't coughing much. Adverse event start date at 27Nov2022 and start time at 02:30 PM. Patient was Recovering. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient was previously receive a COVID-19 Vaccine. Device Date was 27Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
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 contactable reporter(s) (Other HCP).  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 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: "Alzheimer's" (unspecified if ongoing); "breast cancer survivor (24 years)" (unspecified if ongoing), notes: breast cancer survivor (24 years); "low blood pressure" (unspecified if ongoing); "pacemaker" (unspecified if ongoing), notes: pacemaker. The patient's concomitant medications were not reported. Past drug history included: Known allergies: codeine, reaction(s): "Allergy", notes: Known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: COVID 19 Treatment with Paxlovid, Treatment start date: 16Nov2022 and Treatment stop date: 21Nov2022, Indication: Treatment of 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.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported events-Drug Ineffective and COVID-19
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-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; 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. 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Positive tests after turning negative; Positive, notes: Positive tests after turning negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Received Paxlovid as treatment of COVID-19; Received Paxlovid as treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jan2021 at 09:30 as dose 1, single (Lot number: EK9231), in left arm, on 10Feb2021 at 09:15 as dose 2, single (Lot number: EM9809), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: 30135RA), in left arm and on 10Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Mild asthma" (unspecified if ongoing); "Allergis rhinitis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Jan2000, stop date: 13Nov2022; LOSARTAN, start date: Jan2000, stop date: 26Nov2022; HYDROCHLOROTHIAZIDE, start date: Jan2000, stop date: 26Nov2022; LORATADINE, start date: Jan2000, stop date: 26Nov2022; FAMOTIDINE, start date: Jan2000, stop date: 26Nov2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Received Paxlovid as treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: The patient has no known allergies. Patient received Paxlovid as treatment on 13Nov2022 to 17Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events vaccination failure,  covid-19 and suspect drug BNT162B2 cannot be excluded.
Age: 27.0
Sex: F
Vaccine: 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Oct2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had no known allergies. It was unknown if patient had other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovered" (Nov2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 18Nov2022 to 21Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Lot number: BO1458A) at the age of 40 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Sep2022 as dose 4 (booster), single (Lot number: AS7144B), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient 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 Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Paxlovid treatment from 17Nov2022 to 21Nov2022 for Covid-19. Patient have not taken any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously receive a COVID-19 Vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: vaccine_brand_other=Moderna, vaccine_dose_number=1, 2; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). There were no concomitant medications, also reported as no other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine_brand_other=Moderna, vaccine_dose_number=1, 2". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid, Treatment start date was 12Nov2022 and stop date was 16Nov2022.  Clinical course: Patient had no known allergies. Reported that, Patient had rebound of symptoms 7 days after finishing Paxlovid treatment included Headache, Running nose, body aches, tired. Tested positive again after testing negative after completing treatment. Rebound events onset was reported as 24Nov2022 at 20:00. Patient not received any treatment for symptoms and not recovered from symptoms.  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: 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: 62.0
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 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 18:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 24Mar2021 as dose 2, single (Lot number: EP7534), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 06May2022 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "known allergies: Clindamycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Nov2022) Positive, notes: I tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), 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 Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Treatment taken was Paxlovid from 15Nov2022 to 19Nov2022. Still testing positive 13 days after onset of COVID. Symptoms left is dry throat on day 13. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 91-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) 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 Nov2022, outcome "unknown" and all described as "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.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 1= Moderna, Dose 2= Moderna, Dose 3= Moderna, Dose 4= Moderna, Dose 5= Pfizer/BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 88-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9703) at the age of 87 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Feb2021 as dose 1, single (Lot number: 0061N20A), on 13Mar2021 as dose 2, single (Lot number: 013A21A), on 24Nov2021 as dose 3 (booster), single (Lot number: 065F21A), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: 046L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart (bypass and aneurysm surgeries)" (unspecified if ongoing), notes: Heart (bypass and aneurysm surgeries); "Heart (bypass and aneurysm surgeries)" (unspecified if ongoing), notes: Heart (bypass and aneurysm surgeries). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Sep2022 at 11:00, outcome "unknown", described as "Dose 1= Moderna, Dose 2= Moderna, Dose 3= Moderna, Dose 4= Moderna, Dose 5= Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment and the patient previously received a COVID-19 Vaccine. Antiviral details: product: COVID-19 Treatment. The treatment was started on 14Nov2022 and stopped on 19Nov2022. The patient has no known allergies.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Bursitis, Inflammation, Joint range of motion decreased, Pain in extremity
Clinical narrative: inflammation of right arm; can't put on a shirt by herself, can't lift arm or reach for anything on a shelf; Felt like bursitis or crippling arthritis in upper arm in biceps area; Felt like bursitis or crippling arthritis in upper arm in biceps area; can't lift arm or reach for anything on a shelf, excruciating pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Nov2022 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination Yes. Concomitant medication(s) included: SERTRALINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TRELEGY; ATORVASTATIN. The following information was reported: BURSITIS (non-serious), ARTHRITIS (non-serious) all with onset 20Nov2022, outcome "not recovered" and all described as "Felt like bursitis or crippling arthritis in upper arm in biceps area"; PAIN IN EXTREMITY (non-serious) with onset 20Nov2022, outcome "not recovered", described as "can't lift arm or reach for anything on a shelf, excruciating pain"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 20Nov2022, outcome "not recovered", described as "can't put on a shirt by herself, can't lift arm or reach for anything on a shelf"; INFLAMMATION (non-serious) with onset 20Nov2022, outcome "not recovered", described as "inflammation of right arm". Therapeutic measures were not taken as a result of inflammation, joint range of motion decreased, pain in extremity, bursitis, arthritis. Additional information: The patient experienced inflammation of right arm, 5 days after vaccine, can't put on a shirt after vaccine, can't put on a shirt by herself, can't lift arm or reach for anything on a shelf, excruciating pain, felt like she tore something inside her arm. Felt like bursitis or crippling arthritis in upper arm in biceps area. The patient has not recovered. No treatment was given. Additional information: The patient was not COVID tested post vaccination. The patient has no known allergies. The patient had no other vaccine in four weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.