chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza, Lymphadenopathy, Pain in extremity
Clinical narrative: feeling ill; flu; Painful arm; lymph nodes which would swell uncontrollably; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (feeling ill), INFLUENZA (flu), PAIN IN EXTREMITY (Painful arm) and LYMPHADENOPATHY (lymph nodes which would swell uncontrollably) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2022, the patient experienced ILLNESS (feeling ill), INFLUENZA (flu), PAIN IN EXTREMITY (Painful arm) and LYMPHADENOPATHY (lymph nodes which would swell uncontrollably). At the time of the report, ILLNESS (feeling ill), INFLUENZA (flu), PAIN IN EXTREMITY (Painful arm) and LYMPHADENOPATHY (lymph nodes which would swell uncontrollably) had resolved.            No concomitant medication was reported.  It was reported that patient was in immense pain for 3 days and was nervous about taking new shot due to the reaction with the previous shots by moderna (4 shots). He took a 5th shot of the Pfizer one earlier in 2023, but felt worse. He was looking to take the moderna one but has had the adverse reaction to all the moderna shots he would take. No treatment medication was reported.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Blood cholesterol, Taste disorder
Clinical narrative: unable to taste food except for salt, sweet, bitter, sour (tongue); hip pain; This spontaneous case was reported by a patient and describes the occurrence of TASTE DISORDER (unable to taste food except for salt, sweet, bitter, sour (tongue)) and ARTHRALGIA (hip pain) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7646C) for COVID-19 prophylaxis.    The patient's past medical history included COVID-19 on 17-Apr-2022. Concurrent medical conditions included High cholesterol (treating with Atovastatin and Ezetimbe.), Hay fever (treating with Loratadine.) and Acid reflux (esophageal) (treating with Famotadine and Omeprazole). Concomitant products included FAMOTIDINE and OMEPRAZOLE for Acid reflux (esophageal), LORATADINE for Hay fever, ATORVASTATIN and EZETIMIBE for High cholesterol, INFLUENZA VACCINE INACT SPLIT 3V (AFLURIA) for an unknown indication.   On 17-Aug-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) .5 milliliter. In August 2023, the patient experienced TASTE DISORDER (unable to taste food except for salt, sweet, bitter, sour (tongue)) and ARTHRALGIA (hip pain). At the time of the report, TASTE DISORDER (unable to taste food except for salt, sweet, bitter, sour (tongue)) had not resolved and ARTHRALGIA (hip pain) had resolved.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2023, Blood cholesterol: (Inconclusive) reduced to 140 from 260.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use), the reporter did not provide any causality assessments.   Reportedly, since the vaccine patient had been unable to taste food except for salt, sweet, bitter, sour (tongue). Patient had no sickness since the vaccine except for some hip pain for a couple of days that had gone away.  The patient did not experience any additional symptoms/events.  The patient did not have any additional medical history, concomitant disease or risk factor.  No treatment information was provided.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 09-AUG-2023 and administration on 11-SEP-2023; No adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 09-AUG-2023 and administration on 11-SEP-2023) and NO ADVERSE EVENT (No adverse event) in a 24-month-old male patient who received mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (batch no. 201L22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1- Lot  AS1414B) on 29-Jun-2022 and Moderna COVID-19 Vaccine (Dose 2- Lot AS1412B) on 27-Jul-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 11-Sep-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (unknown route) .2 milliliter. On 11-Sep-2023,  after starting mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 09-AUG-2023 and administration on 11-SEP-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 09-AUG-2023 and administration on 11-SEP-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 09-AUG-2023 and administration on 11-SEP-2023).    Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Vial was initially stored in refrigerator on 09-AUG-2023. Vial did not undergo any temperature excursion. Treatment details was not reported by the reporter.
Age: 35.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 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 Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment was Paxlovid. Treatment start date was 30Aug2023 and stop date was 04Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dermal filler reaction, Injection site mass, Scar
Clinical narrative: face surgery casing permanent scar on face; Pfizer Covid Vacines (3 ) vaccine causing side effects in with facial fillers. The side effect is swelling and hard lumps more than 12+  near and around the filler injection sites all over my face; The side effect is swelling around the filler injection sites all over my face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 07Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Nausea", notes: Codeine Vicodin makes me nausea; Vicodin, reaction(s): "Nausea", notes: Codeine Vicodin makes me nausea. Vaccination history included: bnt162b2 (DOSE 2, SINGLE), administration date: 07Mar2021, for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: INJECTION SITE MASS (disability, medically significant) with onset 06Dec2021, outcome "recovering", described as "Pfizer Covid Vacines (3 ) vaccine causing side effects in with facial fillers. The side effect is swelling and hard lumps more than 12+  near and around the filler injection sites all over my face"; DERMAL FILLER REACTION (disability, medically significant) with onset 06Dec2021, outcome "recovering", described as "The side effect is swelling around the filler injection sites all over my face"; SCAR (medically significant), outcome "unknown", described as "face surgery casing permanent scar on face". Therapeutic measures were taken as a result of injection site mass, dermal filler reaction, scar. Clinical course: Patient was in treatment with Privacy who is a Physician Assistant in Privacy. They currently practice at Privacy. Patient was Still in treatment, Surgery, injections corti. Severe adverse side effects from fillers on face after Pfizer Covid Vaccine. Have had ongoing treatment at Privacy.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300299899 same patient/product, different dose (LOE)/event;
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. 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 15Oct2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 59 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Dysautonomia" (unspecified if ongoing); "Orthostatic hypotension" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "a-fib" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lyrica, reaction(s): "Known allergies: Lyrica". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted covid August 28, 2023; contracted covid August 28, 2023; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 13:15 as dose 5 (booster), single (Lot number: GJ6665) at the age of 22 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 25Apr2022 at 13:15 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Lot number: ER8737), in left arm, on 22Apr2021 at 13:15 as dose 2, single (Lot number: EW0162), in left arm and on 10Nov2021 at 13:15 as dose 3 (booster), single (Lot number: FH8028), in right arm for covid-19 immunisation. The patient's relevant medical history included: "MDD" (unspecified if ongoing); "unspecified anxiety" (unspecified if ongoing); "Nuts allergy" (unspecified if ongoing); "pollen allergy" (unspecified if ongoing); "covid", start date: Oct2020 (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Aug2023 at 08:00, outcome "not recovered" and all described as "contracted covid August 28, 2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Aug2023) Unknown results. Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.
Age: 58.0
Sex: M
Vaccine: FLUR4, VARZOS
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: PT RECEIVED SHINGRIX ON 9/6/23 IN LEFT ARM AND WHEN HER CALLED US ON 9/12 HE STATED A FEW DAYS AFTER THE INJECTION HIS LEFT ARM SWELLED UP WHERE THE SHOT WAS GIVEN AND GOT HARD AND WAS WARM TO THE TOUCH. HE TOOK BENADRYL AND PUT ICE ON HIS ARM AND WHEN HE CALLED ON 9/12 HE STATED HE FELT FINE NOW
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy lymph gland
Clinical narrative: The patient reported that she  started having lymph node swelling in January.  She also reported that her physician told her that shingrix could be a cause of it.  She is currently undergoing testing for it.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient was inadvertently given a third dose of shingrix.
Age: 4.0
Sex: F
Vaccine: COVID19-2, DTAPIPV, MMRV
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect dose
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: pt in house   pt is not vaccinated
Age: 79.0
Sex: F
Vaccine: FLU4, PNC20, RSV
Symptoms: Diarrhoea, Dizziness, Immunisation reaction, Pyrexia
Clinical narrative: Patient experienced fever, diarrhea and dizziness later in the evening on the day of her vaccinations.  She visited an urgent care clinic on 9/1/2023 since her symptoms did not improve.  The nurse practitioner on duty told the patient she was having a reaction to the RSV vaccine.  She was treated and released and reported the incident to the pharmacy on 9/5/2023.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Nausea
Clinical narrative: Patient describes one to one-and-a-half week of nausea and right arm numbness.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: Possible patient did not get fully vaccinated. Child suffered no side effects or symptoms
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Transient ischaemic attack
Clinical narrative: aphasia; TIA or mild stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY), in Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset Oct2021, outcome "unknown", described as "TIA or mild stroke"; APHASIA (non-serious), outcome "unknown". Clinical Course: Reporter was actually asking if pfizer boosters contain choline esters. He said that his wife had received the 2 pfizer vaccines, had not received any boosters. He would like to know whether any of the boosters or the new vaccine contains any choline esters. They were thinking of traveling to another state and if it turns out that they would been required have been current on their vaccinations, then either they were go to got his wife vaccinated with one of our boosters or present information about why she could not got one of those boosters. He added that his wife had the 1st 2 vaccines, had the last of the 2 vaccines in oct2021. And about 2 1/2 to 3 weeks later she had a TIA or mild stroke. They had not knew at the time he said. She had aphasia so she was having trouble finding the right words when she spoke, otherwise she was okay. They had not knew at the time but they knew that the vaccine contains the phosphocholine. His wife called the (name withheld) and asked them whether it was safe for her take it. They told her that it was such a minute quantity that other people who had problems tolerating choline esters had not had a problem with it. But other people were not his wife and said she was not gone to take the new formula. He was asking if the new formula was used for people who had the 1st 2 pfizer vaccines but no boosters, or what vaccine was offered to people who had the 1st 2 pfizer vaccines and not had the boosters.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 1.33
Sex: F
Vaccine: DTAP, FLU4, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh, around injection site it is red and swollen and it is hot to the touch.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: Was interrupted during reconstitution. Pt received only diluent. Was never mixed.
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Myalgia, Peripheral swelling
Clinical narrative: Pain and swelling in muscule of left arm roughly 1 month after injection lasting over a week with inability to move arm. this event has happened around the same time after each injection with the same amount of pain and lasted upwards of 2 weeks after each of the 3 doses
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 non-contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "known allergies: PCN (Penicillin)" (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 Aug2023, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: Rebound COVID/ SARS after negative test and resolved symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 29Aug2023 to 03Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely,Linked Report(s) : US-PFIZER INC-202300298495 Same patient, different drug/AE.;
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 56.0
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 57-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 10:00 as dose 3 (booster), single (Lot number: GJ3277) at the age of 56 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy: amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, 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 01Sep2023 to 05Sep2023 as treatment of COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300298951 same patient, different drug/event;
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 05Apr2021 at 14:30 as dose 1, single (Lot number: Ew0158), in left arm, on 10May2021 at 14:00 as dose 2, single (Lot number: Ew01262), in left arm and on 28Feb2022 at 14:30 as dose 3 (booster) single (Lot number: 011-476), in left arm for covid-19 immunisation. The patient's relevant medical history included: "BREAST CANCER DCIS HER2NEU+ ESTROGEN RECEPTORS" (unspecified if ongoing), notes: BREAST CANCER DCIS HER2NEU+ ESTROGEN RECEPTORS; "Animal allergy" (unspecified if ongoing), notes: Shrimp Crab Lobster. 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 06Sep2023 to 10Sep2023.
Age: 63.0
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) (Physician).  A 63-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19May2023 at 13:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 5 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "History of exercise-induced asthma" (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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The evening of 11Sep2020 I started to have recurrent URI symptoms, nasal congestion, cough and body aches. My last day of a 7-day course of Paxlovid was 4 days earlier.  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 available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 43.0
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) (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 10Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 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: "Recovery from Mastectomy" (unspecified if ongoing), notes: Other medical history:Recovery from mastectomy; "Skin necrosis" (unspecified if ongoing), notes: Other medical history: skin necrosis.; "Pre diabetic" (unspecified if ongoing), notes: Other medical history:Pre , diabetic. The patient's concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "Known Allergies: Percocet". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 38.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION, start date: Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got COVID; Got COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2 (BNT162B2), on 04Apr2021 at 16:00 as dose 1, single (Lot number: EW0151), in left arm, on 02May2021 at 16:00 as dose 2, single (Lot number: EW0167), in left arm, on 17Nov2021 at 21:00 as dose 3 (booster), single (Lot number: EJ1620), in left arm and on 21Apr2022 at 21:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin and other similar drugs, Reaction: Allergy" (unspecified if ongoing), notes: Penicillin and other similar drugs, Reaction: Allergy; "Penicillin and other similar drugs, Reaction: Allergy" (unspecified if ongoing); "Very light asthma" (unspecified if ongoing), notes: Very light asthma. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Aug2023, outcome "unknown" and all described as "Got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course details: The patient was treated with Paxlovid from 31Aug2023 to 04Sep2023 for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 13:00 as dose 5 (booster), single (Lot number: gj3277), in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: el9265), in right arm, on 18Feb2021 as dose 2, single (Lot number: en9581), on 19Nov2021 as dose 3 (booster), single (Lot number: fe3596) and on 15Jul2022 as dose 4 (booster), single (Lot number: fm0173), in right arm for covid-19 immunisation. The patient had no relevant medical history. No Known allergies. Concomitant medication(s) included: MULTI VITAMIN ELITE; CALCIUM CITRATE; CO Q10; BABY ASPIRIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment included Paxlovid from 01Sep2023 to 05Sep2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300299746 Same patient/drug, different dose/AE.;
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Rash
Clinical narrative: Rash all over the body; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 65-year-old male patient received pf-06928316 (ABRYSVO), on 30Aug2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (prolonged hospitalization) with onset 30Aug2023, outcome "unknown", described as "Rash all over the body". It was unknown if therapeutic measures were taken as a result of rash. AE resulted in Prolongation of existing hospitalization (treatment received during existing hospitalization).  The information on the batch/lot number for pf-06928316, pf-06928316 has been requested and will be submitted if and when received.; Sender's Comments: A possibly contributory role of pf-06928316 in triggering the onset of rash all over the body cannot be fully excluded, considering the temporal relationship.  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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Wrong product administered
Clinical narrative: delayed inflammatory reaction/still suffering from the inflammatory reaction in my face, it is 11 months later; Pfizer Biv vaccine/Dose Number: 1; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 1, single (Lot number: GJ6665) at the age of 59 years, in left arm for covid-19 immunisation; hyaluronic acid (HYALURONIC ACID), (Batch/Lot number: unknown) at unk (cosmetic filler). The patient didn't receive bnt162b2 (BNT162B2). The patient's relevant medical history included: "breast cancer", start date: 2015 (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: prior vaccination. Concomitant medication(s) included: FISH OIL; VITAMIN D NOS. Past drug history included: Oxycodone, reaction(s): "Known allergies: swelling from oxycodone"; Oxycodone, reaction(s): "Known allergies: swelling from oxycodone". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 17Oct2022, outcome "unknown", described as "Pfizer Biv vaccine/Dose Number: 1"; INFLAMMATION (medically significant) with onset 15Feb2023, outcome "not recovered", described as "delayed inflammatory reaction/still suffering from the inflammatory reaction in my face, it is 11 months later". The event "delayed inflammatory reaction/still suffering from the inflammatory reaction in my face, it is 11 months later" required physician office visit. The action taken for hyaluronic acid was unknown. Therapeutic measures were taken as a result of inflammation with off label use of lisinopril and Hylenex to dissolve.  Additional information: She had cosmetic filler containing hyaluronic acid four days after the bivalent (biv) vaccine and experienced delayed inflammatory reaction. She was still suffering from the inflammatory reaction in her face, it is 11 months later.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 23.0
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 24-year-old female patient received bnt162b2 (BNT162B2), on 01Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures included Paxlovid from 02Sep2023 to 06Sep2023 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: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose number unknown, single (Lot number: GH9697) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19".  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), on 07Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 07Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Severe adverse side effects from fillers on" (unspecified if ongoing), notes: Severe side effects from fillers on face after Pfizer CoVID Vaccine. Ongoing treatment; "swelling" (unspecified if ongoing), notes: more than 12+ near and around the filler injection sites all over my face; "hard lumps" (unspecified if ongoing), notes: hard lumps more than 12+ near and around the filler injection sites all over my face. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine"; Codeine, reaction(s): "nausea"; Vicodin, reaction(s): "known allergies: Vicodin"; Vicodin, reaction(s): "nausea". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300298514 same patient and reported; different vaccine dose number and event;
Age: 70.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 70 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 06Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 26Sep2021 as dose 3 (booster), single (Lot number: FF8839), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 01Sep2023 to 06Sep2023.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 5 (booster), single (Lot number: GJ6796) at the age of 71 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EM9809), on 11Mar2021 as dose 2, single (Lot number: EP6955), on 07Oct2021 as dose 3 (booster), single (Lot number: 30155BA) and on 13Jul2022 as dose 4 (booster), single (Lot number: FK9895) for covid-19 immunisation. The patient's relevant medical history included: "CVID Common Variable Immune Deficiency" (unspecified if ongoing); "Known allergies: Codene Products" (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". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 03Sep2023 to 07Sep2023.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment/ tested positive for COVID; COVID 19 Treatment/ tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pulmonary stenosis" (unspecified if ongoing); "ocular myasthenia gravis" (unspecified if ongoing); "1 kidney (congenital)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalosporins, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Aug2023, outcome "unknown" and all described as "COVID 19 Treatment/ tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Aug2023) positive, notes: tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 31Aug2023 to 05Sep2023.  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 available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective
Clinical narrative: COVID-19 and Pneumonia; COVID-19 and Pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), on 28May2021 as dose 1, single (Lot number: Ew0180) and on 21Jun2021 as dose 2, single (Lot number: Ew0181) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 PNEUMONIA (hospitalization, medically significant) all with onset Oct2021, outcome "unknown" and all described as "COVID-19 and Pneumonia". The patient was hospitalized for drug ineffective, covid-19 pneumonia (start date: 20Oct2021, discharge date: 24Oct2021, hospitalization duration: 5 day(s)). The patient was admitted on 20Oct2021 to the Hospital, where he was diagnosed with COVID-19 and Pneumonia and was discharged on 24Oct2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300269477 same patient/product, different dose number/event;US-PFIZER INC-PV202300155552 same patient/product, different dose number/event;
Age: 62.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Sep2022 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Severe Headache on 13Sep2023. This is the second time the patient had taken paxlovid. The first time was Apr2023 with the same side effect although at the time it was unknown if it was a Covid symptom or paxlovid symptom. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 6 (booster), single (Lot number: 8679), in left arm and on 28Apr2023 as dose 7 (booster), single (Lot number: gv3268) at the age of 69 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pre diabetes" (unspecified if ongoing); "left and right partial bundle branch blocks" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neproxin, reaction(s): "Drug Allergy: neproxin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 01Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraines, but not other chronic conditions" (unspecified if ongoing); "Known Allergy: Kiwi" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL, start date: 02Jan2006, stop date: 13Sep2023. Past drug history included: Ciprofloxacin, reaction(s): "Known Allergy: Ciprofloxacin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.