chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Unresponsive to stimuli
Clinical narrative: Weakness, unable to move, Nauseous, unresponsive, sweaty, hot, no fever, felt dehydrated.  Similar to an Addisonian Crisis.  Lasted about an hour.  Took an extra Cortef, drank water and diet coke, rested.  Then ate bowl of soup.  Same thing happened after 1st vaccine, but 7 days later.  Didn't realize it was from the vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site hypersensitivity
Clinical narrative: Allergic reaction to site. Red / Bruised and 3 side to side dots.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Loss of personal independence in daily activities
Clinical narrative: lost the ability to function as a 22 year old, work, walk, comprehend and losing daily/ can't pay his own bills, he can't live on his own at times can't even show or go to the bathroom without help; lost the ability to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 22-year-old male patient received BNT162b2 (BNT162B2), 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: Covid-19 immunization (Dose 1, Manufacturer Unknown), for COVID-19 IMMUNIZATION. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "lost the ability to function as a 22 year old, work, walk, comprehend and losing daily/ can't pay his own bills, he can't live on his own at times can't even show or go to the bathroom without help"; GAIT INABILITY (non-serious), outcome "unknown", described as "lost the ability to walk".  Additional information: Reporter have a 24-year-old son who at 22, within 2 weeks of 2nd shot has lost the ability to function as a 22-year-old, work, walk, comprehend and losing daily, the want or will to stay and fight, He can't pay his own bills, he can't live on his own at times can't even show or go to the bathroom without help. Stop ignoring the facts and the evidence. How much longer until your company finds a cure for the Vaccine injured, or even acknowledges the damage that has been done, and starts working on fixing the damage. Fix the vaccine issue, and STOP worrying about the common cold (COVID) that we know have enough evidence of. Please help my son and all the Other people that are still suffering, We cant help the ones who have already passed, Sudden heart issues, you can help the one alive and suffering.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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 had no known allergies. The patient's relevant medical history included: "Bicuspid aortic valve" (unspecified if ongoing); "Hypertension" (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". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  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: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dysgeusia, Oral discharge
Clinical narrative: Sour/Salty/Bitter taste and/or drainage in right side of mouth. It is constant over 24 hours never leaves. Note received Flu shot on same day at same location but they were approx. 1 hour apart.
Age: 45.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: COVID-19, Chest discomfort, Chest pain, Cough, Ear discomfort
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 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 14:30 as dose 4 (booster) single (Lot number: GH9694) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 16Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 25Oct2021 at 16:45 as dose 3 (booster) single (Lot number: FF2590), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sinusitis" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Allergy-related asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergy:Codeine"; Phenlyephrine, reaction(s): "Allergy:Phenlyephrine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. including Paxlovid on 18Nov2022 to 22Nov2022.
Age: 45.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Eye pruritus, Nasal congestion, Nasopharyngitis, Nausea, Oropharyngeal pain
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 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 14:30 as dose 4 (booster) single (Lot number: GH9694) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 16Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 25Oct2021 at 16:45 as dose 3 (booster) single (Lot number: FF2590), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sinusitis" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Allergy-related asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergy:Codeine"; Phenlyephrine, reaction(s): "Allergy:Phenlyephrine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. including Paxlovid on 18Nov2022 to 22Nov2022.
Age: 45.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Sinus pain, Sputum discoloured, Throat irritation
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 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 14:30 as dose 4 (booster) single (Lot number: GH9694) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 16Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 25Oct2021 at 16:45 as dose 3 (booster) single (Lot number: FF2590), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sinusitis" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Allergy-related asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergy:Codeine"; Phenlyephrine, reaction(s): "Allergy:Phenlyephrine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. including Paxlovid on 18Nov2022 to 22Nov2022.
Age: 45.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: COVID-19, 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 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 14:30 as dose 4 (booster) single (Lot number: GH9694) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 16Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 25Oct2021 at 16:45 as dose 3 (booster) single (Lot number: FF2590), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sinusitis" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Allergy-related asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergy:Codeine"; Phenlyephrine, reaction(s): "Allergy:Phenlyephrine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. including Paxlovid on 18Nov2022 to 22Nov2022.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Onset of severe hives rash occurred 4 days after shot on 18Jul2022. Medical treatments have been administered until the present time.; dose dose number=1, administration date=04Nov2021; dose dose number=2, administration date=14Jul2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jul2022 at 14:00 as dose 2, single (Lot number: FN2903) at the age of 85 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "prediabetes" (unspecified if ongoing); "right bundle block of heart" (unspecified if ongoing), notes: right bundle block of heart; "mild hypertension" (unspecified if ongoing); "Latex" (unspecified if ongoing), notes: known allergies Latex; "known allergies Black Pepper" (unspecified if ongoing), notes: known allergies Black Pepper,; "known allergies shrimp" (unspecified if ongoing), notes: known allergies shrimp. Concomitant medication(s) included: SIMVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; BISOPROLOL. Past drug history included: Cortisone, reaction(s): "known allergies Cortisone", notes: known allergies Cortisone. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: 330268D, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 04Nov2021, when the patient was 84-year-old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Jul2022, outcome "unknown", described as "dose dose number=1, administration date=04Nov2021; dose dose number=2, administration date=14Jul2022"; URTICARIA (non-serious) with onset 18Jul2022 at 12:30, outcome "recovering", described as "Onset of severe hives rash occurred 4 days after shot on 18Jul2022. Medical treatments have been administered until the present time.". The event "onset of severe hives rash occurred 4 days after shot on 18jul2022. medical treatments have been administered until the present time." required physician office visit and emergency room visit. Therapeutic measures were taken as a result of urticaria.  Additional information: It was reported that no other vaccine in four weeks. other medications in two weeks as Simvastatin Aspirin 81mg Bisoprolol 10mg. Onset of severe hives rash occurred 4 days after shot on 18Jul2022. Medical treatments have been administered until the present time. AE treatment with Prednisone, Elavil, Claritin, Allegra, Montelukast. No covid prior vaccination. Covid tested post vaccination Nasal Swab. Sender's Comments: Linked Report(s) :PFIZER INC-202300044092 same patient/drug, different dose/event;
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Urticaria
Clinical narrative: Onset of severe hives rash occurred 4 days after shot on 18Jul2022. Medical treatments have been administered until the present time.; dose dose number=1, administration date=04Nov2021; dose dose number=2, administration date=14Jul2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jul2022 at 14:00 as dose 2, single (Lot number: FN2903) at the age of 85 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "prediabetes" (unspecified if ongoing); "right bundle block of heart" (unspecified if ongoing), notes: right bundle block of heart; "mild hypertension" (unspecified if ongoing); "Latex" (unspecified if ongoing), notes: known allergies Latex; "known allergies Black Pepper" (unspecified if ongoing), notes: known allergies Black Pepper,; "known allergies shrimp" (unspecified if ongoing), notes: known allergies shrimp. Concomitant medication(s) included: SIMVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; BISOPROLOL. Past drug history included: Cortisone, reaction(s): "known allergies Cortisone", notes: known allergies Cortisone. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: 330268D, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 04Nov2021, when the patient was 84-year-old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Jul2022, outcome "unknown", described as "dose dose number=1, administration date=04Nov2021; dose dose number=2, administration date=14Jul2022"; URTICARIA (non-serious) with onset 18Jul2022 at 12:30, outcome "recovering", described as "Onset of severe hives rash occurred 4 days after shot on 18Jul2022. Medical treatments have been administered until the present time.". The event "onset of severe hives rash occurred 4 days after shot on 18jul2022. medical treatments have been administered until the present time." required physician office visit and emergency room visit. Therapeutic measures were taken as a result of urticaria.  Additional information: It was reported that no other vaccine in four weeks. other medications in two weeks as Simvastatin Aspirin 81mg Bisoprolol 10mg. Onset of severe hives rash occurred 4 days after shot on 18Jul2022. Medical treatments have been administered until the present time. AE treatment with Prednisone, Elavil, Claritin, Allegra, Montelukast. No covid prior vaccination. Covid tested post vaccination Nasal Swab. Sender's Comments: Linked Report(s) :PFIZER INC-202300044092 same patient/drug, different dose/event;
Sex: M
Vaccine: HPV4
Symptoms: Food allergy
Clinical narrative: allergic to peanuts; This spontaneous report was received from a consumer, physician and via a company representative and refers to a male patient of unknown age.  The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection,administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  The reporter stated that the patient became severely allergic to peanuts (food allergy) six months after receiving the vaccine. Their mother had indicated that her son had never had these allergies before receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The causal relationship between food allergy and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.  This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2301USA006450:
Age: 0.17
Sex: U
Vaccine: HPV9, PNC
Symptoms: No adverse event, Product appearance confusion, Wrong product administered
Clinical narrative: No additional AE; The HCP states that the products have similar dark colored syringes and were stored close together; The HCP reports that a 2 month old patient was administered GARDASIL 9 instead of; The spontaneous report has been received from a physician, concerning a 2-month-old patient with unknown gender. The patient's medical history, historical drugs, concurrent conditions, drug reaction/allergies and concomitant drugs were not reported.  On 27-JAN-2023, the patient was vaccinated with the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (0.5 milliliter (ml), lot number W027455 has been verified to be a valid lot number, expiration date was reported as 04-JAN-2025, anatomical location was not provided) intramuscularly for prophylaxis instead of pneumococcal vaccine conj 7v (crm197) (PREVNAR) (wrong product administered). The products had similar dark colored syringes and were stored close together (product appearance confusion). No additional adverse event (AE) details were provided (no adverse event).
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Temperature excursion 47.9 degrees Farenheit; This spontaneous report has been received from a office manager, regarding a 1-years-old female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 15-DEC-2022, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (PROQUAD) oral liquid orally as prophylaxis (lot number: 1892784, which was determined to be valid, with an expiration date on 03-DEC-2023) (product storage error).  On 01-DEC-2022, the administered dose underwent a temperature excursion of 47.9 degrees Fahrenheit (F) (storage in clinical practice) for 47 minutes. Data logger was involved. The operator of the vaccine was a healthcare professional, and the vaccine was used according to the instruction leaflet. No adverse event was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingle shot, ended up with shingles/suspected Vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 31-JAN-2023 Reporter comment: This case was reported by a patient via interactive digital media. The reporter reported that, the patient got the shingle shot and ended up with shingles. The follow-up could not be possible as no contact details were available. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose, not sure if received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date in 2021,  2 years before date of reporting.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-JAN-2023 Reporter's Comments: The pharmacist stated a patient received the first dose of Shingrix 2 years ago.  She stated that she was not sure if the patient might had received the 2nd dose elsewhere but could not find it documented in the database. She stated that she was getting this question more.  She did not report any other patients who were late with the 2nd dose. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023014272:same reporter
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 09JAN2023, 2nd on 30JAN2023; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 5L3HB, expiry date 20th May 2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 30th January 2023, the patient received the 2nd dose of Shingrix. On 30th January 2023, unknown after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: Pharmacist administered to a female adult a Shingrix second dose earlier than recommended by GSK. First dose was on 9th January 2023 and second dose was administered on 30th January 2023. He did not have any information about his HCP. The reporter consented to follow-up via email. HCP´S details are shared on this report Additional Supportive Information: the patient received 2nd dose on 30th January 2023, earlier than recommended schedule, which led to shortening of vaccination schedule.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD.) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD.).    No concomitant medicine were reported. A dose of Moderna COVID-19 vaccine, Bivalent vaccine was given 2 days beyond BUD. No treatment medicine were reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash not all over the body just on the site of injection; redness on site of injection and itchiness; redness on site of injection and itchiness; arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 84 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Jan2023, outcome "recovered" (27Jan2023), described as "arm pain"; VACCINATION SITE RASH (non-serious) with onset 26Jan2023, outcome "not recovered", described as "rash not all over the body just on the site of injection"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 26Jan2023, outcome "not recovered" and all described as "redness on site of injection and itchiness".  Additional information: Caller was a patient. Caller stated that she received Pfizer covid-19 vaccine yesterday and now experiencing rash, itchiness and arm pain. Caller wanted to know if these were normal. Caller clarified that rash was not all over the body but  just on the site of injection, no pain in her arm 4 hours after (maybe after receiving the vaccine), redness on site of injection and itchiness. Consumer stated that she just have a question about the side effect on the fourth one. The fourth Pfizer vaccine for covid. She got the shot yesterday at (Withheld). That is where they got to tell her to go with the Pfizer one and they did not tell her anything about side effects. After a few hours, little pain in her arm that was gone this morning, but she did have like a rash that itches. Caller was querying if that was normal.  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: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fear of death, Myalgia, Pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 53-year-old male patient received BNT162b2 (BNT162B2), on 05Sep2021 at 14:00 as dose 2, single (Lot number: ff2588) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN; DIAZEPAM; AMITRIPTYLIN. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: fc3180, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 15Aug2021, when the patient was 51-year-old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Sep2021, outcome "not recovered", described as "After My shot my arms were sore"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 10Sep2021, outcome "not recovered" and all described as "Also, Now my muscles and joints hurt body wide but mostly in joints of upper body"; ASTHENIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "My physical nature is diminished, lack of energy and ability"; POST-TRAUMATIC STRESS DISORDER (non-serious), FEAR OF DEATH (non-serious) all with onset 10Sep2021, outcome "not recovered" and all described as "PTSD also due to fear of death from shot"; PAIN (non-serious) with onset 10Sep2021, outcome "not recovered", described as "The next few weeks they went from sore to ache. This has never changed. I had no ache in arms prior to shots". The events "after my shot my arms were sore", "the next few weeks they went from sore to ache. this has never changed. i had no ache in arms prior to shots", "also, now my muscles and joints hurt body wide but mostly in joints of upper body", "my physical nature is diminished, lack of energy and ability" and "ptsd also due to fear of death from shot" required physician office visit. It was unknown if therapeutic measures were taken as a result of pain in extremity, pain, arthralgia, myalgia, asthenia, post-traumatic stress disorder, fear of death. Additional information: After patient's shot his arms were sore. The next few weeks they went from sore to ache. This had never changed. He had no ache in arms prior to shots. Also, now his muscles and joints hurt body wide but mostly in joints of upper body. This was reported to (Name withheld) doctor in Oct2021. His physical nature was diminished, lack of energy and ability. PTSD also due to fear of death from shot and fear from government for reporting issues from shot given that all patients were forced to have shot or no benefits. Other vaccine in four weeks were unknown. No covid prior vaccination. No covid tested post vaccination. Other medical history: Nothing related to the joint damage incurred after shot.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Post-traumatic stress disorder
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 53-year-old male patient received BNT162b2 (BNT162B2), on 05Sep2021 at 14:00 as dose 2, single (Lot number: ff2588) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN; DIAZEPAM; AMITRIPTYLIN. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: fc3180, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 15Aug2021, when the patient was 51-year-old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Sep2021, outcome "not recovered", described as "After My shot my arms were sore"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 10Sep2021, outcome "not recovered" and all described as "Also, Now my muscles and joints hurt body wide but mostly in joints of upper body"; ASTHENIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "My physical nature is diminished, lack of energy and ability"; POST-TRAUMATIC STRESS DISORDER (non-serious), FEAR OF DEATH (non-serious) all with onset 10Sep2021, outcome "not recovered" and all described as "PTSD also due to fear of death from shot"; PAIN (non-serious) with onset 10Sep2021, outcome "not recovered", described as "The next few weeks they went from sore to ache. This has never changed. I had no ache in arms prior to shots". The events "after my shot my arms were sore", "the next few weeks they went from sore to ache. this has never changed. i had no ache in arms prior to shots", "also, now my muscles and joints hurt body wide but mostly in joints of upper body", "my physical nature is diminished, lack of energy and ability" and "ptsd also due to fear of death from shot" required physician office visit. It was unknown if therapeutic measures were taken as a result of pain in extremity, pain, arthralgia, myalgia, asthenia, post-traumatic stress disorder, fear of death. Additional information: After patient's shot his arms were sore. The next few weeks they went from sore to ache. This had never changed. He had no ache in arms prior to shots. Also, now his muscles and joints hurt body wide but mostly in joints of upper body. This was reported to (Name withheld) doctor in Oct2021. His physical nature was diminished, lack of energy and ability. PTSD also due to fear of death from shot and fear from government for reporting issues from shot given that all patients were forced to have shot or no benefits. Other vaccine in four weeks were unknown. No covid prior vaccination. No covid tested post vaccination. Other medical history: Nothing related to the joint damage incurred after shot.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Mental disorder
Clinical narrative: exacerbation of joint pain; arthritis; mental health issues; 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 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "exacerbation of joint pain"; ARTHRITIS (non-serious), outcome "unknown"; MENTAL DISORDER (non-serious), outcome "unknown", described as "mental health issues".  Additional information: She knows a woman who has had an exacerbation of joint pain who had a medical condition like arthritis and also had mental health issues, and they don't know if these issues are from taking the Pfizer Covid vaccine or because she had Covid. Call provides feedback that Pfizer should make a medication to treat long Covid syndrome. Caller stated that there should be TV advertisements that list all the potential side effects for the vaccines.  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: Anxiety
Clinical narrative: she cannot get over the anxiety; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "she cannot get over the anxiety".  Additional information: Patient spoked with someone the other day and they were not really giving her information at all. She statet it "was super frustrating" and is requesting to speak with someone else at this time. She said she had a "useless conversation" with someone in medical information who was a pharmacist. Caller states she is "Trying to figure out what is going on and is this vaccine dangerous enquired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Tremor
Clinical narrative: trembling in my chest area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 2, single (Lot number: ENG201) at the age of 75 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Percodan, reaction(s): "known allergies: Opiods (percodan,etc)"; Aspirin, reaction(s): "known allergies: aspirin". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: e11283, Location of injection: Arm Right), administration date: 21Jan2021, when the patient was 75-year-old, for COVID-19 immunization. The following information was reported: TREMOR (non-serious) with onset 14Feb2021, outcome "recovered with sequelae", described as "trembling in my chest area". The event "trembling in my chest area" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tremor.  Additional information: Three days after, trembling in her chest area that didn't go away. Went to the doctor at the time Dr. [Name withheld], who did an EKG that was normal. He could "feel" the tremor. He said he contacted Pfizer and if it didn't go away in 3 weeks, she should come back to him. She still have it from time to time but have moved to another State. He told her not to get any more vaccinations. Her current doctor agrees. No other vaccine in four weeks. No other medication in two weeks. No covid Prior vaccination. No covid tested post vaccination.
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2023) Positive, notes: Rebound of COVID symptoms and test positive 48 hours. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received vaccine. Patient took no any Other medication in 2weeks. Lot no was unknown due to not available provided to reporter at the time of report completion vaccine. Paxlovid Product: COVID 19 Treatment start: date: 19Jan2023, Treatment: stop: date: 24Jan2023 Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received covid-19 treatment with Anti-viral Product Paxlovid from 08Jan2023 till 22Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; 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 52-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) 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), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19.  Clinical course: There was no other medication in 2 weeks. Patient took COVID 19 Treatment from 19Jan2023 to 24Jan2023  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Dizziness, Gait disturbance, Visual impairment
Clinical narrative: Extreme dizziness to the point of not being able to walk unattended. Double vision, left eye not able to look straight ahead.; Extreme dizziness to the point of not being able to walk unattended. Double vision, left eye not able to look straight ahead.; not being able to walk unattended; Double vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Sep2021 as dose 2, single (Lot number: FF2588), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA taken for rheumatoid arthritis. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FC3181, Location of injection: Arm Left), administration date: 16Aug2021, for COVID-19 immunization. The following information was reported: DIPLOPIA (hospitalization) with onset 19Sep2021, outcome "recovered with sequelae", described as "Double vision"; DIZZINESS (hospitalization), VISUAL IMPAIRMENT (hospitalization) all with onset 19Sep2021, outcome "recovered with sequelae" and all described as "Extreme dizziness to the point of not being able to walk unattended. Double vision, left eye not able to look straight ahead."; GAIT DISTURBANCE (hospitalization) with onset 19Sep2021, outcome "recovered with sequelae", described as "not being able to walk unattended". The patient was hospitalized for dizziness, visual impairment, gait disturbance, diplopia (hospitalization duration: 10 day(s)). Therapeutic measures were taken as a result of dizziness, visual impairment, gait disturbance, diplopia.  Clinical Course: Patient administered other vaccine same date vaccine date i.e 08Sep2021. No other vaccine in four weeks. Other medications in two weeks were Humira for Rheumatoid Arthritis. AE had treatment. 5 infusions of steroids after 2nd hospitalization. No COVID prior to vaccination. COVID dose not tested post vaccination. patient had no Known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia
Clinical narrative: my wife has gotten mRNA 2 Pfizer vaccinations; she has gone dumb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE, my wife has gotten mRNA 2 Pfizer vaccinations), for COVID-19 Immunization. The following information was reported: APHASIA (non-serious), outcome "unknown", described as "my wife has gotten mRNA 2 Pfizer vaccinations; she has gone dumb".  Additional information: Reporter stated, since my wife has gotten mRNA 2 Pfizer vaccinations (Clarified as Pfizer COVID-19 Vaccination), she has gone dumb and I need some sort of explanation or at least a report from you guys that compensates me at least one 'green euro camouflage blue' as compensation. Can you help me out?". When paraphrased the concern, Reporter stated, "She has gotten dumb."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
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 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 3 (booster), single (Lot number: Gh9094) at the age of 61 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Oct2021 as dose 2, single (Lot number: Paa165969), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid treatment on 19Jan2023 to 24Jan2023.
Age: 42.0
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) (Nurse). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 16:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 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: "Hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing); "severe obesity" (unspecified if ongoing); "Iga" (unspecified if ongoing); "nephropathy" (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". 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.  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 in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.