chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 10:00 as dose 1, single (Lot number: PAA165969), in left arm, on 06Apr2021 at 11:00 as dose 2, single (Lot number: ERE734), in left arm and on 24Dec2021 at 16:00 as dose 3 (booster), single (Lot number: FJ8757) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Some gastric reflux which is likely why it is worse at night." (unspecified if ongoing), notes: Some gastric reflux which is likely why it is worse at night.; "Known allergies: Yes, antibiotics" (unspecified if ongoing), notes: Known allergies: Yes, antibiotics. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: Paxlovid caused a foul taste in my mouth starting with the first dose. It is worse at night. The Nirmatrelvir pills seem to be the cause. Brother and Father also had same issue with this antiviral. Some muscle aches also experienced but were resolved with Ibuprofen. No other medication in 2 weeks.
Pt recvd vax & 2 wks p/vax exp a spinal cord infarct;
mild shingles outbreak 6-7 days following vaccine; This is a spontaneous report from a non-contactable consumer (patient herself). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9265) via an unspecified route of administration in the left arm on 05Feb2021 15:00 (03:00 PM) as the first dose, single for COVID-19 immunization at Workplace clinic. Medical history included Hashimotos disease, sulfa allergy and pineapple allergy; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was given to the patient in four weeks. The patient has not had COVID prior to vaccination and was not tested for COVID post vaccination. The patient was generally very healthy. The patient experienced mild shingles outbreak on an unspecified day on Feb2021 (reported to be six to seven days following vaccine). The patient have never had a shingles outbreak, nor have been sick in the last 4 years. The patient haven't needed any prescription medication in over 6 years until this shingles outbreak. The event resulted in physician or other healthcare professional office/clinic visit. Therapeutic measure, antiviral medication, was taken as a result of the event. The outcome was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Headache, Myalgia, Diarrhea, SORE ARM/STUFFY NOSE Narrative:
gave Boostrix instead of the Kinrix; gave a patient Boostrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9zk5t, expiry date 7th October 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Boostrix (intramuscular) .5 ml and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-Sep-2022 Reporter's comment: The nurse stated that patient was administered with Boostrix dose when he was intended to receive a Kinrix dose. The reporter consented to follow up. No HCP for follow up. Additional Supportive Information: The patient was given Boostrix instead of Kinrix at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration. The case US2022136487 was identified as duplicate of US2022136489. The case US2022136489 would be voided and all the future correspondence would be added in this case US2022136487 which stands as a case of record for this patient.
Information has been received from a health professional concerning a 24 month old white female with no known medical history or allergies who on 01/27/2005 at 09:30am was vaccinated subcutaneously in her left leg with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  Subsequently, the patient developed less than ten vesicular lesions on her abdomen.  No other symptoms were noted.  Unspecified medical attention was sought.  No laboratory diagnostic tests were performed.  There was no product quality complaint involved.  Follow up information from the health professional indicated that the morning of 02/10/2005 the patient developed 5 or 6 small red maculopapular lesions on her abdomen, some were vesicular.  The patient's mother stated that child was not ill.  On 02/12/2005 the patient recovered.  it was reported that neither the child nor her siblings experienced an adverse event following prior vaccination.  Additional information is not expected.
Pt at clinic for injection on 11-4-11 at 1200PM. Received call from pt. local provider that on 11-7-11 he was admitted to local hospital, with (R) upper arm cellulitis s/p flu shot on 11-4-11. Pt currently hospitalized.
Initial misuse report received from a healthcare professional on 26 February 2013. A Meningococcal vaccine that expired in 10.2012 was administered. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Rapid irregular heart beat, heart palpitations, fatigue, light headed, hard pounding heart
Lethargy within 24 hours of vaccine, holding chest, inconsolable crying. Within 4 days he broke out in petechiae rash all over legs, arms stomach, inside mouth and  back. Was brushing all over his body at the smallest touch.
Information has been received from a physician assistant concerning her daughter who on an unspecified date was vaccinated with a second dose of GARDASIL (lot number, injection site and route not reported). Three weeks after the vaccination, the patient experienced paralysis. The patient had to quit the volleyball team because her walking was effected. The patient underwent "a full work up" that was negative for any medical reason for the paralysis. Therapy with HPV was discontinued. The event was transient in nature and completely resolved in four weeks. It was reported that the patient completed the series of GARDASIL last year. Upon internal review, paralysis is considered to be an other important medical event. Additional information has been requested. 9/19/08 Reviewed PCP #2 medical records of 10/10/07-6/26/08. FINAL DX: viral syndrome & polyarthralgia Records reveal patient experienced morning joint pain & stiffness & swelling of hands & feet for approx 2 wks prior to 10/10/07 visit.  Had cold s/s prior to symptoms start.  Received HPV #2 on 3/21/08.  5/5/08 Had finger laceration w/nerve & tendon involvement & was referred to ortho/hand surgeon, required surgery.  Received HPV #3 on 5/22/08 but no Lot # provided.  Seen 6/26 for sore throat, nausea, malaise, fatigue, decreased appetite, body aches & fever x 1 day.  Tx w/ antibiotics for sinusitis & pharyngitis.
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 61-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 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 had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Aug2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: negative test; (08Aug2022) Positive, notes: Redeveloped COVID symptoms and tested positive for COVID 4 days after completing Paxlovid. 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.
general tiredness; transient Left arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Apr2021, outcome "recovered", described as "general tiredness"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered", described as "transient Left arm soreness". Therapeutic measures were not taken as a result of fatigue, pain in extremity. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 25-JUN-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N024562 and expiration date 06-MAR-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
Patient with  common variable immunodeficiency +  COVID - 19 pneumonia hospitalization s/p vaccination
Headache, UrticariaPruiritus, Palpitations, Reports of symptoms of itchy throat, tingling sensation over her lips after 30 mins of vaccination, and 9 hours later episode of palpitation, itching sensation, clammy skin and lymphnode enlargement at left side of her neck. Symptoms improved after taking Narrative:
Lips were swollen; Arm/injection site red/tender: W/in 8-12 hrs of injection.
The orange cap Pfizer (pediatric) vaccine was administered undiluted which resulted in patient receiving double the dose than intended. Patient was contacted and the only side effect the parent reported was high fever which was controlled by Tylenol. The patient had  fever for one day then it subsided.  No other side effects were reported.
On my right arm I started having a rash that was reddish orange streaks that almost looked like a burn. No pain.
Fever up to 103, Tylenol & Ibuprofen. Resolved within 24 hours. Redness & swelling at vaccine site.
chills; aches; nausea; fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  manufacturer unknown), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), 24 hrs after the suspect product(s) administration, outcome "unknown"; PAIN (non-serious), 24 hrs after the suspect product(s) administration, outcome "unknown", described as "aches"; NAUSEA (non-serious), 24 hrs after the suspect product(s) administration, outcome "unknown"; FATIGUE (non-serious), 24 hrs after the suspect product(s) administration, outcome "unknown".  Additional information: Patient received bivalent COVID vaccine. 24 hours later reports of chills, aches, nausea and fatigue. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Kidney stones; This is a spontaneous report from a contactable Nurse. A female patient of 35-year-old age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EL1284), first dose on right arm via an intramuscular route of administration on 27Dec2021 at unknown DOSE 1, SINGLE for COVID-19 immunization. She was not pregnant at time of vaccination. Medical history includes Asthma, allergies: Laundry detergent. Concomitant medications includes Multivitamin, fish oil, vitamin d, b12. The patient experienced Kidney stones. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent SARS-CoV-2 test and found negative. The outcome of Event was recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Nephrolithiasis and the administration of the vaccine cannot be excluded.. 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.,Linked Report(s) : US-PFIZER INC-202101089640 same reporter/patient/product, different dose/event.
Received Flu vaccine  U2178AA  exp 6/30/07, 4 hours later had generalized raised red rash. No itching, SOB etc. During same evening left hand and arm with increased swelling with slight redness, warmth at left deltoid inject site. Itching began 10/18/06 at 3:30pm Medicated with Benadryl PO 25mg now and 25mg at bedtime.
Patient is a 86 y.o. female patient of MD with history of CKD, COPD, lung cancer that presented to Hospital with shortness of breath. Pt found to have multifocal PNA from COVID. Pt gradually improved on decadron. Pt stable for discharge with meds and recommendations as noted below.      Covid-19 Virus Infection without sepsis Multifocal pneumonia Lactic acidemia POA, resolved CT angiogram was negative for pulmonary emboli.  Positive for multifocal pneumonia. Date of onset of symptoms: 1/13/2023 Symptoms present on admission: Shortness of breath and cough Date of covid positive test: 1/13/2023 Vaccination status: vaccinated Imaging: CT scan of the chest showed multifocal pneumonia.  Partial right pneumonectomy Oxygen requirements on admission: Room air Current oxygen requirements: Oxygen saturation 99% on 2 L nasal cannula Medical therapy: steroids Anticipated special isolation end date: 1/24/2023 Patient still complains of nonproductive cough Continue Decadron and Mucinex.   COPD, not in exacerbation Patient has a history of lung cancer and is status post partial right lung resection pneumonectomy Continue Symbicort  Chronic kidney disease stage III Hypokalemia Hypokalemia resolved  Hx of Orthostatic hypotension Blood pressures are elevated, discontinued the midodrine    Gastroesophageal reflux disease Continue PPI Hyperlipidemia Continue statin  Hypertension Continue losartan
Developed a small ball in the clavicle/ lymph node area; Pain in arm; Tired; Little bit of body pain; This is a spontaneous report received from a contactable consumer. A female patient of unspecified age (age was reported as aged 31) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration on 17Apr2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient developed a small ball in the clavicle/ lymph node area, pain in arm, tired and little bit of body pain. Seriousness of the event was reported as non-serious. The outcome of event the swollen lymph node was not recovered and other events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Increased blood pressure and heart rate.  Chills, sweating, shaking.  Patient called primary care physician who instructed him to take ibuprofen and rest.
Fever of 101+ from 6am next morning - switch between aspirin and Tylenol every 4 hours Fatigue - sleep
This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On 06-AUG-2015, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck), (dose and route of administration were not provided), (lot # L013545, expiration date 17-OCT-2016; lot # L019997, expiration date: 02-DEC-2016; lot # L011079, expiration date: 11-OCT-2016). No concomitant medications were reported. At the time of this report, no adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
sore arm; some slight fatigue; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 09Feb2021 14:30 (Lot Number: EL5318) as single dose for COVID-19 immunisation. The patient medical history included diabetes, atrial fibrillation (AFIB) of heart, high blood cholesterol, high blood pressure. Concomitant medications included metformin taken for diabetes; apixaban (ELIQUIS) taken for atrial fibrillation (AFIB) of heart; pravastatin taken for high blood cholesterol; glucosamine sulfate (MONTRA), lisinopril taken for high blood pressure. He had no other shorts-other than injections in his left eye for macular degeneration once per month on 26Jan2021 15:30. The patient previously received first dose of BNT162B2 on 22Jan2021 19:30 (lot EL3248) for COVID-19 immunization. The patient experienced sore arm and some slight fatigue on an unspecified date. He was tested for Covid 19 on 19Feb2021 before starting radiation for skin cancer on 22Feb2021. Covid-19 Test was negative. The outcome of event was unknown.    No follow-up attempts are needed. No further information is expected.
Labored breathing, weak, fast heart rate, dizziness lasting about 1 min at 9PM night after receiving shot. No treatment needed.
Horrendous cramps In her stomach; Constipation; total weakness in her legs; Chills; Nauseated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (Horrendous cramps In her stomach), CONSTIPATION (Constipation), MUSCULAR WEAKNESS (total weakness in her legs), CHILLS (Chills) and NAUSEA (Nauseated) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer, Drug allergy since an unknown date and Brain operation (Had undergone brain surgery twice). Concurrent medical conditions included Penicillin allergy and Iodine allergy.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Horrendous cramps In her stomach), CONSTIPATION (Constipation), MUSCULAR WEAKNESS (total weakness in her legs), CHILLS (Chills) and NAUSEA (Nauseated). At the time of the report, ABDOMINAL PAIN UPPER (Horrendous cramps In her stomach), CONSTIPATION (Constipation), MUSCULAR WEAKNESS (total weakness in her legs), CHILLS (Chills) and NAUSEA (Nauseated) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient reported her doctor thought she had UTI and put her on Keflex and laxatives. Patient reported stomach issues after first dose were not due to vaccine but Brussel sprouts.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19-Apr-2021. Second details were added.
pt recv vax 5AUG98 & macular rash covering trunk & also to lesser extent on extremities;pt also had nasal discharge & red tympanic membranes;
Patient felt dizziness and giddiness after the vaccine . Onsite EMS was called vitals were taken BP 122/91  96% O2 room air HR 101. Patient refused evaluation/care. Left aginst medical advice.