chrisvoncsefalvay/vaers-outcomes huggingface dataset:
have had a metallic taste since then, it has dissipated slightly; This is a spontaneous report from a contactable health care professional (patient).  A 37-year-old female patient received the first dose of BNT162B2 (also reported as Pfizer-BioNTech COVID-19 mRNA vaccine, lot no: EK5730, expiry date: 01Mar2021), intramuscular on the on the left deltoid on 17Dec2020 (reported as 'at about 12:40 PM') at 0.3 mL at a single dose for COVID-19 immunization and ipratropium bromide (manufacturer unknown, specified as non-Pfizer, lot no: 348501, expiry date: May2022), nasal from an unspecified date to an unspecified date, 2 sprays, in each nostril as needed for rhinitis.  Medical history included seasonal allergy for which the patient receives allergy injections regularly but have not received one recently or within the last 14 days and ongoing rhinitis.  Concomitant medication included fexofenadine hydrochloride (ALLEGRA) and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient stated that she was a healthcare worker and received the vaccine at her workplace. She called as she had a question about a very benign symptom that she was wondering if it's related to the vaccine or if it's something separate. She developed a metallic taste in her mouth about 2 hours after getting the vaccine, it's slowly dissipating but it's still there. She said no one else said  that they did have it and actually one other person who she works with said that they also had a slight thing (upon further clarification it was unspecified) but it's not in the list of expected symptoms so she just wanted to call and check. The patient did not receive any treatment for the event. She stated that she also used a nasal spray, Ipratropium Bromide Nasal Solution because she has rhinitis and she did use that and she never had a symptom or side effect with that because she uses it chronically but she did use that right before and noticed the taste develop so she doesn't know if there is a possible interaction between that and the vaccine. That morning she did 2 sprays in each nostril about 6 o'clock in the morning and then she did 2 sprays in each nostril about 2:15 PM and got her vaccine at about 12:40 PM that day. The patient got blood test for serology antibodies on 04Dec2020 with unknown results. The outcome of the event was recovering.
This spontaneous report has been received from  a physician via Pfizer(manufacturer # 2017242573). The physician heard of a patient/cousin of patient(gender unknown) who was vaccinated with a dose of GARDASIL and a dose of TRUMENBA at the same time on an unknown date. Subsequently, on an unknown date the patient developed Guillain-barre syndrome. The outcome of Guillain-barre syndrome was  unknown. Upon internal overview, the Guillain-barre syndrome was considered to be a medically significant event. Additional information has been requested.
Had 2 year old shots at health department went home gave Tylenol gave Motrin by 11:45 pm called pt MD said keep giving Tylenol or Motrin. We gave Tylenol fever all sapozateries 12 seconds later had her 1st seizure.  Called 911 transported pt to hospital, fever 103.7 by EMT's.
pt states that approx. one week after receiving the vaccine his left hand went numb and he has numbness throughout his arm.  His hand is also swollen.  Pharmacist advised that he see is PCP or go to the dr.  Pt stated he doesn't have a doctor and that he has never hand any medical issues or problems until he got the vaccine
No additional AE reported; During the evaluation the customer reported that the PNEUMOVAX 23 was administered to the patient after the excursion occured.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, past drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 09-MAR-2022, the patient was vaccinated with improperly stored and administered dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, (valid lot #U022819, expiration date: 14-JAN-2023) (strength, dose, frequency and route of administration were not reported) for prophylaxis.  The temperature was 0.1 Celsius degrees during 24 hours. Additionally, a previous temperature excursion was reported. No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA006587: US-009507513-2206USA007068: US-009507513-2206USA007098: US-009507513-2206USA007094:
Muscle jerks; Can't stand or sit up because of muscle jerks; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Muscle jerks), DYSSTASIA (Can't stand or sit up because of muscle jerks) and PYREXIA (Slight fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (Muscle jerks), DYSSTASIA (Can't stand or sit up because of muscle jerks) and PYREXIA (Slight fever). At the time of the report, MUSCLE TWITCHING (Muscle jerks), DYSSTASIA (Can't stand or sit up because of muscle jerks) and PYREXIA (Slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested
she had her first dose; she tested positive with COVID-19; This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority Support. This is a report from a contactable female consumer (patient herself). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: FC3182, Expiry Date: Unknown), via an unspecified route of administration on 08Sep2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 56 years). The patient medical history included depression, blood cholesterol, thyroid. Concomitant medications included Levothyroxine, 75mg taken for thyroid, Lamotrigine, 200mg taken for depression, Atorvastatin, 20mg taken for cholesterol.  The patient prior vaccination (within 4 weeks) information was not available. On 08Sep2021, the patient experienced she had her first dose, she tested positive with COVID-19. The patient underwent lab tests and procedures which included SARS-COV-2 test: COVID-19 positive on 08Sep2021. Therapeutic measures were taken as a result of the event include Steroids and Remdesivir. The seriousness of the event was serious and medically significant. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Information has been received from a RN concerning a healthy 20 yr old female who on 21Jul05 was vaccinated SC with a 0.5ml dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 648668/1069P). Concomitant therapy included hep A virus vaccine inactivated (+) hep B virus vaccine rHBsAg (yeast) (Twinrix). On 25Jul05 the pt developed photosensitivity, lymphadenopathy of neck, low grade fever, muscle aches, joint pain and headache. Unspecified medical attention was sought. At the time of the report, the pt's photosensitivity, lymphadenopathy of neck, low grade fever, muscle aches, joint pain and headache persisted. Additional information has been requested.
Expired vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial did not undergo any temperature excursions.  No treatment medication was reported.
administered with vaccine which was beyond the use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter stated that the beyond the use date is 09Dec2021 at 10:00PM.
VACCINES WERE OUTSIDE THE RECOMMENDED STORED TEMPERATURE; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-JUN-2021, the subject experienced vaccines were outside the recommended stored temperature. On 17-JUN-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccines were outside the recommended stored temperature and poor quality vaccine administered was not reported. This report was non-serious.
Narrative:  76yo male patient in home care (palliative care) died at home on 12/6/2021. Pt was on home IV ABX - TOBRAMYCIN INJ,SOLN INJECT 180 MG INTRAVENOUS EVERY 24 HOURS Has been receiving daily at 1100 in hospital (outside hospital) END DATE: 12/14/21 but pt died at home prior to completion of therapy on 12/6/21. No other details known regarding patient's death. Pt had covid vaccines on 2/26/21 & 3/26/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
low fever with temperature around 99; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low fever with temperature around 99) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (low fever with temperature around 99). At the time of the report, PYREXIA (low fever with temperature around 99) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 f Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided by reporter. She was scheduled to receive her 2nd dose of vaccine on 31st March.
rash around injection site; Arm sore; itchy; breaking out with red spots around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), PRURITUS (itchy), VACCINATION SITE ERYTHEMA (breaking out with red spots around injection site) and VACCINATION SITE RASH (rash around injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (breaking out with red spots around injection site). On an unknown date, the patient experienced VACCINATION SITE RASH (rash around injection site). At the time of the report, PAIN IN EXTREMITY (Arm sore), PRURITUS (itchy), VACCINATION SITE ERYTHEMA (breaking out with red spots around injection site) and VACCINATION SITE RASH (rash around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported.  Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: significant Follow-up: event injection site rash added
This spontaneous report was received from an attorney and refers to currently 62 years old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided. On an unknown date in April 2016, the patient was vaccinated by the pharmacist with ZOSTAVAX injection (dose, route of administration, anatomical location, lot# and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced herpes zoster, which was treated by a healthcare provider. The patient claimed damages as a result of: injury to themselves; loss of consortium, loss of services and economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; punitive damages. The outcome of the events was unknown. The reporter considered herpes zoster to be related to ZOSTAVAX. The relatedness between the product quality issue and ZOSTAVAX was not provided.
Swelling, itching, SOB, hives, swelling of face and puffy eyes.
Pt. states that after receiving the 2nd dose of Phizer 02/27/2021, started experiencing symptoms 03/2021 of rash developing on the left arm eventually moving to the right arm area. 3 months post vaccination rash has developed throughout the body. Primary visit 04/2021 Blood Work preformed, with recommendations for Follow-up with Dermatologist. Dermatologist visit 04/2021. 05/2021 Emergency Room  visit referral to Follow-Up with on-site Dermatologist, preformed Biopsy with Diagnosed = soria spongiotic dermatitis. Pt. still experiencing symptoms.
Redness/heat in face and hands. Painful to the touch. Hard to use hands. Face still red in color.   Constant pain in joints. Mild chest pains.   Took ibuprofen  every 6 hours and kept ice packs on hands.
Arm pain, nausia, vomiting, fatigue and slept for 18 hours straight.
4pm. Headaches, chills, low fever, joint pains, muscle pains, weakness, dizziness, diarrhea, swollen glands, thirst
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 80-year-old patient received BNT162b2 (BNT162B2), as dose 4 (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; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (First booster dose, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "recovering", described as "felt very tired". Additional information: Reporter stated that his son and he, both received our second Pfizer Booster (COVID-19 Vaccine) so number 4th shot almost 2 weeks ago now and just we little bit felt tired couple of days 2-3 days with it. Then they felt better and but now we felt very tired again. Is that something that you have heard people, report or what because he understood that the side effects can be off and on" No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
18 month old got Pentacel, including the polio, that was not due with no reported adverse event; Initial information  was received on 04-May-2022 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 18 months old female patient who got pentacel, including the polio, that was not due with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included:  Pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 03-May-2022, the patient received 4th dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [pentacel] 0.5 ml  (Batch number: U6971AA, expiration date: 11-Sep-2022) via intramuscular route in the left thigh for prophylactic vaccination.  On 03-May-2022 the patient got pentacel, including the polio, that was not due with no reported adverse event (wrong product administered) (latency: on the same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [pentacel].  Action taken: Not applicable. Corrective treatment: Not reported. Outcome:  Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Dose 1 had only very mild symptoms (mild fever (99 F); Dose 1 had only very mild symptoms (injection site soreness day after); This is a spontaneous report from a non-contactable consumer (patient himself). A 60-years-old male patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 06Mar2021 at 01:15 (at the age of 60-years-old) as single dose for covid-19 immunisation. Medical history included moderate hypertension. Patient had no known allergies. The patient's concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior vaccination. Patient was not tested for covid post vaccination. Patient reported that he experienced only very mild symptoms of injection site soreness day after and mild fever (99 F) 4 days after dose 1. All the dose 1 symptoms resolved on their own without treatment. The patient underwent lab tests and procedures which included body temperature which was 99 fahrenheit. The outcome of the events was recovered on unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Swelling under arm, when I woke up Friday I noticed under my arm is pretty painful , I can feel what I would describe as a lump right in my armpit. Just started Friday . I am going to see how it is over the weekend.
c/o fever & chills x 1wk p/vax 6OCT98;pt thought had the flu;same sx again p/dose 2, APAP taken w/little relief;suggested advil;advised not to recv #3 hep b;
RA flare; mental fogginess; extreme fatigue; increased blood sugars; joint pains; increased depression; generalized weakness; the worst migraine in over 25 years; This is a spontaneous report from a contactable other health professional (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Jul2021 10:30 (Lot Number: EW0179; at the age of 49-years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included rheumatoid arthritis (RA), hypothyroidism, allergies, and migraine. Concomitant medications were not specified. The patient previously took etanercept (ENBREL) and ibuprofen (MOTRIN) for migraine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 14Jul2021, the patient experienced RA flare, extreme fatigue, increased blood sugars, joint pains, increased depression, mental fogginess, generalized weakness, and the worst migraine in over 25 years. It was reported that patient have not had a migraine in 20 years that was untreatable with Motrin (for clarification) and thought this was after not having Enbrel for weeks prior to COVID vaccination. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available.   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 RAs, Ethics Committees, and investigators, as appropriate.
Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). In September 2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-338604 (Patient Link).
Fever > 102 x 5-7 days irritability, rhinorrhea same sx after 2 month and 4 month shots.