chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Back pain-started Naproxen; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain-started Naproxen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included NAPROXEN SODIUM for Back pain.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced BACK PAIN (Back pain-started Naproxen). On 05-Mar-2021, BACK PAIN (Back pain-started Naproxen) had resolved.            Treatment details included None.    Reporter did not allow further contact
This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age and gender. On an unknown dates between 05-JAN-2016 and 15-JAN-2016, the patients were vaccinated with incorrectly stored doses of GARDASIL 9 (dose, frequency, route of administration and indication were not reported, lot # L019291, expiration date 18-AUG-201; L020015, expiration date 16-AUG-2017). This is one of several reports received from the same reporter. Additional information has been requested.
Had an allergic reaction closing of throat , chills , very cold , co;or changing , panic attack , and more I was in state of shock
Anything I eat / drink taste like I'm chewing on aluminum foil / metallic aftertaste; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er873cl) via an unspecified route of administration in the left arm on 31Mar2021 at 17:30 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergy with sulfa drug (BACTRIM). The patient received an unspecified prescribed medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 22:00, about 4 hours after receiving dose, anything the patient ate/ drank tasted like she was chewing on aluminum foil / metallic aftertaste. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event. The clinical outcome of the event metallic taste was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Dose given was 0.25 ml but should have been 0.5 ml as third dose as she is immuno-compromised and then a 4th dose 5 months later.  The third dose should have been given one month after the second dose so third dose also delayed.
erythema multiforme; developed a rash; This case was reported by a nurse via call center representative and described the occurrence of erythema multiforme in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 26th August 2020, unknown after receiving Shingrix, the patient experienced erythema multiforme (serious criteria GSK medically significant) and rash. On an unknown date, the outcome of the erythema multiforme was not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the erythema multiforme and rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient developed a rash, erythema multiforme after getting a Shingrix shot. The reporter was uncertain about vaccination date of Shingrix. The reporter consented to follow up.
Pruritic macular rash on all extremities; resolved with Benadryl over 3 days.
Swollen left armpit; Feeling of tenderness and pain; Feeling of tenderness and pain; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 21May2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24May2021, the patient had swollen left armpit, it was more the feeling of tenderness and pain, not "that" swollen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen left armpit and feeling of tenderness and pain was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient states she came down with shingles, nerve pain in back, was treated with Valtrex and gabapentin 6 days after immunization.
several hours after the shot i got very tired / sleepy. had to sleep. slept until the next day. had a fever that lasted  . had general body achiness. chills and teeth chattering. bundled up in layers and got under a blanket..had to simply lie still and sleep, drink , eat crackers. when i checked my fever it was above 100. at other times i believe i had a fever but it was lower. had a short pronounced episode of nausea while walking around the next day after eating a piece of chocolate. had to lie down pronto. so then decided to stay horizontal as much as possible. rest/sleep  and being horizontal/still  were necessary. i also had loose stool but not a big deal.that may or may not have been related to vax. also for context my menstrual cycle had started the morning of april 21st.
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:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 02-SEP-2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a health department, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2012, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 34 year old white Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to sulfa, rash, and fever. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 30-APR-2021, the patient had confirmed immunological vaccine failure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Negative, which was done after 5 weeks of vaccination. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with PQC number 90000178455.; Sender's Comments: V0:20210503229-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Painful joints, redness and soreness at injection point, difficulty, in getting up from chair/bed, loss of appetite, unsteadiness on my feet. Went to bed, experienced chills, extremely cold feet, restless sleep.  Took Tylenol at bedtime. Symptoms gone today.
Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: ER8727) at the age of 64 years as dose 1, single and administered in arm left, administration date 12Apr2021 (Lot number: EW0153) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Blood Pressure high" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Coedine, reaction(s): "Known_allergies: Coedine"; Pyridium, reaction(s): "Known_allergies: Pyridium"; Sulfur, reaction(s): "Known_allergies: Sulfur". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sore arm".  Additional information:  The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  There had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. Were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On unspecified dates the patients were vaccinated with improperly stored ZOSTAVAX lot # L006382, expiration date 25-MAY-2016 (dose and route of administration not provided). No concomitant therapies were reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of two reports from the same reporter. Additional information has been requested.
I experienced severe headaches at the time of first injection. I continued to experience severe headaches and about 5-6 months after receiving my third shot 07/31/00 I began to experience joint pains, most notably in mid-upper back and neck region.  I also experienced pain in my shoulders.  I continued to have these pains in my joints and headaches and still do to this day.
Patient had migratory pains the night after the vaccination. He died within 24 hours of unknown cause, unknown if related to vaccine.
booster.; mild headache; sore arm; developed irregular spotting; Periods have stopped; This is a spontaneous report from a contactable Other Healthcare professional (patient). A 40-year-old non-pregnant female patient received third dose of bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, Lot number: FF8841), via intramuscular route, administered in arm left on 08Oct2021 (at the age of 40-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EX0904), via intramuscular route, administered in arm left on 06Apr2021 (at the age of 40-year-old) and second dose of bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, Lot number: FA9091), via intramuscular route, administered in arm left on 26Jun2021 (at the age of 40-year-old), both doses for COVID-19 immunization and after second dose experienced sore arm and fever. The patient had no known allergies. Prior vaccinations within 4 weeks and other medications within 2 weeks were reported as none. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for COVID-19. On 08Oct2021, the patient experienced mild headache, sore arm, developed irregular spotting and periods had stopped. Clinical course: No to-very mild immediate side effects: sore arm, fever (controlled by Tylenol in 2 hours)-second dose mild headache, sore arm-booster. Booster mistakenly was done at 3 months after 2nd dose. Noticing since 2nd dose and especially after booster, I find a connection in affecting my menstrual cycle. Periods have stopped, developed irregular spotting. Adverse events required physician office visit. Treatment received for the adverse events was reported as unknown. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Mother states child cried inconsolable for 4 hours after receiving Dtap, IVP, HIB and Prevnar on 3/31/06. Slight fever x 24 hours (not taken per mother). Vomited x1 that same pm after crying.
During the night after vaccination the patient experienced chills,  severe headache, fever, cough and  and fatigue.  All abated after 24 hours except the headache, which continue 48 hours later
Information has been received from a Nurse Practitioner concerning a patient who on unspecified dates received all 3 doses of RECOMBIVAX HB (lot number not provided). On an unspecified date, the titers were less than 10mlu/ml. The patient did not seek medical attention. No treatment was given. At the time of the report the patient had not recovered. Additional information has been requested.
Severe muscular pain in neck, shoulders, upper back on/around 08/26/2021. Went to ER on 08/30/2021. MRI & CT scan done; released after 10 hours. On 08/31/2021 found pea sized bump/rash behind left ear, went to Clinic for test.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Vaccine administered at 9am. Patient came back to pharmacy around 10am stating her right side neck/cheek has reddness. Recommened staying at the pharmacy for monitoring and can given benadryl. Patient left. Called at 3pm. Patient took 50mg benadryl and went to work. Stated the redness went down. Unclear if rash was from fear of vaccine or from vaccine itself.
EXTREMELY BITTER TASTE IN THE BACK OF MOUTH ON TONGUE; This spontaneous report received from a patient via Pfizer concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression. The patient was previously received two doses of Moderna vaccine (Spikevax) (elasomeran) (Dose number in series 1) (form of admin, route of admin not reported, batch number: 038A21A for dose 1, batch number: 046821A for dose 2 and expiry: UNKNOWN) dose was not reported, administered on right arm on 11-MAR-2021 and second dose on 20-APR-2021 for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first two doses of Moderna (Spikevax) covid-19 vaccine (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 20J14-03, and expiry: UNKNOWN) dose was not reported, 1 total, administered on DEC-2021 for prophylactic vaccination. Age at time of vaccination 27 years old. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (Dose number in series 2)  The patient received non-company suspect Pfizer Biontech covid-19 vaccine (Tozinameran) (Dose number in series 3) (form of admin, route of admin were not reported, batch number: GA1188 expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2022 for prophylactic vaccination. Concomitant medications included amlodipine (from MAR-2022), dextromethorphan hydrobromide/paracetamol/pseudoephedrine hydrochloride (18-MAY-2022), and duloxetine (from JUL-2020) for unknown indication.  On 18-MAY-2022, the patient experienced extremely bitter taste in the back of mouth on tongue, similar to bitter grapefruit. It woke patient up several times throughout the night (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and Tozinameran was not applicable. The patient had not recovered from extremely bitter taste in the back of mouth on tongue, and the outcome of off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Severe stomach pains; headaches; fatigue; graying of the skin; brain fog; sinuses; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on 21Sep2021 12:30 (at the age of 52 years old) (Batch/Lot Number: FE3592) as dose 1, single for COVID-19 immunisation.  Medical history included known allergies to Penicillin, erythromycin and eggs. The patient was not pregnant at the time of vaccination. It was unknown if patient had COVID prior to vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. On 21Sep2021 15:00, the patient experienced Severe stomach pains, headaches, fatigue, graying of the skin, brain fog and sinuses. Treatment for the events was yes, acupuncture. The events resulted in a doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. (Results in death: No, Life threatening: No, Caused/prolonged hospitalization: No, Disabling/Incapacitating: No, Congenital anomaly/birth defect: No). The outcome of the events was recovering. Post vaccination COVID test type nasal swab on 15Oct2021, result: negative.  Follow-up attempts are completed. No further information is expected.
Discharge Provider:  Primary Care Provider: DO Admission Date: 4/17/2023 Discharge Date: 4/20/23  PRESENTING PROBLEM: Emesis    HOSPITAL COURSE:   Patient is a 70 yr old male with hx IPF, short telomer, osteopenia CAD, HTN Tachycardia s/p Bilateral Lung Transplant for IPF 12/2022. His post op course has been complicated by multiple GI issues. He has a history of patulous esophagus, esophogeal dysmotility with GERD, and dysphagia prior to transplant. PGJ was placed for feeding and meds in the post operative period. Since transplant he continues to struggle with nausea, emesis of even liquids, dysphagia of large volumes (can't tolerated barium for esophagram test). Reglan started for presumed gastroparesis as well.  Additionally,  pt was noted to have hx of pneumotosis coli on imaging post op (this was treated conservatively). Overall he called complaining of intolerance of liquids (can keep down applesauce and 2 meds he takes orally) , nausea, and increasing diarrhea despite reglan and venting G port. He has been taking 100% enteral  nutrition via J port.  He also has complaints of new cough and dypnea with stable lung function at home. He is directly admitted to further evaluate.     Upon admission bowel rest with 24 hour drainage of G port, CT abd/pelvis, film array obtained. No acute findings on imaging. Film array + for COVID 19. Remdesivir started for 3 day course as minimal symptoms. GI symptoms resolved, enteral feeding started on day 2 with continues g port drainage and tolerated well. Day 3 advanced to nocturnal feeding with nocturnal drainage of g port and clamping during the day. Ice chips started and tolerated well.  This was tolerated wee.  3 days of remdesivir completed and patient stable for discharge
Information has been received from a health care professional concerning a patient who is pregnant who in 1995 was vaccinated with the first and second doses of varicella virus vaccine live. Subsequently, the patient had lab work which revealed that she had not seroconverted. Unspecified medical attention was sought. Additional information has been requested.