chrisvoncsefalvay/vaers-outcomes huggingface dataset:
night "sweating like crazy"; swelling of injection site; headache; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night "sweating like crazy"), VACCINATION SITE SWELLING (swelling of injection site), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZIDE) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced NIGHT SWEATS (night "sweating like crazy"), VACCINATION SITE SWELLING (swelling of injection site), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, NIGHT SWEATS (night "sweating like crazy"), VACCINATION SITE SWELLING (swelling of injection site), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.
Sudden onset of never ending tinnitus/ The occasional tinnitus I experienced before this booster was ringing in the ears. This still occasionally occurs. The other is constant and never ending.; Some times it's worse than others, but it has definitely affected my ability to hear clearly; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 68-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 21Dec2021 at 11:45 (Lot number: unknown) at the age of 68 years as dose number unknown (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: Known allergies: yes and "Tinnitus" (unspecified if ongoing), notes: Occasional tinnitus she experienced before this booster was ringing in the ears. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunisation.  The following information was reported: TINNITUS (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Sudden onset of never ending tinnitus/ The occasional tinnitus I experienced before this booster was ringing in the ears. This still occasionally occurs. The other is constant and never ending"; HYPOACUSIS (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Some times it's worse than others, but it has definitely affected my ability to hear clearly". Therapeutic measures were not taken as a result of tinnitus and hypoacusis.  Additional information: The patient had unspecified allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. It was also reported, tinnitus sounded like a forest of insects (at twilight) in her head non-stop. Sometimes it was worse than others. Tinnitus still occasionally occurred. The other was constant and never ending. It was reported that the patient had not yet sought for professional help, she will see in the near future and she was also waiting if this was temporary. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
hypertensive crisis; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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: Bnt162b2 (dose 1, single, Batch/Lot number: unknown), for COVID-19 immunisation; Bnt162b2 (dose 2, single, Batch/Lot number: unknown), for COVID-19 immunisation; Bnt162b2 (dose 3 (booster), single, Batch/Lot number: unknown), for COVID-19 immunisation; Bnt162b2 (dose 4 (booster), single, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: HYPERTENSIVE CRISIS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of hypertensive crisis. Clinical course: It was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine dose 1, dose 2, dose 3, dose 4, and dose 5 for COVID-19 immunization. It was reported the patient developed hypertensive crisis and was on four high blood pressure pills. It was also reported that it all happened four weeks ago.  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: As there is limited information in the case provided, the causal association between the reported event hypertensive crisis with the suspect drug BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded. The case will be reassessed once new 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
1150 vaccine by pharmacist Rush of warm within 1 min, returned to car; woozy, lightheaded/dizzy Hungry ate nutrigrain bar 1200 Burning skin arms and legs, burning stomach, burning feeling occ to chest with deep breath; no throat, tongue, breathing issues,;still lightheaded. Notified pharmacist. 1205 Benadryl 50 mg from pharmacist, tums 2 1225 ok to leave parking spot, Starting itchy skin abd/ thighs, skin still burning, took Pepcid  10 mg ( recommended by pharmacist) 1240 skin still burning thighs, arms and abdomen. Nausea. Ate lunch 1:40 some nausea, occ waves of skin burning and itching, very tired (from 50 Benadryl), lightheaded, shaky still. 3:00 nausea only. No burning or itching 0430 burning stomach, nausea only Minimal Nausea throughout evening and morning of 1/15
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: PATIENT PASESED OUT AFTER VACCINATIONS ADMINISTERED. MOVED TO THE FLOOR, PATIENT PULSE AND BREATHING STEADY. PATIENT BEGANT TO SEIZE. CALLED 911. SEIZING STOPPED, PATIENT CAME TO, VERY CLAMMY AND SWEATY. WIFE AND PHARMACIST REMAINED WITH THE PATIENT UNTIL HE CAME TO AND EMERGENCY TEAM ARRIVED AT PHARMACY.
Within two weeks of 2nd shot left arm and leg went numb, spent the night at hospital and they said it was carpal tunnel. Started seeing Dr.  a few weeks later and he diagnosed right shoulder pain as rotator cuff issues. Pain is currently the whole right arm a tingle in the right hand, I will be calling the doctor again tomorrow.
This spontaneous report was received from a consumer of an unknown age and gender who reported that on a 20-NOV-2013, was vaccinated with a dose of ZOSTAVAX (lot # not reported). On an unknown date the patient had been having headaches, redness, pain at the site of injection and also got herpes on the lips. The outcome of herpes on the lips, headaches, redness, pain at the site of injection was unknown. Additional information is not expected.
Breakthrough of Covid: 05/13/2022, I had sudden onset of scratchy throat. 05/14/2022, I had very sore throat and laryngitis and loss of appetite. 05/15/2022, I had very sore throat and laryngitis, loss of appetite, general body aches 05/16/2022, the very sore throat and laryngitis, loss of appetite, diarrhea, runny nose and I was chilled, no fever 05/17/2022, continued with the very sore throat and laryngitis, loss of appetite, diarrhea, runny nose and I was chilled, no fever, I would cough and it was so dry I would choke - it was a choking cough. Saw doctor prescribed Paxlovid and started it that evening. 05/18/2022, still a sore throat, laryngitis, no runny nose, a little bit of an appetite. 05/19/2022, A little bit of laryngitis nothing like I had, less of a sore throat, appetite is back and I slept really well.
Extremely sore arm,  full body aches, and headache the day after the vaccine. Resolved the following morning. Also presented with hive like raised red itchy rash on lower back starting approx. 9 PM the night of the vaccine on 12/24,. I still have the rash- it hasn't gotten any worse or any better. It hasn't changed in size either. I tried Benadryl spray with fair effect.
Rt leg discrete Linear petechial rash in subcutaneous tissue spreading caudally. No fever, or systemic problems.
This spontaneous report as received from a Licensed Practical Nurse via company representative refers to a 65 year old female patient. No current condition was reported. No historical medication was reported. On 01-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 (dose strength was not reported). No concomitant medication was reported. On an unknown date approximately in November 2014, the patient experienced flush, weak, dizzy and developed a fever. Treatment given to the patient was METAZINE (manufacturer unknown) (dosage and frequency was unknown). Sought medical attention was reported as yes. The outcome of flush, weak, dizzy and developed a fever was unknown. No PQC was involved. The causality between PNEUMOVAX 23 and event was not reported. No further adverse event information was provided. Additional information has been requested.
PT STATING SHE WAS NAUSEATED, SHAKING, HAD HEADACHE ,NECK TENDERNESS, EAR RINGING AND HYPERTENSION (180)  AND SPEAKING PROBLEM AND BIG BUMP AT INJECTION SITE
p/receiving 1 dose of Typhoid vax, pt exp allergic rxn characterized by shaking, chills, malaise, joint aching, & a fever 102, red inject site, tender, warm to touch; swelling of cervical nodes; sx persisted 2 days;
Day 1:  Red, small hard knot, feverish to touch Day 2:  Larger knot, sill feverish Day 3 - 6  Vertigo - unable to walk/care for self/nauseated--stayed in bed and with meds slept majority of time slept and unable to remember what was going on--could not move head without getting dizzy (vertigo) Day  7 - 10:   Vertigo seemed better/improving, but still dizzy Day 11:  Vertigo better/swelling gone  All the while breathing difficulty and that continues through this date/tired when gets up to do anything//concerned about permanent damage as well as blood sugars
Vomiting and diarrhea - overnight into next morning. Weak and lethargic.
SWOLLEN LEFT EYE; HEADACHE; INJECTION SITE SORENESS; TIREDNESS; This spontaneous report received from a patient concerned a 33 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection site soreness. On 09-APR-2021, the subject experienced tiredness. On 21-APR-2021, the subject experienced swollen left eye. On 21-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness, and tiredness on APR-2021, and had not recovered from swollen left eye, and headache. This report was non-serious.
Acute viral infection Shingles.   Treating with valacyclovir and gabapentin.
stomach hurting; before the vaccine, had a tiny dizzy/ after the vaccine, more dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8732) via an unspecified route on left arm single dose for COVID-19 immunization on 27Mar2021 18:00, at 70-year-old. Medical history included: ongoing osteoporosis for a long time maybe 10 years, calcium deficiency, abdominal pain upper, bone density decreased, dyspepsia, rhinorrhoea, dizziness/ tiny dizzy, cerebrovascular accident. Concomitant medications included: Vitamin D from Jan2021 and ongoing; ongoing calcium carbonate (TUMS) twice daily for osteoporosis, bones need the calcium, bone density, heartburn; ongoing loratadine (LORATADINE, 10 mg tablet) oral as needed for runny nose; acetylsalicylic acid (BABY ASPIRIN, 81 mg tablet) oral 1DF a day for dizziness after the meal; famotidine oral 20mg half hour before a meal. The patient experienced very dizzy, nauseous, stomach hurting; all on an unspecified date. The patient was very dizzy, nauseous from Mar2021 and ongoing; ongoing stomach hurting. After the patient had the vaccine for the first 3 days was ok, the fourth day (maybe 30 Mar2021 or 31Mar2021, maybe Tuesday or Wednesday), she started getting very dizzy, she has to hold onto something, she's nauseous. The patient stated before she had the vaccine, she had a tiny dizzy, but after the vaccine, even now, she's more dizzy and sometimes nauseous. Took calcium carbonate sometimes she takes 1 pill, sometimes 2 pills, when her stomach was getting hurt, it would help so she will take more. After the shot, her stomach sometimes it hurt and she took more calcium carbonate because calcium carbonate could be for the treatment of her stomach hurting, so she will take more than 2 pills a day. The patient stated that before the vaccine, her stomach sometimes had problems too. The patient stated when her stomach had problems, then she took the calcium carbonate and she didn't think its because of the vaccine. No emergency room or physician office visited. Outcome of the event was resolving.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The event "stomach hurting" is attributed to an underlying medical condition and assessed unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).
Lt arm pain, itching w/rapid onset papular erythematous rash; urticarial satellite lesion w/mild nausea, lightheaded; ?IgE response devel to tetanus toxoid sx initial enduced serum sickness;
Redness, swelling to upper left arm and hot to touch. Called the Dr. and advised to take Benadryl. Swelling and redness relieved within 3-4 days.
Got vaccinated and still got shingles/suspected vaccination failure; Shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got vaccinated and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-APR-2023 This case was reported from the patient via  interactive digital media. The patient got vaccinated and still got shingles. 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. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR053081, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR053081:Same reporter
fatigue; chills; sweating; muscle aches; fever that fluctuated up to a maximum of 100 Ffever that fluctuated up to a maximum of 100 F; This is a spontaneous report from a non-contactable consumer.  A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in Arm Left on 05Feb2021 as dose 2, single for COVID-19 immunization. Medical history included anxiety disorder and allergies to sulfa antibiotics. Concomitant medication included sertraline (SERTRALINE) and levothyroxine sodium (THYROXINE).The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 15Jan2021 as dose 1, single for COVID-19 immunization. The patient did not received any other vaccine within 4 weeks of COVID vaccine. The patient did not had COVID prior to vaccination. The patient was not tested for COVID post vaccination. On 06Feb2021, within about 24 hours of receiving the vaccine the patient experienced fatigue, chills, sweating, muscle aches and fever that fluctuated up to a maximum of 100 f. Most of the symptoms subsided within 36 hours of onset except for the fatigue which persisted for 48 hours after onset of the adverse event. The events were not treated. The patient underwent lab tests which included pyrexia: 100 Fahrenheit on 06Feb2021. The patient recovered from events in Feb2021  No follow-up attempts are possible. Information on the Lot/Batch number could not be requested. No further information is expected.
Shingrix adjuvant without antigen component; Shingrix adjuvant without antigen component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 03-Aug-2022 Reporter's comment: The reporter was the Healthcare professional (nurse).  The patient received Shingrix adjuvant without antigen component (inappropriate Reconstitution Technique).   The reporter had nothing else to report.  The Vaccine Administration Facility was the same as Primary Reporter. The consent to follow up was given. Additional Supportive Information: The patient received Shingrix adjuvant without antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Chills, sweats started after a few hours of vaccination. At 1630 increased severity and visibly puffy face. No SOB. Temp 102.6 F.
103 degree fever fairly steady for 1 day then off and on for a second day; body aches and pains lasting 2 days chills steady for day 1, off and on for day 2 fatigue that lasted approximately a week It felt like a bad flu. Took approximately a week to really feel like myself.
PATIENT LIED TO STAFF ABOUT NOT HAVING RECEIVED TWO DOSES OF MODERNA VACCINE PRIOR TO ADMISSION TO OUR FACILITY ON TWO SEPARATE OCCASIONS AND SIGNED VACCINATION CONSENT FORM STATING HE HAD NOT RECEIVED A DOSE OF A DIFFERENT COVID-19 VACCINE BEFORE TODAY (08/13/2021).  PATIENT ARRIVED TO THIS FACILITY ON 08/09/2021 WITHOUT RECORD OF HAVING HAD THE COVID-19 VACCINATION.  A RECORDS SEARCH OF THE IMMUNIZATION INFORMATION SYSTEM SHOWED THE PATIENT RECEIVED 1ST DOSE MODERNA, LOT#052C, 07/10/2021 AND 2ND DOSE MODERNA, LOT#065D21A,  08/07/2021.   ALL NEW ARRIVALS TO OUR FACILITY ARE QUARANTINED FOR 14-DAYS IF THEY ARE NOT FULLY VACCINATED AGAINST COVID-19 OR IF THEY DO NOT HAVE PROOF OF VACCINATION.  THIS PATIENT SAID HE LIED BECAUSE HE DID NOT HAVE PROOF OF HIS VACCINATIONS AND WAS UNAWARE WE COULD LOOK THEM UP; THEREFORE HE AGREED TO TAKE THE J&J VACCINE TO OBTAIN A CARD FOR PROOF OF VACCINATION TO AVOID A FUTURE QUARANTINE SITUATION.
Severe joint pain in knees hips as well as muscle weakness most notable in legs with very mild left foot "drop" symptoms began on 11/01/09 - treated with intermittent MOTRIN and with exercise. Pain became more moderate around 12/14/09. Pain now mild mainly affecting right knee. Minimum leg weakness now.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of an unspecified age. The patient's height, and weight were not reported. 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 and expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in AUG-2021, the patient was asking about the need of a booster of covid-19 vaccine or getting another vaccine brand after testing negative for antibodies (confirmed immunological vaccine failure) and the patient had visited physician/healthcare professional office. Laboratory data included: COVID-19 antibody test (NR: not provided) negative for antibodies. 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).; Sender's Comments: V0-20210834860-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 has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
pt had fever 100-100.8 w/rash;seen by MD;8/9/99 fever decrease on 8/10/99;rash cont under 8/15/99 tx w/APAP & calamine lotion;eyes were reddened;no problems today;
A report had been received from a Health Professional concerning an 8 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 04-DEC-2014. It was reported that three patients inadvertently received expired FLUMIST Quadrivalent on 04-DEC-2014. The outcome of the event of three patients inadvertently received expired FLUMIST Quadrivalent was unknown. The report was considered to be non-serious.