chrisvoncsefalvay/vaers-outcomes huggingface dataset:
All started about 10:00pm the same night Headache - still have, advil takes it away for short periods of time Dizzy - still have Nausea - still have Extreme exhaustion - slept 20 hours the next day and then 16 the following day... still tired Pains in the chest when breathing and shortness of breath Pain at injection site (which was expected) - still sore 4 days later  Starting about 2 days later: pain in left armpit region, feels harder too
Information has been received from a registered nurse regarding her granddaughter who is a 18 year old patient with allergies to peanuts who on 18-JUL-2011 was vaccinated with a 0.5 ml dose of GARDASIL (Lot # not reported). Concomitant therapy included meningococcal A polysaccharide vaccine (manufacturer not reported). On 26-Jul-2011 (also reported as one week after receiving the first dose of GARDASIL in the administration series), the nurse reported that the patient developed stomach pain, low grade fever and constipation. The nurse reported one week later the patient went to a local emergency room on two separate occasions and on one visit the patient was given an enema. The patient was not admitted on either visits. The nurse reported that the patient visited her pediatrician and received no specific treatment. On 10-Aug-2011, the patient developed a 102 degrees Fahrenheit temperature and severe abdominal pain and went to the emergency room. She was admitted to the hospital with a 19,000 white blood cell count, and a CAT scan that showed a ruptured appendix with an "abscessed wall with appendiceal phlegmon." The patient had a complete blood cell count and an X-ray. The patient was treated with intravenous antibiotics and fluids. The patient's status at the time of the report was not recovered. Action taken in relation to therapy was not reported at the time of the report. Information received from a telephone call on 16-Aug-2011 with the nurse, who reported the patient's treatment with antibiotics had worked and her abscess was "cured" and that the patient should be home within the next couple of days. The reporter felt that the events of stomach pain, low grade fever, constipation, "went to a local emergency room on 2 separate occasions and on one visit was given on enema", 102 Fahrenheit temperature, severe abdominal pain, white blood cell count of 19,000, ruptured appendix with an abscessed wall with appendiceal phlegmon were disabling and life threatening. The reporting registered nurse contacted during telephone follow-up would not supply the patient's name, date of birth, lot number, and healthcare provider's name and contact information. No additional information provided. Additional information has been requested.
I have been experiencing headache, ear pain, swollen glands, extreme fatigue, eye nerve pain, weakness, and dizziness for nearly 6 months beginning the day following the Shingrix booster.  I had Pleurisy for about a month about two weeks after the booster.  I had several months of not being able to control my body temperature.  I had several weeks of thyroid gland pain, even though an ultrasound was normal.   I have had numerous labs, imaging, doctor and specialist appointments plus the one ER visit for pleurisy.  I tested positive for the Epstein Barr Virus (negative Mono) and even though I've been on Prednisone for the past 5 weeks, my inflammation markers are still high and it only seems to be suppressing my symptoms for a bit until they increase the dose again.  There seems to be no hope in sight.
Pneumovax 23 given in left deltoid on 11/13/2001. Left arm, chest, and back extremely swollen, red, hot to touch, exquisitely painful. Fever of 104.
This spontaneous report was received from a licensed register nurse concerning a 5 year old male patient with no pertinent medical history or drug reaction/allergies. In August 2014 (reported as on an unspecified date in August 2014), the patient was vaccinated with a dose of (Oka-Merck) PROQUAD (dose, dose number, lot number, expiration date and route were not reported) on left arm, for vaccination. Other suspect therapies included KINRIX. No concomitant therapies were reported. The licensed registered nurse reported that one day of the administration (reported as on an unspecified date in August 2014), the patient experienced swelling at the injection site of the (Oka-Merck) PROQUAD (left arm) and a body rash which looked like hives. In 2014 (reported as on an unspecified date), the symptoms were resolved. Patient seek medical attention at the reporter's office. No lab diagnostics studies were performed. Additional information has been requested.
12/29 red spots showed up on forehead. Low grade temp not exceeding 100.4 started 12/27 and resolved by 12/29. No rash. Injection site WNL. Stooling and Voiding WNL. PO WNL.
Moderna vaccine; it si also on legs 7 feet body rash mostly Face neck & hands,
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 18-year-old female patient of an unspecified race and ethnicity received the first single dose of TRUMENBA via an unspecified route of administration on 28Feb2017 for immunization. The patient medical history and concomitant medications were not reported. The patient experienced severe headache on 28Feb2017 within 20 minutes from the vaccination. Her vital parameters were stable but pain was 100 on a scale of 1-10 and she needed wheel chair assistance. Headache resolved within ibuprofen and paracetamol (TYLENOL) after 20 minutes, outcome of pain was unknown. The patient did not want to receive the second dose to complete the series.
Hot; Hard; Itchy; 2 1/2 inch diameter spot at injection site that is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot), VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (2 1/2 inch diameter spot at injection site that is red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (2 1/2 inch diameter spot at injection site that is red). At the time of the report, VACCINATION SITE WARMTH (Hot), VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (2 1/2 inch diameter spot at injection site that is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Fever of 101F; Patient feels as if they have a cold; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101F) and NASOPHARYNGITIS (Patient feels as if they have a cold) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 101F) and NASOPHARYNGITIS (Patient feels as if they have a cold). At the time of the report, PYREXIA (Fever of 101F) and NASOPHARYNGITIS (Patient feels as if they have a cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
PATIENT STATED HER ARM GOT HOT AND SWOLLEN AND STAYED RED AND SWOLLEN FOR ABOUT 2 WEEKS AND HAD TO RESCHEDULE PET SCAN BECAUSE OF REACTION
Pt mom brought pt to HD. She said pt has had an allergic reaction to one of the immunizations she received Wed. Pt L thigh is red, slightly swollen, and slightly time. Inst mom to give pt Tylenol 2-4-6 HR AD, and Benadryl PO AD on Box and apply cool compresses.
This spontaneous report as received from a nurse and refers to a patient of unknown age gender. On an unknown date the patient was vaccinated with first dose of VARIVAX, dose route and frequency unknown. On 15-AUG-2011, the patient was vaccinated with improperly stored dose of VARIVAX lot # 669601/0138AA. No adverse effect reported. This is one several reports received from the same source. Additional information has been requested.
3/9- 1pm vaccine, injection site discomfort 9pm-chills 10pm-fever (reaching 103.8), body/muscle aches, headache through night and into morning  3/10- 12pm-fever, body aches gone, slight headache remained and tired the next day but continued to improve  3/11- No symptom but  arm still sore
loss of appetite; bad cough; aches all over; extreme weakness; could barely move; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (aches all over), ASTHENIA (extreme weakness), GAIT INABILITY (could barely move), COUGH (bad cough) and DECREASED APPETITE (loss of appetite) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012220A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN (aches all over), ASTHENIA (extreme weakness) and GAIT INABILITY (could barely move). On 20-Jan-2021, the patient experienced COUGH (bad cough). On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite). At the time of the report, PAIN (aches all over), ASTHENIA (extreme weakness), GAIT INABILITY (could barely move), COUGH (bad cough) and DECREASED APPETITE (loss of appetite) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case concerns a 68-year-old male, with PMH of COVID-19, who experienced unexpected events of pain, asthenia, unable to walk, cough, and loss of appetite.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included acetaminophen. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: This case concerns a 68-year-old male, with PMH of COVID-19, who experienced NS unexpected events of pain, asthenia, unable to walk, cough, and loss of appetite.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included acetaminophen. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Might have Guillain-Barre Syndrome; her mother's legs "went numb and weak"; her mother's legs "went numb and weak"; her speech started to slur; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received BNT162B2 (Solution for injection) via an unspecified route of administration on 30Mar2021 (Batch/Lot number: unknown) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. It was reported that upon returning home after the vaccination, her mother was unable to get out of the car under her own power, with the caller reporting her mother's legs "went numb and weak". Later on that day, her speech started to slur. They had contacted their family physician who thinks her mother Might have Guillain-Barre Syndrome. The outcome of the events was unknown.   Information about lot/batch number has been requested.
1st dose 22Nov2022,  2nd not yet; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 23-year-old female patient who received HBV (Engerix B) (batch number WO25778, expiry date unknown) for prophylaxis.   On 27th December 2022, the patient received Engerix B. On 27th December 2022, unknown after receiving Engerix B, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 24-JAN-2023 Reporter's Comments: Medical assistant called to report that the patient intended to get a vaccination schedule for Hepatitis B got a first dose of Twinrx and then a second dose of Engerix-B. The reporter consented to follow up via email. Additional Supportive Information: the patient received Engerix B vaccine as a second dose after receiving Twinrix vaccine, which led to wrong vaccine administered.; Sender's Comments:  US-GSK-US2023010233:same reporter
I had the vaccine 3 days ago, and this morning my arm got really red snd hot around the injection site.  About  an hour later, my lips and throat starting itching a little bit,
Eye irritation, swollen and sore throat. Took Benadryl. Swollen throat and flu symptoms for 24 hrs. Continued Benadryl. Visited doctor next day and he confirmed was reaction to flu shot.
Pt reported left arm feeling heavy, itchy, hard hot. Pt also reported having chest pain, and shortness of breath. (Late evening day after vaccine 10/21/16). Pt. called 911 a EKG was done. Pt was given aspirin. Pt was taken to ER. Pt. followed up with PCP 10/28/16 and reported ER visit.
Systemic: mom said he was having seizure but i didnt see it after calling 911 he was alert but pale and lips white, beaded with sweat said he was hot, nauseous, ears ringing and thirsty.-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: his color started to come back and he was responsive and said he was no longer nauseous when paramedics got there
Patient was admitted with left sided weakness consistent with stroke. Stroke was nonhemorrhagic on CT scan. MRI could not be done due to presence of pacemaker. Stroke is presumed embolic or ischemic, surprising given pt is on both pradaxa and plavix and is compliant.
ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN HYPOTENSION ACUTE RESPIRATORY FAILURE 1/17/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
1st dose 21Sep2020, 2nd not yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 21st September 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 21Sep2020, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 28-Mar-2023 The reporter consented to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The case was linked with case US2023046728, reported by same reporter.; Sender's Comments:  US-GSK-US2023046728:Same reporter
Unilateral hearing loss; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 32-year-old male patient received BNT162b2 (BNT162B2), on 07Jan2022 as dose 3 (booster), single (Lot number: FH8027) at the age of 32 years for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 07Jan2022 as dose 1, single (Lot number: NK45F), in arm for immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing); "HTN" (unspecified if ongoing). Concomitant medication(s) included: TRIUMEQ; BIKTARVY; HCTZ. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6200), administration date: 09Apr2021, when the patient was 32-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6204), administration date: 19Mar2021, when the patient was 31-year-old, for COVID-19 immunization. The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 23Mar2022, outcome "not recovered", described as "Unilateral hearing loss". The event "unilateral hearing loss" required physician office visit. Therapeutic measures were taken as a result of deafness unilateral.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.What treatment received for the adverse event was Steroids, no improvementPrior to vaccination, was the patient not  diagnosed with COVID-19.Since the vaccination, has the patient not had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Deafness unilateral" and the suspect drug BNT162B2 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 drug 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.
Resident received her first booster vaccine of COVID-19 Moderna on 2-3-2022.  She was administered a second booster vaccine of COVID-19 Moderna on 4-19-2022.  This second booster dose was administered less than 4 months after the first booster dose.
I became very sick with fever at 3am.  I was vomiting and diarrhea at the same time for hours. I was weak, had a fever of 101, my heart was racing and my breathing shallow.  This went on for hours.  24 hours later body aches, stomach hurts, temp 100. 36 hours later body aches, crying
Administered vaccine child started to cry. Lips turned blue, cried, mother picked up child. I went to call a provider child started to have a seizure. Took child and mother to ER.
pt recv vax NOV95 & DEC95 pt became pregnant;during the pregnancy med included prenatal vitamins;In 1996 pt exp gestational diabetes;SEP96 pt delivered a healthy girl;
A 8 years old patient was given Fluzone High Dose by mistake/no AE; A 8 years old patient was given Fluzone High Dose by mistake/no AE; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked with cases 2020SA242184, 2020SA242185, 2020SA242186, 2020SA242187 (same reporter).  This case involves a 8-years-old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] by mistake (product administered to patient of inappropriate age and overdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy received by the patient.   On 31-Aug-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ450AB and expiry date 30-Jun-2021) via intramuscular route at the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration and it was also a case of overdose (latency: on same day).  No adverse event reported at the time of reporting.  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 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.
The patient is only 18 years old, but received the Engerix-B vaccine for ages 20 and up. She reports no side effects.
Received Shot Friday, Dec 3rd at 0800.  Saturday at 1200 I developed fever of 101.5, nausea, runny nose, cough, sneezing, and dizziness.  Injection site is swollen and red/ warm to the touch. All symptoms remand till about 1pm on Dec 6th.  From Dec 6th at 1pm to current, still feeling fatigued/weak and injection site still same, but that is all.
Pt. started with chills that night.  I (his wife) was out of town but spoke to him twice a day. He had body aches, loss of appetite, fatigue, running temperature and eventually health went down hill that a neighbor found him on floor of bathroom.  He had fallen and could not get up.I had called Sunday morning, Aug. 22, 2021, and when he did not answer I called my neighbor to check on him.  He had to carry him to chair and paramedics were called. I returned home the next day and could see the remnants of his downhill health with water bottles and granola bars strewn all over house.  Clothes were in hallway, bathtub, office and family room.  It was quite obvious of what I found he had been suffering from the evening he received his booster.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) 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).    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In December 2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). In December 2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this Female with an unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy for this female with unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
This spontaneous report as received from a pharmacist refers to a 53 year old female patient. The patient did not have a pertinent medical history and no drug reactions/allergies. On 23-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously ("physician recommended") (lot # J010447, expiry date: 22-APR-2014). Concomitant therapies included gabapentin, sertraline hydrochloride and lorazepam. The pharmacist reproted that after the patient received ZOSTAVAX, she developed redness and soreness at the injection site. The patient developed these symptoms shortly after administration of the ZOSTAVAX, when she was still in the pharmacy. No lab tests were performed and no treatment was given for the events. The pharmacist reported that all of the patient's symptoms "subsided within a day". No reporter causality was provided. Additional information has been requested.
Right sided facial paralysis ( unable to blink or completely close right eyes, unable to raise right eye brow, right sided mouth droop, unable to taste on right tounge, right tounge numbness)
SkinRash, Diarrhea, NauseaVomiting,  fatigue