chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Recurrent vomiting for approximately 6 hours. Requiring ER visit. 1/5/09-records received for DOS 11/21/08-Follow up from ER visit evening prior for C/O bilious abdominal x-ray negative. No vomiting since leaving ER. Presently fussy but easily consolable, abdomen soft, normal bowel sounds no masses. Suspect vomiting secondary to recent rotateq on 11/8/08.
Day 0-4: arm soreness Day 8: onset of bulls-eye rash at injection site of left arm. Rash is raised, erythematous, firm. Associated with several 1-3 cm enlarged tender axillary lymph nodes.  Day 9-11: severe left sided headache not responded to over-the-counter analgesics. Headache resolved on Day 12. Day 9-13: ongoing fluctuations in left arm rash and adenopathy. By day 13, adenopathy mostly resolved. Rash persists.
soreness; psoriatic patch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and VACCINATION SITE RASH (psoriatic patch) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Psoriasis.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (soreness) and VACCINATION SITE RASH (psoriatic patch). At the time of the report, PAIN (soreness) and VACCINATION SITE RASH (psoriatic patch) outcome was unknown. Not Provided       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt was sitting in lobby after receiving vaccinations. RN was notified via interpreter that the pt mother was requesting an alcohol wipe for pt to smell. RN went to pt in lobby with interpreter. Pt sat upright in chair having difficulty keeping eyes open. Pt appeared to lose consciousness and regain it several times. Pt was combative, pushing RN and parents away with attempts to have pt drink juice and sucker. Pt was confused, not oriented x3. Pt moved to exam room for more monitoring. Pt blood pressure checked every 5 minutes and was WNL. Pt drank more juice and ate a marshmallow treat and was able to answer RN questions appropriately. Pt became A&Ox4 after juice and snacks.  Pt reported that she felt a lot better and was able to walk around and answer questions with no difficulty.
HYPOTENSION 7/27/2021 NONALCOHOLIC CIRRHOSIS
Flu shot didn't work for me this year; was very sick for about 2 weeks; Initial information was received on 15-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional.  This case involves Adult and unknown gender patient who experienced flu shot didn't work for me this year and was very sick for about 2 weeks after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (with lot number, strength, formulation, dose not reported) via unknown route in unknown administration site for prophylaxis.  On an unknown date the patient developed a serious event of flu shot didn't work for me this year (vaccination failure) and a non serious event of was very sick for about 2 weeks (illness) (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken : Not Applicable.  It was not reported if the patient received a corrective treatment for the was very sick for about 2 weeks.  Outcome: Unknown for both the events.  Seriousness Criteria: Medically Significant for Vaccination Failure.; Sender's Comments: Sanofi CompanyComment Dated 23-Dec-2022: This case involves Adult and unknown gender patient who experienced flu shot didn't work for me this year and was very sick for about 2 weeks after receiving vaccine INFLUENZA VACCINE. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical and vaccination history, lab investigations, concomitants and concurrent conditions excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
pt recv vax 22AUG96 & the following day pt c/o numbness @ the site of inj;pt was examined by a neurologist & was cleared w/o any deficits;
Fever 7/10, Rash 7/11 - firm head to trunk and extremeties. Generalized macula papualr rash.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. On unknown dates the unspecified patients were vaccinated with doses of improperly stored ZOSTAVAX (lot # K021953, expiration date 10-FEB-2016) (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse effect was reported. This is one of several report from the same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 28Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm and on 25Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; CYTOMEL; DESVENLAFAXINE; DULERA; FLUTICASONE; IMMUNE GLOBULIN; LAMOTRIGINE; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19; COVID 19 Treatment PAXLOVID from 03Aug2022 to 07Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Patient called pharmacy on 10/13/2020 to report she was still experiencing pain in her shoulder following influenza vaccine given 10/08/2020.  Patient reported having tenderness, warm to the touch, and visible swelling on vaccinated arm that lasted approximately 36 hours. Patient reports she now has pain radiating out from injection site to the shoulder and while she has full range of motion in shoulder, she is self limiting her range due to the pain.  Patient took Ibuprofen 10/12/2020 in the evening for pain .  Pharmacist recommended patient continue with anti-inflammatory medication, ice for pain, and to follow up with physician for evaluation.
24 hours after 2nd vaccine on 4/29 had typical reaction, foggy head, head ache, chills, body ache, fatigue  36 hours after 2nd vaccine on 5/30 had very painful constant and unrelenting stomach cramps for a solid 7 hours  48 hours after had unusual skin pain on torso area off and on for 2-3 days  10 days after vaccine developed first stages of shingles with significant pain in upper back and torso, mostly on left side  12 days after shingles rash appeared on upper left back, side and chest, lymph nodes in arm pits swollen and tender  15 days after full blown case of shingles with large rash and significant pain in left torso area
Fully vaccinated, not boosted.  COVID infection breakthrough with inpatient hospital stay.  Asthma underlying condition
10/8/2021-Tremors started 5 minutes after the shot was administered. Felt like I could not breathe, but it was not enough to administer the epi-pen that I had in case. The doctor provided 25ml of benadryl which relaxed my muscles. The office gave juice and water.  10/11/2021- Tremors continued but then I noticed speech delays and stuttering. 10/14/2021- Went to the emergency room where more tests were done and referred to a neurologist. next visit December 6, 2021
Heavy Bleeding , blood clots for a week straight i woke up in a puddle of blood and i was not on my period at all
4 year black male with onset of rash x 3 days ago. Pruritic water blisters. Came in 1 stage. School excuse given until lesions heal.
Moderna product was stored in the fridge and experienced warm excursions; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna product was stored in the fridge and experienced warm excursions) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 063B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna product was stored in the fridge and experienced warm excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna product was stored in the fridge and experienced warm excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna product was stored in the fridge and experienced warm excursions).    No concomitant information provided  Lot 063B22A (Monovalent) was delivered on 9/9 and placed in the freezer upon delivery. Lot was relocated to the fridge on 11/3/2022 and quarantined 8pm 11/20.  No treatment information provided
Information has been received from a medical assistant concerning a 45 year old female with migraines (approximately 18-Mar-2005), multiple sclerosis relapse with optic neuritis and dizziness (approximately September 2005), burning with injections of interferon beta-la (REBIF) therapy, pneumonia (December 2005) and a history of pneumonia (2000) who on 03-Jan-2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #651319/1007P). Concomitant suspect therapy included interferon beta-la (REBIF), SC, 44 mcg, 3 times weekly, for the treatment of multiple sclerosis, initiated on 18-Mar-2005. Other concomitant therapy included eletriptan hydrobromide (RELPAX) and levofloxacin (LEVAQUIN). On 03-Jan-2006, the patient went to an emergency room, and subsequently, was hospitalized. The patient's pneumonia was reported as not worse, however, had not cleared up. Therefore, the patient's pneumonia was evaluated at that time. In January 2006, the patient's white blood cell count was noted to be 19,000. The patient was placed on intravenous antibiotics and pain medication for the treatment of cellulitis. On 10-Jan-2006, the patient was discharged with a peripherally inserted central catheter (PICC) to continue intravenous antibiotic treatment. The patient had a discussion with her neurologist on approximately 11-Jan-2006, the cellulitis area was no longer painful and had looked better, and the patient stated that her pneumonia was better, although, she felt tired. It was reported that as of 01-Mar-2006, the patient was doing well and "everything had completely resolved." It was also reported that the patient's physician stated she felt therapy with interferon beta-la (REBIF) contributed to both the pneumonia and vaccination site cellulitis due to interferon bet-la (REBIF) causing decreased immunity. Additional information has been requested.
Completely hypo-tonic, labored breathing,weak cry. Dx of transverse myelitis was made.
The day after the vaccine, about 24 h following injection, noticed small tender bruises on both my legs, about 4 or 5 bruises per leg, w no trauma or cause. No Hx of similar past issues.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 12Apr2021 at 16:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus, spondylarthritis, eczema and tachycardia. Concomitant medications included hydroxyzine (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), loloestrine (MANUFACTURER UNKNOWN) and semaglutide (OZEMPIC), all were from an unknown date and for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the arm left on 17Mar2021 at 16:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 22:00, the patient noticed small tender bruises on both of her legs, about 4 or 5 bruises per leg, with no trauma or cause, a day after the vaccine, about 24 h following the injection and no Hx of similar past issues. The events did not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event bruise was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
The patient had the Moderna vaccine booster on 10/28/21, and on 11/9/21 had started experiencing symptoms (one side of face swelling/redness/drooping). The patient had called the MD office and was referred to us. Apparently, the patient had not actually spoken to the doctor but to someone in the office. I advised to get checked out by the doctor and to contact them again. The patient did not seem to indicate that the symptoms were severe. I was concerned about whether the reaction was from the vaccine or something else entirely (stroke).
Generalized weakness; Hyponatremia; Dehydration; COVID-19 virus infection; Recurrent right pleural effusion; Fall, initial encounter; Hypokalemia
A  23 month old patient / was vaccinated on June9th with Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 23-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9L39Z, expiry date 8th October 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th June 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 9th June 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The health care professional reported that a 23 months old patient had received Boostrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
"I had pain in the middle of my back an every time I tried to take a breath it would hurt like a broken rib."
few hours later when I pee it had oil spot on my urine. It repeat again on next time I went to bathroom then it stop.
This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Moderna product on 03/04/2021, 04/01/2021, 11/11/2021, and 04/07/2022. They first tested positive via antigen test at the long term care facility at which they were a resident on 09/21/2022. They presented to emergency department on 09/25/2022 with sore throat, fever, malaise, decreased appetite, and fatigue. They were admitted to hospital and found to have bronchopneumonia and to be hypoxic. They were discharged back to the long term care facility on 09/28/2022.   They then presented to emergency department on 10/10/2022 with a chief complaint  of "a brief episode of unresponsiveness while eating" which was possibly attributed to choking. They were discharged back to the long term care facility, on hospice on 10/11/2022. They were seen by the LTCF provider on 10/12/2022 and hospice status was confirmed. They died on 10/17/2022.   Even with the length of time between the positive COVID-19 test and the death, COVID-19 is on the death certificate.
Rash - area blotchy, redness around vaccine site, swollen, warm to touch, soreness.
Dizziness, Weak, Fatigue - could not drive and called out sick from work.  It was an effort to brush teeth.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received TWINRIX adult. On an unknown date, the patient received TWINRIX adult at an unknown dose. On an unknown date, unknown after receiving TWINRIX adult, the patient experienced injection site pain and injection site bruising. On an unknown date, the outcome of the injection site pain and injection site bruising were unknown. It was unknown if the reporter considered the injection site pain and injection site bruising to be related to TWINRIX adult.
Intense ear ache in both ears beginning an hour after injection.   Consistent ringing in both ears beginning afternoon of following day as the ear ache subsided. Ringing in ears has persisted ever since and has not gone away. It does vary in intensity between background noise and severe.
Patient has tingling,numbness, in Left thumb, index, and middle fingers.  Feels as if fingertips are asleep.  She has not sought treatment.
This spontaneous report was received from a other health professional referring to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX intramuscular after being improperly stored at 33F (for an unspecified amount of time) (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the event was unknown. The case has been linked with the cases (same reporter link) 1406USA008158, 1406USA008474, 1406USA008476 and 1406USA008477. Additional information is not expected.
Patient reported itching beginning at injection site and spreading around to various spots 2 weeks after her vaccine.  I checked with her 2 days later to see if it resolved and it had.
Delayed redness and swelling in arm at injection site, hot to touch, soreness, itchy
First two days, fever, aches and malaise. The 2nd and 3rd days, malaise, extreme muscle and joint pain. Body tender; pain with touch. Right axillary swollen and painful.
I immediately had heart flutters after receiving each vaccine. Administrator of vaccine stated it might be nerves but I was not nervous. I had chest pains intermittently and sought care at an urgent care facility in July 2021. EKG showed sinus arrhythmia.  CHest pains continued and saw a Cardiologist in December 2021. Echocardiogram showed a leaky tricuspid valve.
Shitty feeling; Not feeling well; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL, MALAISE (Not feeling well) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS, Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced FEELING ABNORMAL, MALAISE (Not feeling well) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Shitty feeling), MALAISE (Not feeling well) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant medication included unspecified blood pressure and cholesterol medication.  The patient had a goody packet which has Acetaminophen, Aspirin and Caffeine and an extra bottle of Tylenol. The patient was concerned if she could take the goody packet for the symptoms she developed after the 2nd shot.  Treatment details were not provided.   This case was linked to MOD-2021-049382 (Patient Link).
Bells Palsy,  Paralysis of face,  Prednisone for 7 days,.  Hospital  emergency room on the 18th of March to  diagnosis.
This spontaneous report was received from an unspecified reporter referring to a 16 year old patient of unknown gender. Information about the patient's medical history or concurrent conditions were not reported. On 04-AUG-2015, the patient was vaccinated with hepatitis a vaccine (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided). Other suspect therapies included hepatitis b vaccine (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided); HPV (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided); and meningococcal vaccine (manufacturer unknown), (dose, route of administration, lot #, expiration date and indication were not provided). Concomitant medication was not reported. On an unknown date, the patient experienced a vaccine adverse experience. At the time of reporting, the outcome of vaccine adverse experience was unknown. The causality between vaccine adverse experience and hepatitis a vaccine (manufacturer unknown), hepatitis b vaccine (manufacturer unknown), HPV (manufacturer unknown) and meningococcal vaccine (manufacturer unknown) was unknown. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a registered nurse refers to a 6 month old male patient. On 08-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
9 x 10 cm tender induration (L) deltoid - site of KINRIX vaccination.
Presented to ED w/SOB, hypoxia; admitted w/ COVID-19 pna and acute hypoxic resp failure; tx w/steroids, abx, O2, Vit C, Remdesivir, zinc; dc'd to rehab w/O2.