chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A serious spontaneous report of short of breath and swelling of face and non-serious events of shaky, stomach upset and rash have been received from a consumer concerning herself, a 35-year-old female, subsequent to FLUMIST. Neither medical history nor concomitant medication was reported for this patient. On 13-Oct-2010, the patient received FLUMIST. On 16-Oct-2010, the patient experienced short of breath, shaky, swelling of face, stomach upset and rash. The outcome of the events short of breath, shaky, swelling of face, stomach upset and rash was not resolved.
Ongoing issues with Diarrhea for several weeks.  He meant to call in a prescription for Lomotil, but it hadn't been called in at last check.  Taking OTC Imodium (generic) currently - which seems to make it manageable.  I have a 'consultation' scheduled with GI Consultants on March 2, 2023.
pt recvd vax w/Hep B vax & devel diabetes; No further details were provided;
Pt vaccinated with Meruvax II developed arthralgia & fatigue which persisted for a few months w/improvement.
No additional AE reported.; an expired dose of MMR II was administered; This spontaneous report was received from a pharmacist referring to a 4 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-JUL-2022, an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (therapy type: rHA (recombinant Human albumin) (lot # T020656, expiration date: 16-JUN-2022) was administered to the patient for prophylaxis (strength and route of administration were not provided) (expired product administered). The vaccine was stored in the recommended storage range until administration. No additional adverse event reported (no adverse event).
This spontaneous report was received from a pharmacist via a company representative, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, frequency, route, lot # and expiration date were not reported) to prevent shingles. After administration of ZOSTAVAX, the patient developed a "large erythema on the back of the arm;" the type of erythema was unknown and it was not clear if it manifested as redness or as a rash. At the time of the report, the outcome of the event was unknown. No product quality complaint was involved (PQC). The causality between the adverse event and ZOSTAVAX was unknown.  Additional information has been requested.
<15 min from immunization, individual experienced LOC <60 sec, hypotension, convulsions, and loss of bladder. Comfort care and oral fluids given, and donor recovered within 20 minutes. No EMS care necessary.
My son was diagnosed with Crohn's disease. During the first year he lost weight of a dancing failure to thrive however we did not correlate it originally to the vaccine or the disease. After the second dose he developed various dermatitis and G.I. issues consistent with Crohn's disease and an adverse reaction. After the third dose, his G.I. symptoms increased and he developed Rotavirus anemia and other symptoms consistent with Crohn's disease.
03/22/2000 Chills, fever 99.9 orally. Rash, generalized, itchy. 03/23 treated with medication. 03/27 Nurse called and pt had recovered completely.
Came Seventy-four year male past medical history hypertension or CVA congestive heart failure, in which a complaint of worsening shortness of breath for past 4 days the emergency room patient is impulsive COVID-19 below were showing WBC 8.3 hemoglobin 9 point platelet count 126 troponin 0.086 BNP 103  is 0.6 rapid influenza negative lung perfusion scan negative for  PE, CT showing extensive multifocal atypical pneumonia distributed on upper greater than lower lobes a typical for COVID-19 admitted for further workup and treatment on 12/3/21.Patient was managed  on ceftriaxone , doxycycline for suspected secondary bacteria pneumonia , decadron , remdesivir . Oxygen requirements have been stable. Patient needs and is being discharged on 4 L NC at rest and 6 L NC with exertion. Discharged on 12/10/21
swollen arms; headache; red patch; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arms), ERYTHEMA (red patch) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0071321A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LORATADINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), SPIRONOLACTONE (SPIROLACTON), GABAPENTIN (NEURONTIN), CARVEDILOL (COREG), INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ERYTHEMA (red patch). On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arms) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swollen arms), ERYTHEMA (red patch) and HEADACHE (headache) outcome was unknown.
A report has been received from a Pharmacist concerning a 9 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 25-NOV-2014. It was reported that we inadvertently administered expired FLUMIST Quadrivalent in two patients which started on 25-NOV-2014. The outcome of the event of inadvertently administered expired FLUMIST Quadrivalent is unknown. The report was considered to be non-serious.
07/22/2021: Positive COVID test 1 day prior and headache, body aches, wheezing, and diarrhea 2 days prior to admission. Wheezing and diarrhea worsened and brought her into hospital.  07/23/2021: Improved SOB and bowel issues.  Continue to monitor and treat.  07/24/2021-07/25/2021: Cough shows improvement. Patient O2 Sat remains > 90% on room air.  07/26/2021: Discharged in stable condition with a new prescription for albuterol.
Patient following administration of the vaccine became lethargic and pulse slowed down. Epinephrine was administered and patient was responsive. She did vomit and was hot to the touch and mildly sweaty.
Blood in urine and semen. Went to primary dr for blood and urine analysis and everything came back fine she had no idea why that was happening. I then made an appointment for cscan from my andrologist and that also came back fine after two weeks it stopped so scary. Also my girlfriend did not get her period for two months we both had real sore arms for a week and both have never felt the same way since.
never received their 2nd due to COVID (pandemic); This case was reported by a pharmacist and described the occurrence of social problem in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patient never received their 2nd due to COVID pandemic, which led to social problem. No lot or expiration date available because it was administered at a different site. The reporter consented to follow up.
Patient had a possible stroke, or possible head bleed from her fall yesterday. Documented s/s  of CVA prior to immunization. Pt has left-sided lower extremity functional limitations. left arm extremity weakness. left leg extremity weakness. Admitted to hospital from 1/14 - 1/18    Diagnosis CVA
Dry mouth right after injection; This spontaneous case was reported by a pharmacist and describes the occurrence of DRY MOUTH (Dry mouth right after injection) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: NSAIDS (Long term use of NSAIDs) on 19-Aug-2021. Concurrent medical conditions included Foot callus since 19-Aug-2021, Pain in hip since 19-Aug-2021 and Leg pain since 19-Aug-2021.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter once. On 19-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DRY MOUTH (Dry mouth right after injection). At the time of the report, DRY MOUTH (Dry mouth right after injection) outcome was unknown.        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.   Concomitant medications were not reported.  Treatment information was not provided.  Reporter states that two different patients, one male and one female, given the vaccine reported severe dry mouth right after injection.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Added patient demographics, medical history
29 y/o G2P1 at 36 weeks GA had symptomatic tachycardia HR 150's and shortness of breath after injection. Went to emergency room morning after. D-dimer negative no PE suspected. UTI was suspected at that time and Keflex prescribed but culture result showed insignificant growth. Pt's sxs self resolved without further treatment.
VACCINE RELATED HEALTH ISSUES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was perfectly healthy person with an uneventful medical file before 07-MAR-2021. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021, the patient experienced vaccine related health issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccine related health issues. This report was non-serious.
Constant headache , feeling like pressure in the head, feeling like head is very heavy, constant laud noise
Joint ache, chills, running nose, coughing, slight feverish, headache.
Patient returned to clinic after 30 min from receiving vaccines reporting an allergic reaction. Patient presented with macular papular rash on left cheek. No SOB, no itching. Overall feeling fine.
9/14/06 developed low grade fever, fine red rash starting in groin and covering body. 9/19/06 developed intermittent shivering and tremors lasting 4 to 6 hours visited ER, child subdued "not like herself". 9/20/06 Rash resolved no further tremors, acting more like usual.
Patient was booked by his family in system as his 13 year old sister.  Information was changed at vaccine site to this patient who was only 11 years 5 months old.  This was not caught until after the patient received his shot. We aware of any untoward effects.  Patient's mother was informed this would be reported to the DPH and CDC.  Patient's mother indicated she was aware he was not eligible at this time.  This was her second attempt to get him vaccinated as he was turned away at a previous clinic.
Client became light headed and dizzy after injection. Pale skin and some chest tightness. Denied any difficulty breathing.
Information has been received from a physician assistant concerning a 74 year old female patient who on 04-FEB-2010 was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck). Physician assistant stated that no adverse effect. Additional information has been requested. This is one of several reports from the same source.
On  4/29/21 she reported a metallic taste in her mouth. on 4/30/21 she had foggy brain, forgetfulness. The metallic taste and foggy brain continued until the next week. On 5/5/2021 she reported she had a day with God and had several encounters throughtout the day that she stated she was receiving messages from God. Thursday 5/6/2021 she remained home with family and was continously religously preoocupied, paranoid, ranting about the day prior that she had spent with God, mentioned she had been tremboling all day long because she was in the present of God. The next day she couldnt put her thoughts together, disorganized thinking, she had forgetten basic skills of everyday living and how to accomplish them. Laughing and crying at inappropriate times. She was then on 5/7/2021 around 3pm taken to the ER to be evaluated. In the ER she was yelling and screaming responding to voices, hallucinating, delusional. She had to be physically and chemical restrained. They were unsuccessful in stabilizing her and identifying any cause except for post COVID vaccine psychosis and was transferred to psychiatric Hospital for further evaluation and treatment. Which she has been at for 6 days with no improvement. She has not responded to any treatment given.
fatigue; malaise; Low fever; Flu-like symptoms; Sweaty; Laying bed; This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number M95T2, expiry date 29th October 2021) for prophylaxis.   On 25th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced fatigue, malaise, fever, influenza-like symptoms, sweating and bedridden. On an unknown date, the outcome of the fatigue, malaise, fever, influenza-like symptoms, sweating and bedridden were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, malaise, fever, influenza-like symptoms, sweating and bedridden to be related to Shingrix.  Additional details were provided as follows: The healthcare professional (HCP) reported that a patient received her first dose of Shingrix and 8-12 hours later she was laying bed with fatigue, malaise, low fever, sweaty and flu-like symptoms that are still unresolved. The reporter was consented to follow up. The reporter stated that they can follow-up with the HCP. The HCP reported that she reported this information through VAERS previously.
Was given Tdap HPV (Gardasil) and MCV Menveo.
We received on 13 DEC 2007 the following information from a health care professional: A 23-year-old male patient, born on 29 AUG 1984, was vaccinated i.m. with Fluvirin 2006/2007 (expired on 30 JUN 2006), batch no. 69690, on 10 DEC 2007.  On 12 DEC 2007 the patient developed an adverse vaccination reaction (not further specified) and was hospitalized.  The patient was still hospitalized at time of reporting.  Further information was requested.  Company assessment: seriousness criterion: hospitalization.  Causality: insufficient data.  The amount of data is insufficient to assess causality of this case.  Expectedness assessment: Administration of expired vaccine is not expected.  No change in benefit-risk-ratio.  No measures necessary.  Ref no.: NA07-007052.
Got chicken pox from her second dose.  HUGE sores and infection.  Caused staph. Hospital prescribed Keflex. Problem is that she has to have a DTAP shot again (one on 8/9 also) but shes sick now and school says "its the law". May be forced to keep her out, but the school says they will call cops.
I am not sure if this is related to the Flu shot or not, but I had the exact same effects last year at this time, and possibly the year before at the same time.  Within a few days of the shot, I had belly bloat and felt like there was something stuck in my throat.  I would also get winded after walking up a flight of stairs.  I took Protonix because I though the belly bloat may have been GERD, which would hamper my breathing.   Plus my legs feel very sore, like to a point of muscle failure.  I am eating much healthier this year than last and I had been riding a stationary bike a few times per week and my legs never started hurting like this until a few days after the flu shot.  Last year, it took about 2-3 months for my legs to start feeling strong again and being able to climb stairs without needing a huge breath at the end.  Like I said, I am not sure if this is flu shot related, but it's suspect as its the same symptoms at the same time of year.  My plan is TO NOT get a flu shot next year and see the outcome.   I am not sure of which lot or anything we were given.
Information has been received from a medical assistant concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. Since 06-SEP-2017, the patients were vaccinated with M-M-R II (lot # M034387 with expiration date 19-JUL-2018) rHA (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent. The administered vaccines were improperly stored at temperature greater than 47°F but less than 77°F for 1 hour and 20 minutes without any previous temperature excursion; this information was registered in a digital data logger. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA009573:
This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a female patient who received BEXSERO for prophylaxis. On 24th August 2018, the patient received the 2nd dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site erythema, injection site swelling, injection site bruising, injection site induration and skin discoloration. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site bruising and skin discoloration were unknown and the outcome of the injection site induration was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site bruising, injection site induration and skin discoloration to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. Lot number was unavailable at time of reporting. The reported that the patient experienced an injection site reaction after vaccination with BEXSERO. The injection site was red, swollen, bruised, and brownish in color, and at the time of reporting the site was hard after 1 week.
My breast got so sore with the Moderna Dose 1 which I received in my Left arm. I have fibroids in my chest. So I received the Moderna  Dose 2 in my right arm and I did not have that problem. Not very long after the 2nd shot I got the flu, around the end of May. They tested for COVID-19 and it was negative. So they decided it was the flu. It has progressively gotten worse. I don't know if its long-hauler symptoms because I have had COVID1- 19 twice. I started to feel like I had mono. I feel like I weighed a ton. It takes every ounce of energy to lift my arm. I am tired all the time. I am a singer, and I would do an exercise with my lungs, before having COVID-19 ,  now I have trouble doing the exercise.   I have headaches. I have a broken neck which causes me to have headaches. They did a procedure where they killed the nerves. But this is a different kind of headache. The kind of headache you get when you have mono. My migraines have increased. For a while I was having them everyday. I have been able to slow the headaches down. I now walk like a drunken sailor, I have a hard time getting my balance. I have trouble finding words.  I don't know what is causing this. It might be the vaccine. It might be the flu or having the COVID-19. My dreams have changed since I have had COVID-19. I had COVID-19 in November and I had the vaccines in March . My dreams have become far more realistic. I was sent to a Psychologist . They said I do not have Alzheimer or Dementia . They can't explain the changes in my dreams. They are not nightmares. They are just dreams. I am not blaming it on  the vaccines. I would just like to feel better.
Information has been received from a registered nurse, via a company representative, concerning a female patient (age not specified), who on approximately 08-AUG-2007 ("two weeks" ago) was vaccinated with a dose of Gardasil (Lot # not provided).  On approximately 08-AUG-2007 the patient experienced pain and soreness at the injection site, and the nurse indicated it continued, two weeks later.  At the time of this report, the outcome of the event was not recovered.  The patient sought unspecified medical attention.  Additional information has been requested.
2 days after being vaccinated stared with headache, nausea, and abdominal discomfort.
In Aug I had the Delta variant couldn't get out of bed, 2022 covid, 2023 covid/ Long Covid is killing me; In Aug I had the Delta variant couldn't get out of bed, 2022 covid, 2023 covid/ Long Covid is killing me; In Aug I had the Delta variant couldn't get out of bed, 2022 covid, 2023 covid/ Long Covid is killing me; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Aug2021, outcome "unknown" and all described as "In Aug I had the Delta variant couldn't get out of bed, 2022 covid, 2023 covid/ Long Covid is killing me"; DISEASE RECURRENCE (medically significant) with onset 2022, outcome "unknown", described as "In Aug I had the Delta variant couldn't get out of bed, 2022 covid, 2023 covid/ Long Covid is killing me". Additional information: The patient received the first round of double Covid vaccine back in Jan2021, the patient had a reaction to it in the left arm and that night the right hand started trembling, so when the patient went for the second the on-hand pharmacist had the patient get it in the right arm. In Aug2021, the patient had the Delta variant and couldn't get out of bed, 2022 COVID, 2023 COVID. It's like the patient have no immune system anymore thanks to the vaccine and the patient's body just keeps getting weaker and weaker. Doctors are no help. Long Covid was killing the patient.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Widespread hives, itchiness, redness on face, neck, chest, back, legs, arms, hands, and feet. Hives started two days following 3rd dose (booster) of Pfizer vaccine. By third night, hives were so severe that an urgent care visit was needed. Prescribed prednisone, benadryl, zyrtec, and pepcid. Six days post-vaccine and hives are still persistent. They go away for a few hours at a time with medications, but come back all over body.  Benadryl not extremely effective and helpful for only 2-3 hours at a time. No exposure to any other allergens.