chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2009, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 10-JUN-2016, the patient was treated by a physician for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
pt recv vax & w/in 48-72hr p/vax pt exp bell's palsy rt side;sx cont as of 9JAN96;
Severe headache ad nausea . Trouble breathing and felt like my tongue was swollen, Came very close to calling 911.  Finally went to sleep sitting up. Did not go into work the next day. Was able to breath ok in the morning.. The trouble breathing was very scary. I get the flu shot every year and never had a problem. I will never get this shot again. Last year I was given the Flu ad 65+ Quad PF 0.55ml and no issue. This year Fluzone HD 65+ 0.7 ML too strong.
This is a spontaneous report from a non-clinical study program. A contactable 74-year-old female consumer received PREVNAR 13 on unknown date. The consumer stated that she had pneumonia 13 times. She stated that health was not good still getting over the pneumonia from 6 months ago, still coughing up stuff from her chest. Consumer stated that when she was in the fifth grade she had a severe allergic reaction to Diphtheria shot. At the time of reporting, the patient was recovering. Follow-up (13Sep2013) Follow-up attempts completed. No further information expected.
NO SYMPTOMS - GIVEN WRONG BIVALENT DOSE. WRONG DOB WAS PROVIDED AND PHARMACIST WAS NOT NOTIFIED UNTIL AFTER SHOT WAS GIVEN. PT SHOULD HAVE GOTTEN PEDIATRIC BIVALENT BOOSTER (ORANGE CAP)
Within 24 hours of injection had fairly intense headache lasting about 36 hours. Associated with Nausea. No vomiting. Unresponsive to Motrin 800mg taken three times during course of headache.
Myalgia & NauseaVomiting  Narrative:  Employee had the vaccine 01/04/2021 at 1pm. Employee claimed  that later in the evening she started having body ache, nausea getting worse  progressively till the following day. Employee took Aleve and Zofran to alleviate  the symptoms , that resolved completely
Severe nausea, headache, chills, dizziness, joint pains, muscle aches, 104 deg fever Treated nausea with  Treated fever and other symptoms with 1000 mg Tylenol
I had severe chills on Friday and my arm was feverish and sore until this morning. I also had weakness and dizziness.
Local (around area of injection) swelling, redness, pain, and itching that has been worsening since 2/27/09 (when given).
Bilateral upper anterior to lateral thighs with approx 2+ inch clusters of fine firm pink papules, some excoriated.
PAINFUL LYMPH NODE IN THE ARM WHERE VACCINE SHOT WAS GIVEN; FEELING BAD; RASH ON  ARM; SWOLLEN LYMPH NODE IN THE ARM WHERE VACCINE SHOT WAS GIVEN; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 07-SEP-2021, the patient experienced chills. On 07-SEP-2021, the patient experienced headache. On 08-SEP-2021, the patient experienced painful lymph node in the arm where vaccine shot was given. On 08-SEP-2021, the patient experienced feeling bad. On 08-SEP-2021, the patient experienced rash on arm. On 08-SEP-2021, the patient experienced swollen lymph node in the arm where vaccine shot was given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache, swollen lymph node in the arm where vaccine shot was given, rash on arm, painful lymph node in the arm where vaccine shot was given and feeling bad was not reported. This report was non-serious.
I began having heart palpitations on 2/8/2021 which I recieved an ekg for which indicated I have a sinus arrhythmia - I have also had parasthesia in my R hand starting 2/13/2021.
Employee reported diminished sense of smell and taste and 12/18 the day following vaccine. A nasopharyngeal swab was performed for PCR testing for COVID-19 on the day (12/18) and was negative for COVID-19 (Not Detected).
Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Diarrhea-Mild, Systemic: cramps-Mild
accidental administration of FLUBLOK Quadrivalent instead of FLUZONE HIGH DOSE Quadrivalent with no reported adverse event; Initial information received on 30-Oct-2023 regarding an unsolicited valid non-serious case received from patient.  This case involves a 82 years old male patient who experienced accidental administration of Influenza Quadrivalent Recombinant vaccine [FLUBLOK QIV] instead of Fluzone High Dose quadrivalent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Oct-2023, the patient accidentally received 0.5 ml dose of suspect Influenza Quadrivalent Recombinant vaccine (formulation, lot number and expiry: not reported) via unknown route in the left arm for immunization; instead of Fluzone High Dose Quadrivalent with no reported adverse event (wrong product administered) (latency: same day). Information on the batch number was requested.  No lab data was reported.  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 the 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.
Fever, chill, tired, diarrhea  Fever, chill, and tiredness all cleared up with 8 hours. The diarrhea persists (9 weeks). Current diagnosis is microscopic colitis and I will be beginning a course of steroids to stop the inflammation
p/vax pt exp a lot of swelling of the entire area;red & hard;warm to touch;
2 days, post vax, child developed a fever of 103F, fatigue, leg aches, mild tongue swelling and a whoop-like cough, lasting 3 days. Did no go to physician for evaluation. Mother reports that these symptoms began on 3/23/01. She reported to health dept. this reaction on 4/5/01.
Per EMS, " nausea and facial flushing" post injection. She  reported a similar reaction to the H1N1 shot (not reported verbally to injector). 25 mg Bendryl IV by paramedic, she reported relief felt and declined transportation.
patient did not receive the full dose administered because of "issues with the needle"; Accidental underdose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (patient did not receive the full dose administered because of "issues with the needle") and ACCIDENTAL UNDERDOSE (Accidental underdose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-May-2021, the patient experienced DEVICE CONNECTION ISSUE (patient did not receive the full dose administered because of "issues with the needle") and ACCIDENTAL UNDERDOSE (Accidental underdose). On 17-May-2021, DEVICE CONNECTION ISSUE (patient did not receive the full dose administered because of "issues with the needle") and ACCIDENTAL UNDERDOSE (Accidental underdose) had resolved.        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.   No concomitant medications reported by investigator. No treatment medications provided by the reporter.
1/4/21 within 4 hours of patient receiving 1st dose COVID-19 vaccination, itching began on sole of right foot in arch area.  Morning of 1/5/21 itching began on sole of left foot in arch area.  Patient look at both feet and noticed a red rash on soles of both feet in arch area approximately 1.5" - 2" in diameter.  1/6/21 blisters developed on right foot in rash area.  1/8/21 patient went to dermatologist; the dermatologist ruled out bacterial and fungal infections.  Dermatologist prescribed a topical steroid lotion and an oral antihistamine (Hydroxyzine HCL 25mg).  1/9/21 patient reported severe burning and itching of both feet and self-treated with a frozen foot roller which successfully subsided the burning and itching.  1/10/21 discontinued use of steroid lotion.  Continues to take oral antihistamine.  1/11/21 blisters are gone but rash is deep red and still exists as of today without itching or burning.
Rebound positive test result of COVID; Rebound positive test result of COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "GERD" (unspecified if ongoing). There were no known drug allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound positive test result of COVID". 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 which included Paxlovid. There was rebound positive test result of COVID-19 1 week after finish of Paxlovid course. The device date was reported as 27Apr2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant referring to a multiple, unknown patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. The medical assistant reported that, on unknown dates, the patients received improperly stored doses of PROQUAD Lot # M022402 with an expiration date on 01-NOV-2017 and Lot # reported as M043307 with an expiration date on 24-APR-2018 (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. The vaccines were stored in a temperature in the range of -9°C to 8°C (-6°C) for a total time of 18 hours. The call was because of a data logger and no previous temperature excursion was registered. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013351.
It felt like a heart attack type of thing; Pins and needles through his chest, arm pits, and arms; Electric shock waves...feelings / felt like he was poisoned; acidic reflux feelings; really weak; felt nauseous; he did not go back to receive his second shot; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that he received the first shot of the vaccine on April and he did not go back to receive his second shot due to a serious reaction that was a lot worse than others. He also mentioned needles, electric shock waves, and acidic reflux feelings. He reported that he felt like he had electric shock waves, he felt really weak and nauseous, felt like he was being poisoned. He said that it lasted for weeks and months and sometimes he still feels it. He said that he also had the pins and needles through his chest, arm pits, and arms. He said that it felt like a heart attack type of thing although he has never had a heart attack. There was no way he was the only person that had bad side effects  He said that he has never had a problem with any other vaccines that he has taken in the past, but he did have a problem with this vaccine. He said that he feels better, but said that he does not know the long term implications of the vaccine. He also asked if he was the only person to ever report a serious adverse reaction with the vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Body aches for 24 hours.  Itching and welts  in areas 42 hours after injection.
Information has been received from the authors in a published literature article. This literature report refers to a 7-year old male with Williams Syndrome and a history of recurrent infections (otitis media, sinusitis, bronchiolitis, and upper respiratory infections) since infancy presented for immune evaluation. He had congenital heart disease, renal disease, and recurrent nephrocalcinosis. His immunoglobulin G (IgG) and immunoglobulin M (IgM) were normal, but his immunoglobulin A (IgA) was low (8 mg/dL). Initially low S. pneumoniae antibodies responded well to PNEUMOVAX 23 (strength, dose, route, lot # and expiration date unknown, for prophylaxis) (product use issue). He was diagnosed with selective IgA deficiency (immunodeficiency).
Upon receiving the Covid booster I started with nonstop headaches.  After 2 months of severe headaches, onset of blurry vision, and shooting pains behind my ears my primary care ordered bloodwork and CT scan. The CT showed an empty sella due to increased intracranial pressure. After following up with a neuro-ophthalmologist who diagnosed idiopathic intracranial hypertension and swollen optic nerves, scheduled a lumbar puncture. I started topiramate, increased the dose then added acetazolamide and increased the dose.  The doctors cannot increase the medications because I have neurological side effects so they can not keep the pressure down in my head and have discussed transverse sinus stenting as the next step to relieve the pressure.  I did consult with a neurosurgeon in April.
Vaccines that were administrated beyond use date after the thaw process.; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administrated beyond use date after the thaw process.) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     It was unknown  if patient had ever been diagnosed with/ tested positive for COVID-19.  It was unknown if patient had chronic or long-standing health conditions  It was unknown if patient had acute illnesses at the time of vaccination and up to one month before.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administrated beyond use date after the thaw process.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administrated beyond use date after the thaw process.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 36 years and 8 months.  No concomitant medication information was provided.  It was reported that the had no adverse reactions after the administration of the vaccines.  No treatment medication were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-542869 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-542869:MCN
Developed some sores; Developed some bumps; painful knot; Painful knot; Painful knot that feels like a sore muscle; Redness / at left arm injection site; Itching at left arm injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 22nd August 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema and injection site itching. On 21st September 2020, the patient experienced skin ulcer, papular rash, pain, mass and muscle soreness. On 1st September 2020, the outcome of the injection site erythema and injection site itching were recovered/resolved. On 12th October 2020, the outcome of the skin ulcer and papular rash were not recovered/not resolved. On an unknown date, the outcome of the pain, mass and muscle soreness were not recovered/not resolved.   The reporter considered the injection site erythema and injection site itching to be related to Shingrix. It was unknown if the reporter considered the skin ulcer, papular rash, pain, mass and muscle soreness to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Consumer reported that she received her 2nd shingrix dose on 21st August, 2020 and About a day later, she experienced Redness and itching at left arm injection site which lasted for 10 days. She also reported that around 3 weeks ago, on the same arm, she developed some bumps/sores and that on the back of her arm she had a very painful knot that felt like a sore muscle. The reporter did not consent to follow up.
2/17/2021 slight itch noted; 2/18/21 red area below injection site, itches, warm, swollen; 2/19/21 larger red area, itches, warm, swollen; 2/20/21 area continues to grow, red on edges-slightly paler in center, itches, warm, swollen, occasional slight pain
Pt was driving home after receiving vaccine.  Noted chest tightness et jaw pain.  Pt gave self BENADRYLl et ALBUTEROL inhaler.  Evaluated in UC- further treatment included  ATARAX, PREDNISONE, ALBUT. inhaler and EPINEPHRINE PEN.
This spontaneous report was received from a nurse and refers to a 74-year-old female patient. The patient's concurrent conditions were not reported. Relevant medical history was reported as "cardiovascular history". Concomitant medications were reported as "lots of medicines" (not specified). On an unspecified date of 2005 (also reported as when she was 60 years old), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufactured unknown) (strength, dose, route of administration, lot # and expiration date were not reported) for pneumococcal prevention. On an unspecified day of December 2018, the patient developed pneumonia that required hospitalization; subsequently, the patient was admitted to the hospital. Some unspecified laboratories and diagnostic studies were performed (details not reported). On an unspecified date, the patient recovered from the event of pneumonia, and, on 02-JAN-2019, she was discharged from the hospital. No further information was provided. Causal relationship between pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and the event of pneumonia was unknown. Upon internal review, the event of pneumonia was considered to be medically significant.
getting COVID.; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (getting COVID.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (getting COVID.). At the time of the report, COVID-19 (getting COVID.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant & Treatment drug reported.  The patient wanted to check for how long should he/she should wait to get the booster, after getting COVID.     Company comment: This case concerns a patient of an unknown age and gender with no medical history provided, who developed non serious unexpected event of special interest - COVID-19 after vaccination with the mRNA-1273 vaccine. The temporal relationship between the event occurrence and vaccination cannot be determined since no dates were provided. There were no reported signs or symptoms of COVID-19 infection and no information regarding the clinical course of the event was disclosed. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with no medical history provided, who developed non serious unexpected event of special interest - COVID-19 after vaccination with the mRNA-1273 vaccine. The temporal relationship between the event occurrence and vaccination cannot be determined since no dates were provided. There were no reported signs or symptoms of COVID-19 infection and no information regarding the clinical course of the event was disclosed. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.