chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse, referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 20-JAN-2017 and 20-MAR-2017, the patient was vaccinated with the first and second dose of GARDASIL (lot#, expiration date, route, concentration and dose were unknown), and then on 24-JUL-2017, the patient was vaccinated with the third dose of GARDASIL 9 (lot#, expiration date, route, concentration and dose were unknown), all three doses for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
outbreak of shingles occurred on the left side of my torso/suspected vaccination failure; outbreak of shingles occurred on the left side of my torso; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (INFLUENZA SHOT) for prophylaxis.   The patient's past medical history included shingles (had shingles twice before (in 1981 in my 20s and then later on)).   On 12-JAN-2021, the patient received Shingrix. On 29-SEP-2023, the patient received INFLUENZA SHOT. On 01-OCT-2023, 992 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: outbreak of shingles occurred on the left side of my torso/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: outbreak of shingles occurred on the left side of my torso).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK receipt date: 6-Oct-2023 The patient received a Shingrix vaccination and on 29th September 2023,  received his or her annual flu shot vaccination.  Two days later after Flu shot, the patient had an outbreak of shingles occurred on the left side of his or her torso. The patient was very disappointed to be suffering the effects of shingles now at age 65 after receiving the Shingrix medication. The physician said that no vaccine was 100 percent effective but come on man. The patient really did not want a callback. It was unknown if the reporter considered the shingles to be related to Flu shot. This case was considered as suspected vaccination failure as details regarding completion of primary schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.
C/O rash on left arm x 2 days after receiving DTAP vaccine.  2x3 inches induration erythematous.
Information has been received from a consumer concerning herself (a 61 year old female) with no medical history and drug allergies who on 21-APR-2009 was vaccinated with a dose of ZOSTER vaccine live (Merck).  Concomitant therapy included HYDROCHLOROTHIAZIDE.  On 22-APR-2009 the patient developed an injection site reaction after receiving ZOSTER vaccine live (Merck).  Initially redness was about 2 and 1/2 inches across.  On 24-Apr-2009 the redness has increased from her shoulder to her elbow.  The area was "hard" and very painful like a "bee sting".  The patient sought medical attention and was seen by nurse and pharmacist.  At the time of reporting the patient was not recovered.  Additional information has been requested.
Injection given 01/06/2005 according to patient noticed red spots in his left arm, muscle pain.  Brownish discolored blistered noted.
Patient received first dose Moderna. Stated to nurse he needed Pfizer. Inadvertently received Pfizer and then realized patient was supposed to have received Moderna. Per CDC interim recommendations,  patient is fully vaccinated
Patient began experiencing Shortness of Breath, which increased until he had to be transported to the ER on 3/26/2021.  He was diagnosed with severe Congestive Heart Failure, with an injection fraction of 15% and kidney function below 30%.   He was released to hospice care 4/5/2021 with Pleur-Ex drains to both lung areas.  He continued to get worse, including TIAs, until he died on 5/31/2021.
second dose they administered a 1mL dose and not the recommended 0.5mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (second dose they administered a 1mL dose and not the recommended 0.5mL dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced OVERDOSE (second dose they administered a 1mL dose and not the recommended 0.5mL dose). At the time of the report, OVERDOSE (second dose they administered a 1mL dose and not the recommended 0.5mL dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
continued to get worse; her arm was very heavy; pinpoint pain traveling down her elbow and around down to her middle finger; throbbing, continued to get worse; diarrhea; raised a bit, red, and started itching; raised, spreading where injection site was,bigger than size of a baseball,raised a bit; raised a bit, red, and started itching; body aches; fatigue, tired, just wants to sleep; headache; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (continued to get worse), LIMB DISCOMFORT (her arm was very heavy), PAIN IN EXTREMITY (pinpoint pain traveling down her elbow and around down to her middle finger), PAIN (throbbing, continued to get worse) and DIARRHOEA (diarrhea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 003A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol and Insomnia. Concomitant products included SIMVASTATIN for Cholesterol, ALPRAZOLAM and TRAZODONE for Insomnia, NORTRIPTYLINE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced CONDITION AGGRAVATED (continued to get worse), LIMB DISCOMFORT (her arm was very heavy), PAIN IN EXTREMITY (pinpoint pain traveling down her elbow and around down to her middle finger), PAIN (throbbing, continued to get worse), DIARRHOEA (diarrhea), VACCINATION SITE PRURITUS (raised a bit, red, and started itching), VACCINATION SITE SWELLING (raised, spreading where injection site was,bigger than size of a baseball,raised a bit), VACCINATION SITE ERYTHEMA (raised a bit, red, and started itching), MYALGIA (body aches), FATIGUE (fatigue, tired, just wants to sleep) and HEADACHE (headache). The patient was treated with BETAMETHASONE for Adverse event, at a dose of topical cream 0.1%. At the time of the report, CONDITION AGGRAVATED (continued to get worse), LIMB DISCOMFORT (her arm was very heavy), PAIN IN EXTREMITY (pinpoint pain traveling down her elbow and around down to her middle finger), PAIN (throbbing, continued to get worse), DIARRHOEA (diarrhea), VACCINATION SITE PRURITUS (raised a bit, red, and started itching), VACCINATION SITE SWELLING (raised, spreading where injection site was,bigger than size of a baseball,raised a bit), VACCINATION SITE ERYTHEMA (raised a bit, red, and started itching), MYALGIA (body aches), FATIGUE (fatigue, tired, just wants to sleep) and HEADACHE (headache) outcome was unknown.            It was reported that patient was on BRAT diet.   This case was linked to MOD-2021-033090, MOD-2021-410512 (Patient Link).
Pfizer 4/2/21, 4/23/21, 9/27/21. Positive on 1/9/22
Headache, Nausea, Dizzy, confusion, moodswings, Fever, Sweats, Insomnia
vaccine Dose 1  given 3/30/2021 Moderna Lot # 020B21A Pt died in the ER following a motor vehicle accident
Menstrual changes, memory impairment, migraines, numbness. Tingling. Vision changes, diarrhea
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated subcutaneously with lot # (670816/0693AA exp date 11-AUG-2012), 0.65 ml dose of ZOSTAVAX on 13-AUG-2012. The only patient identifier that the nurse had available at the time of the report was the prescription number 175715. The pharmacist stated that to her knowledge the patient had not reported or exhibited any adverse effects. Additional information has been requested.
Information has been received from a physician concerning a 36 year old female with a zinc allergy who on 9/27/99 "accidentially" vaccinated IM in the right deltoid with 1 dose of haemophilus b conjugate vaccine. The pt was intended to receive Hep-B vaccine recombinant. On 9/28/99, the pt noticed shortness of breath and right sided chest pain in the morning and also thoracic pain. The pt sought unspecified medical treatment. Anti-inflammatory medications were prescribed. No further information is available.
Slight temp 99.2 since 8JUN91, spiked to 105 on 10JUN91 then to 99 on 11JUN91; swelling on rt side jaw x 10 days starting 2 wks post vax;
Status Migrainosus. - IN  ER for severe migraines that began 6 hours after the vaccine shot on 4/13/201 In Hospital for IV Infusions, Neurology specialist are following her. Migraines are still happening
Rash x yesterday. Itches Tx with Acyclovir 2 1/2 tsp QID x 5 days 200/s.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  OBSTRUCTIVE SLEEP APNEA ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Shivering x 2 hrs after injection. Redness, warmth and swelling on arm below injection site, including elbow. Approx 6" in length. Advised ibuprofen and antihistamines. Appt if gets worse.
Body aches, fever, severe chills began about 8-12 hrs after receiving vaccine, and lasted approx 16 hrs. Treated with ibuprofen (Motrin) and hot showers.
Health department went to  Nursing Home on 11/18/21 to vaccinate employees/residents as needed.  Client received 1st pfizer vaccine.  Client called and left message 11/19/21; tried to call back; no answer left message.  Made contact with client 11/22/21.  Client reported after vaccination on 11/18/21 developed numbness and tingling of the right side of her face, neck, down to shoulder.  She reports started shortly after vaccination and resolved midday 11/19/21.  Reports she has notified her PCP.   Denies any issues at this time.  As of our conversation on 11/22/21, client reports feels fine with no issues.
Patient states the area of the injection is red and swollen as large as a baseball and is painful. Advised patient to follow-up with his primary care physician.
Report completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose: 01/21/21,Pfizer   Lot#EL3248 2nd dose: 02/04/21,Pfizer ,Lot# EL9264 04 Diagnosed covid positive:04/07/21 Exposure:Unknown Symptoms:Fever,HA,fatigue,runny nose.
I did not have an adverse event after receiving the vaccine. I started having symptoms of a sore throat and runny nose on 10/19/2021. I tested for COVID-19 on the week of 10/19/2021 each day and it was negative. On 10/27/2021 I tested positive with a home test for COVID-19. I contacted my doctor and was given two prescriptions for inhalers. One month later, I tested positive for COVID-19 again on 11/27/2021. As of today, I do not consider myself recovered. I continue to have a cough, shortness of breath, heart issues, palpitations, body aches and severe fatigue.
It started on May 20th in the morning with very watery diarrhea and I had a stool test was negative for bacteria and parasites and lactate and then a tissue sample was taken and I was diagnosed with microscopic colitis. My doctor stated that I need to take three Pepto Bismol tablets three times per day. The doctor also stated that they could not say for certain what cause the condition. I received the diagnosis today.
approx 10min p/vax pt fell down on floor w/generalize body movement 15-20seconds;
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 04-MAY-2013, the patient was vaccinated with a dose of GARDASIL (lot # H020002, expiry date 08-AUG-2015), with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
PATIENT STARTED EXPERIENCING SWELLING IN HER ARM WHERE THE INJECTION WAS GIVEN. ARM WAS ALSO WARM TO TOUCH AND ITCHING. SHE EXPERIENCED BODY ACHES AND CHILLS, BUT NO FEVER. SYMPTOMS BEGAN ABOUT 7 HOURS AFTER THE VACCINE WAS GIVEN.
Pt reports to the pharmacy 70 days after vaccine was administered complaining of shoulder pain. Pt says that pain only started after immunization was given. He states having trouble going to sleep due to the pain and has already seen his Dr.
Wrong solution used; Wrong solution used; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-APR-2022 Reporter's Comments: Quality assurance pharmacist reported that a one of his/her outlying clinics noticed a discrepancy in the number of Shingrix vials and diluent vials. They surmised that there was a possibility that sterile water stocked in the clinic might had inadvertently been used for reconstitution instead of the diluent. The reporter would like to know if there were consequences/implications to any affected patients if sterile water was used for reconstitution and asked if had any information on this. Health care professional(HCP) stated that there was no information regarding date, patient, lot/expiry date.  The reporter consented to follow up via email. Additional Supportive Information: As the patients were administered the shingrix vaccine using the sterile water diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022058850:Same reporter. FU1 - deleted.
a patient received a dose of PENTACEL which was delayed a day in transit, took too long to deliver to the office/ No AE; a patient received a dose of PENTACEL which was delayed a day in transit, took too long to deliver to the office/ No AE; Initial information received on 29-Mar-2021 regarding an unsolicited valid  non-serious case received from an other health care professional via physician (Reference number- 00539892).  This case involves a 15 months old and unknown gender patient who received a 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was delayed a day in transit, took too long to deliver to the office (batch number UJ403AAA, expiry date: 09-OCT-2021) Frequency: once, Strength: standard via intramuscular route in the left thigh on 25-Mar-2021 for prophylactic vaccination (product storage error and product distribution issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  List concomitant or no other vaccines: none.  It was an actual medication error due to incorrect product storage and product shipment delay (latency: same day).  Potential Product Technique Complain: No, Caller states that their PENTACEL was delayed a day in transit but were placed in the fridge as soon as they arrived, the ice packs were still cold. Informed caller that the stability info is only after they have arrived to the facility. Caller stated that three doses were given right when it was delivered, do they need to repeat the doses. How far apart should they be administered. Vaccine given after product took too long to deliver to the office.  Emergency Room/ Doctor Visit date: 25Mar2021, Product used and Still using product: No.  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
a little hot/ felt kind of hot; Fatigue; Chills; muscle aches; a little fever; This is a spontaneous report contactable consumer(patient). A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0161) via an unspecified route of administration in arm left on 10Apr2021 13:00 (age at the time of vaccination 72-year-old) as dose 1, single for COVID-19 immunisation at clinic. The patient's medical history included had tested positive for COVID back in November. The patient stated he believed he received vaccine for flu and shingles sometime in Mar2021. The patient's concomitant medications were not reported. The patient stated that he had the first shot a week ago Saturday and had a little reaction the day after. He stated he experienced fatigue, chills, muscle aches so nothing too serious and possibly a little fever on 11Apr2021. He stated since then he had been hearing all this chatter about the antibodies and if one had the antibodies the shot could have some sort of reaction because of the antibodies in the system. He stated as far as he knew he never had the test to see if he had antibodies and wondering since he was getting the second shot here in a couple of weeks and since he did not want complications and plan on getting the second shot if there was any definitive information about the antibodies. He stated he just had the symptoms for one day which was the day after the vaccine. He never took his temperature he just felt kind of hot and so he was not sure if he had a fever, it just seemed like he did since he was hot. He clarified that he just experienced feeling a little hot. The patient did not think he received treatment for adverse events. History of all previous immunization with the Pfizer vaccine considered as suspect and additional administered vaccines were none. Adverse events were not resulted into emergency room and physician office visit. Adverse events following prior vaccinations were none. Family medical history relevant to adverse event was none. He had not relevant tests. The outcome of adverse event was recovered on 12Apr2021.  No follow-up attempts are possible. No further information is expected.
Diagnosis of acute flaccid myelitis, Hx improvement RUE symptoms, followed by clinical worsening post influenza vaccine with new onset lower extremity weakness.
Severe lower back muscle sprain/strain; it happened while doing a normal activity of weeding, but I had also been hiking earlier in the day, but it was not unusual for me. The sprain/strain was very severe and I was extremely limited in mobility for days. I went to a chiropractor several times. She adjusted my back and gave me exercises. I also treated it with medicated patches and a massager. It gradually improved until after about 3 weeks I did not need the medicated patches anymore and could get back to my normal activities.
C/O rt lower abd pain 3-4 wks after GARDASIL vaccine given - CT scan done 6-14-13 - showed mesenteric lymphadenitis - continued to have pain off and on RLQ - ultrasound done 6-30-13 1.7 cm rt adnexal cyst revealed - Feb 19, 2014 ultrasound RLQ showed large complex hemorrhagic cyst in rt ovary.
Patients husbands described coughing, ill feeling while driving received some antihistamines and breathing treatments. Patient got worse at MD's office. Epi administered ambulance called. Symptoms resolved at ER.
On 2/13/08, child came to clinic for immunizations.  Nurse noted that child received Varicella vaccine 3 days after receiving MMR vaccine.  Was told by operator at clinic to complete VAERS.  Explained to father that nurse would repeat the Varicella since Varicella given 9/22/07 was too soon after MMR. No reaction. Was given too soon after MMR.
My symptoms started the next day after my second dose of phizer, my lymph nodes were swollen in my arm and my neck and chest...this subsided but my arm and wrist ached for weeks...it seemed to get better and now 4 weeks out, my left arm is sore again, some burning in my shoulder and bicep muscle again
Cellulitis in arm patient received vaccine. Treated KEFLEX 500mg every 6 hours for 7 days.
05/25/2021 - 6:00am - 2:00pm: Nauseous, 2:00pm - 5:00pm Dizzy 05/25/2021 - 05/26/2021 5:00pm: Headache on and off 05/26/2021 - 5:00pm : Migraine, light sensitivity: Took Aleve 05/26/2021 - 8:00pm : Migraine, light sensitivity : Emergency Room, Received shot for migraine and CT scan, saw bleeding on brain Transferred to Hospital by ambulance.  CT scan done found blood clot in left side of head and blood work showed blood platelets were low.  Diagnosis: Cerebral Venous Sinus Thrombosis, Thrombocytopenia. 05/27/2021 : Admitted to hospital in the Neuro ICU Transfusion of Nonautologous Globulin into Peripheral Vein Transfusion of Nonautologous Platelets into Peripheral Vein Placed on blood thinners. 06/02/2021  Discharged from hospital into Doctors' Care
Employee says her left arm where she had injection became sore after vaccine received that night. Her entire arm has hurt now for 2 wks and difficulty lifting arm above head or dressing herself.  She denies any numbness or tingling unless lays on it for long period of time.  She also denies any fever and site looks normal where injection given and no swelling noted.
Post vax, the pt developed mild chicken pox; several vesicles over the body-following normal course of disease. Treated symptomaticly.