chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse concerning to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date since 23-APR-2015, the patients were vaccinated with an unspecified number of improperly stored doses of PNEUMOVAX 23 (lot # K008927, expiration date: 17-MAR-2016) (dose and route were not reported). No concomitant therapies were provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Initial misuse report received from a healthcare professional on 08 JULY 2013. A 2-year-old patient was administered a dose of ADACEL. No adverse event was reported. Documents held by sender: none
Couple of hours afterward, notice a little sluggish feeling. Few days later, I began to be very anxious and irritable.
pt started vomiting during the evening-large amounts & had swelling @ the inj site;lt thigh where DTAP was given two days before;
1st dose few years ago, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose (0.5 ml) on an unknown date, on left arm, a few years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 25-OCT-2022 Reporter's comment:  The patient reported that she had not gotten the second vaccine yet. She did not want to provide anymore demographics and did not have any further information about the vaccine itself.  The reporter did not consent to follow up. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Swelling lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swelling lymph nodes). At the time of the report, LYMPHADENOPATHY (Swelling lymph nodes) outcome was unknown. Not Provided      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.  The patient received their first dose on 18-Mar-2021 and developed swelling of the lymph nodes.  No Concomitant product use was reported. No treatment information was provided.
102 F fever and rash developed around mid arm. Also a rash new vaccine injection site.
18 hours after vaccine very severe headache and nausea accompanied by being light headed and blurred vision.  After three hours the headaches got worse and I eventually blacked out.  Fell out of chair and hit my head on the floor.  When I came to I was still light headed and more tired than what I was before I blacked out.
Pounding headache; Chills; body aches; fever of 100.2; This is a spontaneous report from a contactable nurse. A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular in the right arm on 08Jan2021 14:30 at a single dose for COVID-19 immunization. The patient's medical history included high blood pressure. The patient had no known allergies to medications, food, or other products. Concomitant medications included levothyroxine sodium (SYNTHROID), hydrochlorothiazide, and losartan potassium (LOSARTIN). The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in the left arm on 18Dec2020 14:30 at a single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 09Jan2021 02:30, the patient experienced pounding headache. On Jan2021, 18-40 hours after vaccination, the patient experienced chills, body aches, and fever of 100.2. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021. The events were considered non-serious by the reporter.
Vaccine given 09/18/13 - started with redness, swelling at injection site Thursday - worse by next day Friday 9/20/13 - doctor evaluated - diagnosed secondary cellulitis and prescribed Augmentin for 10 days.
I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 6/10/2021 ALZHEIMERS DISEASE
started him on his oxygen; O2 went from 85 to 98; bp 155; notably shuffled; became non-responsive; looks like he is having a stroke; This is a spontaneous report from a contactable consumer (patient's daughter). A 94-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 25Feb2021 13:45 (at 94-year-old) at single dose (Arm Right) for COVID-19 immunization. Vaccination facility type is clinic. Medical history included congestive heart failure, early stages dementia. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 04Feb2021 (at 93-year-old) on right arm for COVID-19 immunization.  The patient had no covid prior vaccination. Patient has no known allergies. The patient (father) seemed to be doing fine until 19:45 on 26Feb2021 roughly 30 hours after vaccination. He has early stages dementia, so if he was feeling ill he didn't report anything, and they didn't notice anything. He got up from the table, notably shuffled the 10 feet to the bathroom, sat down on the toilet before we could "pull down his pants", and then became non-responsive. The reporter said to her son it looks like he is having a stroke. They got him onto the floor. started him on his oxygen concentrator (usually used only at night), O2 went from 85 to 98; bp 155 from an unspecified date. after a while he came to. he is dnr, dni, so they didn't call an ambulance. Eventually they got him up. no signs of stroke. He does have congestive heart failure. This has never happened before, and he has no history of falling. Daughter was reporting the next morning. He has not yet been awake since this occurred. it is now 8am 27Feb2021. Covid was not tested post vaccination. The outcome of the event o2 went from 85 to 98 was recovered, while for other events was unknown.  Information on the lot/batch number has been requested.
Mom states child started acting strange within 1-2 hrs after receiving vaccines.  She started acting tired then started having a "meltdown" and being very angry and physically violent.  They had to restrain her because she was hitting and kicking dad when he was getting her out of the car.  Strange behavior continued at home.  Report was taken two days after vaccinations and mom states she is doing better but still some problems with behavior. Mom states child has a hx of behavior problems.  They will be talking to a counselor to help deal with her.  Mom requested VAERS be submitted.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "IV Contrast Dye" (unspecified if ongoing), notes: Known allergies: IV dye. The patient's concomitant medications were not reported. Past drug history included: Nsaids, reaction(s): "Known allergies: NSAIDS", notes: Known allergies: NSAIDS.Other medication in 2weeks: Unknown. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (07Aug2022) Negative; (11Aug2022) Positive; (24Aug2022) Positive. COVID 19 Treatment with Paxlovid ,Treatment start date: 28Jul2022,Treatment stop date: 01Aug2022. Covid symptoms stopped 07Aug, negative test 11Aug, tested positive again 24Aug, husband tested positive 23Aug.Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Administered a dose reconstituted with sterile water; Administered a dose reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA603A, expiry date 30th September 2022) for prophylaxis.   On 10th May 2022, the patient received Menveo. On 10th May 2022, unknown after receiving Menveo, 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: 16-MAY-2022 Reporters comment: The patient received a dose of the lyophilized powder vial of Menveo reconstituted with sterile water. The reporter consented to follow up. Additional supportive information: The patient received a dose of the lyophilized powder vial of Menveo reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Patient has experienced chest pain, occasional sharp stomach/back pain; tingling in hands and feet; dizziness; lightheaded; feeling as though they are going to pass out; palpitations; shortness of breath; anxiety.
Onset Sunday February 21, 2021: headache, stomach cramping, diarrhea, fatigue, muscle aches Monday Feb 22: symptoms not as severe Tuesday Feb 23: headache and stomach cramps remain, with some gastrointestinal distress Weds Feb 24: symptoms diminished significantly Thursday Feb 24: symptoms dissipated completely
Mother noticed rash on legs, trunk and arms on 2/18/2000, Red area around injection site x 2. Mom called reguarding rash to body, post vax, and instructed her to bring child to clinic. On questioning, mother remembers similar rash after DTAP-HIB IZ on 8/7/99. Mother did not report this to the nurse on 2/17/2000. Per call to her MD, report given and she was instructed to give child Benadryl.
Patient received 4 mo vaccine; 24hrs post vaccine was given, pt has progressively needed increased oxygen requirements related to desaturations. Septic workup done and antibiotic therapy started. Within 72hrs, pt was retintubated on 06/24/06 due to respiratory distress. All cultures were negative, antibiotics stopped after 3 days. Pt improved and was extubated on 06/26/06. 10/13/2006 Received medical records which reveal patient was hospitalized from birth 2/12/06 until d/c to home 9/27/06.  Hospitalization included multiple probable episodes of sepsis, treated with antibiotics, multiple episodes of hypoglycemia and pneumonia.  Trached. Eczema.  Received multiple blood transfusions for anemia, and platelet transfusions for thrombocytopenia.  Large PDA treated with fluid restriction.  Multiple episodes of coding. Final Active Dx: bronchopulmonary dysplasia, cor pulmonale./ss
Individual is Her2 Positive; This is a spontaneous report from a contactable consumer (patient). An adult female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 25Mar2021 (Batch/Lot number was not reported) as single dose, dose 2 intramuscular on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included aromotase inhibitor anastrozole; hormone therapy of intravenous trastuzumab (HERCEPTIN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The individual was Her2 Positive on an unspecified date and during treatment associated with post chemo there was a change in 2 cancer antigen markers in blood work:  1) Cancer Antigen 15-3 (CA 1503) and 2) Carcinoembryonic Antigen (CEA). Outcome of event was unknown.  Information about lot/batch number has been requested.
The expired Jynneos vaccine was administered to the patient, intradermally; The expired Jynneos vaccine was administered to the patient, intradermally; Case reference number US-BN-2023-000051 is a spontaneous case report initially received from other health care professional via Communications (reference number: USBAV23-0058) on 11-Jan-2023 and concerns an adult patient of unknown gender.  The patient's medical history and concomitant medication details were not provided.  On 03-Jan-2023, the patient was vaccinated with the first dose of expired Jynneos vaccine (batch number: FDP00014; expiration date: 19-Dec-2022), at an unknown dose or site of administration, intradermally, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection').    At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 11-Jan-2023 included the local BN case ID.  This case is linked to cases US-BN-2023-000050, US-BN-2023-000052, US-BN-2023-000053, US-BN-2023-000054 and US-BN-2023-000055 (same reporter).; Reporter's Comments: An adult patient of unknown gender was vaccinated with the first dose of expired Jynneos vaccine, at an unknown dose or site of administration, intradermally, for monkeypox, which is considered as expired product administered. No associated adverse events were reported. Intradermal injection and expired product administered are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and expired product administered are not related to Jynneos vaccine, but to a human factor. The case is non-serious.; Sender's Comments: An adult patient of unknown gender was vaccinated with the first dose of expired Jynneos vaccine, at an unknown dose or site of administration, intradermally, for monkeypox, which is considered as expired product administered. No associated adverse events were reported. Intradermal injection and expired product administered are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and expired product administered are not related to Jynneos vaccine, but to a human factor. The case is non-serious.
This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of PNEUMOVAX, (dose number, lot/batch number, expiration date, route of administration not reported), that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also M-M-R II, GARDASIL, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS# 1405USA012894, 1406USA000955, 1406USA000957 and 1406USA000958 respectively). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Nasal Congestion, Runny Nose, Sneezing, Sore Throat, Chest Congestion, Lethargy
Information has been received from a health professional concerning a 4year old female patient who on 11/14/97 was vaccinated with varicella virus vaccine live. concomitant therapy that day included MMRII and poliovirus vaccine (manufacturer unknown). On approximately, 06/26/01, the patient experienced more than 50 lesions. The patient was seen in a physician's office. It was noted that the patient's three cousins (WAES01071705, WAES01071706, WAES01071707) had  similar experiences after receiving varicella vaccine live. Additional information has been requested.
Large erythema/bruising & sl induration around injection site.  Erythema 4x5 inches, no warmth.  Walking fine.
congestion in his throat; pain in the jaw that radiated from his jawbone up to the ear; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: EL9266, Expiration Date not reported) via an unspecified route of administration, administered in the right arm on 14Feb2021 08:00 (at the age of 76-years-old), as dose 1, single for COVID-19 immunisation. Medical history included stroke from 2017 and ongoing. Concomitant medications included warfarin taken for stroke from 2017 and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other vaccines was administered with COVID-19 vaccine. The patient experienced pain in the jaw that radiated from his jawbone up to the ear on 15Feb2021 and congestion in his throat on 17Feb2021. Patient reported he had a lot of congestion in his throat that doesn't go up or down. He did not have any other problems and nor was he not feeling well. At night things were worse for him.. He reported that he was scheduled to get the second dose 07Mar2021. Patient took paracetamol (TYLENOL) every 8 hours as a result of pain in the jaw. Event did not result to either physician office or emergency room visit. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
sx arthralgia bilat shoulders, elbows & hips flu-like sx: dizziness, malaise, weakness, & nausea; also pos swollen lymph glands @ neck & axilla; initial onset of arthralgia 24 hrs, flu-sx 72 hrs; duration 7-8 days; pharyngitis
Patient begin to feel faint about 5 minutes after receiving vaccine. He became very pale and fainted briefly (less than 2 minutes). Patient sat and waited at the facility for about 30 minutes after regaining consciousness. He regained his color and was able to leave.
Injection site devolped a sore red circle around the site. On day 3 the soreness & red area has moved from my shoulder to cover more of my arm and it very mildly itchy.
in the same month received Fluarix and an Influenza vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 15-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number NS775, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season).   On 22nd October 2021, the patient received the 2nd dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device and an unknown time after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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 provided were as follows: Age at vaccination was not reported. The pharmacist reported that the patient was administered Fluarix QIV and after administration it was discovered the patient already received an influenza vaccine on 11th October 2021 at a different facility which led to extra dose of vaccine administered. Pharmacist was not sure which influenza vaccine did the patient received. The Pharmacist stated that the patient seems fine at the time of reporting. The reporter consented to follow-up.
Pt recv vax on 10/16/98; on 10/27/98 pt exp seizure.
Pt received Johnson & Johnson vaccine 8/9/21 @ 1000 at a pharmacy out in town. At approximately 1400, pt reported shortness of breath and throat tightness to his corpsman. Pt received unknown amount of Tylenol and Benadryl with no improvement. Pt brought to Hospital ER at 1700 c/o worsening shortness of breath, throat tightness, myalgias, nausea, headache, chills. Pt  found to be tachycardic to 115bpm, mildly tachypnic at 22RR/min, and febrile with TMAX 38.6. Pt's lung sounds clear, tolerating PO secretions, speaking in full sentences, satting 100% on RA. Pt was treated with additional anti-pyretics, IV steroids and fluids with improvement. Pt discharged to home after a few hours in the ER with recommended PCM follow-up.
lot of people are getting injured with the kids and heart stuff; heart stuff; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INJURY (lot of people are getting injured with the kids and heart stuff) and CARDIAC DISCOMFORT (heart stuff) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJURY (lot of people are getting injured with the kids and heart stuff) and CARDIAC DISCOMFORT (heart stuff). At the time of the report, INJURY (lot of people are getting injured with the kids and heart stuff) and CARDIAC DISCOMFORT (heart stuff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-307789, MOD-2021-308041 (Patient Link).
She developed chills, headaches and weakness starting the day after vaccination 1/14. Profound weakness. She was unable to get out of bed. She developed hypoxia 86 to 90%. She was sent to the emergency room, she was noted to have a urinary tract infection.