chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Insomnia; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 05May2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included oral antibiotics from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 12Apr2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 10May2021, the patient experienced insomnia. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of insomnia was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Had a stroke; A spontaneous report was received from a healthcare professional concerning a 57-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a stroke.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10-Mar-2021, at 13:30, the patient received first of two planned doses of mRNA-1273 (batch: not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 10-Mar-2021, at 15:30, the patient had a stroke and was admitted.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event had a stroke was considered resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 27-OCT-2012 11:44, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
9/21/13 fever 100.2, stomach pain. 9/22/13 - 10/10/13 - very sleepy, several naps, not active. 9/26/13 - not feeling well, runny nose no fever. 10/7/13 - sent home from school, fever 100.1. 10/9/13 - sent home from school, can't stay awake, uneasy on feet. 10/9/13 - went to primary care seen nurse practitioner. Labs (mono, strep, WBC, RBC) negative results. Sent home. 10/10/13 - no fever, unable to walk, unable to stand, unable to sit up without falling, balance off, not talking much. Took to ER. Seen Dr. Lab work, urine sample, nasal sample, EKG, chest x-ray (pneumonia), CT head (normal), spinal tap (fluid not clear). Admitted to hospital. 10/11/13 - ran on IV fluids and antibiotics for pneumonia. Received a call from primary care strep (+). 10/12/13 - MRI brain, T-spine, L-spine. Neurologist diagnosed A.D.E.M. Spinal cord inflamed, brain inflamed. Treated with IVIG (5 treatments x1 per day). 10/13/13 - 2nd treatment IVIG. Unable to walk, sit up, tired pain in lower back. 10/14/13 - 3rd treatment IVIG. Able to sit up with little help. OT and PT. 10/15/13 - 4th treatment IVIG. Able to walk with some help, balance still off. 10/16/13 - 5th treatment IVIG. Able to walk with little help, balance off some. OT and PT. 10/17/13 - stable, able to go home, must be under supervision. 10/21/13 - f/u w/neurologist cleared to go to school no restrictions.
No additional adverse experiences reported; Caller reports that an improperly stored vaccine was administered to a patient. Caller reports there have been no additional adverse experiences reported. No further information provided. Caller declined being contacted regarding the event. Additiona; This spontaneous report was received from a physician, and refers to a patient of unknown age and gender. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On 11-JAN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 1 dose, lot number: W023866, expiration date: 24-JAN-2024 (route of administration was not reported).  On an unknown date, the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) underwent temperature excursion of 10 Celsius degrees for a time frame of 1 hour and 28 minutes. No previous temperature excursions were reported. No adverse events were reported.
About 15 minutes after receiving Pfizer vaccine dose 1 IM LD, pt experienced itchiness and tightness of the throat and breathing difficulty. Pt immediately brought to nearby cots to lay down. BP 130/78, Pulse 92, O2 99. 5 minutes later BP increased to 142/86, Pulse 70, O2 99. Pt began to relax a bit but symptoms were unchanged and Epinephrine 0.3mg x1 given & EMS called. BP 10 minutes later 144/80, pulse 70 O2 99. EMS arrived 10 minutes later, BP 146/90, and brought to nearby hospital.
FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 18-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
About a week later, my arm had a mild "covid arm" reaction (red, warm, swollen).   I also got a mild headache (sharp, forehead area) that has not yet fully resolved.  It is different from the vestibular chronic issue that I have.
First booster dose gave me a bad reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (First booster dose gave me a bad reaction) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (First booster dose gave me a bad reaction). At the time of the report, IMMUNISATION REACTION (First booster dose gave me a bad reaction) outcome was unknown.            No concomitant medication was reported.  Patient mentioned that she received Moderna's Primary series, first booster and the new Bivalent as a second booster. Batch number of new Bivalent second booster was AS7146B. The patient heard in the internet that some batches of the Moderna New Bivalent were contaminated. She was worried and would like to know if the lot number AS7146B that she received was contaminated or not. No treatment medication was reported.
Patient temporarily relocated due to hurricane, deficient in vaccines per country standards. Was ordered and given a combination vaccine QUADRACEL at age 9, not recommended over age 6.
Chills, migraine, photophobia, muscle aches, armpit soreness, extreme thirst. All began about 16 good after my dose and later about 2 days.
Fatigue  Muscle or body aches  Headache  New loss of taste or smell  Congestion or running nose  Nausea or vomiting
Lightheaded. Nausea Seen by on site EMT BP=116/57 P= 50 02=100
At 06:00 pm, my entire body began to ache along with a severe headache. At 08:00 PM, my body temperature was 101. I was shaking, became nauseous, vomited. My fever subsided around 02:00 am, and by 06:00 all my adverse reaction was over.
I had a severe headache with sensitivity to light, a very sore arm, and fatigue the day after the second shot. Fatigue continued for several days.   take combination estradiol birth control on a 28 day cycle with 7 placebo pills, and have for 9 years. Normally I begin withdrawal bleeds 1-2 days after I start the placebo pills, and have one day of moderate-light bleeding with cramping, and two days of light bleeding with occasional spotting the fourth day.   The first menstrual cycle I had about a week after the second shot, this was not the case. The withdrawal bleeding began several days late (day 4 or 5 of the placebo week) and was extremely light, only lasting for one day. I took a pregnancy.  I had a severe headache with sensitivity to light, a very sore arm, and fatigue the day after the second shot. Fatigue continued for several days.  More significantly, I take combination estradiol birth control on a 28 day cycle with 7 placebo pills, and have for 9 years. Normally I begin withdrawal bleeds 1-2 days after I start the placebo pills, and have one day of moderate-light bleeding with cramping, and two days of light bleeding with occasional spotting the fourth day.   The first menstrual cycle I had about a week after the second shot, this was not the case. The withdrawal bleeding began several days late (day 4 or 5 of the placebo week) and was extremely light, only lasting for one day. I took a pregnancy test which was negative. A week later, I began to experience breast soreness, lasting up through the next withdrawal bleeding cycle; I took a second pregnancy test just before the second placebo week. In the next placebo pill week, I experienced 5 days of heavy bleeding, the first two of which presented with severe cramping, which has not happened in many years.
MISCARRIED TWICE; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported.  The patient was pregnant at the time of vaccination. The patient was gravida 2 and para 0. The date of the patient's last menstrual period and expected delivery date were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine exposure during pregnancy and had miscarried twice. It was reported that "A niece miscarried twice". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the miscarried twice and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220750036, 20220750167, 20220750301, 20220752219 and 20220750085.; Sender's Comments: V0:  20220752074- covid-19 vaccine ad26.cov2.s -Miscarried twice. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable  20220752074 -Covid-19 vaccine ad26.CoV-2.s- Vaccine exposure during pregnancy. This event is considered not related. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Started having a headache, sore throat and congestion. Took a home COVID-19 test and was positive. Contacted doctor and told to rest.
fever of 102 for 2 days after getting the Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever of 102 for 2 days after getting the Covid vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: she got the Pfizer vaccine back in May and now she cannot get the flu, shingles. and the pneumonia shot because she is a servivor of GBS. She wants to know if Pfizer is making those vaccines with the MRNA rather then the virus so she can get the other vaccines. She also said she had a fever of 102 for 2 days after getting the Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is a chemical receiver at work.  This could be a possibility for his reaction. He believes it is related to vaccine. I am not fully convinced this is the case but would like to report for a possible cause.  He developed skin rash during the last week of July . It started with rash on face and get escalated. His whole body is hot red with diagnose of Erythrodermic skin eruption with skin peeling.   He was diagnosed of DVT on Sept 20, 2021.
This spontaneous report as received from a consumer refers to her daughter, a female patient of unknown age. A consumer reported that on an unknown date her daughter was administered a first dose of intramuscular GARDASIL (lot#, dose/frequency not provided) injection and they missed the 2nd administration. There was no adverse reaction. No additional information was reported. Additional information is not expected.
Information has been received from a physician concerning a female who was vaccinated with GARDASIL injection. The physician reported that a patient received GARDASIL and five days later developed blotches on her back. Patient was referred to dermatologist. The outcome was not reported. There was no product quality complaint. Additional information has been requested.
As part of the FDA?s actions, the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized.
Severe joint pain; Headache; 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 ARTHRALGIA (Severe joint pain) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.    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 ARTHRALGIA (Severe joint pain) and HEADACHE (Headache). At the time of the report, ARTHRALGIA (Severe joint pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Rash at injection site first appeared on evening of day 8 post-vaccination. Elevated temperature (102) and general body aches appeared day 11 @ 8PM. Temperature normal (98.7) day 12 @ 7AM.  Reported to doctor (virtual appointment). Recommended Covid test.
Patient was given Varicella-SQ on 12/22/05.  Patient has no known allergies of any kind.  12/29/05 mother called to report the patient woke this morning 12/29/05 at 10:30 with swollen lips.  Only symptom patient has.  Patient admitted to consuming salmon prior to going to sleep 12/28/05.  Patient's mother also states that patient has a history of eczema.  Mother states that child had flare up of eczema located on her scalp starting earlier in the week of 12/29/05.
difficulty swallowing   day 2 fatigue drowsy diarrhea  day 7
This spontaneous report as received from a pharmacist, via a company representative, refers to a patient of unknown age and gender. No information of patient's medical history, concurrent conditions or concomitant drugs was provided. It was reported that on unspecified dates the patient received 2 doses of ZOSTAVAX subcutaneously (dose and lot # not reported). There were no known adverse effects. Additional information has been requested.
Constant soreness jab site along with swollen throbbing glands in arms , neck, head; constant sharp joint ache elbows, neck, left hand;
I had the super flu shot on 11.02.15. That night I got very sick...nauseated and huge fatigue that has lasted until today, 11.04.15. My physician prescribed nausea suppositories but I still am not feeling well. Not as nauseated but had dry heaves last night...as no food in my stomach. I'm concerned that for seniors (I am 73 years old), this super flu shot can be very very dangerous and there should be much  more warning. Pharmacy sort of blew it off when I called say it was very rate. I've spoken with several friends who have had the same reaction. I believe better and more information and warning up front should be made available to consumers.
Received Varivax on 7/11/06. On 7/21/06 rash on abdomen, R T 104 with Motrin. Seen at ED, diag with varicella.
This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. On 12-MAY-2014 the patient was vaccinated with a dose of PROQUAD (Merck), subcutaneously. It was reported that the patient received the PROQUAD (Merck) in error. No known adverse effects reported. No further information was provided. Additional information has been requested.
Information has been received from a registered nurse concerning an 18 year old female who on 15-OCT-2007, was vaccinated with a dose of Gardasil (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were reported.  It was unknown whether medical attention was sought.  There was no product quality complaint.  This is one of several reports from the same source.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Hoshimoto" (unspecified if ongoing), notes: Other medical history: Hoshimoto; "Known allergies: Iodine" (unspecified if ongoing), notes: Known allergies: Iodine. Concomitant medication(s) included: ZOLPIDEM, start date: 01Sep2021, stop date: 21Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (30Nov2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (30Nov2022) Negative, notes: Prior tested negative twice 30Nov2022; (30Nov2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment: Paxlovid from 22Nov2022 to 26Nov2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 07/09/2001 DTaP, IPV, MMR and 2nd Hep B given. At noon 07/09/2001 client developed low grade fever followed by vomiting and diarrhea. Fever subsided after 1 dose of Tylenol. On 07/11/2001, mother called with the above information. Instructed to go to urgent care.
Almost immediate severe suicidal thoughts. Within hours.  Crying.  Anger.  Inability to control thoughts of self-harm and crying.  I thought I was contacting a help line by clicking this link, but it?s just a long form.  It?s upsetting.   So many mental health issues since getting COVID.  I hope everyone reading this is well.
Patient received first dose of Jynneos Vaccine was observed for 15 mins, departed the facility in stable condition and returned 10 mons after due to reported nausea, Vomiting, Dizziness and diarrhea. Fluid provided, leg elevation and iced pack provided. During extended observation time Vital sign are WNL throughout incidents. Patient states he has a history of anxiety and took medication this morning prior getting vaccinated. Patient symptoms is fully resolved and encouraged to follow up with pcp if the symptoms returned . Patient departed from facility by Head clinician. Patient was alert, oriented x 4 with steady gait, in good condition and showing no signs and symptoms of distress.
Quadracel was accidentally administered to a 24 month old, male child/ No AE; Initial information received on 12-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 24 months old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patients past medical history and family history were not provided.  Concomitant medication included HEPATITIS B VACCINE.   On 12-Jun-2019, the patient received first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5500CA, expiry date 16-Aug-2020 via intramuscular route in the left thigh.  It was an actual medication error due to inappropriate age at vaccine administration.  It was reported that Quadracel was accidentally administered to a 24 month old, male child.  The patient did not experience any adverse reaction after the injection.   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 and Module VI of the 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.  List of documents held by sender: none.
Pt recvd vax & less than 24 hrs p/vax had confluent macular rash on both arms/back thighs; pt was seen by MD; treated w/DPH;
SEVERE RASH CHEST, NECK, AND FACE EACH DAY IMPROVING WITH BENADRYL AND HYDROCORTISONE 2.5% CREAM
Felt weak, diaphoretic, pale, had patient lie down.  Patient felt better after lying down.  Color returned, skin warm and dry. Denies breathing problems.  09:50: 10/50,68,20.  10:05: 88/60,64,20.  10:20: 109/60,64,20.  Sitting up talking, feels "okay".  Color pink, skin warm/dry.  10:30: ambulating, talking no s/u.