chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Admitted to the ER complaining of 103-104 fever, extreme fatigue, headache, weakness, and nausea.  Initial diagnosis was inflammation and sepsis from unknown origin.  Patient was slightly anemic and had borderline enlargement of the heart on Xray.  Pulse Ox levels were 91-93 prior to giving 02.    Patient had traces of blood and protein in urine.  WBC levels were normal.  Blood cultures failed to reveal a bacterial, viral, or fungal infection.   IV Antibiotics were administered and patient was discharged with no fever after 5 days.  However, patient began experiencing mild afib onn the 5th day.  Metoprolol was prescribed and patient scheduled a follow up echocardiogram. No infection ever located.
5"x5" area of erythema and induration on right thigh; fever of 102.8.
Information regarding Prevnar was received from an investigator regarding a 5 month old male participant in a study who experienced SIDS. The participant received the first dose on 12/4/01. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 12/4/01. Dose regimen was 1 dose. Concomitant therapy included Hib-Titer, Infanrix, Engerix B, and IPV. The patient died on 1/15/02. The coroner's office reported the cause of death as SIDS. An autopsy was performed and material has been requested. The investigator and medical monitor considered sudden infant death syndrome not related to the study product. This report of a serious, labeled, not related event is being submitted in a 15-day time frame as requested by FDA. Autopsy report received which revealed COD as SIDS in 7-week preemie.
03/12/2003: Hands swollen, Headache, cough; 03/13/2003: Chest pain with PVC's on monitor, no sleep, malaise, dry cough, tight chest, axillary adenopathy, headache-took Benadryl, went to hospital to rule out heart attack-sent home.  Symptoms faded over next few days.
1 hour after administration noticed redness, swelling the size of a baseball, hot to the touch, then about 3-4 hours later I was fatigued, then I got fever, chills, Migraine, and vomited.
Patient's mother called at 8:10 AM stating that her son started feeling bad around 11 PM last night. This morning he had a fever of 100.4, chills, muscle aching, severe headache, teeth chattering, and nausea.
Pt had a rash all over the body for 30 days before seeing an md. Got some pills and is fine. Also had watery eyes.
arm swelling; arm redness; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced swelling arm, erythema of extremities and pain in arm. On an unknown date, the outcome of the swelling arm, erythema of extremities and pain in arm were recovered/resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient was the caller's daughter.  The patient received Shingrix and developed arm swelling, redness and soreness and better at the time of reporting. The reporter consented to follow up. This case linked with US2020126270 and US2020126273, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020126270:same reporter US-GLAXOSMITHKLINE-US2020126273:same reporter
Day one:  soreness at injection site, mild achiness and headache, brief episode of intense coughing/wheezing Day two:  slight lightheadedness, episode of vertigo and nausea.    All totally resolved by the end of day 2
In dose 1, i felt extremely tired, sleep a lot, heavy arm to raise.  In dose 2, i got fever, chills, Headache.   After that, the next month after the shot, my period got irregular, more heavy period.   After 4 month, i am getting a pain in the muscle where i got the shot.
FLUVIRIN .5 ml administered IM (L) deltoid 9/23/14 pt developed rash on arms and legs 2 weeks later and still has injection site pain 1 month later. Rash has since cleared. There are no visible abnormalities at injection site.
Infant developed watery diarrhea stools greater than 10 times daily on the day after vaccinations.  No fever, no blood observed in the stools. Still continuing to have frequent watery and loose stools greater than 6 times daily on 10/3/2018 (10 days after vaccinations given). Normal stools for infant are 1-2 times daily. No change in diet or foods (mostly breast fed, but occasional formula supplements).
Not feeling well. Feel like throwing up. Chills. Loss energy. Fever. Dizzy/muscle pain.
local reaction after her first dose; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received (BNT162B2, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced local reaction after her first dose. The outcome of the event was unknown.  Information on the batch number has been requested.
Information has been received from a physician concerning a female who on 05-AUG-2008 was vaccinated with her third dose of GARDASIL vaccine (yeast). After receiving GARDASIL vaccine (yeast), the patient left the office and a few minutes later, she returned. The patient's blood pressure dropped 18 points and she looked dazed. She was given juice. The outcome of the patient was not reported. Additional information has been requested.
Mom states redness and swelling in right thigh started within 4-6 hours after vaccine administered. Applied ice packs, tried soothing bath. Spoke with this office on 03/02/2005, advised warm compresses 4-5x per day. Motrin for discomfort.
My mom would still be alive today if she hadn't been given the jab.; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported for a female patient (mom) that:  A female patient of an unspecified age received bnt162b2 (BNT162B2), dose number unknown via an unspecified route of administration on an unspecified date (at an unspecified age  of vaccination) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient died on an unspecified date. The course of events was as follows: My mom would still be alive today if she hadn't been given the jab. It was not reported if an autopsy was performed.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: My mom would still be alive today if she hadn't been given the jab.
I started getting a mild headache as soon as I got home last night after I got vaccinated. I rested, but this morning im still having headache. My body feels aching , chills and very fatigue, slightly soar. A mild mild cough has even occurred.  Including Soar Arms all the way down to my hands.
Contracted Covid-19; Contracted Covid-19; Inappropriate route of vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation. The patient's relevant medical history included: "T2D (Type 2 diabetes)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "Contracted Covid-19"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate route of vaccination".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
During sleep 15-16Oct04, L neck to left elbow achy and painful. Upon awakening, pain increasing, numbness and tingling in left hand. Pain 8/10 L neck to L elbow at time of this report. Ice applied, L arm elevated. Grips= Pt took 2 Tylenol before bed last NOC and 2 Tylenol in AM 16Oct04. Rec: pt to be seen by PCP.
The first symptoms were immediate pain and swelling in arm which lasted 5 days along with severe fatigue and body aches and headache which lasted two weeks before subsiding. About a week after the shot I started getting pain in my left armpit and could feel a hard painful lump. After doing research I found swollen glands in the armpits were a side effect of the shot. The swollen gland in the armpit went away after 4 days. But is still sensitive to the touch. Then I started to get migraines which have been continuously worse throughout the week with no way to ease the pain. Then I started getting hard painful lumps in my groin area and feeling a sharp pain in my lower stomach and today I noticed I have very cloudy urine but the only pain I have is in my lower stomach.
Hives after Rocephin given on 12/26/01 for strep and at 19 months of age on 8/15/01, had hives from MMR given at well check appt.
immediate lesions at opening of each nostril, within one week severe head and chest congestion, within 6 weeks - near total loss of smell
Patient had stated that he tended to pass out after giving blood.  After shot was given pharmacist stayed with patient in case something happened.  Patient almost immediately said he didn't feel right.  Patient started to lose color and was very hot. Pharmacist got up and stayed next to patient.  Patient slowly lowered  his head and started to breathe heavily.  Pharmacy technician then came over with a cool towel to place on patients head. The pharmacist couldn't tell if patient had in fact passed out because patients head was down and pharmacist was holding patient in place so he didn't fall.  The pharmacy tech was asked if patient passed out and she saw his eyes were open.  Patient then asked how long he was out for.  That was for a total of roughly 5 seconds.  Patient then stayed at pharmacy for around 45 minutes.  He regained his color and his body temp returned to normal.  He did say he was drowsy but felt he was fine to go home.  Patient was called later in the day and he said he was drowsy but feeling much better.
Initial and follow-up information has been received from a physician concerning a 68 year old retired female with a thyroid nodule and raised cholesterol levels and a history of drug reaction to amoxicillin (laryngeal oedema) who on 23-OCT-2006, at 4 p.m., was vaccinated IM, into the left deltoid, with a 0.5 ml first dose of Pneumovax 23 (lot #651401/0619F). Concomitant therapy included Crestor. Several days after the vaccination, the patient experienced pain of the the left upper extremity, 4 to 6 inches above the injection site. There was no redness or swelling. Medical attention was sought and the patient was treated with ibuprofen. There were no laboratory or diagnostic tests performed. At the time of the report, the patient's outcome was unknown. The reporting physician considered the patient's pain in left upper arm to be disabling. No additional is not expected.
Sore arm; chills; fever; fatigue; This is a spontaneous report from a contactable consumer. This 21-year-old (at the time of vaccination) female consumer (patient) reported that she received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9267) via an unspecified route of administration on 18Feb2021 at 09:30 am at single dose on left arm for covid-19 immunisation. Vaccine was administered at School or Student Health Clinic. Patient was not pregnant at the time of vaccination. Patient's medical history was not reported. Past drug included Allergies to medications, food, or other products: Amoxicillin. Historical vaccine included first dose of dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EN9581) on 27Jan2021 at 10:00 am at single dose on left arm for covid-19 immunisation. Patient did not have covid prior vaccination. Patient was tested for covid post vaccination; name covid test; type post vaccination; other on 18Feb2021 with the result as negative. Concomitant medications (within 2 weeks of vaccination) included sertraline hcl, ethinylestradiol, norelgestromin (XULANE). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced sore arm, chills, fever, fatigue on 18Feb2021 at 08:30 pm. Treatment for the adverse event was not given. The outcome of events was recovering.
high-pitched, nonstop screaming for 3 hours, could not be comforted  vomited
devel a temp to 103-104 12hrs p/shot then had sz activity x 2 mins;
Patient had brief period of vasovagal syncope lasting 30-60 seconds. Pt was then alert and oriented and BP, HR, and SpO2 WNL. Patient was able to ambulate out of clinic on her own.
fever/temperature reached 101 degrees; Chills; Swollen lymph node in left armpit/swollen lymph node under her left arm, which is the same side that she received her vaccine; Passed out; Body aches; This is a spontaneous report from a contactable nurse (patient). This 32-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL1283, Expiry Date: Apr2021), via an unspecified route of administration on 27Jan2021 09:00 at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were none. No family history. The patient previously took first dose of BNT162B2 (Lot# EL1283) on 07Jan2021 for COVID-19 immunization. Vaccination facility type was nursing home patient was employed at; administered by pharmacy. No additional vaccines administered on same date of Pfizer suspect. No prior vaccinations received within 4 weeks. No adverse events follow prior vaccinations. Patient had fever: temperature reached 101 degrees, early morning on 28Jan2021; chills on 28Jan2021; body aches: at night of 27Jan2021; passed out: later on day of 27Jan2021, didn't get out of bed, didn't remember passing out. Remembers waking up on the floor; swollen lymph node: under her left armpit/left arm noticed on 28Jan2021, which was the same side that she received her vaccine. Hurts less when she puts her arm down. Really was sore to the point where she had to keep her arm open. She can rest her arm now, but it is still sore. Everything has subsided except for the swollen lymph node. Her energy was back. No relevant tests. Relatedness of bnt162b2 to events for Fever/Chills/Body aches/Passed out/Swollen lymph node in left armpit: Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related. Event relatedness between COVID-19 Vaccine and fever/Body aches/Swollen lymph node in left armpit was Related. Outcome of the event was swollen lymph node was not recovered, outcome of other events was recovering. No investigation assessment.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vials were placed in refrigerator on 6-Dec-2021. The vaccine was used past 30-day use by date. It was reported that patient received booster dose.  No concomitant medications information was reported. No treatment medications reported.   This case was linked to MOD-2022-449729, MOD-2022-449524, MOD-2022-448109 (Patient Link).
Large hard ball at injection site carrying under the arm and moving toward the neck. Patient instructed to go to er.
Both eyes with Keratoconjunctivitis virus; A spontaneous report was received from a pharmacist concerning a 75 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced both eyes with keratoconjunctivitis virus.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On an 07 Feb 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 026L20A and expiery date 28 Jun 2021) intramuscularly for prophylaxis of COVID-19 infection.  On 08 Jan 2021, the patient experienced irritated eyes, problems with vision, sensitivity to light, didn't sleep  the night, and felt like someone put acid in his eyes. On 09 Jan 2021, the patient was seen by his eye doctor and diagnosed with immune response to vaccine with keratoconjunctivitis virus with no infection. Treatment included an unspecified drug.   Action taken with the mRNA-1273 in response to the event was not reported.  On 15 Jan 2021, the outcome of the event keratoconjunctivitis virus was resolved.; Reporter's Comments: This case concerns a 75-year-old, male, who experienced a serious unexpected event of Keratoconjunctivitis (bilateral). The events occurred 2 day after mRNA-1273 (Lot# 026L20A). Treatment information was not provided. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Extreme chills (put in a mouth guard to protect teeth due to chattering ). Lasted a few hours. Fine by morning.
Following fourth anthrax shot, developed a nonpruritic maculopapular rash on neck around 12 days post vaccine. A dermatologist diagnosed as dermatitis and gave elodil cream. Following 5th shot anthrax 4/10/03 rash moved to involved face except scalp. Cream not resolving.
pt recv vax & 5wk later pt tested positive for HBsAg;f/u from the MD indicated that the pt HBsAg was positive only by a non-specific screening test the confirmatory test was negative;
Redness, swelling, and itching at the injection site. Patient instructed to take benedryl.
Started experiencing tinnitus a few hours after receiving vaccine..I'm now having multiple ear issues tinnitus, clogging, itching, pain etc. I made an appointment to see my doctor.
I felt swelling, burning, muscle pain and fever in the left arm. On the third day after the injection the symptoms were worst.
26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreased perfusion added bilateral knee joint pain; 25Dec2020 added facial edema; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; throat scratchy and tight; throat scratchy and tight; 23Dec2020 slight swelling on feet and ankles; 23Dec2020 slight swelling on feet and ankles; Tingling and best flutter 5 minutes after administration; Tingling and best flutter 5 minutes after administration; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number: EJ1685, expiration date: Mar2021), intramuscularly on 22Dec2020 at 09:45 at single dose for COVID-19 immunization in hospital. The patient medical history included known allergies: Sulfa, Penicillin; fibromyalgia; hypertension; high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications included other medications was received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced on 22Dec2020 09:45 tingling and best flutter 5 minutes after administration; 23Dec2020 slight swelling on feet and ankles; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen, throat scratchy and tight; 25Dec2020 added facial edema; 26Dec2020 continued decreased perfusion added bilateral knee joint pain. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included diphenhydramine hydrochloride (BENADRYL) 50 mg every 6 hours. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: Flutter occurred 5 minutes after vaccination; a possible causal association between administration of the suspect vaccine bnt162b2 and the serious event onset cannot be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
tachycardia, palpitations, anxiety, sweating within a few minutes of receiving  the vaccine
Redness and numbness all over the body, unable to swallow, chest tightness. Went to ER was given epi pen to take home. Still currently being monitored
Employee had normal arm pain for the first couple of days after receiving vaccine.  Employee began to develop a dull ache which has continued to be present even on assessment today (10/13/2022)  ROM is good and pain is not in shoulder but locally around the injection site.  No relief with Tylenol or Ibuprofen.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 17-JUL-2014, the patient was inoculated with ZOSTAVAX at the pharmacy, (by an unspecified health care professional), as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-JAN-2016, the patient was treated by a nurse practitioner at a medical group, for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir, lidocaine, and MEDROL for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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.  The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.