chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the Pfizer COVID vaccine at around 4:50pm and while under observation he began to feel dizzy. He eventually passed out and became unconscious (5:00pm). Unfortunately he hit the ground with his head after he became unconscious. He also appeared to begin shaking while unconscious. He regained consciousness after about 20 seconds and was immediately fully alert. He stated he had no history of losing consciousness in the past. He was then taken to a nearby hospital via ambulance for evaluation and required staples to address the cut. He was discharged from the hospital around 8:00pm.
C/O pain that originates from Tdap injection site radiates up (R) side of neck to base of occiput and down radial aspect of forearm to hand. No weakness or paresthesias. No fever joint pain or rash. No redness, warmth or swelling.
I got my first Vaccination of the Pfizer shot on Wednesday, with no immediate symptoms. Gradually muscle soreness and fatigue kicked in, but nothing concerning. The next day, my stomach had a burning and unsettling feeling. I tried a couple of Tums, thinking I was having some pregnancy issues, but that didn't help. I was having waves of nausea. I didn't have much appetite, and could only manage to eat some potato soup for dinner. I was feeling very weak, lethargic, and needed to lay down the majority of the evening.  I finally had some uncontrollable vomiting by around 9pm, followed by the chills. I slept all night, struggled the next day at work, and left early to sleep the rest of the day since I was just too weak and lethargic to do anything. I consider myself to be very healthy, I exercise every morning, and the pregnancy has been normal. I am in the early 3rd trimester, and my due date is June 14 - this is my second pregnancy. I am an onsite teacher, thus I have built up a strong immune system and never get sick, so this caught me by surprise. I am feeling much better today, and I will absolutely get the second Pfizer shot later this month. I will try to better prepare myself as I hear the symptoms may be worse on the second shot. My sister, a pharmacist, insisted that I should share this information, in case it is helpful for data.
This spontaneous report as received from a physician via a field representative, refers to at least two or three unspecified patients of unknown age and genders. On an unknown dates, the patients were vaccinated with a dose of ZOSTAVAX (lot#, dose, routes and sites of administration were not reported). On an unspecified dates at least two or three unspecified patients experienced an outbreak of shingles after being administered ZOSTAVAX. According to the physician, the unspecified patients were treated with VALTREX on an unspecified dates for the shingles outbreak. The unspecified patients that experienced the outbreak of shingles had no symptoms of post-herpetic neuralgia. The outcome of shingles outbreak was not reported. The relatedness between vaccination with ZOSTAVAX and outbreak of shingles was not reported. Additional information is not expected.
This spontaneous report as received from a nurse via a company representative refers to an unspecified patients (children) of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. The nurse reported that she watched a webinar (unspecified) for GARDASIL 9 at the Hospital. In the webinar, an unspecified physician stated that he vaccinated his children with three series of doses of GARDASIL (dose, route, lot #, expiration date were not reported) and then gave them a booster dose of GARDASIL 9 (dose, route, lot #, expiration date were not reported) on an unspecified dates. Additional information has been requested.
approx 1-2 hrs p/vax pt devel shaking, chills, fever 105.3, ?sz; no previous hx of immun problems;
3 inches total erythema around injection site left deltoid area. Started on  Keflex (150mg/5 ml) 1 1/2 tsp X 10 d for  cellulitis.
Information has been received from a health professional referring to a 16 month old patient. On 03-AUG-2015 the patient was inadvertently administered vaccinated with ZOSTAVAX lot # L003218, expiration date: 30-APR-2016, (dose, route and application site were not reported) (drug administered to patient of inappropriate age). No adverse effect reported. No medical attention was sought. Additional information has been requested.
10/26/2013 S/P flu vaccine. 10/28/13 developed tingling (L) Leg and pressure in (R) shoulder area. Over course of week muscle tighten in both legs and upper arms.
Confirmed with customer that no other AE ocurred; a dose of PROQUAD was administered afte experiencing a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  Information about the patient's pertinent medical history, concomitant medication and drug reactions or allergies was not provided.  On 24-MAR-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) (Lot No. t005404 has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA), expiration date reported as 24-MAR-2022, but upon internal validation established as 12-AUG-2021) 1 dose for prophylaxis (vaccination scheme frequency, route and anatomical location of vaccination were not provided).  The dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) experienced a temperature excursion of 37.2  degrees Fahrenheit for 3 hours and 28 minutes. There wasn't a previous temperature excursion, and this was called because of a data logger. No adverse events occurred.
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other= Moderna; vaccine administration date= 04Nov2021/vaccine brand= Pfizer/BioNTech; vaccine administration date=27Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Nov2021 as dose 3 (booster), single (Lot number: 066F21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mild hypothyroid" (unspecified if ongoing); "mild hip arthritis" (unspecified if ongoing); "Known allergies: pineapple" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 01Apr2021, stop date: 24Aug2022; CYTOMEL, start date: 01Apr2021, stop date: 24Aug2022. Past drug history included: Ibuprofen, reaction(s): "Known allergies: ibuprofen". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 27Apr2022, outcome "unknown", described as "Vaccine brand other= Moderna; vaccine administration date= 04Nov2021/vaccine brand= Pfizer/BioNTech; vaccine administration date=27Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2022) Positive, notes: Treatment of COVID-19; (16Aug2022) Negative, notes: tested negative by antigen test day 6; (24Aug2022) Positive, notes: it's day 14 and I still have nasal congestion and test positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid on start date 12Aug2022 and stop date 16Aug2022.
Pt. states the evening of vaccine her arm was very painful.  Difficult for her to sleep.  She had to take Motrin and arm hurt all the way up to shoulder/neck area.  Pt. states pain has gotten better but still has difficulty lifting arm up all the way.  Her range of motion is limited due to pain 1 week after administration.
3 weeks to the day from second shot developed acute onset of paresthesias to legs, palpitations/tachycardia and abnormal proprioception.
Presented to ED 4 days after administration of vaccination with redness and swelling of the right upper arm. He denies any fever, chills, night sweats, nausea, vomiting, diarrhea, or shortness of breath. He describes pain in the back sustained after jerking too quickly.
Information has been received from a physician concerning a "previously healthy" 9 year old female with no known allergies who has a questionable history of vaccination with a dose of varicella virus vaccine live. The grandparents of the child verbalized to the physician that they "think child was vaccinated with (varicella virus vaccine live) a few years ago but unknown when." The pt was reportedly immunized at approximately 4-5 years of age, in approximately 1996 or 1997. It was also unknown if concomitant medication was given. Attempts to obtain her vaccination records are under way. On 10/10/02 the pt developed chicken pox and a maximum temp of 100F. The pt also experienced facial and eye pain. On 10/17/02 the pt was hospitalized. The pt's initial diagnosis was poison oak rash and mild hepatitis. The pt was placed on high doses of steroids after which she told physicians that another child at school had the same type of rash. The pt had a "brief" exposure to chickenpox at school 10 days prior to outbreak. The pt had greater than 200 diffuse bulbous lesions on her face, chest, arms and a "rare" amount on her lower extremities. The diagnosis was changed to chicken pox, and she was treated with acyclovir and recovered. On 10/21/02, the pt was discharged from the hospital. On 10/17/02, the physician collected a specimen from a vesicle type lesion which grew VZV and will be sent for analysis. Additional info has been requested.  A 15-day follow up report received on 7/29/2003 adds: The specimen (collected 10/17/2002) was identified as wild type. Follow up info was received from the physician who reported that the pt and her entire family were lost to follow-up. The physician felt that the pt had never been vaccinated with varicella virus vaccine live, but did not think that he would ever know for sure. No further info is available.
Not certain if related, but for research thought I'd report.  On approximately May 4th, I began to have wheezing and felt like one feels with bronchitis or asthma where you cannot take deep or full breaths. There was associated wet coughs, coughing up phlegm, but a lot of wheezing throughout the day, more at night. COVID tests were negative. (Same has happened two other times after this May incident which is why I am reporting.) Have also been feeling extra tired since  approx. 3 weeks post vaccine dose #2.
Patient came into the pharmacy around 2:35 pm wanting to get the new COVID-19 vaccine. Patient got with no contraindications or problems with previous dose. Patient woke up the next morning feeling fine but throughout the day she noticed she had a headache and vomited a few times. Patient's partner took them to the Hospital (ER) and they gave her some IV drugs and sent in some prescriptions for symptom management. Patient is now at home.
A report has been received from a health professional (registered nurse) concerning a female patient. Relevant medical history or concomitant medication was not reported. The patient, who was 30 weeks pregnant, received FLUMIST (intranasal) by her general practitioner on 02-Nov-2015. Shortly following the administration, she experienced abdominal pain. She was brought back and it was concluded that the abdominal pain was not contractions. On 03-Nov-2015 the abdominal pain had subsided. The action taken of FLUMIST was unknown. The outcome of the event of pregnant and received drug was unknown. The reporter assessed the event of pregnant and received drug to be serious with serious criteria of important medical event. The company physician has been identified and captured the event of abdominal pain from the source document and assessed it as non serious.
loss of smell; loss of taste; cough; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of smell), AGEUSIA (loss of taste) and COUGH (cough) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced ANOSMIA (loss of smell), AGEUSIA (loss of taste) and COUGH (cough). At the time of the report, ANOSMIA (loss of smell), AGEUSIA (loss of taste) and COUGH (cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Have a rash on my legs, it's just my lower legs; Saw the rash today; Leg started itching; Hurt a little bit; This is a spontaneous report received from a contactable consumer (patient herself). A 53-year-old-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0177 and expiry date: Aug2021) via an unspecified route of administration in left arm on 02Jul2021 13:45 as single dose for COVID-19 immunization. Patient medical history included Hashimoto, Epstein Bar and Asthma. Concomitant Medications were reported as none. Patient stated that "she got vaccinated on 02Jul2021and she just wanted to report that she has a rash on her legs, it's just her lower legs on 05Jul2021". She got the shot on Friday and her leg started itching Saturday on 03Jul2021 and then she saw the rash today, she had issues with 'Asthma' in the past (intent of medical history). On an unspecified date in Jul2021 patient stated, "she took Just like a regular shot, she doesn't really know, she mean it hurt a little bit." Time of Administration of vaccine was reported as patient stated that "the time, so like it was around 01:30, it might have been closer to 2, she is thinking that her appointment was at 01:30 and she got it about it quarter to 2 is what she is thinking, yes she got it at 1:45 in afternoon". Outcome of events was unknown.
immediately post-injection: no noticeable reaction, effects, or symptoms. 6 hours post-injection: soreness in injected arm. 12 hours post-injection: exhaustion, nausea, vomiting, light-headedness, fever, chills, body aches, head ache, severe soreness in injected arm, weak. 18 hours post-injection: exhaustion, fever, chills, body aches, head ache, severe soreness in injected arm, weak. 24 hours post-injection: exhaustion, body aches, head ache, soreness in injected arm, weak. 30 hours post-injection: head ache, tooth ache, sinus pain, runny nose, eye aches, jaw aches. 36 hours post-injection: head ache, tooth ache, sinus pain, stuffy nose, eye aches. 42 hours post-injection: head ache, stuffy nose, sinus pain. 47 hours post-injection: stuffy nose. (this is the time that I'm writing these notes)
Cold tingling throughout my body, body pain, headache, nausea, diarrhea
Low grade fever started last night rectal temp today was 100 given Tylenol today. Left upper thigh is 3/4 an inch diameter larger than right thigh. 5/D eval schedule for today.
Developed Shingles; This morning had a lot more burning; Itching and Burning; A spontaneous report  was received from a consumer concerning a 91 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Shingles, itching and burning, this morning had a lot more burning and it was running down the leg.  The patient's medical history was provided not by the reporter. No concomitant medications were reported.   On 28 Jan 2021, about seven days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: probably 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, a week later, the patient developed shingles and an itching and burning. On 05 Feb 2021, this morning had a lot more burning and it was running down the leg. Treatment included anti viral drug for shingles and lidocaine for itch and burning and pain. Lab details were not provided.  The seriousness criterion for all the events was reported as other without a rationale. The event is serious meeting Medical Significant criteria due to the necessity of treatment.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, developed shingles, itching and burning, this morning had a lot more burning and it was running down the leg was considered as unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Pt states she cannot hear out of her left ear; This is a spontaneous report from a contactable pharmacist. A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscularly, administered in left arm on 24Apr2021 05:00 (Batch/Lot Number: EN5318) as a single dose (at the age of 17 years old) for COVID-19 immunization. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient's medical history and concomitant medications were not reported.  On 26Apr2021 13:00,  the patient experienced she could not hear out of her left ear. The event resulted in a doctor or other healthcare professional office/clinic visit. There was no hospitalization for the event. The outcome of the event could not hear out of her left ear was unknown.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of "could not hear out of her left ear" cannot be 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.
I had a really bad cold and cough for ten days. I had a hard time breathing and had low energy. I tested negative for COVID-19.
The administration of improperly stored VARIVAX.; This spontaneous report was received from a physician referring to a 4-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 01-DEC-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), for prophylaxis (lot #W018830 had been verified to be a valid number; expiration date 14-JUN-2024, and upon internal validation established as the same date)(dosage, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported). The administered dose of the vaccine was stored at a temperature of -5 degrees Celsius (C), during a time frame of 12 hours, as recorded by a digital data logger. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2212USA003172:MSD
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a male patient who received Shingrix for prophylaxis. On 12th December 2018, the patient received Shingrix. In December 2018, less than a week after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown. It was unknown if the reporter considered the general body pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. On Wednesday evening last week from the date on reporting, the patient received Shingrix and experienced body ache for five days. The patient asked how long would these side effects last. The patient provided limited information. The patient did not consent to receive call back.
Possible PCV13 reaction right leg (right leg "locked up" in flexed position for 48hrs).
Pt. states that after receiving the 1st dose of Phizer 08/08/2021, started experiencing symptoms 1hr later of frequent urinating. Strong urge to urinate lasting 24hrs. Clinic tested for UTI (Negative). No noted Primary visit. Symptoms has since subsided.
Administered flu vaccine to patient after verifying patient was due for second dose for this flu season as first flu vaccine was given greater than 30 days from 11/17/23 date. Flu vaccine was given to patient.  Patient had already received two flu vaccines in the same season last year and the "booster" dose this flu season was not needed.
Rash, purpura, prolonged. Persisting. We are trying to decrease med list. Purpura B upper extremities >> trunk> lower extremities
After second shot I had extended menstrual; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Mar2021 (Lot number: Er8732) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Muscle spasms" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "mitral valve prolapse" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3; BACLOFEN; TYLENOL; ZINC. Past drug history included: Flagyl, reaction(s): "Allergy: Flagyl". Vaccination history included: Bnt162b2 (dose number-1, lot number- En6204, vaccine location-Right arm), administration date: 05Mar2021, when the patient was 51 years old, for Covid-19 Immunization. The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "After second shot I had extended menstrual".  Follow-up attempts are completed. No further information is expected.
PATIENT FAINTED AFTER RECEIVED THE PEDIATRIC PFIZER VACCINE.  PATIENT WAS PALE.  WE LET PATIENT REST ON FLOOR FOR FEW MINUTES. THEN PATIENT WAS LIFTED UPRIGHT AND SAT IN THE CHAIR FOR A FEW MORE MINUTES. THEN PATIENT SAT IN THE WAITING AREA AND PATIENT WAS MONITORED FOR 30 MINUTES.  PATIENT WAS FINE AFTERWORDS AND PALE FACE RETURNED NORMAL AND THE PATIENT WHEN HOME WITH FAMILY. NO OTHER TREATMENT WAS NEEDED.
Injection site was firm, warm, and tender no redness or drainage. Patient also reports diarrhea.