chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Given accurately but received information from company that this specific Lot # of the covid vaccine expired 08/31/2022. and was given to the patient in 9/9/2022 as it was labeled expiration date was 09/26/2022 following CDC guidelines wherein the expirations dates change according to the dates & time we receive these vaccines and placed them in the refrigerator as we received them frozen. No specific communication to the field that this specific lot# should expire in 08/31/2022 regardless  of when you received them.
Patient received dose 2 of Moderna COVID vaccine. After administration patient saw blood and passed out while seated. Pharmacy staff noticed body twitching and called EMS. Patient had a pulse and was breathing. Patient returned to consciousness prior to arrival of EMS. Was given water. EMS checked patient vitals, vitals were normal. Patient declined to be taken to hospital. Remained seated for about 20 minutes after incident. Husband picked her up. Patient was awake and alert on leaving pharmacy
The evening after pt felt very tired so she went to bed. Upon waking, her arm was painful, red, and inflamed. She presented to the pharmacy for a Dr. note around 3:30pm. She still had the same symptoms, which were noticed by both pharmacist on staff. They were present from about 1/2 inch below the injection site down to just above the elbow. It has not gotten worse, but not yet better.
Sore left arm    Red raised rash about 2" by 4" inches appeared on the 11th day at site of injection for about 30 hours
There was no adverse event. Vaccine was given unintentionally outside of approved age range. Father of patient filled out the VAR (Vaccine Administration Record) incorrectly. He verbally told us  patient was 12 years old and wrote 12 on the form.  However after the covid vaccine clinic when we were processing the records we noticed patient was actually 11years old. Patient was informed they will have to wait till the age of 12 for the second dose.
Crazy nightmares; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 15Apr2021 at 14:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 12:00, the patient experienced crazy nightmares. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event nightmares was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Severe leg cramps that lasted for a couple of hours. They resolved by 8:00 that morning, probably earlier, but they were enough to make her wake up screaming in pain.
some fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2020 17:15 (Lot number: eH9899) at the age of 79 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "some fatigue".  Additional information: No Emergency Room or Physician Office visited.  No follow-up attempts are possible. No further information is expected.
Explained having some dizziness and fully body aches, stomach bloated, mild temperature increase especially on injections site, unable to sleep, sore throat.  Medium sized knot on shoulder given (left deltoid).  Seems to manage with Tylenol Arthritis and Plenty of Fluids.   On oxygen regularly, feeling that it is working, but no increase in utilization.  Noticed some tiny bruises on arms after shot (not sure if related).
Patient c/o headache, nausea and weakness 2 minutes after getting the FluMist vaccine. Patient reported vomiting one time in the afternoon.  Patient taken to ED on 23Sep09 and arrived at 1100. Patient diagnosised with "Medication Reaction" and given Zofran for nausea and discharged at 1310 in stable condition and medically cleared.
Admitted to hospital on 9/6/2021 with fever chills . genralized wakness . He was exposed to his daughter and son in law who had fever and tested pos for covid , Poor Appettie severe weakness and muscle aches , no  Shortness of breath , + productive sputum .  The
Mobility and balance were off. Couldn't walk properly without assistance with 2nd vaccine. Went to primary care, went to  ENT. Went to physical therapy. 20 sessions of physical therapy. Went to Neurologist. Ruled out Pakinsons and MS.  Took Booster on 10/4/2021. Same symptoms came back, not as severe as with 2nd shot.
Patient complaining of severe diarrhea and vomiting starting 2 days after he received the vaccination and continuing through today. He was instructed to contact his pcp.
ocean sound in head making not sleep and not put head down/whistling in head; ocean sound in head making not sleep and not put head down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "ocean sound in head making not sleep and not put head down/whistling in head "; SLEEP DISORDER (non-serious), outcome "unknown", described as "ocean sound in head making not sleep and not put head down".  Additional information: Reporter called about an "ocean sound in their head" making them not sleep and not put their head down. Also, there was a whistling in their head while on the phone. Reporter stated that she knows five people off the bat that has the same experience.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-202300124718 same reporter, product and event, different patient;
Low grade fever, erythema and warm at inj. site, diarrhea, fatigue, malaise.
PATIENT DEVELOPED SORENESS AND TINGLING SENSATION ON HIS CHEST AREA; THEN FOLLOWED BY APPEARANCE OF RED BLISTERS IN ABOUT FIVE DAYS.
VAGINAL BLEEDING; 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: 043A21A and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-APR-2021, the subject experienced vaginal bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaginal bleeding. This report was non-serious.
Pt received his first Moderna vaccine on 2/25/2021. 3 days later he developed significant oral pain located on the roof of his mouth, back of mouth and throat. He presented to clinic about 1 week later for evaluation. There were no obvious signs of trauma or infection at the time. He followed up with this Dentist and it was suggested he likely had a chemical burn secondary to citrus foods. He followed up with another provider and was treated with a 3 day course of an antiviral medication for herpes without any change in symptoms. He hasn't had oral herpes before, but has had shingles.  He received his second Moderna vaccine on 3/25/2021 and 3 days later developed significant throat pain and swelling in his neck glands that was visible to him. His symptoms improved slightly, but have never completely resolved. He has had what feels like a dry sore throat for 7-8 weeks and intermittent white patches in the back of his mouth. He has no history of or active allergy symptoms. Was treated for oral candidiasis on 4/19/2021, but it's unclear if his vaccine triggered these symptoms.
Infant screamed for 9 hours starting 1 1/2 hrs. after receiving 4 mo. immunizations.
I developed a painful burning rash below the injection site; I developed a painful burning rash below the injection site; I developed a painful burning rash below the injection site; It appears my skin is beginning to peel as well. It remains painful to touch; This is a spontaneous report from a contactable consumer, the patient.  A 44-year-old non-pregnant female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3246), via an unspecified route of administration in the left arm on 15Jan2021 at 2:30 PM (at the age of 44-year-old) as a single dose for COVID-19 immunization.  Medical history included  unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), intramuscular, left arm  on 29Dec2020 for COVID-19 immunization. On 17Jan2021, approximately 48 hours after, the patient developed a painful burning rash below the injection site. It appears her skin is beginning to peel as well, it remains painful to touch. Treatment with over the counter (OTC) medicine was taken as a result of patient developed a painful burning rash below the injection site, it appears her skin is beginning to peel as well, it remains painful to touch. The clinical outcome of the events patient developed a painful burning rash below the injection site, it appears her skin is beginning to peel as well, it remains painful to touch was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
temperature excursion involving punctured IPOL and unopened ADACEL and MENACTRA range from 31.7F to 52.4F for 300 hours due to a refrigerator malfunction (not human error) with no reported adverse event; The IPOL has been administered once, ADACEL administered three times and MENACTRA administered twice since the excursion with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who had temperature excursion involving punctured ipol and unopened adacel and menactra range from 31.7f to 52.4f for 300 hours due to a refrigerator malfunction (not human error) with no reported adverse event and the ipol has been administered once, adacel administered three times and menactra administered twice since the excursion with no reported adverse event while receiving vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-APR-2022 there was a temperature excursion involving punctured ipol and unopened adacel and menactra range from 31.7f to 52.4f for 300 hours due to a refrigerator malfunction (not human error) with no reported adverse event (product storage error).  On 19-Jul-2022, the patient received a dose of 0.5 ml of suspect IPV (VERO) (formulation, strength: unknown) lot V1A024M, expiration date: 17-Feb-2024, via intramuscular route in the right thigh as immunization.  On 19-JUL-2022 the ipol has been administered once, adacel administered three times and menactra administered twice since the excursion with no reported adverse event (poor quality product administered) same day following the administration of IPV (VERO) and  (unknown latency) following the administration of other suspects. This situation was reported as a medication error due to administration post excursion.  On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown) lot number not reported in unknown administration site as Immunization.  On an unknown date, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE(formulation, strength: unknown) lot number not reported in unknown administration site as Immunization. Lot numbers were requested.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Ipol reached a temperature of 61F for an hour and a half.; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves 2 patient who received vaccine IPV (VERO) [IPOL] (batch and expiry date was not reported via unknown route in unknown administration site), which reached a temperature of 61 F for an hour and a half. It was reported that IPOL vaccines were to be discard.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of document held by sender: none.
Medium-flow menstral-like bleeding the night after (approx. 32 hours) receiving the Pfizer COVID-19 vaccine. Light cramping.
receiving a 3 dose of SHINGRIX; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 5393G, expiry date 1st April 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th July 2020) and Shingrix (2nd dose received on 8th October 2020).   On 22nd November 2021, the patient received the 3rd dose of Shingrix. On 22nd November 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The patient received 3 dose of Shingrix till date, which led to extra dose administered. The reporter consented to follow up.
pt recv vax 10APR96 & on 7JUL97 pt devel breakthrough varicella consisting of approx 50 vesicles & papules;
Menquadfi reached a low temperature of 32.9F with no reported adverse event; the vaccine was administered with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA157204 and 2023SA157696.  This case involves a 11 years old and unknown gender patient who was administered with vaccine meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] that reached a low temperature of 32.9f with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for prophylactic vaccination (Immunisation).  On 15-May-2023, the patient received a dose 1 of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (batch number: U7576AB; expiry date: 28-Feb-2025) via intramuscular route in the left arm for immunization with no reported adverse event (poor quality product administered) (same day latency) that on an unknown date, had underwent temperature excursion as a low temperature of 32.9f was reached with no reported adverse event (product storage error) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event menquadfi reached a low temperature of 32.9f with no reported adverse event and was Unknown for the event the vaccine was administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had chills, fever of 101 for a couple days, back pain, diarrhea, eye burning, sweats, headache, severe congestion, sneezing, and cough. I was sick for 6 days. I talked to my doctor, and she prescribed me over the counter drugs. I took MUCINEX, NYQUIL, and TYLENOL. She said I had bronchitis by my symptoms. I tested for COVID-19 and I was negative. I still have chest congestion.
Pharmacy error: The Moderna vaccine with lot#003C21A that was sent out on 11/24/21 to our clinic should have the absolute expiration date of 12/17/21 and not 12/24/21
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: unconscious for less than a minute.Has a history of fainting from many years ago but no incidents since.Epi pen given 4:10p and 911 called. Paramedics arrived ~4:18p.Bp was 110/80 @4:13p, 128/88 @ 4:18p, 132/86 (pulse 70) @4:21p.Was clamy, shaky, sweaty,and had a headache post.Paramedics monitored sitting and standing.Advised to followup with physician.
The pt received Prevnar #2 (last of series) on 1/14/02 in the left thigh, IM. The office notified on 1/16/02, that the pt was experiencing swelling and erythema at the site of the injection of the left thigh. It was treated with Benadryl tid and Keflex X 10 days.
Red, hot, itchy spot on arm several days after vaccine and AFTER initial redness/soreness had subsided.
This  77 year old male received the Covid shot on  1/13/21    and went to the ED on  1/20/21     and was admitted  on 1/20/21 with the following diagnoses listed below. J12.82 - Pneumonia due to Coronavirus disease 2019 U07.1 - COVID-19
12 hours after shot swelling and itching burning of injection site, continued to grow and swell until dr prescribed steroids and regime of benedryl. 6 days after facial swelling, doctor recommended to continue benedryl and additional steroids
initial dose on 6/14/2022, second on 6/30/2022 / 2nd dose was given 2-weeks after the 1st; This case was reported by a other health professional via other manufacturer and described the occurrence of drug dose administration interval too short in a 44-year-old female patient who received HBV (Engerix B adult) (batch number 333m4, expiry date 7th April 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HBV (Engerix B adult).   On 30th June 2022, the patient received the 2nd dose of Engerix B adult (intramuscular) and Engerix B Pre-Filled Syringe Device. On 30th June 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device and an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comments: The patient was given their second dose of Engerix-B 2-weeks early. The second dose was given 2-weeks after the first versus the recommended 4-weeks. The reporter gave consent to follow up. Additional Supportive Information: The second dose was given 2-weeks after the first dose which led to shortening of vaccinations schedule.
Narrative: Large bruising/ecchymosis (10 cm x 20 cm) to the area surrounding vaccine injection site on the R deltoid area
erythema, itching, pain, tenderness, in left upper arm starting about 1 week after the vaccination
Information has been received from a registered nurse concerning a female between the ages of 9-years-old and 12-years-old who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the child developed a severe case of varicella, and was "covered" with lesions. The child was treated with calamine (+) camphor (+) pramoxine hydrochloride (AVEEN0), diphenhydramine hydrochloride (Benadryl), and acetaminophen (Tylenol) prn. Unspecified medical attention was sought. Additional information is not available at this time. The reporter indicated that 4 other females (2 or which are the child's sisters) were vaccinated with a dose of varicella virus vaccine live from different lot numbers and experienced varicella (WAES #0304USA00358, WAES #0304USA00480, WAES #0304USA00482, WAES #0304USA00483). Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-JUN-2016, the patient was vaccinated with improperly stored dose of M-M-R II 0.5 ml injection, lot# L032181, expiry date: 25-AUG-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one several reports received from the same reporter. Additional information has been requested.
pain, fatigue, syncope, blackout out for 18hr;multiple sclerosis; Annual follow-up received 09/20/01 provided no additional data.
8 days post vaccination developed "COVID" arm: localized swelling, redness and warm to touch. On Day 9, developed generalized hives trunk, arms and legs which required a 2 1/2 week prednisone burst. Resolved slowly over a month duration. 3 weeks out experienced joint pain/lupus flare which again required prednisone. PCP recommended to refrain from Dose 2. Rheumatologist did not advise.