chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 0.3 ml of the Pfizer vaccine from a vial that was reconstituted with 1.3 ml of normal saline, not the recommended 1.8 ml. This was the only dose used from this vial, the rest of it's content was discarded. Patient did not exhibit adverse reactions during her observation period. Parent was re-instructed on adverse signs/symptoms/emergent and reporting procedures. Will follow-up with parent re: patient's status
tested positive today; tested positive today; This is a spontaneous report from a contactable consumer (Patient herself) or other non-HCP. A female patient (Age: 64 unit : Unknown) of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Not reported, Expiration Date: Not reported) via an unspecified route of administration on 30Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced tested positive today, fever, cough, elevated pulse, persistence dry cough. The patient stated first Pfizer covid vaccine on Tuesday and thinks she might have been exposed to covid in the weekend before that. she tested positive today, after vaccine she had fever (fever is gone now), cough, blood pressure is normal, elevated pulse, persistence dry cough, used inhaler for it, she takes aspirin and stated she is on lockdown till April 11. The patient wanted to know if vaccine will moderate symptoms from covid.  The outcome of events was Unknown.  No follow-up attempts are needed. No further information is expected.
Pt called and described red rash and muscle pain day after receiving Pneumo23. Few hours later came to pharmacy to show. Consulted patient to go walk in clinic. Patient went to clinic next morning and md prescribed antibiotic and stated most likely not due to vaccination.
Continuous growth of injection site Tuesday-Saturday.  Full body hives Tuesday (Day 2) Site hardened. (Day 6) Intense heat, redness, itching and swelling all days.
Tested positive for COVID-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 26Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose on 26Mar2021 then she was tested positive for COVID-19 last Tuesday (30Mar2021). The patient wanted to know if she can get the second dose of vaccine on 16Apr2021. The outcome of the event was unknown.  Follow-up attempts are completed; information about batch number cannot be obtained. No further information is expected.
Slight bump at site of vaccination; Quite tired.; This is a spontaneous report from a contactable consumer. This 70 Years Old female consumer reported. A 70-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 11:00 (at the age of 70-years-old) as a single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included multiple sclerosis. Concomitant medication(s) in two weeks included venlafaxine (VENLAFAXINE) taken for multiple sclerosis. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 (at the age of 70-years-old) as a single dose for covid-19 immunization. The patient did not have any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced slight bump at site of vaccination, quite tired on an unspecified date. The patient did not receive any treatment. Outcome of the event was recovered, at the time of this report. Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021239805 similar report from same reporter
The next day: fever, legs shaking, malaise; unable to eat; severe headache; dazed; arm very sore and heavy.
Initial report received from a consumer who is the patient's daughter on 05 November 2010. A female patient had received a Tetanus Toxoid vaccination on an unknown date in 1950 while in the second grade for an injury she had sustained. It was reported the patient had a bad reaction of "anaphylactic reaction" in which her throat closed up. Recovery status was not reported. The reporter declined to provide any further information. No further information is expected. Documents held by sender: None.
Cancel her 2nd dose/scheduled for 2nd dose on Feb 27th; Diagnosed for COVID; A spontaneous report was received from a consumer concerning 55-years-old female consumer, who received Moderna's COVID-19 vaccine (mRNA-1273) and was diagnosed for COVID after 27 days of vaccination without any symptoms.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for the prophylaxis of COVID-19 infection.  The patient was diagnosed for COVID on 13 Feb 2021.  She was exposed on 06 Feb 2021 and had no symptoms. The patient was on a 10 day quarantine and canceled the second dose for 20 Feb 2021.   The patient was tested negative for the first rapid test. The first PCR test result was inconclusive and the second PCR test was positive.  The patient was scheduled for second dose on 27 Feb 2021, which is an inappropriate schedule of administration (greater than one month apart).  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event COVID-19 infection was unknown and outcome for event inappropriate schedule of product administration was considered as resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273. Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the event of COVID-19, is assessed as unlikely related.  Further information has been requested.
mom states pt arm became severely swollen & red @ inj site from shoulder to elbow 1 day p/vax;As of 25MAR98 redness gone skin ow sl rash & peeling;
Body aches, headache, chills, fever, sweating, begain at 2:00 am.  Dizziness and nausea began at 11:00 am. Continued intermittently throughout the next 48 hours.   Menstrual spotting began on 2/17, and spotting continued through 2/19
This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX. In May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The case was reported by medical assistant via chat. The age at vaccination was not reported. The patient received SHINGRIX 2 weeks ago. The 1st couple of days the patient felt pain in arm but now she was unable to lay the left arm due to the pain. The patient went to my chiropractor but that did not help. the patient took an appointment with primary care physician for Tuesday to talk about this. The 1st shot at pharmacy was fine but he booster at another pharmacy. It was unable to clarify or obtain any additional information. The health care professional ended the chat abruptly.
Feels sick; Having Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Feels sick) and CHILLS (Having Chills) in a 70-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced ILLNESS (Feels sick) and CHILLS (Having Chills). At the time of the report, ILLNESS (Feels sick) and CHILLS (Having Chills) had resolved.            No treatment information was reported.  Concomitant product use was not provided by the reporter.   This case was linked to MOD21-066015 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Additional information included, event outcome was updated.; Sender's Comments:  MOD21-066015:
Runny nose; Feel dizzy; Headache; Tired; Sore injected arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore injected arm), RHINORRHOEA (Runny nose), DIZZINESS (Feel dizzy), HEADACHE (Headache) and FATIGUE (Tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D) for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore injected arm). On 25-Apr-2021, the patient experienced RHINORRHOEA (Runny nose), DIZZINESS (Feel dizzy), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Sore injected arm), RHINORRHOEA (Runny nose), DIZZINESS (Feel dizzy), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by reporter.
Hospitalized 6/18/22-6/22/22 aphasia, weakness, SOB, diarrhea, decreased appetite, tachycardia, HTN, GI bleed, atrial flutter with RVR, elevated troponin, dyspnea, fever,
Shingles like rash luin incubation of vaccine, red and tender area as congealed pre vaccine.
Dizziness, Tachycardia,  Emp states she felt her heart racing and felt dizziness   Narrative: Employee was seen in the ACC by a  provider and discharged without complaints.
nurse not mix the Pentacel correctly and only gave a portion (acthib) to their patient; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves patient of an unknown age who received only ActHib portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number, expiry date, route and site of administration were unknown).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate reconstitution technique. Had a nurse not mix the Pentacel correctly and only gave a portion (acthib) to their patient.  It was unknown whether the patient had any 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  Documents held by sender: none.
2 days after administration pt had 2 seizures. Unsure if vaccine was related or not.
ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY  12/23/21, 02/14/2323, 02/18/2023 - RECURRENCE OF SAME SYMPTOMS
headache, arm pain swollen and sore, chills, brain fog, foot cramping Vaccine was given at 1 pm and chills, headache  pain started at 8 PM that same day.
They gave a third dose of 0.5ml, instead of a booster dose to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (They gave a third dose of 0.5ml, instead of a booster dose to a patient) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B22A, 039B21A and 022c21a) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 26-May-2022. Concomitant products included LISINOPRIL for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 11-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (They gave a third dose of 0.5ml, instead of a booster dose to a patient). At the time of the report, ACCIDENTAL OVERDOSE (They gave a third dose of 0.5ml, instead of a booster dose to a patient) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's height was reported as 5 feet 10 inches. No treatment details were reported. AE did not caused the patient to seek medical care. Patient had never experienced the similar event in the past.   This case was linked to MOD-2022-606454 (Patient Link).
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/27/2021, 2/16/2021 and 8/14/2021. Presented to ED 2/11/22 c/o SOB, O2 sats in 30s on arrival. Admitted for acute hypoxemic resp failure 2/2 covid PNA. Oxygenation demands escalated to Bipap w/eventual intubation on admission day 2. Received inhaled epoprostenol and one day of remdesivir. Started on empiric antibiotics. Large DVT resulting in Phlegmasia cerulea dolens dx'd 2/12/22 c/b multiple PEs on CTA and sepsis. 2/13/22 pressor requirements increased with MAPs below 60 tx'd w/3 pressors. Transiioned to comfort care, expired 2/14/22.
extreme pain when moving the arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) (batch number 2CPQB ?, the reported lot number doesn't match any GSK lot number, expiry date 12th April 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 77 or 78 years.  Post vaccination with Shingrix the patient felt extreme pain while moving the arm of the injection. The reporter consented to follow up.
Expired Havrix Administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 31-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 8th February 2023, the patient received the 2nd dose of Havrix. On 8th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-FEB-2023 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient inadvertently received Havrix vaccine which was expired on 30th January 2023. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
Patient had history of fainting with needles/blood draws. Mother of patient still wanted to get the immunization. The patient became light headed and was in and out of consciousness/slouching in chair. Said her vision was blurry and her eyes were dilated. This is typical for the patient but this time it lasted about 20+ minutes before emergency medical help took her to an ambulance to evaluate her. Mother said it never lasted this long before. We had a fan on the patient and ice on her forehead but she was very pale. Patient was able to speak but sounded very weak.
Pharmacist failed to dilute the Pfizer vial. Patient received almost 6x the dose. Patient reported she had fever and vomiting that went away the next day.
Pt presents to clinic with left leg swelling and redness. Received vaccines on the previous day. No fever noted. Dx: Left leg shot reaction to DTAP. Treatment: Monitor.
The 2 nights after the inject I was very uncomfortable and wakeful. The third day, I began noticing a soreness in my left breast which during the next several days became much worse. It was a extremely painful searing pain that occured with touch including clothing, turning over in bed. Got worse lasting 2 weeks+.
1 day after getting vaccine at his local pharmacy he developed a scattered vesicular rash on and erythemic base  to his bilateral forearms, one spot on his chest and 3 days later several to his bilateral ankles.  some erythema to injection site.  rash is puritic  which benadryl and hydrocortisone improve this.
This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. There was no information on the patients' concurrent conditions, medical history and concomitant medications. On unspecified dates, the patients were administered doses of improperly stored RECOMBIVAX HB (lot # M001578, with expiry date 21-NOV-2018 and lot # L045117, with expiry date 06-OCT-2018). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
UrticariaPruritus Narrative: RASH LEFT UPPER ARM 7 DAYS AFTER VACCINE USING MODERNA VACCINE RASH MEASURING 10x9CM
Presented to ED on 3/20/21  w/HA, vomiting-- >found to have bilateral SDH on CT Head.
Patient given undiluted covid vaccine. Patient monitored and feeling fatigued today with appetite not quite normal. Patient given zofran and ibuprfen. Providers in contact with parents.
Rash to upper body with hives, redness of skin, itching, anxiety. Recieved Benadryl and possible steroid dose.
Information has been received from an RN concerning a 11 year old male Caucasian with no know drug allergies, who on 8/16/00 and 9/20/00 was vaccinated with the 1st and 2nd dose of Hep-B vaccine recombinant (yeast), 0.5 ml, IM, in the left arm, respectively. This does not comply with the recommended dosage schedule. On 8/17/00, the pt developed hives on his arms and legs, a generalized maculopapular patchy skin rash on his trunk, insect bites, increased temperature, and experienced itching. The pt missed 8 days of school. On 8/23/00, the pt was seen in the ER and was given methylprednisolone acetate (Depo-Medrol) 80mg, IM, in the left dorsal gluteal. The pt recovered. On 9/20/00, the pt was administered the 2nd dose of Hep-B vaccine recombinant (yeast) 0.5ml, IM, in the left arm lot 1027K. On 9/21/00, the pt developed hives on his arms and legs, rash, itching and increased temperature. He missed 4 days of school. The pt recovered. Upon internal review, hives on the pt's arms and legs, a generalized maculopapular patchy skin rash on his trunk, insect bites, increased temperature and itching were determined to be "Other Medical Events". Additional information has been requested.
MMRV was mixed with sterile diluent that expired on 2022Jun02. This nurse is not aware of  any adverse reactions by the patient. Contacted MERK and was given the following information: Merk has in house data to support potency of the dose of Merk vaccine/sterile diluent that was inadvertently administered after its labeled expiration date. Stability data indicates that sterile diluent is expected to maintain all quality attributes within the label claim for up to 12 months beyond the labeled expiry. Merk does not make any recommendations on revaccination, that is up to the HCP.
Dose #1 on January 06,2021 / wants to know when he should get dose #2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th January 2021, intramuscularly).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not applicable for this report. The patient received first dose of Shingrix and till the time of reporting did not receive the second dose, which led to incomplete course of vaccination. The patient wanted to know when he could take the second dose. Limited information was provided by the patient. The patient also stated that he was in a hurry.
States that she had a bad taste in mouth right after MMR; 3 days later, area of injection is red, hot to touch, tender & raised. The next day, she had complaints of more tenderness at injection site & that the left side of her throat felt "tight". The shot was given in the left arm.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 31-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 19th December 2022, the patient received Havrix. On 19th December 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: Adverse event contains all reported information. The reporter consented to safety team follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.