chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; night sweats after 2nd dose; lethargy for 12-24 hrs; This is a spontaneous report from a non-contactable consumer. A 37-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on  an unspecified date in Mar2021 as single dose for covid-19 immunisation. Medical history and Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient was tested for COVID-19, since the vaccination. On an unspecified date in Mar2021, the patient experienced sore arm, night sweats after 2nd dose and lethargy for 12-24 hrs. The patient did not receive any treatment for the reported events pain in arm, night sweats and lethargy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, night sweats and lethargy was recovered on unspecified date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.   Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility. Events start date and stop date added "Mar2021". Narrative ending sentence updated to "No follow-up attempts are needed; information about lot/batch number cannot be obtained".
third dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th November 2018) and Shingrix (2nd dose received on 8th February 2019).   On 24th August 2021, the patient received the 3rd dose of Shingrix. On 24th August 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 case details were reported as follows: Pharmacist reported that they inadvertently administered a 3rd dose of Shingrix to a patient which led to extra dose administered. Pharmacist thought the patient never received the 2nd dose of Shingrix but then after administration of 3rd dose, they found out the patient received the full series of the 2 doses. The reporter also stated they spoke with patient and no adverse reactions reported The reporter did not consent to follow-up.
no adverse event; the patient was administered a pediatric dose instead of adult dose; This spontaneous report as received from a medical assistant, refers to a 19 year old patient. The patient concurrent conditions, pertinent medical history, allergies or drug reactions were not reported.   On 20-JUL-2020,  the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form,(lot 3, expiration date, route of administration were not mentioned) booster dose for prophylaxis, instead of an adult dose (product administered to patient of inappropriate age)  However, at the time of this report the patient had not presented any adverse event.
Immediately 6 hours after the first dose had symptoms similar to a heart attack; Involuntary muscle spasms; pain head to toe; Brain fog affecting his mental health; Depression; Brain fog affecting his mental health, causing depression; Unable to work; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CARDIAC DISCOMFORT (Immediately 6 hours after the first dose had symptoms similar to a heart attack) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MARIJUANA, DULOXETINE HYDROCHLORIDE (CYMBALTA) and NALTREXONE for an unknown indication.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced CARDIAC DISCOMFORT (Immediately 6 hours after the first dose had symptoms similar to a heart attack) (seriousness criterion hospitalization prolonged), MUSCLE CONTRACTIONS INVOLUNTARY (Involuntary muscle spasms), PAIN (pain head to toe), FEELING ABNORMAL (Brain fog affecting his mental health), DEPRESSION (Depression), EMOTIONAL DISTRESS (Brain fog affecting his mental health, causing depression) and IMPAIRED WORK ABILITY (Unable to work). The patient was hospitalized on 17-May-2021 due to CARDIAC DISCOMFORT. At the time of the report, CARDIAC DISCOMFORT (Immediately 6 hours after the first dose had symptoms similar to a heart attack), MUSCLE CONTRACTIONS INVOLUNTARY (Involuntary muscle spasms), PAIN (pain head to toe), FEELING ABNORMAL (Brain fog affecting his mental health), DEPRESSION (Depression), EMOTIONAL DISTRESS (Brain fog affecting his mental health, causing depression) and IMPAIRED WORK ABILITY (Unable to work) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was hospitalized on 17MAY2021 and again on 19MAY2021.  No treatment information mentioned.  Company comment- Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. however, the patient is a marijuana user and the psychiatric disorder in this report could be confounded by the use of this drug as repeated marijuana use can result in worsening depression symptoms , emotional distress and brain fog.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. however, the patient is a marijuana user and the psychiatric disorder in this report could be confounded by the use of this drug as repeated marijuana use can result in worsening depression symptoms , emotional distress and brain fog.
This spontaneous report was received from a health professional refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 08-FEB-2016, the patient was vaccinated with an improperly stored dose of oral, ROTATEQ (lot # L013202, expiry date: 27-JAN-2017). The temperature excursion details were reported as follows: temperature 0.6 degree C, time frame 30 hours, 20 minutes. COMVAX and GARDASIL appeared on the product list since they were involved in the excursion, however no improperly stored doses of these vaccines were administered. No adverse effect was reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
03JAN91 pt vax w/MMR; devel mild URI-like sx. 31JAN91 seen by MD w/left parotid swelling & temp 100.4F axillary.
Bone marrow biopsy 10/20/14. Severe aplastic anemia. Transfusion dependent since then. Hospital short stay 11/30/2014 and 01/03/2015.
The pt developed red, warm to touch, swollen, itching, tender to touch area size of a baseball on the right arm.
I scratch it to death; it itches like the 'dickens'; inside of her arms and hands started to breakout in hives; rash inside her arm/skin rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 14:20 (Lot number: 330308D) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heartburn" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE MAGNESIUM] taken for dyspepsia. Vaccination history included: Bnt162b2 (DOSE 1, Lot: EL9264), administration date: 30Jan2021, for covid-19 immunization; Bnt162b2 (DOSE 2, Lot: EN6201), administration date: 20Feb2021, for Covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 15Dec2021, outcome "not recovered", described as "inside of her arms and hands started to breakout in hives"; RASH (non-serious) with onset 15Dec2021, outcome "not recovered", described as "rash inside her arm/skin rash"; SCRATCH (non-serious), outcome "unknown", described as "I scratch it to death"; PRURITUS (non-serious), outcome "not recovered", described as "it itches like the 'dickens'". The events "inside of her arms and hands started to breakout in hives", "rash inside her arm/skin rash" and "it itches like the 'dickens'" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of urticaria, rash, scratch, pruritus.  Additional information: Patient showed no reaction to any of the doses in the primary series (hardly any sore). She had no issues with the booster until 15Dec2021 where she started experiencing hives/rash inside of her arm. This recurring, random hives inside of her hands and arms, comes and goes and they appear in different parts of her arm. the rash is not debilitating but she wants to make it stop. she is not taking any antihistamine nor is using any itch creams. and she has not change anything in her routine prior to receiving the booster dose (no new lotion or perfume). she has visited a dermatologist and the derma has confirm that she has seen the rash with patients who have received the Pfizer BioNTech vaccine. She is asking why is it not on the top of her arms and hands but instead on the inside of her arms and hands, which is weird. It is persisting. Sometimes its really bad and it is a big old swath of it. This morning she had it and it is already gone, it was the size of a quarter. Patient did not received treatment, and said just don't feel like I need to be taken a antihistamine every day. I just don't take medicine at all, I don't take medicine. So, I am not doing anything, I am not rubbing any cream on it, any cortisone cream or any itch cream. I am not doing anything, it just comes at random.  Follow-up (18JAN2022): Follow-up attempts are completed. No further information is expected.
Day after vaccine, felt weak, achy & lethargic. Temp of 99.6 also c/o back pain. Can't handle smells mom cleaning with strong product.
delayed skin reaction; covid 19; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (delayed skin reaction) and COVID-19 (covid 19) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (delayed skin reaction) and COVID-19 (covid 19). At the time of the report, SKIN REACTION (delayed skin reaction) and COVID-19 (covid 19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient stated he been taking Moderna vaccine since January 2021. Patient had the first 3 full doses and then he got a delayed skin reaction. Patient was fine with the half dose booster and had no reaction.  Treatment information was not reported.
rash, lips tingling, tightening of throat, SOB. reaction occurred within 1 minute of receiving the second dose. Prior to getting the vaccine I took 200mg of benadryl because I had a similar allergic reaction to the 1st dose.  Broke out into a rash and had SOB with the first dose.
Vial diluted with normal saline more than 3 hours after removal from refrigerator. 6 doses were given to patients from this vial with identities unknown. No symptoms or signs were reported to vaccine administrators at time of administration.
Myalgia, Fever, LOW GRADE FEVER, CHILLS, DECREASED APPETITIE, BODY ACHES Narrative:
Well child visit 8/27/08.  Reported positive pregnancy test via mother 9/8/08.
pt recvd vax 23SEP94 & w/in 24hrs exp a thick rash on thigh @ the Tetramune inj site; days later pt seen in the office;2 wks later, rash still present;no treatment initiated;
Myalgia, Arthralgia, warmth and pain of injection site, general soreness, extreme fatigue, stomach pain Narrative:
Nurse reviewed vaccine requirements/catch up criteria for patient. Nurse acknowledged vaccine and removed from refrigerator. Vaccine was drawn up in syringe. Vaccine was administered to patient. Office staff reported to nurse that vaccine was not listed in the inventory. Upon checking and verification, nurse realized vaccine expired on 8/06/2021 but had not been removed from inventory refrigerator. Nurse reported to patient's mom the incident and that the Hib vaccine was not valid due to expiration. Patient's mom acknowledged and agreed to return in one month minimum to receive Hib vaccine. No treatment was needed for patient. No adverse symptoms reported to nurse prior to patient leaving the clinic.
Diarrhea and fatigue and vomiting started around 2:30 pm on 3/15/2021. I received the second vaccine injection on 3/15/2021 at 1:15 pm.  I've been unable to keep any food in and I've had between 4-5 bouts of loose stool within a 24 hour period. I've been staying hydrated with ginger ale and chicken soup broth, and resting.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 70-year-old female patient who received SHINGRIX (batch number C523T, expiry date 7th July 2020) for prophylaxis. Concomitant products included Atorvastatin, Metformin) NITROSTAT, PLAVID, hydrochlorothiazide, MYRBETRIQ, trandolapril and verapamil. On 6th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In June 2018, 14 days after receiving SHINGRIX, the patient experienced shingles, blister and erythema of extremities. On an unknown date, the outcome of the shingles, blister and erythema of extremities were recovering/resolving. The reporter considered the shingles, blister and erythema of extremities to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on left arm. The concomitant products included EBSE vitamin. The pharmacist reported that the patient experienced a patch on back of left arm close to elbow about the size of her palm, which looked like a shingles outbreak with small blisters and redness.
a 5 month, 22 day old patient received a dose of Fluzone Quadrivalent vaccine, no AE; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 months 22 days old female patient who received a 0.5 ml dose of influenza quadrival a-b vaccine (Fluzone Quadrivalent) (batch number: UJ211AA and expiration date 30-Jun-2020) via intramuscular route in left thigh on 15-Oct-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.   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 Disclaimer: 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.
Patient came to clinic, Lt arm red/warm from Pneumonia injection on Monday afternoon 10/25/10, patient afebrile, notified Dr. who examined/spoke with patient, antibiotics ordered for window pickup, patient instructed if not showing improvement by late Friday morning come into the clinic, verbalized understanding and agreement. Symptoms: Rash. Treatment: Clindamycin 300 MG TID.
Temporary blindness for 1-2 minutes after getting out of bed at about 14 hours after the vaccine. Could not tell the difference when switching the light on or off, everything dark. After about 2 minutes, vision returned. No lingering effects so far.
Hot at injection site; Big red patch on left arm at the injection site that was 2 inches wide and 3 inches long; Itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE ERYTHEMA (Big red patch on left arm at the injection site that was 2 inches wide and 3 inches long) and VACCINATION SITE PRURITUS (Itchiness at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE ERYTHEMA (Big red patch on left arm at the injection site that was 2 inches wide and 3 inches long) and VACCINATION SITE PRURITUS (Itchiness at injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE ERYTHEMA (Big red patch on left arm at the injection site that was 2 inches wide and 3 inches long) and VACCINATION SITE PRURITUS (Itchiness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 20 Apr 2021. Now new information was reported.
Moderna was given instead of Pfizer per request of mother, even though mom was told the Moderna  was not recommended for children under 18.
if the lot # above is not correct try 0z4cz1a cant read the handwriting. Patient starting running a temperture 101.5, vomitting, and very dizzy. He was sick with these symptoms for 3 days. The tech that gave him the injection knew that he was 10 yrs old. I was unaware of the age restricions he should have never had this.
Pharmacist drew up vaccine for technician. While administering shot the needle came disconnected from syringe. This caused product to leak on patient's arm and there was still remaining product in syringe. Technician was confident that minimal dose was administered, so a full dose was administered to patient.
This spontaneous report was received from a licensed practical nurse and refers to an 18 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-MAY-2016, the patient was vaccinated with a dose of GARDASIL 9 (lot # L048237, expiration date, exact dose, route of administration and anatomical location were not reported), that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Had the shots and still got shingles/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case. The age at vaccination was not reported. The patient had the Shingle shots and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available
Headache shortly after injection, 16 hours later chest pain , facial and mouth numbness.  days later  sharp eye pain
Patient became unconscious and fell out of his chair about 5 minutes after receiving his first Moderna vaccine.   He came too but loss conscious two more times.  He was clenching his arms and fist like someone having a seizure.  When he came too he was not aware of what happened but he knew his name.  Blood pressure was taken several times and each time was low.  911 was called and paramedics arrived about 15 minutes after he first loss consciousness.  Paramedics took blood pressure and started IV fluids and took patient to hospital.
Vaccine was administered on 11/1/07 @ 0700 hr.  At 1300 hr after eating lunch she developed some tightness in her throat.  No new foods eaten.  She was given Benadryl 25 mgs p.o. and symptoms were relieved and did not reappear.
she got home and removed the bandage, there was some clear liquid that came out, patient thinks it was the vaccine that came back out /no AE; she got home and removed the bandage, there was some clear liquid that came out, patient thinks it was the vaccine that came back out /no AE; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via The agency (Reference number- US-SANOFI-00333577) and transmitted to Sanofi on 27-Oct-2020.  This case involves a 59 year old female patient who was administered an INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date (underdose and injection site extravasation).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Pharmacist wants to know if a patient. Stated she was given FLUZONE QUAD (pre-filled syringes) on 10/13 but when she got home and removed the bandage, there was some clear liquid that came out, patient think it was the vaccine that came back out and wants to be re-vaccinated.  It was a case of an actual medication error due to she got home and removed the bandage, there was some clear liquid that came out, patient thinks it was the vaccine that came back out (latency same day).  At the time of reporting, 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.