chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHILLS 3-4 HOURS AFTER THE SHOT, TEMP NOT TAKEN; FEELS VERY WEAK; ACHES ALL OVER THE BODY; This spontaneous report received from a consumer. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: not reported) .5 ml, administered on 10-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the patient experienced chills 3-4 hours after the shot, temp not taken. On 10-MAR-2021, the subject experienced feels very weak. On 10-MAR-2021, the subject experienced aches all over the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills 3-4 hours after the shot, temp not taken, feels very weak, and aches all over the body. This report was non-serious.
2/11 5pm rash on forehead, swollen lips, pale  2/13 6:00am same as above plus rash on buttocks 2/14 8:00pm same as above plus fever of 101 and rash covering body except palms and soles of feet
The excursion expiration date of 7 days thawed in refrigerator was followed because of the Pfizer email approving the 7 days. Pharmacy policy was to follow the expiration of 5 days.
Vaccines Pediarix given in R thigh on 7/5/07 2d later onset fever Tm 99 ax, red "bump" at injection site appeared 3d after inj. Pt seen on 7/11/07 Dx injx vs focal rxn. Started on Keflex x 10d.
COVID vaccine breakthrough care. Vaccinated Moderna 3/22/21 045A21A, 4/20/21 026B21A, and boosted 051F21A.
State got vaccine 3/10/21 and developer ash under bilateral axillary areas, then sides of body. Leg weakness. Was in bed 4-5 days because didn't feel well. Last a few days feels better but  now groin rash that looks fungal for a few days.
Facial edema, cough while at home.  Video of facial edema.  Took Benadryl at home.  Did not seek medical attention.
Tounge and front upper teeth and jaw became very numb, as if I had a shot of Novocain.
9/23/22 Adverse Event: Vaccination Error History of moderate to severely immunocompromised client was requesting her 3rd Pfizer in the series. The Pfizer primary dose was clearly labeled with an extra label for card in a basin and was on the table, separate from booster doses which were in green covered container clearly labeled. She was given a Pfizer bivalent booster Lot GH9694 instead. The RN did not review the labeling prior to administration.  (Note the primary Pfizer was returned to me for replacement into the pharmacy area so it was unavailable for anyone else).  Treatment: we identified the mistake and staff talked with charge RN who consulted. He discussed that this was the only dose she would need for now and that she was ok. Patient was watched for 15 minutes and felt fine. She was aware of the situation and the plan. She agreed. After the client left, the nurse involved we discussed reviewing label, lot and vaccine information with scribe to confirm correct dose.  Regional Manager were also informed.  Final Plan: Dr called back after our initial discussion and agreed no repeat dose today - this finishes the series but she will need a monovalent booster in 2 months.  I will call her Saturday morning with the updated plan. Make sure puts bivalent dose as 3rd in series. (Admin) sent email to support,  RN,Site Supervisor,  and myself.  Person Reporting: Charge Nurse
Dose administered from a vial punctured for more than 12 hours; patient was administered yesterday (6Oct2021) a dose of the Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial punctured for more than 12 hours) and PRODUCT STORAGE ERROR (patient was administered yesterday (6Oct2021) a dose of the Moderna) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (patient was administered yesterday (6Oct2021) a dose of the Moderna). On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial punctured for more than 12 hours). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial punctured for more than 12 hours) and PRODUCT STORAGE ERROR (patient was administered yesterday (6Oct2021) a dose of the Moderna) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications include blood pressure, cholesterol, anticoagulant and an inhaler.  No treatment medications were provided.   Reporter did not allow further contact
second dose after one week of first dose; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, 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.  Additional details were provided as follows: The age at vaccination was not reported. The 2nd dose of Shingrix administered after one week of 1st dose which led to drug dose administration interval too short. The follow-up would not possible as no contact details were available.
JAW PAIN; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 201 pounds, and height was 194 centimeters. The patient's concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 05-AUG-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced jaw pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from jaw pain. This report was non-serious. This case, from the same reporter is linked to 20210626627.
pt recv vax 7FEB97 3PM about 6PM felt weak;flu sx devel by 8FEB sneezing, coughing, joint pain in arm, shoulder & elbows-hurt to move;9FEB exp one fast irregular beat, felt weak in heart for 2 days;felt nl by 13FEB97;
Patient developed rash on body 3-4 days after vaccination of shingle. Pt was advised to seek medical attention. Pt was told that she had chicken pox or shingle by a covering MD.
This writer noted that patient accidently received 2 doses of IPV  when lot numbers were entered in electronic medical chart.  This writer notified mother of error immediately and assessed patient for adverse reaction. Noted that patient did not have adverse reaction while in clinic. Pt was assessed by provider 40 minutes after this writer administered vaccines.  Provider reviewed s/sx mother is to report to clinic.
tested positive; tested positive; This is a spontaneous report from a contactable consumer (patient). This 40-Year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Sep2021 as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The reporter asked how long she needed to wait before getting her second COVID vaccine dose after having COVID. She received her first COVID vaccine dose on 04Sep2021. Her son came home with COVID and she tested positive on 09Sep2021. She was scheduled to get her second vaccine dose on 25Sep2021 and asked if she still keep that appointment or if she need to change it. She has heard from her doctor to wait 30 days, then somewhere else she heard to wait 90 days and she calls now to obtain clarification. This case was reported as Non-Serious. The outcome of the event was unknown.  The lot number for [BNT162B2] was not requested and will be requested during follow up.
Patients arm became swollen, red and painful on next day after receiving vaccine (left).  Was taken to ER and diagnosed with cellulitis.  Treated with antibiotic.  Still a knot 8/11/06 but improved.
The index finger of the arm where injection given was red, swollen and itchy the next morning after vaccine.
Rash area, chest, abdomen, hot happened 2 days later - muscle pain, vertigo, shaking, slow - motion.
Dr informed us, if reaction, it would be 7-10 after, possibly fever, due to live vax   Patient became intolerable itchy, with fever over 101.  She described pain in her legs, could not put weight on legs, and lost ability to walk.  Dr office called and we were told to give her motrin
Flu Symptoms 13 hours after J&J Vaccine on Wed April 7th @ 10am - Started Vomiting 11pm-1am and then was on the Toilet from 2am - 8am and Dull Headache and Bodyache until Friday April 9th @ 10am.  It was like a Colonoscophy Cleanse that started in my upper digerstive and then my lower digestive system.  Feel Back to Normal Friday April 9th @ 3pm
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 14-AUG-2014 the patient was inadvertently vaccinated with a dose of M-M-R II (0.5 ml, subcutaneously) (lot # H012140, expired date 29-JUN-2014). No adverse effects reported. It was unknown if the patient had sought any  medical attention. Additional information is not expected because the pharmacist can not to be contacted.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Narrative:  COVID infection following COVID vaccine series 03/17, Pfizer, dose #1 04/07, Pfizer, dose #2 1/2 COVID swab, result: detected 01/02 pt cc: fatigue, fever exposure: unknown 01/02 CXR IMPRESSION: No acute productive cough, fatiue. body aches, and bilateral anterior lower chest wall pain. dx:  Covid illness; LOS; 1 day
bleeding on one side; rare rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via unspecified route of administration at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had the COVID first shot and was getting some rare rash, some rare side effects. Patient was bleeding on one side and then it stopped and patient was totally fine for a couple of days and then all of a sudden, it all started up again. Patient reported that this morning, patient was bleeding again. Outcome of the events was recovered with sequel.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Very ill; Extremely achy; Tired; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very ill), PAIN (Extremely achy), FATIGUE (Tired), VOMITING (Vomiting) and NAUSEA (Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0303L20A and 028L(I)20A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome (Lupus).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received 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 ILLNESS (Very ill), PAIN (Extremely achy), FATIGUE (Tired), VOMITING (Vomiting) and NAUSEA (Nausea). At the time of the report, ILLNESS (Very ill), PAIN (Extremely achy), FATIGUE (Tired), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) Blood pressure went very high and normal (normal) Blood pressure went  back to normal.         No concomitant medications were reported.   Treatment included blood pressure medication since the blood pressure went very high which required an adjustment in blood pressure medication.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up information includes no new information
The evening of receiving the immunization patient started experiencing fever, weakness, fatigue that lasted for 2 days; patient also experienced local reaction at the site of administration (swelling, redness, hot). Patient went to see her primary care physician on Monday 9/10/18 and was given antibiotics. Local reaction site was marked for monitoring.
Facial swelling vomiting x 2 days. Temp 103 max. Phenergan supp
Thursday night, 2/14/2019, approximately 20 days post vaccine administration, patient noticed pain upon light touch to left deltoid where HPV vaccine had been administered. The site was moderately raised but had no erythema or bruising. The patient began taking 500 mg acetaminophen PO PRN for pain and applied alternating heat/ice pads. The patient reports that the pain became progressively worse over the following 4 days, on Tuesday (2/19/2019, today) reporting that arm movement elicits pain at injection site. Patient reports sleeping throughout Sunday (2/17) afternoon to Tuesday (2/19) morning, noting feeling feverish and calling in sick to work on Monday (2/18). Today (Tuesday 2/19): Light palpation produces pain rated as 4 on a 0-10 scale per patient. The site is moderately raised and palpation feels firm with no warmness. No erythema or bruising is present. The patient reports no complaints or adverse symptoms regarding right deltoid, which received an HAV vaccination at the same time as the HPV vaccination.
My upper respiratory infection started on 12/20/2022 in the morning when I woke up around 8:00AM. I had a Sinus drainage. The next few days I had cough, sinus drainage, mucus, throat irritation. I did a home COVID-19 test on 12/22/2022 which was negative. I went to the clinic on 12/26/2022 they gave me a dexamethasone and prednisone 20mg for 2 times daily, and cough syrup 4 times a day. I was also prescribed albuterol on 06/02/2022 which I used along with this medication.
16 year old received vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received vaccine) in a 16-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company comment: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: Unknown) with no associated AEs.
I expected a sore arm, but it hurt so much I could barely move it, and when I did, I winced in pain. As the night went on, my neck and shoulders became very stiff. Was unable to sleep due to the discomfort and pain, even after taking Advil. The following morning my lower back was aching so much I had to lay down. I was cold, but my hands and feet were super cold. I could barely eat and had bad heartburn when I did. The second night my teeth hurt. However, when I had the virus in December (recently tested positive for the antibodies), I had none of those symptons and did not feel as bad as I did from the vaccine.
Since 03/06/2020 swelling and redness of arm, Pain at level 7, headache, low grade fever, nausea.  On 03/09 symptoms gone with exception of redness at injection site and swelling in upper left arm. Worst reaction I have ever had to a vaccine.
Two days after getting the shot, my existing tinnitus increased dramatically.  I thought the tinnitus blocker in my hearing aids had failed because they were so effective, prior to the shot.  They were checked out as okay, so I think the shot caused the increase.
Pt instructed to apply warm moist compresses QID for discomfort, OTC Benadryl cream for itch.
Redness, soreness, swelling, itchiness all experienced in the evening hours of 20MAR17 and persist to 23MAR17 when presenting to clinic to address concerns.
Initially with erythema and arm soreness that resolved within 1-2 days. On day 6 after injection, she developed significant itching and recurrence of erythema at vaccine site. She was treated for cellulitis with antibiotics and topical steroids for itching. She has long history of skin sensitivity and rash with previous vaccines.
Event occurred after 2nd dose. Presents to the emergency department for evaluation of persistent palpitations.
Patient dizzy immediately after immunizations given. Passed out and arms stiffened. Was able to get patient is a prone position. The possibility of syncope with HPV vaccine was discussed with patient and his father. Dad and nurse describe patient's arms as stiff but no clonic activity. When Dr. arrived in room approximately 10 seconds later. Then patient was awake and answering questions but initially confused...back to normal quickly. Patient was observed for more than 30 minutes and his physical exam was normal. Patient has a migraine headache that came on 7/21/2015 in afternoon and continued through 7/22/2015. Excedrin did not help headache. No vomiting. Mother called on-call physician 7/22/15 around 10pm. On-call physician recommended aleve and hydration. If worsens should go to ED for further evaluation and we need to recheck in office 7/23/15 morning. Mom reports 7/23/15 in a morning phone call with Dr. that Aleve has helped patient's headache.
Information has been received from a registered nurse concerning a 5 year old female with a positive streptococcal test, who on 02/10/1998 was vaccinated SC in the left arm with a first dose of varicella vaccine. The pt had between five or six streptococcal infection over the last two months. The pt's mother reported that on 06/07/2001 the pt developed a few spots at bedtime on 06/08/2001 the pt had chicken pox, a fever of 103 deg. F. and was "covered with pox." The pt sought medical attention. The chicken pox "came to a head, opened, then crusted." On 06/13/2001 the pt recovered. No further info is expected.
This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 07-year-old child of an unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which the vaccine were stored, dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 14-Feb-2018, the patient was administered with FLUCELVAX QIV (dose, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195236, expiry date: 30-May-2018) that was stored out of recommended temperature. The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realised that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
n/v, h/a (double vision, unable to focus, staggering gait;eye movement rt dec 80degree out to rt;has improved 95%;3rd cranial nerve +;
This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 22-year-old male 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) (unknown route) 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 an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown. Possible      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    No relevant concomitant medications were reported.   No treatment information was provided.  All cases occurred within 2 weeks of a dose of the COVID-19 mRNA vaccine with the majority occurring within 3 days (range 1-13 days) following the second dose (6/7 patients, 86%). Overall, cases were mild, and all patients survived.  Myocarditis was a rare adverse event associated with COVID-19 mRNA vaccines, and in adult males it occurs with significantly higher incidence than the background population rate. Recurrence of myocarditis after a subsequent mRNA vaccine dose was not known at this time.  This literature case concerns a 22-year-old male patient with no details on relevant medical history, who experienced the expected serious event/AESI of Myocarditis after mRNA- 1273 Moderna vaccine. The event occurred within 2 weeks after the second dose of mRNA- 1273 vaccine. The case was mild. Very limited information is avaliable at this moment. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-380819, MOD-2021-380877, MOD-2021-380878 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This literature case concerns a 22-year-old male patient with no details on relevant medical history, who experienced the expected serious event/AESI of Myocarditis after mRNA- 1273 Moderna vaccine. The event occurred within 2 weeks after the second dose of mRNA- 1273 vaccine. The case was mild. Very limited information is avaliable at this moment. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report.