chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator was on 26 Jan 2022 and administered on 03 Mar 2022; Patient received Moderna booster dose ,found out that they were possibly expired due to past the thirty days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna booster dose ,found out that they were possibly expired due to past the thirty days) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was on 26 Jan 2022 and administered on 03 Mar 2022) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna booster dose ,found out that they were possibly expired due to past the thirty days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was on 26 Jan 2022 and administered on 03 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna booster dose ,found out that they were possibly expired due to past the thirty days) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was on 26 Jan 2022 and administered on 03 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. It was reported that the patient received dose as 0.25. The vial was initially stored in the refrigerator was on 26 Jan 2022 and the reporter was unaware if  the vial undergo any temperature excursions. No treatment information was provided.
2 weeks after vaccine right earring started a week after the left ear.   Ear ringing has not stopped, it has been 24/4 since 12/2021. I never had more than a moment of earringing before this.
Information has been received form a mother concerning her 20 month old daughter with no medical history or allergy who "a few months ago", was vaccinated with ATTENUVAX (lot# not reported). There was no concomitant medication, "Soon after getting the vaccine", the patient developed a fever of 105F. The patient was evaluated at a local emergency room but was not hospitalized. The fever resolved in 4 days and the patient fully recovered. This is one of several reports from the same source. Additional information is not expected.
Post vax the injection site was red, hot and itchy. The patient had hives on her chest and abdomen. The patient was treated with Medrol Dispenspack and Zyrtec.
Patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with ENGERIX B, (GlaxoSmithKline). On an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (unknown). At an unspecified time after vaccination series completion with ENGERIX B, the subject experienced not responding to therapy and pharmaceutical product complaint. A total of six employees were vaccinated with three doses of ENGERIX B. All had titers drawn at an unknown period after the third dose and the titers were negative (0) for antibodies. There were two lots given to these six subjects at some point in the series, lots: AHBV13734AA and AHBV670AA. The lot numbers were reported as AHBV13734AA and AHBV670AA from the reporter; however, based on a safety lot number review, the lot numbers were updated to AHBVB734AA and AHBVB670AA respectively. For the other cases see A0891212A- A0891214A, A0891216A, and A0891217A. Follow-up information was received on 09 November 2010 via Quality Assurance, who stated there was no product complaint associate with the adverse event; therefore the pharmaceutical product complaint was voided.
Mild side effects within 11 hours of vaccine (same as dose one which was previously reported, but less severe) fever, chills, extreme fatigue, nausea.   On date provided a rash broke out on my vagina.  I saw doctor on Wednesday 2/10/21 who cultured the area.  HSV 1 was confirmed.  I have never before had HSV and have been in monogamous marriage for 20 years.  Symptoms resolved after completing round of antiviral.
Information has been received from a physician concerning a female who on an unspecified dates was vaccinated with first and second doses of GARDASIL (dose, route and lot number not provided). The physician reported that after receiving the two doses the patient was diagnosed with human papilloma virus (HPV). The patient sought unspecified medical attention. Additional information has been requested.
pt received 2nd booster 3/31 and that night she developed 105  fever. she took aspirin to lower it to 101. She has been shaky and has experienced memory loss since she received the vaccine.
Fatigue; chills; headache; nausea; sore throat; runny nose; cough; This is a spontaneous report from a non-contactable consumer. This consumer reported for a 46-year-old male patient. A 46-year-old male patient received bnt162b2 (PFIZER COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm left on 08Mar2021 15:00 as dose 1, single (age at vaccination: 46 years) for covid-19 immunisation. Medical history included glaucoma from an unknown date and unknown if ongoing. Concomitant medications included clopidogrel bisulfate (PLAVIX); rosuvastatin calcium (CRESTOR); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); vitamin a [retinol] (VITAMIN A [RETINOL]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), all from an unknown date and unknown if ongoing. 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. Since the vaccination, the patient had not been tested for COVID-19. No known allergies to medications, food, or other products. On 09Mar2021 02:00 PM, the patient experienced fatigue, chills, headache, nausea, sore throat, runny nose, cough, chills. No treatment was received. The clinical outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
generalized mild urticaria w/in 2hrs of vax;no angioedema,wheezing or GI sx;
Teen received HPV #1 and MENACTRA on 10/29/08. + Urine pregnancy test on 11/4/08 (LMP 9/28/08). No treatment.
This spontaneous report as received from a physician via company representative refers to a male patient (relative of physician) of unknown age. Patients medical history, reactions and allergies were unspecified. On an unknown date the patient was vaccinated with ZOSTAVAX, Subcutaneous injection, (Lot Number unspecified) (dose and frequency as directed) subcutaneous for prevention of shingles. Concomitant medications were unspecified. On an unknown date the patient experienced fairly serious rash about 5 days after receiving ZOSTAVAX. The event was treated with unspecified anti viral therapy. the physician told that the patient was otherwise healthy when the vaccine was administered. There was no significant disability or incapacity to the patient due to the event. The event was not life threatening. The patient was not hospitalized. No product quality complaint was involved. The outcome of fairly serious rash was reported as recovered (on an unknown date). The reporters causality assessment for the event fairly serious rash with the therapy of ZOSTAVAX was not reported. Additional information has been requested.
patient had  2 primary covid vaccine series of age 6mo-4 years when she was 4 years old. patient turned 5 and was administered  age 5-11 Bivalent covid booster.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. On 23-APR-2015, the patient was vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported; lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever/Fever of 102 degrees Fahrenheit that went down to 100 degrees Fahrenheit last night; Light sensitivity; Headache; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient) reported for himself. A 29-years-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 11May2021 (age at vaccination was 29 years) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 18Apr2021 (age at vaccination was 29 years) as dose 1, single for COVID-19 immunization. The caller wanted to report the sides effects after the 2nd dose of the vaccine. On an unspecified date, the patient experienced fever of 102 degrees Fahrenheit that went down to 100 degrees Fahrenheit last night, some light sensitivity and headache due to the fever and the light sensitivity. The caller stated that he would just call his doctor later. The patient underwent lab test which included body temperature: 102 Fahrenheit (fever of 102 degrees Fahrenheit that went down to 100 degrees Fahrenheit last night) on an unspecified date in May2021.The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a registered nurse refers to a 71 year old patient of unknown gender. No pertinent medical history of drug reactions/allergies were provided. On 20-OCT-2014, the patient was vaccinated with (Oka/Merck) VARIVAX INJ, subcutaneous (dose and lot number not provided). The nurse reported that the patient received (Oka/Merck) VARIVAX outside of the recommended age range. No adverse effects were reported. Additional information has been requested.
Customer called Pharmacist and reported her arm was still sore from her flu shot. She denied it being red or any other symptoms. The pharmacist advised her to take some Advil and call and report to us on Friday.
CDC reports: 5 mo infant had fever, wheezing & screaming episode day following DTP/OPV immunization. duration of illness 4 days.
17 year old patient was given Moderna covid-19 vaccine rather than Pfizer. This was her first in the series. Patient was monitored for 15 minutes post-administration and experienced no adverse effects.
Patient received 1st dose Covid -19 Janssen 03/24/2021  Patient received 2nd dose (Booster) Covid-19 Janssen 10/25/2021 at Pharmacy Patient received a 3rd dose Covid-19 Janssen 01/15/2022
?Moderna COVID?19 Vaccine EUA?  Since my first shot I have had a tingling starting under my left arm and running down to my left hand. It troubles me most at night when trying to sleep, but occurs at various time during the daytime, mostly when that arm is in a resting position.
Tinnitus hissing in both ears. Stronger hiss in left ear.  Never stops
Along with body aches, headache, and a sore left arm the next morning, there was also left ear pain. The patient has been taking Advil since that morning.
The patient reported pain and swelling in the lymph node under her left armpit approximately 2 days after administration.  She reported that she visited the doctor on the third day.  She stated that the Dr said the vaccine was given in the wrong spot of the deltoid and should have been given more centrally in the deltoid.  The Dr prescribed unknown antiobiotics, steroids and pain medication and asked to see the patient in a week or two.
had problems driving and with indoor activities; disorientation; This non-serious case was reported by a consumer and described the occurrence of disorientation in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included hydrochlorothiazide and carvedilol.   On 21-DEC-2022, the patient received Shingrix. On 27-FEB-2023, 68 days after receiving Shingrix, the patient experienced disorientation (Verbatim: disorientation). On an unknown date, the patient experienced activities of daily living impaired (Verbatim: had problems driving and with indoor activities).  On 01-MAR-2023, the outcome of the disorientation was recovered/resolved (duration 2 days). The outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the disorientation and activities of daily living impaired to be related to Shingrix.     It was unknown if the company considered the disorientation and activities of daily living impaired to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-MAR-2023 The reporter said patient had problems driving, with indoor activities and disorientation. The reporter consented to follow up.
diagnosed with pericardial effusion; This case was reported by a consumer via call center representative and described the occurrence of pericardial effusion in a adult female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine (intramuscular). On an unknown date, less than 2 years after receiving Flu vaccine, the patient experienced pericardial effusion (serious criteria GSK medically significant). On an unknown date, the outcome of the pericardial effusion was not recovered/not resolved.   It was unknown if the reporter considered the pericardial effusion to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 1-Apr-2022 Reporter's Comments: The caller was the patient. The patient stated that she received a GlaxoSmithKline Flu vaccine (unknown name) in 2016 and was diagnosed with pericardial effusion in 2017. No Lot number or Expiration date was known. The patient provided health care professional information. The reporter consented to follow-up. Additional Supportive Information: The patient received a dose of Flu vaccine in an unknown arm.
pt recv vax & 72 hr later exp a knot, induration, pain & a rash @ inj site;no tx was given;
Approximately 3-4 days after dose 2 pt developed a migraine and diarrhea. Ever since then (5 weeks now) pt has had vertigo. She initially went to a walk-in urgent care and was put on medication and given exercised to do at home. She then followed up with her PCP because she was not better and he prescribed physical therapy. She remains on medication and has completed two physical therapy sessions. She feels the therapy has helped.
The patient had a legal complaint. An attorney reported that a male child received a series of Tetramune, Recombivax-HB, Orimune, and MMR vaccines when he was 2 months of age through 10 months of age. It is alleged that as a result of the cumulative exposure of thimerosal in the vaccines he received, the child experienced mercury poisoning. This case was considered serious since mercury poisoning was considered medically important in this case.
The patient tested positively for COVID-19 today. She denied SOB, cough, fever, or upper respiratory symptoms.
Immediate hive, about 1cmx2cm on right thigh with small area of surrounding erythema at injection site of MMR on right thigh
Pt recv vax on 7/23/98; on 7/25/98 pt found blue in bed.  Pt exp cardiopulmonary arrest; autopsy c/w SIDS.
Patient noted to be flushed, lightheaded and Diaphoretic. Treated with cold compress, gave water, juice and crackers. Patient observed for 60 minutes.
This is a spontaneous report received from contactable consumer or other non-HCP (patient). Other case identifier: GI-2021-10389. A 42-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 42, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced pain (vaccine hurt), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
got the Flu 3 weeks later and it was a nasty one at that; Initial information received on 22-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (patient).    This case involves an unknown age and unknown gender patient who got the flu 3 weeks later and it was a nasty one after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer with unknown formulation, strength, batch number & expiry date via unknown route in unknown administration site for prophylactic vaccination. Batch number was requested.  On an unknown date the patient developed the flu 3 weeks later and it was a nasty one at that (influenza) (unknown latency).  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown.
This spontaneous report was received from a patient's mother refers an approximately 1 year old male patient of unknown age without pertinent medical history. He did not have drug reactions and allergies. On unknown date in 2009 the patient was vaccinated with ROTATEQ orally (dose and lot # were not reported). There were no concomitant medications. On unknown date in 2009 the patient experienced vomiting, fever and diarrhea after receiving oral ROTATEQ, however, the patient did not seek medical attention. There were no laboratory diagnostics studies performed. The outcome the above mentioned events was unknown. Additional information has been requested.
1) Fever (101.1 degrees) 2) Extreme Fatigue 3) Muscle pains 4) Shooting pains under left arm 5) Nausea
pt vax 2nd hepta B. 2 days later pt ex 5th and 7th nerve paralysis characterized by unilateral motor and sensory deficits of the face.  sx were resolving
5 mins p/getting 2nd shot noted pain @ site, diffculty in movement; no pain @ initial time of inj; transported from medical eval cont to have redness, itching, site swelling; 18AUG94, using DPH, ice, advil for discomfort;
High fever started from the date of immunization lasting already 5 days (still have as of this time) from 38C to 40C, weakness, sleepiness, swollen eyes, some shortness of breath and coughing. (The manufacturer of vaccine is Aventis, as recorded in medical history by nurse/doctor, lot number is not clear).
went 2d ago for covid vaccine #1 (Moderna) at 5:30pm; LT upper arm - no rash around injection site - yesterday at noon felt feverish, then rash on torso in the evening ~5pm
a red, itchy area was noted on the morning of 3/19 about the size of a silver dollar, by Saturday morning, 3/20 the area had increased to 3x4 inches, red and still itchy. I took 12.5 mg Benedryl mg at 8 pm on 3/19, I took 400mg of Ibuprofen at 7 am 3/20
Chills, muscle aches, headache, lightheaded, food aversions over about 36 hours
Initial and live follow-up information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a female (age reported as 36) patient who received 0.5 ml of vaccine FLUZONE QUADRIVALENT (lot number not reported) via subcutaneous route instead of intramuscular route in further back of right arm and not in Deltoid muscle (wrong location). 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 route of vaccination and vaccine administered at inappropriate site. The patient was not having any problems and has not been seeking any treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Varicella Rash >100 Lesions, cellulitis face - treated with oral antibiotics
Became very hot and flushed an hour after receiving the shot.  Arm started to hurt and a red circle around the injection site was visible 2 hrs after the shot was received.  Next morning arm was very sore and a round red raised tennis ball ring surrounded the site.  Felt dizzy and disoriented rest of day.  Next day fever reached 102 degrees, very sore, muscles ached along my neck and shoulders.  Extreme fatigue and breathing seemed strained.  Remained sick with fever til present day--now low grade.  Continue to have fatigue past 96 hrs of injection.
Chills; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "Chills"; PAIN (non-serious), outcome "recovered", described as "Pain".  Additional information: Reporter stated that no one she knows with diabetes in her family, her mom and grandma don't had neuropathy and she has had it longer and acquired nerve damage. Reporter states her mom had chills and pain, no nerve pain maybe 2-3 weeks ago and it took about a week and a half and went away like all of a sudden she felt great. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Moderna COVID-19 vaccine EUA  Injection Site began to redden and swell days after injection. A reddish circle Initially was about the size of a nickel, now has grown to the size of a baseball over the last 10 days.
Pt was admitted to Hospital for a 6mm kidney stone.  It was incidentally discovered that she was COVID positive.