chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient feels pain at the injection site, left arm deltoid region, with tenderness to the "touch or pressure" and weakness of elevation of the left arm. No atrophy. Presented on 05/17/06; improving on Diclofenac 75 mg twice daily.
administered expired Moderna vaccine to female patient on 05May2021/Moderna vial was punctured and it was suppose to discard after 6 hours but she used that vaccine near about 18 hours; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Moderna vaccine to female patient on 05May2021/Moderna vial was punctured and it was suppose to discard after 6 hours but she used that vaccine near about 18 hours) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Moderna vaccine to female patient on 05May2021/Moderna vial was punctured and it was suppose to discard after 6 hours but she used that vaccine near about 18 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Moderna vaccine to female patient on 05May2021/Moderna vial was punctured and it was suppose to discard after 6 hours but she used that vaccine near about 18 hours) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medication reported.
Covid positive through work contact.  Client did receive booster but was not within the 2 week period
ZOSTAVAX given 5/24, rash at injection site appeared 5/28 about 10cm in diameter, red, itching, now resolving. No longer itching, about 2-3cm in diameter on 5/31.
Moderna bivalent vaccine was given too early due to cdc guidelines. Her most recent Moderna booster given 7/31/22, and bivalent booster given 9/8/2022, a few weeks before the two month interval. Patient was not experiencing any adverse effects or side effects after administration.
2-10-06 Pt received vaccine. 2 days later mother noticed urticaria - comes and goes with milk ingestion. Present today at clinic visit.
Information has been received from a consumer concerning her 13 year old son who in August 2000, was vaccinated with a dose of "chickenpox vaccine" (manufacturer unspecified) and developed chickenpox. The patient felt sick on 10-APR-2010 and on 11-APR-2010, with a sore throat and nausea and he felt tired. On 12-APR-2010 the patient went to school and came home with "a blister on his collar bone". On the morning of 14-APR-2010 he had a blister on his inner thigh and his calf and had a sore throat. It was unknown if medical attention was sought. The outcome of the patient was not reported. Follow up information has been received which reported that on 30-AUG-2000 the patient was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported). He had a few red pustular lesions on his leg, arm and neck. He went to see the physician and the physician's impression was questionable chickenpox, but could not diagnose today. At the time of this report, the patient's outcome was unknown. Follow up information has been received from the physician concerning the 13 year old male patient with no allergies and no other medical history. The physician reported that the patient's sister developed wild type chickenpox one week after the brother given vaccine at different clinic. There was no illness at the time of vaccination. Typing was done in our lab. This is one of several reports from the same source. Additional infection is not expected.
One day post vax pt experienced generalized rash, urticaria; which was treated with Benadryl.
at approximately 11:30 am 12/23/20 began to have: generalized body aches and weakness,headache,severe pain in left arm , chills, temperature max 99.9 degrees F; extreme fatigue,drowsy,small area of redness at injection site with mild itchiness. Symptoms resolved approximately 12 hours later. I took Motrin 800mg at onset of symptoms and Excedrin extra strength (2) caplets approximately 8 hours later for lingering headache.
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9, lot# K026246, expiry date 28-JAN-2017. No adverse effects reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of four reports received from the same reporter. Additional information has been requested.
Pt presented within couple minutes of vaccine admin. with difficulty breathing. Vitals were obtained and BP markedly elevated (syst 170-180). Symptoms progressed rapidly with pt complaining of burning of ears and then severe pain in hips. Paramedics were called. Epipen was administered. Pt symptoms improved quickly after epipen admin. Pt transported to ER.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 05-APR-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
I had high blood sugar that I couldn't control, I kept taking more insulin to try stabilize it and it wasn't working. I got dizzy, began vomiting, and was really nauseous and then I went to Diabetic Ketoacidosis. I called 911 on 04/12/2021 and I went to the ER. They gave me fluids and took blood and sent home. They were going to admit me but then saw I could handle myself on my own with a personal glucose monitor and discharged me.
Itchy rash on scalp, neck, shoulders, back of hands, forearms, knees, thighs, torso (striated rash on torso), top of feet.
COVID-19 Disease, 6 months after 2nd dose; Positive PCR ,6 months after 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19 Disease, 6 months after 2nd dose) and DRUG INEFFECTIVE (Positive PCR ,6 months after 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2021, the patient experienced COVID-19 (COVID-19 Disease, 6 months after 2nd dose). 31-Dec-2021, the patient experienced DRUG INEFFECTIVE (Positive PCR ,6 months after 2nd dose). At the time of the report, COVID-19 (COVID-19 Disease, 6 months after 2nd dose) and DRUG INEFFECTIVE (Positive PCR ,6 months after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     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 case refers to a male patient of unspecified age with no known medical history who experienced the unexpected events of Drug ineffective and COVID-19 approximately 8 months after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case refers to a male patient of unspecified age with no known medical history who experienced the unexpected events of Drug ineffective and COVID-19 approximately 8 months after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient woke the morning after her vaccine with hives over much of her body. No airway involvement, no trouble breathing, no other symptoms. She was treated symptomatically with over the counter antihistamines. Improved, but still having some hives as of the time of this report.
Right leg Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right leg Pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right leg Pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Right leg Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient came back to pharmacy on 11/02/2015 to report that his arm was still very sore, and wondered if that was normal. Stated no redness, swelling, rash, or itching.  Only extreme soreness in the muscle. Also, stated that the injection itself "hurt really badly".  Was instructed to give it a few more days while taking OTC pain meds, and then maybe see primary care physician for further analysis.
MMR vaccine was used to reconstitute shingrix and it was administered to a patient; MMR vaccine was used to reconstitute shingrix and it was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 34MK3, expiry date 08-JUL-2024) for prophylaxis.   On 29-AUG-2023, the patient received Shingrix. On 29-AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: MMR vaccine was used to reconstitute shingrix and it was administered to a patient) and inappropriate dose of vaccine administered (Verbatim: MMR vaccine was used to reconstitute shingrix and it was administered to a patient).The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 05-SEP-2023 The reporter called to report the diluent for MMR vaccine was used to reconstitute Shingrix and it was administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up.
No adverse reaction; got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
Report 20010040181 describes injection site pain and injection site swelling in a 7 year old female who received Engerix-B. Allergies, medical history, and concomitant medications were denied. The vaccinee is Caucasian-Hispanic. On 01/09/2001, the vaccinee received her third left deltoid dose of Engerix-B. "Since receiving the injection," she experienced a painful left deltoid, and her left side was slightly larger than her right side. No erythema was reported. No treatment was given. As of 02/06/2001, the outcome of the adverse events is unresolved.
Twelve Moderna vaccines were given in office. Only 11 were drawn up this morning and the 12th dose was, most likely, a left over dose from yesterday. After incident was discovered, Moderna manufacturer was contacted per CDC recommendation. The lady in Quality was also notified.  Communication to patient: The Moderna Vaccine you  received may have been outside of the 6 hour thaw recommendation. We contacted the Moderna manufacturer and CDC. At this time, there are no recommendations for revaccination. You will still receive your 2nd dose as previously scheduled. Titers will be available at no cost in 2-3 months after your second vaccine.
Received the shot and within one to two minute I was extreme dizzy to the point I had to Touch the side of the shelving because I thought for sure I was gonna pass out on the floor. I felt like I needed more oxygen is the reason I got up out of that chair the pharmacist had advised me to sit in. This  extreme dizziness lasted  for a few minutes and then I regain composure and left the store. No I did not tell anybody because they were very very busy and what could they do about dizziness nothing. I got into my car I drink my drink I went to the pool I swim for about an hour and a half of course I felt better during
Patient returned on 9/21/17 at 830am, to pharmacy to report fever, aches and muscle pain, area to the left of injection site was red. Patient reported she had taken ibuprofen and used ICY HOT on the painful area of left arm. RPh recommended to continue to treat fever/aches and pains with ibuprofen to take oral BENADRYL and to use topical BENADRYL and ice on the painful area. She was told to not use ICY HOT rub which would aggravate the area. She was advised to seek medical treatment if condition worsened.
This spontaneous report was received from the patient's father, referring to his 14 month old son. No patient's medical history, concurrent conditions and drug reactions or allergies were present at the time of the report. On 31-AUG-2015, the patient was vaccinated subcutaneously with a dose of MMR II (dose, lot # and expiration date were not reported) for measles, mumps and rubella prophylaxis. On the same date, on 31-AUG-2015 a few hours after receiving the vaccine, the patient had red spots on his back between his shoulder blades and on his lower neck. The patient was treated with BENADRYL the same evening and recovered on unspecified date in 2015. No concomitant therapies were reported. No laboratory diagnostic studies were performed. The father's patient sought unspecified medical attention. No product quality complaint was involved. Additional information has been requested.
No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 4 year old female patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 04-DEC-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
The varicella vaccination administered to the patient has resulted in chickenpox.  At this time, I could not determine how severe the effect on a one year old kid. So far, he might have approximately have 125 bumps all over the body which does not seem like a mild case.
48 hrs after DTaP vaccine administration IM in L arm, noted erythema and swelling 4in x 3in around injection site. No fever.
Patient is a USAFR female service member, and was on military status on 29 March 2009, when she received a TDaP vaccination (0.5 mL, IM, L upper arm). The patient experienced swelling to injection site, with intermittent tingling, and numbness to L hand just shortly after vaccination. Later, in the evening of the 29th Mar 2009, patient had continued swelling with palpable tenderness, and a lump formed below the swelling; tingling and numbness to L hand has been intermittent since administration of vaccine.
Patient received COVID19 vaccine (Moderna) and felt flushed afterwards requiring an ED visit. In the ED she received diphenhydramine 50mg PO and prednisone 60mg PO x1 dose each. Patient symptoms improved and patient was discharged.
No adverse event occurred, notified parent of medication error and counsel per CDC guidelines for 2nd dose to complete Pfizer series of COVID-19 vaccination.
Swelling, pain to (L) shoulder; LAD (L) neck; ongoing prednisone 1 year later still for ongoing muscle pain (polyarthralgia). Multiple attempts to stop prednisone have failed.
Patient was given undiluted pediatric pfizer vaccine- so dose was too high. Patient has not called in to report any adverse effects so far.
Patient was prepped to receive Pfizer Covid-19 vaccine, vaccine was administered and in approximately 2 minutes patient experienced vasovagal syncope, fainting.  Pharmacist tried to alert patient who remained non-responsive for approximately 2 minutes and EMS was called.  When patient regained consciousness, patient was confused and pale.  Patient became more alert and within approximately 5 minutes began to vomit.  EMS arrived and took over care of patient.
received a Pentacel vaccination that was expired with no reported adverse event; Initial information received on 28-Feb-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who received a diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] vaccination that was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Jul-2022, the patient received 0.5 ml Once (1x) (total) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (strength and lot number not reported; Expiration Date :09-Jul-2022) via unknown route in unknown administration site for Immunization that was expired with no reported adverse event (expired product administered) (latency: same day). Patient  received a PENTACEL vaccination on 12-JUL-2022 that had expired on 09-JUL-2022. Reporter states that she is in clinic today and could not provide any additional information about the patient that received the expired PENTACEL vaccine on 12JUL2022 or the lot number of the PENTACEL  Action taken : not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, exact dose and route of administration were not reported). On an unknown date, only 22 days after the first dose was administered, the patient was inadvertently administered the second dose in the GARDASIL series (lot#, expiration date, exact dose and route of administration were not reported). No adverse effect was reported. Additional information has been requested. The pharmacist wished to be contacted via email.
Vaso vagal. Had patient lie down, took vital signs, kept them for over 30 minutes. Patient felt well and left.
Feels very tired after each rabies Imovax injection, also c/o nausea symptoms resolve within a few hours.
have a patient who received the Prevnar 13 vaccine in 2016 and went to a local pharmacy and forgot she had already received it and was given it again last week in 2020.; She is having some arm soreness; This is a spontaneous report from a contactable other health professional. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration in Aug2020 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient who previous received the pneumococcal 13-val conj vac (dipht crm197 protein) vaccine in 2016 for immunization and went to a local pharmacy and forgot she had already received it and was given it again last week in Aug2020. Her name is hyphenated so they did not see the first immunization. She was having some arm soreness but other than that was there any cause for concern. The outcome of event was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        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.   Reporter did not allow further contact