chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via interactive digital media and described the occurrence of blister in a 7-year-old male patient who received Meningococcal B vaccine for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced blister, sickness and inappropriate age at vaccine administration. On an unknown date, the outcome of the blister and sickness were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the blister and sickness to be related to Meningococcal B vaccine. Additional details were provided as follows: This case was reported by the patient's parent. It was stated that, when the patient was young, about 7 years old, the patient received Meningococcal B vaccine, which led to inappropriate age at vaccine administration. The patient experienced a bad reaction which looked like he had boiled water poured on his arm and back. The patient blistered and felt very sick for days.
Firm knot, swollen, lightly bruised area approx 2.5cm to right upper arm.
Severe mood swings causing intense anxiety attack and depression. Also developed painful ovarian cysts immediately after receiving the second dose
I got the shot at 5:20 the night before, then so woke up with my entire face swollen.
expiration date was yesterday and four shots were accidentally given out; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expiration date was yesterday and four shots were accidentally given out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expiration date was yesterday and four shots were accidentally given out). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expiration date was yesterday and four shots were accidentally given out) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that the vaccine they had in stock said the expiration date was yesterday 28-Apr-2022 and four shots were accidentally given out. The date the vial was initially stored in the refrigerator was 26-Apr-2022. It was reported that the vial didn't undergo any temperature excursions. The doses administered were booster 0.25 mL doses.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up received contains no new information.
pt recv vax 04feb97; concomitant vax included MMR vax; 21feb97 pt devel a non-vesicular rash on both lower legs, an erythematous rash & central swelling;
Information has been received from a medical technologist concerning a 70 year old female patient with high cholesterol, osteoporosis and "EMY" allergy who on 26-AUG-2010 was vaccinated IM with the second 0.5 ml dose of PNEUMOVAX 23 (lot number 667136/0499Z, exp date 25-NOV-2011). The patient was vaccinated with the first dose of PNEUMOVAX 23 in 2005 with no adverse event reported. Concomitant therapies included: simvastatin, alendronate sodium and NASONEX. Her family called the office on 30-AUG-2010 to report the patient was in the hospital and receiving IV intravenous, antibiotics for a possible injection site reaction. No additional information is available at this time. Doctor was concerned about others having similar reactions with this lot of PNEUMOVAX 23 and was requesting a lot check. Intravenous antibiotics was considered to be an other important medical event by the reporter. Additional information has been received from a medical technologist reported that she was uncertain if the patient was still in the hospital. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. Additional information has been requested.
p/vax pt became preg;LMP 8/16/98;expected date of delivery is 5/23/99 the date changed to 6/9//99;pt given parlodel during preg;pt exp nasal stuffiness;
SICKNESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (prolonged-release tablet, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. Concomitant medications included adalimumab. On FEB-2022, the patient experienced sickness. The action taken with covid-19 vaccine ad26.cov2.s, and upadacitinib was not applicable. The patient recovered from sickness on FEB-2022. This report was non-serious.
approx 6day p/vax pt devel bleeding gums & epistaxis. thrombocytopenia; hospitalized, given iv, steroids, apheresis; finally splenectomy
Janssen COVID-19 Vaccine EUA; Fever ( 99.4 ),  fatigue, general muscle pain, some nausea, lack of appetite , light headache,
Dyspnea; injection site erythema; injection site swelling; mass Information has been received from a 45 year old female with hypertension and borderline diabetes who in October 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitant therapy included pioglitazone hydrochloride )Actos) and "antihypertensive medications". The patient had previously been vaccinated with pneumococcal 23v polysaccharide vaccine between 4 and 8 years prior to October 2004. upon vaccination, the patient experienced redness and swelling at the injection site. She also developed a large lump on her arm and shortness of breath less than 24 hours after vaccination. She was seen by her physician and treated with prednisone, diphenhydramine (Benadryl) and ibuprofen. Subsequently the patient recovered from redness and swelling at the injection site, shortness of breath and large lump on arm. No further information is available.
Pt had angioedema and rash (pruritic) on face - hives - required ER visit.
Atrial fibrillation; Abnormal heart rhythm; This case was reported by a nurse via call center representative and described the occurrence of recurrent atrial fibrillation in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cardiac arrhythmia (had abnormal cardiac rhythm), cardioversion and cardiac ablation.   In May 2019, the patient received the 1st dose of Shingrix. In May 2019, 1 day after receiving Shingrix, the patient experienced recurrent atrial fibrillation (serious criteria GSK medically significant) and cardiac arrhythmia (serious criteria GSK medically significant). On an unknown date, the outcome of the recurrent atrial fibrillation and cardiac arrhythmia were unknown.   It was unknown if the reporter considered the recurrent atrial fibrillation and cardiac arrhythmia to be related to Shingrix.  Additional details were received as follows: A nurse reported the adverse events experienced by her husband. After the previous cardio-version with ablation, the patient was stable for 1.5 years.  One day after receiving Shingrix, the patient experienced a re-occurrence of atrial fibrillation and developed abnormal rhythm.  The patient was under the care of a Cardiologist and had another cardio version scheduled. The reporter consented to follow up.
C/O pain, redness and swelling at site of injection that eventually spread down her entire right arm  Couldn't write with her right hand at school next day. Arm in pain swollen from shoulder to fingers could not make a fist or lift arm from Mar. 30 10 until Apr. 6 remain swollen tender to touch with a burning sensation site still swollen & sore ran fever & dizzy.
two small blisters / injection site.; blisters appear like shingles blister; This case was reported by a physician via call center representative and described the occurrence of injection site blisters in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Prolia injection (several months ago). Concurrent medical conditions included osteoporosis and allergy. Concomitant products included benadryl (nos) (Benadryl).   On 11th September 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 12th September 2020, 1 days after receiving Shingrix, the patient experienced injection site blisters and vesicular rash. On an unknown date, the outcome of the injection site blisters was not recovered/not resolved and the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the injection site blisters and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and the next day noticed two small blisters one on each side of the injection site.  The reporter stated the blisters appear like shingles blister, but they are not red or oozing, only tan.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: EW0151), in right arm, on 26Apr2021 as dose 2, single (Lot number: Ew0170), in right arm and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2022) Negative, notes: I tested negative on two home tests, 04Aug2022 and 06Aug2022; (06Aug2022) Negative, notes: I tested negative on two home tests, 04Aug2022 and 06Aug2022; (08Aug2022) Positive, notes: I tested positive on a home test on 08Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient has not had other medications in 2 weeks. The patient has no known allergies. It was reported that after a five-day course of Paxlovid, patient tested negative on two home tests, 04Aug22 and 06Aug22. I tested positive on a home test on 08Aug2022 and have very mild cold symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a 60 year old female patient refers to herself. Three days ago (approximately on 23-SEP-2013) the patient was vaccinated with ZOSTAVAX (route, dose and lot # were unknown, expiry date was reported as 14-JUL-2014). Two days later (approximately on 25-SEP-2013), the patient noticed a singular "welt" covering the injection site, which was accompanied by pain and redness. The patient also experienced a headache after receiving the injection, however the headache has since resolved and the patient "was not sure it was due to the vaccine." The outcome of headache was reported as recovered/resolved. The outcome of "welt, pain and redness" was unknown. The patient did not sought medical attention. No treatment was given for adverse event. Additional information is not expected.
Patient received vaccination 9/12/17 and went to the ER 9/18/17 and stayed until 9/22/17 for a bladder infection. Patient feels it was related to vaccination.
9/7/17 C/O ONE INCH REDDENED AREA, RIGHT DELTOID @ SITE OF MENINGOCOCCAL IMM.  NO C/O PAIN, OR ITCHING. PT. /MOTHER INSTRUCTED TO USE COLD COMPRESSES, AND IF NO RELIEF, TO RETURN TO CLINIC FOR PROVIDER TO ASSESS. CALL TO MOTHER, AREA RESOLVED  9/9/17.
HCP has no further AE information; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; This spontaneous report was received from a medical assistant concerning to a 13-month-old male patient.  Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 19-SEP-2023, according to a digital data logger, there was a temperature excursion in clinical practice at 9:28, temperature was 8.3 Celsius degree and at 10:02 the temperature was 7.5 (units not provided) for a total excursion time of 34 minutes for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number reported as 1933911 (expiration date 18-APR-2024) and with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot  number reported as W001598 (expiration date 14-JAN-2024), albumin status was not provided, however, upon internal validation it was stablished as rHA. On 25-SEP-2023 at 11:08 temperature was at 9 Celsius degree and at 15:01 it was at 8.0 Celsius degree, for a total excursion time of 4 hours. On 29-SEP-2023, the patient received the improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, and route of administration were not provided) (product administered to patient of inappropriate age) and the improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, and route of administration were not provided) (product storage error) both of them administered as prophylaxis. It was reported that the patient received the vaccination in a private doctor's office.  No adverse effect was observed (no adverse event).     This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA002926: US-009507513-2310USA010775: US-009507513-2311USA003147: US-009507513-2311USA002927: US-009507513-2311USA002928: US-009507513-2311USA002929: US-009507513-2311USA002930: US-009507513-2311USA002931:
I had a COVID breakthrough infection.; I had a COVID breakthrough infection.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Apr2021 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single and intramuscular, administered in arm left, administration date 18Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 07Jan2022, outcome "recovered" (Jan2022), VACCINATION FAILURE (medically significant) with onset 07Jan2022, outcome "unknown" and all described as "I had a COVID breakthrough infection.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. Patient did not receive any other vaccines in four weeks prior to the  COVID vaccine. Patient did not receive any other medications within two weeks of vaccination. Hospitalization prolonged was no.  The patient was not diagnosed with COVID-19 prior to vaccination. The patient had been tested for COVID-19 since the vaccination. No known allergies.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Localized redness on (R) thigh, 1 x 3 cm with 4 small vesicular lesions.
pt recvd vax; devel tenosynovitis; f/u indicated that did not have adverse rxn; arm pain due to cervical arthritis; also exp dupuytren's contracture due to the vax;
Shortly after vaccination patient felt hot and nauseous. Had to lay down. Never fully lost consciousness but was very close. Never had any trouble breathing.
Immediately after receiving GARDASIL #3 pt. became dizzy, lightheaded, and c/o nausea. Pt. was laid down, feet elevated. Pt. was given cheese crackers and juice, as she denied eating breakfast. Reported previous reaction with other vaccines.
Bell's Palsy system, left side of face and tongue  numbness and tingling. primary care Dr. visited, prescribed Medrol( steroid), slightly numbness and tingling is better but it's still there and effecting daily life.
Pt reported she had swelling and redness starting from the injection site of her right arm that spread to her entire arm day of injection 10/16/19. She took 600 mg of ibuprofen around 5:30pm, iced with a pack of peas, 400 mg ibuprofen 12 am 10/17/19. Called pharmacy around 3 pm 10/17/19 to report symptoms (swelling, redness, hot on Right side of arm), took 800 mg ibuprofen and iced arm. Took 50mg of Benadryl around 6:10 pm and continued to ice for an hour as redness was spreading to back. By 8:20pm redness reduced to elbow and shoulder area.
Approx 9:15A noted redness at site on (L) outer thigh area. Redness approx size of tennis ball and one small dime size slightly raised areas Dr notified and looked at site. Per him advised to give BENADRYL one tsp 4 time a day and monitor for fever or any worsening at site. Contact office or emergency room. V 7-30-15 mom voiced reaction gone.
Cellulitis; Hot at the injection site; Itchiness at the injection site; Redness at the injection site; Pain at the injection site; A spontaneous report was received from a 67 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed cellulitis, redness at the injection site, itchiness at the injection site, hot at the injection site, and pain at the injection site.  The patient's medical history and concomitant medications were not provided.  On 18-FEB-2021, 8 days prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (batch number: 010M20A) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On 26-FEB-2021, the patient developed cellulitis, redness at the injection site, itchiness at the injection site, hot at the injection site, and pain at the injection site. Treatment included administration of antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, cellulitis, redness at the injection site, itchiness at the injection site, hot at the injection site, and pain at the injection site, were reported as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Morning following the booster, I had a sore rash on the right side of my face and the right eye was irritated with some discharge.  I went to the urgent care physician and was diagnosed as having Shingles.  Given anti-viral medication.
Patient called 7 day post Moderna Covid vaccination #1 saying that she had been experiencing some muscle soreness on both sides of her neck as well as some redness/swelling around the injection site. Told her the injection site reaction was quite common and should subside over time and is ok to use with OTC pain relievers (ibuprofen, naproxen, acetminophen). The muscle soreness was a noted adverse event in trials and told her if it did not appear to get better or progressed, she should notify her physician.  She did not seem real concerned, just thought we should know and she still planned on getting her second shot in approximately 3 weeks.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 3:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 3:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 48.80 for dose administered on 13-Feb-2021.  No concomitant medications were reported. Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.