chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 20-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U010395 expiration date 01-APR-2023 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2109USA006537:
Sudden onset crying accompanied by red, non-raised rash over entire body. Event occurred 30 minutes after receiving vaccines. Treatment received at hosp.
Approx 20 min after the injection a wave of dizziness came over me as I parked my car at home, I sat in the car it lasted 1 to 2 minutes.  Approx 60 min after the injection the 2nd wave of dizziness came over me lasting less than a minute.  I read the paperwork provided and noticed this was a reaction, not a side effect.  I told myself if it happened again I would go to the emergency room.  Luckily it did not happen again.  I will make them aware of this when I go for my booster vaccine on Jan 8th, 2021  Happy New Year and thank you for all of your hard work on this project to help people all over the world.
expired vials were used (Second Dose); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vials were used (Second Dose)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) 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, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used (Second Dose)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vials were used (Second Dose)) 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.
Very sore shoulder Little swelling Redness...2-3? Chills Headache Very sore back across middle Rapid Heart beat in sleep Achey body Feels like I have a temperature Feel pressure behind right knee...clot? Funny sensation during night....           pin pricks all over  Dizzy
known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; This is a literature report.  Authors sampled 130 Nursing Home (NH) residents and 95 Health Care Workers (HCWs) 6 months after vaccination who had been previously evaluated 2 weeks following vaccination. Patients were studied from December 2020 to July 2021 from 4 NHs. The HCWs were workers at the buildings and medical center who all had access to the same vaccine at the same time as the residents. All participants received 2 doses of vaccine regardless of prior SARS-CoV-2 infection. Of 225 participants with available 6-month follow-up, 13 (6%) were excluded for presumed or known SARS-CoV-2 infection between the 2-week and 6-month draws. All of these participants were in buildings or workspaces with known outbreaks. Those with presumed infection had an increase in titer greater than 100% at 6 months from the 2 week post-vaccine level in at least 1 of the immune assays. Five participants had known PCR-confirmed diagnoses; the other presumed cases were clinically undetected. Subjects that have been excluded with documented or presumed infection in the 2 week to 6 month interval: 72-year-old male. Reason for exclusion: PCR +ve, Titer rise (Titer rise denotes an increase greater than 100% in either or all of anti-spike, anti-RBD or neutralization titers); Clinical: Symptomatic (Symptomatic denotes subjects with COVID-like symptoms).  A 72 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws". The patient underwent the following laboratory tests and procedures: antibody test: titer rise; blood immunoglobulin g: unknown results; fluorescent in situ hybridisation: unknown results; sars-cov-2 antibody test: titer rise; sars-cov-2 test: positive; unknown results.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200314527 Same article/ drug/event and different patient
Patient received the Pentacel vaccine. With the Pentacel vaccine, only the blue top vial containing DTap and IPV were administered to the patient. The green top vial containing the HIB was not mixed with the blue top vial. Pt did not receive the HIB green top vial. Mother contacted the office today, 2/08/2023, to inform us that the patient has been running a fever since Monday after the vaccines were given. Also stated that she brought the patient to an ER today, 2/08/2023, which the staff at the ER informed mom that fever is normal after receiving vaccines.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 53-year-old male patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). On 28th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd April 2018, 6 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving. The reporter considered the shingles to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX in the left arm. The patient visited his physician and received a prescription for antiviral medication (brand not specified). The patient required emergency room visit. The reported batch number CE23T for SHINGRIX did not exist and was updated to C523T as per the sales database.
Inappropriate age at vaccine administration; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 47-year-old female patient who received DTPa (Infanrix) (batch number J947T, expiry date 30th May 2021) for prophylaxis.   On 14th November 2019, the patient received Infanrix. On 14th November 2019, unknown after receiving Infanrix, the patient experienced adult use of a child product. On an unknown date, the outcome of the adult use of a child product was unknown.  Additional details were provided as follows: The case was reported by medical assistant. The patient received Infanrix in the left deltoid. The reporter stated that, the patient was prescribed with Boostrix but inadvertently received a dose of Infanrix and also the patient's age was above the indicated age range for Infanrix, which led to adult use of a child product. The reporter consented to follow up.
I have not got my period since this first dose of my vaccine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that, she was wondering if this was normal that she had not got her period since this first dose of her vaccine. It was been like 2 or 3 months. The seriousness for event was unspecified. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient developed swelling 2- by 4cm in size and 3cm long hive, immediately after shot. Patient was given Benadryl 1/2 tsp and was observed for 30 min
This child was give a Pfizer vaccine dose that was prepared on Friday 01/21/2022, it was in drawn into a syringe sitting in the refrigerator at temp 37-42  degrees F. The nurse thought it was freshly prepared vaccine from today, she gave it to the child.
12/09/2021 numbness on right side of tongue. 12/11/2021 drooping of right side of face, seen in ER -- ruled out stroke. 12/14/2021 diagnosed by PCP with Bell's Palsy. Stated course of steroid treatment. 12/15/2021 confirmed diagnoses of Bell's Palsy with Neurologist. Started course of antiviral treatment. Due to Bell's Palsy have sight issues in right eyes and breathing issues through right nostril.
This is a spontaneous report from a contactable pharmacist. A 74-year-old female patient received a PREVNAR 13; (Lot Number: M60993, Expiration Date: 31Jul2017), intramuscular in the left arm on 19Sep2016 at 0.5 ml single dose for immunization. There was no medical history or concomitant medications. On 19Sep2016, the patient experienced redness and inflammation at the injection site. The area was not as big in the beginning but has gotten a little bigger and was now about 2 inches in diameter. There was no pain or itching. The patient went to her doctor to have labs done.  The doctor looked at the redness and inflammation and at that time was not concerned. The patient reported there was still redness and inflammation at the injection site. The clinical outcome of the events, redness and inflammation at the injection site, was not recovered.
Information has been received from a pharmacist concerning a 72 year old female consumer who on 24-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck) subcutaneouly. On 26-MAR-2008 the patient presented with a red, warm and hard area at the injection site. Medical attention was sought, the patient spoke to the pharmacist. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/24/2008. Subsequently the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Patient received vaccines Tdap, MENACTRA & Varicella on 8/24/11. Pain on (R) arm occurred that night. Morning on 8/25/11 (R) arm swollen, red, tender. Mother reports redness & swelling progressively work. Seen at clinic on 8/26/11.
This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to BOOSTRIX. Additional details provided were as follows: This case was reported by the patient herself. The reporter stated that she experience headache while using BOOSTRIX vaccine. The reporter declined to answer questions for the report.
This case was reported by a consumer (friend of subject) and described the occurrence of hive in a female subject of unspecified age who was vaccinated with HAVRIX, (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of HAVRIX (unknown details). At an unspecified time after vaccination with HAVRIX, the subject experienced hive and itching. The reporter stated that a female he had spoken with experienced hives and itching after vaccination with HAVRIX. At the time of reporting the outcome of the events were unspecified. The reporter documented another case with HAVRIX. See case A1034117A for details on the other case.
Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Medium
She woke up with mouth sores,mouth sores, Inflammation of mouth; Inflammation in joints; Imprints of teeth on tongue; lethargy; Increase in vascular migraines; Increase in vascular migraines; swollen tongue, jamming on the edges of teeth; pain at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 42-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number j93gx, expiry date 25-NOV-2024) for prophylaxis.   The patient's past medical history included migraine.   On 25-JAN-2023, the patient received Boostrix (left arm). On 25-JAN-2023, less than a day after receiving Boostrix, the patient experienced injection site pain (Verbatim: pain at injection site). In FEB-2023, the patient experienced sores mouth (Verbatim: She woke up with mouth sores,mouth sores, Inflammation of mouth), joint inflammation (Verbatim: Inflammation in joints), scalloped tongue (Verbatim: Imprints of teeth on tongue), lethargy (Verbatim: lethargy), migraine (Verbatim: Increase in vascular migraines), condition aggravated (Verbatim: Increase in vascular migraines) and swollen tongue (Verbatim: swollen tongue, jamming on the edges of teeth). The outcome of the injection site pain was resolved and the outcome of the sores mouth, joint inflammation, scalloped tongue, migraine, condition aggravated and swollen tongue were not resolved and the outcome of the lethargy was unknown.   It was unknown if the reporter considered the injection site pain, sores mouth, joint inflammation, scalloped tongue, lethargy, migraine, condition aggravated and swollen tongue to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, sores mouth, joint inflammation, scalloped tongue, lethargy, migraine, condition aggravated and swollen tongue to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-APR-2023 The reporter was the consumer. The reporter stated that she did experience pain at the injection site after administration of Boostrix. The reporter reported about 10 days later she woke up with mouth sores, inflammation in joints, imprints of teeth on tongue, inflammation in mouth, lethargy, increase in vascular migraines, and a swollen tongue that was jamming on the edges of her teeth. Consented to follow up.
Patient had an appointment to get immunized by Dr. for the first time.  A total of six shots were administered to patient on 09/08/2008.  After approximately two weeks patient was taken to her family doctor and diagnosed with pneumonia.  She was hospitalized for 4 days. Ater two days of being released she had a relapse. She was taken to back to the Hospital and immediately put into ICU.  She stayed in ICU for about 3 days. She was then allowed to move to a private room.  She was diagnosed with a bad lung infection by her pediatrician that admitted.  She was leased within 2 days after coming out of ICU.  On November 4th patient developed a high fever(104) and was taken to her family doctor because i(mom) was out of town at the moment.  She was again put on Antibiotics and is still on that medication.  She was scheduled to return to her pediatrician on 11/07/08 to follow up on six more shots.  The school nurse then put her out of school because she's not up to date on her shots. She now has an appointment on 11/13/08.  i am very concerned about her taking so many shots in so little time. Her immune system is so low that she can't stay well enough to stay in school for at least a week. Now they want to give her more shots. I don't feel comfortable with that and i will try to fight it off as much as i can.  I don't want to gamble with my child's life just so she can catch up with her shots and stay in school.  I'll home school her if i have to.  I almost lost her once, i don't want her to be put in that situation again. 1/20/09-records received for DOS 10/6/10/908-DC DX: Respiratory distress, resolved. Hypoxia, resolved. Reactive airway disease. Vomiting, resolved. Dehydration, resolved.  Day prior to admission developed difficulty breathing, shortness of breath, vomiting, lethargy with fever of 104.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 06-OCT-2015, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number L021608 and expiration date 10-SEP-2016) that was improperly stored. Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
pt recv vax 11AUG97 & 25AUG97 devel severe itching, hives-no temp;phone call to family MD;rx pred;rash worse 31AUG;went to immediate care clinic;rx pred;2SEP went to family MD cont  pred;dx consistent w/lymphomas drug eruption;erythema;
Employee stated within a few hours she had watery eyes and sinus congestion.  Next day developed a rash across her back and stomach.
Pain went from injection site into left breast area through lymph nodes. Swelling, excessive pain within left breast since 3-28-2022
24 hours after the shot, there was intense muscle ache all over the body and at some joints.  Most of these were gone in 24 hours.  However, I feel joint pain along mine spine, sensitivity at my epidural point from the delivery that was 7 years ago. My rib cage is hurting when I move along with my spine. I feel like there is still some kind of inflammation. It has been over 3 weeks and it still continues.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. Later in 2013, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
would not want no one to touch her after second dose; sore arm after every shot; body hurting after second dose/very achy after second dose; light chills after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (would not want no one to touch her after second dose), VACCINATION SITE PAIN (sore arm after every shot), MYALGIA (body hurting after second dose/very achy after second dose) and CHILLS (light chills after second dose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013M20A) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), ESCITALOPRAM OXALATE (LEXAPRO), IBUPROFEN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-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 PAIN (would not want no one to touch her after second dose), VACCINATION SITE PAIN (sore arm after every shot), MYALGIA (body hurting after second dose/very achy after second dose) and CHILLS (light chills after second dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of UNK UNK, qd. At the time of the report, PAIN (would not want no one to touch her after second dose), VACCINATION SITE PAIN (sore arm after every shot), MYALGIA (body hurting after second dose/very achy after second dose) and CHILLS (light chills after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Tylenol reported as both concomitant and treatment medication.   This case was linked to MOD-2021-390091, MOD-2021-390060 (Patient Link).
Around 4PM on the 14th I started with chills. 2 hours later I took my temp and it was 102.8F ad I had really bad fever, chills, muscle aches, nausea and then the right breast pain started again (around 3AM). I noticed the redness on the same location as it happened with the 1st dose. I had a clogged duct this time as well.  On the right breast. The symptoms with the second dose were much worse/stronger than the 1st dose. I consulted with urgent care over the phone and was prescribed Keflex. Symptoms subsided in about 3 days.
She developed a "weakened" version of the shingles per her MD. She had a rash on her abdomen/chest. Patient reported minor distress.