chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients mother stated that on 16 June she saw a rash all over the childs body.  On June 17th she stated he started scratching and crying and the rash was worse, more like lesions.  She then took him to Urgent care.  She was told by the Physician that the rash was measles and more likely a reaction to the MMR portion of the vaccine.  No medication was prescribed and she was told to use calamine lotion and oatmeal baths. Mom states the rash/lesions has since cleared up and the child is doing fine.
Patient developed erythema and pain to bilateral thighs one day after vaccines. Since then the redness has improved, but discoloration noted. Not painful, no induration, just purple discoloration.
Immediately after vaccines administered patient seemed giddy to aid saying "whoo-whoo". She encouraged her to lie down but patient stated she was fine. Aid observed for ~ 2 min & left room. Dad states she felt faint and he went to lie her down when began having jerking & stiffening of her body with incontinence. Episode lasted 30 - 40 seconds. Fully recovered. Discharged home.
1/13/22 Unknown, nothing listed.  Only note is phone note trying to contact patient about test result.
developed "throat lump" 5 mins after vaccine. continued to worsen. NADN. denies trouble breathing, zyrtec 10 mg PO x1 dose given @ 1253, symptoms subsided. pt sent home
Hospitalized with + COVID , dyspnea and fever, fatigue, myalgias, cough, lack of taste and smell and headache.  Treated with remdesivir
Redness, swelling Lt thigh at injection site at warm to touch-covering most of thigh area. Ibu and cool compress.
Whole right arm burned from injection site to fingers. Developed a headache. About 12hrs later woke up with severe bodyaches, nausea, injection site felt like arm was sliced open, temp of 100.5, body chills and then would be burning up and drenched in sweat.
patient got booster shot on 10/14/21. started complaining of arm pain (tingling feeling) on 10/24/21 when she lifts her arm.patient also states she feels her arm has started to swell. called the pharmacy 10/25/21 to report it.
Information has been received from a physician concerning a 20 year old female who on 12-DEC-2008 was vaccinated with a second dose of GARDASIL vaccine. Subsequently, the patient developed a rash at injection site. As of approximately 18-DEC-2008, the patient's rash had spread to her face. No reactions were reported after the first dose was given. The patient contacted the physician for medical attention. At the time of this report, 18-DEC-2008, the events persisted. Additional information has been requested. Follow-up information from the physician indicated that the patient was diagnosed with follculitis and her rash was not related to her prior GARDASIL shot. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown demographics. On an unknown date, the patients received improperly stored, oral, ROTATEQ (lot # K023532, expiry date: 21-JUN-2016, four doses). No adverse effects were reported. Outcome was unknown. This case is also related to 1509USA006820, 1509USA006365, 1509USA006822, 1509USA006821, 1509USA006824 and 1509USA006825 (same reporter link). Additional information has been requested.
Localized erythema, induration and pain at injection site.Systemic: body aches, chills, fever 101, nausea, rash(entire body appearing flushed)joint aches, diarrhea starting 24 hours after receiving vaccine. Went to ER and put on Keflex and pain relievers/fever reducer.
Patient came to mass vaccination clinic and received Moderna for second dose. Second dose should have been Pfizer.
Initial report was received from a consumer, who was also the patient's parent, on 18 July 2012. A male patient who was currently 13-years-old had received all of his vaccines as an infant including an injection of IPV (brand name, manufacturer, lot number, route, site and date of administration not reported). The reporter believed his child had "polio disease" from the previous polio vaccinations as an infant and autism as a result of those vaccines. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.
This spontaneous report as received from a pharmacist refers to a 59 years old female patient with no pertinent medical history reported and no drugs reactions or allergies. On 20-FEB-2013 the patient was vaccinated with ZOSTAVAX (lot # H019996, expiration date 02-FEB-2013), 0.65 ml, subcutaneous. No other co-suspects or concomitant medications were reported. On an unknown date, shortly after being vaccinated, the patient developed an injection site reaction of redness and swelling. Her injection site reaction lasted for about 1 and 1/2 weeks. Approximately two weeks after her injection site reaction resolved, the patient began to experience chills, nausea, loss of appetite and headache. The patient developed 10 lesions on her back and she was recently diagnosed with chickenpox. The outcome for chills, nausea, loss of appetite, headache and chickenpox was reported as not recovered. No treatment information was reported. The patient sought medical attention by calling the pharmacist and an by an office visit. Additional information has been requested.
AFFECTED VISION; FELT SICK FOR 5 DAYS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced affected vision and felt sick for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt sick for 5 days and affected vision was not reported. This report was non-serious.
Myalgias, fatigue started first. Endo thought might be Hashimoto's but test negative. AMA, RF neg. EBV positive. She developed anxiety (panic attacks). Any activity seems to make symptoms worse. Doesn't sleep well. Tried Cymbalta but didn't help. Tried amitriptyline. Saw neuro + rheumatology - no answers. ER for abd pain - no acute process (3/13/19). 3/19 - pt remembered she had flush of right before this started. Saw Endo in April, 2019 - no change. Not thyroid.
IMMEDIATELY FOLLOWING VACCINE ADMINISTRATION, PATIENT REPORTED FEELING HOT THEN COLD AND VOMITED CLEAR FLUID.
She had SHINGRIX shot #1 on an unknown date in September 2022. She was never told that she needed shot #2 to complete the series; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: She had SHINGRIX shot #1 on an unknown date in September 2022. She was never told that she needed shot #2 to complete the series).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-OCT-2023 The patient self-reported this case. She was never told that she needed shot 2 to complete the series. She did not have the lot number of the injected product. She did not recall which pharmacy she went to get the immunization. The VAERS details was reported for 1st dose of Shingrix. The reporter consented to follow up. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient reported no adverse event or allergies at pre-screening so received vaccine around 1:55pm and around 3.25pm patient reported of headache, SOB, faster heart rate, having to stop in middle of sentence, chest hurting breathing in . Emergency services was called and patient was assessed while waiting for emergency services to arrive. At 3.39pm BP 125/80 mmHg, 84 bpm and oxygen stat. 97%, again at 3.42pm oxygen stat. 98% and pulse 81bpm
This spontaneous report was received from a medical assistant, referring to a 14 year old patient of unknown gender. The patient had no pertinent medical history, concurrent conditions, drug reactions/allergies, or concomitant medications. On 31-JUL-2018, the patient was vaccinated with GARDASIL 9 lot # N025429 (expiration date: 21-JUL-2020) for prophylaxis (strength, dose, frequency, and route of administration were not reported). Subsequently, about two minutes after the administration, of GARDASIL 9, the patient became "unresponsive, shortness of breath and looked pale in the color" (unresponsive to stimuli, dyspnea, and pallor, respectively). Subsequently, the emergency medical service was called and the patient was taken to an unspecified hospital emergency room. No laboratory diagnostic studies and no intervention to prevent serious criteria were performed. By the time of the report, the outcome of unresponsive to stimuli, dyspnoea and pallor was unknown. The causality relationship between the aforementioned events and GARDASIL 9 was not reported. Upon internal review, unresponsive event was determined to be medically significant. All telephone attempts to obtain follow up information had been unsuccessful and additional information has been requested. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA000591: US-009507513-1808USA000592:
Mother driving client home.  Client c/o not feeling well, became hot, eyes rolled back and head went down.  Mother called the EMS.  When the squad arrived, the client was coherent and not transported.  The mother reported from home after the EMS left.  No problems noted at time of her call to the Health Dept.
Information has been received from a physician concerning a patient who was vaccinated with Gardasil (conflictingly reported oral route). Reportedly. the patient passed out. At the time of the report, it was unknown if the patient recovered.
Loss  of strength in  arms and legs progress to near complete paralysis below the neck after 4 days. Preliminary diagnosis of Guillian Barre Syndrome. Five day treatment of IVIG.  Hospitalized for 12 days of which 6 in ICU and requiring oxygen for 1 day. Released (2-25-2020) to rehabilitation hospital for physical therapy for 4 weeks. Release 3-24-2020 moderately high functioning.  Extent of permanent disablity of any unknown at this early date.
Vomiting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 19:45 (Lot number: FKS127) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VOMITING (non-serious) with onset 18Nov2021 20:15, outcome "unknown", described as "Vomiting". Therapeutic measures were not taken as a result of vomiting.  Additional Information: The patient was a child. The patient had no known allergies. The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had no other medical history. The patient not received other medications in 2 weeks.  No follow-up attempts are possible. No further information is expected.
Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from other health care professional (Medical Assistant). This case involves a 4 years, 10 months old male patient who received vaccine FLUZONE QUADRIVALENT. The patients past medical history and family history were not provided. It was an actual medication error due to vaccine under dose and syringe leak. On 28-Sep-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6261LA, expiry date 30-Jun-2019 via unknown route in unknown administration site. This was not his 1st flu immunization. He did not receive any other vaccines on 09-Sep-2018. It was reported by Medical assistant with product technical complaint that during vaccine administration, pre-filled FLUZONE syringe leaked a lot between needle and hub/ table paper was wet and uncertain how much vaccine the child received. It was unknown whether patient experienced any adverse reaction after the injection. 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.
09:53 tingling / numbness to back of throat no sob or tongue swelling  wctm. Recheck 10:10 vs. tingling  decrease pt going. instructions for calling EMS should allergy symp. increase. pt stable  decreasing symptoms no sign of allergic reactions
No adverse event; Vaccines experienced temperature excursion and were administered after the excursion; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-OCT-2021, a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # U017140, expiring on 28-NOV-2022 was improperly stored and experienced a temperature excursion of 6°F up to 14°F for 4 hours and of 14°F up to 26°F for 4 hours and 45 minutes (product storage error).   On an unspecified date after the excursion, the patient was vaccinated with the improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), for prophylaxis (dose, route and site of administration  were not reported).   The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Pt recvd Engerix-B 24MAY90, 25JUN90 & 19NOV90 & p/3 doses of vax, Antibodies were checked 22FEB91 & there was no antibody;
Information has been received from a physician concerning a female (age unknown) who sometime in 2007 was vaccinated intramuscularly with a first dose of GARDASIL (Lot # unknown). There was no concomitant medication. The physician reported that the patient on unknown dates experienced burning sensation after all three doses. Subsequently, on unknown dates the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/13/2008.  Follow up information has been received from a 36 year old female physician with no pertinent medical history, who on 18-JUL-2007 at 10:15 AM was vaccinated with the first dose of GARDASIL IM, on 29-AUG-2007 at 11:00 AM was vaccinated with the second dose of GARDASIL (Lot # 9725101) IM on 21-FEB-2008 at 11:00 AM. On 18-JUL-2007 at 10:15 AM, the patient experienced painful administration sensation of ardor on muscular area that persisted for almost 3-5 minutes. The patient experienced the symptoms with all three vaccine administration. There was no illness at the time of vaccination. Additional information is not expected.
Initial unsolicited misuse report received from a pharmacist on 15-Oct-2015. This case involves a patient, who was vaccinated twice with Flu vaccine (manufacturer: unknown, batch number, route and site of administration were not reported) on an unspecified date. It was an overdose vaccine administration. No adverse event was reported. Follow up information received from a pharmacist on 21 December 2015. The patient's identifiers was updated. This case involves a 65-year-old female patient who was vaccinated with a dose of FLUVIRIN (batch number: 1514621, manufacturer: Novartis) intramuscularly in right arm and with a dose of FLUZONE HD (batch number: UI453AA) intramuscularly in left arm on 14 October 2015 at 11:45 AM. The patient vaccinated with a first dose of PREVNAR 13 (batch number: H86652, manufacturer: Pfizer) intramuscularly in left arm on 29 October 2015. Illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and adverse event following prior vaccination were reported as none. On 15 October 2015, one day following the vaccination, the patient had developed sore arm, no redness, no swelling and mild headache. On 19 October 2015, five days following the vaccination, the patient had sneezing and runny nose. The patient was not seen by MA following administration. On an unknown date, the patient was recovered from all the events. Documents held by sender: none.
acute onset parasthesias in left arm and bilateral lower extremity weakness within 15min of injection. Unable to stand without assist. no radicular symptoms
This report is regarding the Pfizer COVID-19 vaccination the patient  received on the above date, which was lot number FD0809. The Public Health District, per guidance from the Department of Health, Centers for Disease Control and Prevention, and Pfizer have determined that the dose of vaccine that the patient received is valid.
Body aches; Significant Malaise; Stay in bed for 48 hours; This case was reported by a physician via sales rep and described the occurrence of general body pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. In November 2018, immediately after receiving Shingrix, the patient experienced general body pain, malaise and bedridden. On an unknown date, the outcome of the general body pain, malaise and bedridden were recovered/resolved.   It was unknown if the reporter considered the general body pain, malaise and bedridden to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter's husband. Soon after receiving dose of Shingrix, the patient experienced significant malaise and body aches causing him to have to stay in bed for 48 hours. The reporter stated that, all symptoms were resolved after 48 hours. The sales representative indicated that, the reporter provided this information to her during a Congress she was attending and was unable to provide any additional details. For tolerance to the 2nd dose of Shingrix, refer case US2019AMR175952. This was 1 of the 4 cases, reported by the same reporter.
1st dose on 2022, did not come back for their doses; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in June or July 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   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: 17-FEB-2023 Reporter's comment: The pharmacist had several patients who received first dose of Twinrix back in June or July 2022 and most of them did not came for their second dose. No further details about patients were provided. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patients did not receive the 2nd dose, which led to incomplete course of vaccination. This case had been linked with US2023AMR028405, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR028405:same reporter
Vaccine was given after the 10 week expiration from being placed in the refrigerator. 10 week expiration should have been April 7, 2022 but vaccine was given on 4/11/22. All other proper storage requirements were followed.
Patient reports around 8:00pm on 1/8/2021 she began vomiting, having diarrhea, and being short of breath. Patient reports these symptoms continued through the night. Patient reports om 1/9/2021 feeling fatigued but no other symptoms. Pt reports totally better now and didn't go to the doctor or hospital.
Pt recvd HIB/OPV/DTP on 9SEP91 & exp inconsolable crying on & off following vax; cry more persistant 10SEP91 lasting more than 3 hrs; tx w/APAP;
9FEB99 pt recv vax & 6 days later devel rash seen in office 16FEB99 dx urticarial rash;
We received from a health care professional via the Medical Communication the following information on 30 JAN 2009: A 52-year-old male patient was vaccinated with FLUVIRIN, batch-no. 881292P, i.m. into the right upper arm on 27 JAN 2009. Additionally he was vaccinated with PNEUMOVAX in the right upper arm on the same day. On 28 JAN 2009 he was admitted to the hospital with necrotizing fasciitis in the right shoulder. The patient was surgically debrided. Vaccination history: previous vaccination (s) was (were) given, no information about tolerance. On 04 FEB 2009 we received the following information by phone from the reporting physician: The injection was given by a registered nurse and the reaction started approximately 6 to 8 hours after injection. Laboratory result: wound culture, gram stain negative after 48 hours. The patient's status did not recover and he is to be discharged home on oral antibiotics. No change in assessment. Review of manufacturing protocols on 06 FEB 2009 demonstrated that there were no concerns about sterility.
Felt warm; Arm was itchy; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was itchy, arm was more itchy, felt warm.  The patient's medical history was not provided. Concomitant medications reported were metoprolol 25mg, Eliquis 5mg, digoxin 125mcg, furosemide 40mg, Tylenol ES for drug use for unknown indication.  On 20 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event(s) arm was itchy. On 24 Feb 2021, the patient experienced the event(s) arm was more itchy, felt warm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm was itchy, arm was more itchy, felt warm was unknown.