chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 7-months old patient of unknown gender, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J001254, expiration date 19-SEP-2014), on 10-FEB-2014 at 5:20 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event was also reported as 27-FEB-2014 at 10:00 AM). The patient was revaccinated on 28-MAR-2014 without charge. No adverse event was reported for the patient. The reporter reported the outcome as recovered on 28-MAR-2014. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Acute onset sharp chest pain 1 week after administration of vaccine Feb 08. Given presumptive diagnosis of pericarditis. No clinical evidence of pericarditis on ECG, echo and CT scan. Persistent chest pain not responding to NSAIDS, colchicine or narcotics.  06/12/2008 MR received from2-6/2008 with DX: Pericarditis/ Chronic recurrent pericarditis.  One week after receiving YF vax pt developed sharp Left sided chest pain, worse lying down. DX with pericarditis. Chest pain has continued to recur, and is worse than initial episode. Occasional tachypalpitations. C/o dizziness.  Still w/ sx 6/4/08.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "G6PD" (unspecified if ongoing); "Known allergies: Faba beans" (unspecified if ongoing), notes: Known allergies: Faba beans; "Known allergies: iodine contrast, iodine" (unspecified if ongoing), notes: Known allergies: iodine contrast, iodine; "Known allergies: iodine contrast, iodine" (unspecified if ongoing), notes: Known allergies: iodine contrast, iodine; "Known allergies: nitro gas" (unspecified if ongoing), notes: Known allergies: nitro gas; "Known allergies: adhesive tape" (unspecified if ongoing), notes: Known allergies: adhesive tape. There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any other medication in 2 weeks. Patient received anti-viral COVID-19 treatment with Paxlovid from 08Sep2022 (lot: GE9805). Headache other than a migraine. Disorientation. Felt completely different, pressure on the temporal part of the left side of brain. Insomnia, could not sleep even if it was 3 in the morning, felt like it was daytime. Completely stunned.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
-  Moderna COVID- 19 Vaccine   The patient may have been given a partial dose of the Moderna COVID- 19 Vaccine on 3/12. Per Moderna and CDC recommendations, the patient returned to the clinic on 3/19 and the Moderna COVID- 19 Vaccine was  administered.
Post vax, the patient developed a red, swollen area on the right deltoid. The patient was already on Keflex for a dog bite.
Vaccinated at 12:20pm. At approx 12:34 pt told wife he felt faint, was sitting in observation area in drivers seat of his own vehicle. Had brief syncopal episode witnessed by his wife with jerky motions of legs and arms lasting a few seconds. Patient awoke immediately with memory of event, was oriented and remember events leading up to being vaccinated. No incontinence. Car seat reclined. Reports no pain, pt appeared pal but no diaphoretic. BP 140/82, P 64 regular RR 14 unlabored. Oxygen sat 98%. EMS called, patient refused transport to hospital but agreed to follow up with primary care provider. Wife sis he was very anxious about his vaccine.
Patient received a high dose Flu vaccine at an off-site clinic day a Church. Pt. called concerned that she experienced hives 4 hours after receiving vaccine.
This spontaneous report as received from a pharmacist refers to a currently 62 years old female patient. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not reported). On an unknown date (after administration of ZOSTAVAX), the patient developed redness and warmth at the injection site. The patient sought medical attention (unknown type) and did not require a medical treatment. There was no lab diagnostics and studies performed. On an unknown date, the patient recovered from the adverse events. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
This 61-year-old morbidly obese female presents here to emergency department complaining of 2 weeks of cough and shortness of breath which is gotten worse.  She also complains of a sore throat.  They called the ambulance and at her house her O2 sat was found to be in the 70s.  Patient states she is not on oxygen at home she does have oxygen but she is not on it.  She states her brother had a cold as well 2 weeks ago but his symptoms have resolved.
Fever (101.9), achiness, headache, throwing up the morning after the shots, feeling week
High fever of 102, nausea, vomiting, severe pain in arm, back and shoulders.
After unknown time after injection, patient developed rash at injection site.  Patient reported afterwards.  Unknown intervention.
Technician was under the impression that you add 1.8 ml of diluent (NaCl 0.9%) to the vial prior to withdrawing each vaccine dose.  She added 1.8 ml of diluent to the non-punctured vial and withdrew a 0.3 ml dose, which was correct and given to a patient.  She then proceeded to add another 1.8ml of diluent to the same vial and then withdrew dose #2.  This patient received dose #2, which contained twice the normal amount of diluent.  Another 1.8 ml was added to this same vial and a 3rd dose was withdrawn and given to a different patient.  The error was realized when she attempted to add another 1.8 ml to the vial to draw up dose #4 and could not physically add any more diluent into the vial.   We contacted Pfizer to seek further guidance on the administration error and whether another dose was required to be given.  The representative informed us that Pfizer did not have any specific recommendations themselves regarding the administration error, but stated that we should follow the current recommendations outlined by the Committee.  They emailed us the Committee recommendations outlined in Appendix A, which indicate that for doses administered with diluent volume greater than 1.8 ml, do not repeat dose.* (Note: dilution with a volume up to 4.0 ml [which exceeds vial capacity] results in more-than-half of the authorized dose administered).  The dose given in error was the first dose and the second dose will be administered to the patient at the recommended interval of 21 days, as specified in Appendix A.  No adverse reactions have been reported by the patient as of 7/20/21.
Client reports feeling dizzy, light headed "unwell in general" toward end of monitoring , Paramedic assessment Pt transported to BFMC after 1.24 hours of observation
40 hours after receiving the 2nd dose of the Pfizer COVID-19 vaccine, the patient discovered small hives on the underside of arms and thighs. In addition, there is a rash consisting of small red spots that span the underside of the arms, thighs, stomach, back, chest, and neck. The rash is itchy but not hot to touch. Antihistamines both oral and topical have not helped the rash subside.
ERYTHEMA & INDURATION TO INJECTION SITE ~ 10CM X 5 CM; BLURRED VISION RIGHT EYE; STIFF NECK.
10/8@3PM: Shot.  10/9@7PM: Forearms started hurting mildly. 10/10@2AM: Woken from sleep by intense pain in bothforearms, couldn't get back to sleep.  Started having nausea.  @4AM: Woke up mom, took temperature, 99.5.  Called health insurance on-call nurse for advice, advised to take some Tylenol and see the doctor in the morning.  Immediately after hanging up, developed a bloody nose, temperature rose to 100.1, started having mild trouble breathing, nausea too intense to eat crackers to take Tylenol.  Called back, also remembered about taking covid booster, the nurse recommended going to the ER for possible immunization reaction.
Anemia, unspecified type; Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present.   Work-up was unable to find any other source of infection, so the patient was initiated on treatment for severe sepsis.  At the time my evaluation, the patient is feeling better. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Extreme dry skin patches, red, scaly, oozing, itchy, sometimes painful and blistered. Never had before shot. has continued for over two months now. have pictures.
Severe headache - onset about 8 hours after administration of vaccine and lasted continuous 24 hours, muscle stiffness/soreness on left arm - onset about six hours after administration of vaccine which lasted 48 hours.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. Between 03-SEP-2017 and 11-SEP-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # M003701, expiration date 01-NOV-2019 and lot # N003700, expiration date 01-NOV-2019) (dose and route were not reported) for prophylaxis. The vaccine was exposed to 8.5 Celsius degrees (°C) for 1 hour. There was no previous temperature excursion and also there was no "data logger". No adverse effects were reported. Lot number M003701 is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate). This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA005606: US-009507513-1709USA009443: US-009507513-1709USA009439: US-009507513-1709USA009440: US-009507513-1709USA009441: US-009507513-1709USA009442: US-009507513-1709USA009436: US-009507513-1709USA009435: US-009507513-1709USA009438.
had two of your vaccines and one of your booster; I tested positive for COVID; had two of your vaccines and one of your booster; I tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "had two of your vaccines and one of your booster; I tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional Context: Consumer stated, I am 67-years-old and I have had two of your vaccines and one of your booster and then I tested positive for COVID this past Saturday. My symptoms were very much improved but my doctor, the Internist recommended that I take the Paxlovid (Suspect captured conservatively) and I am reading all this information and now I have only had one dose. I am really getting a bit nervous with it (Event captured conservatively as per verbatim) specially the information about the vaccinated people. Can you share any information, can it be discontinued after just one dose of it or is there a risk with that? Consumer stated, I do not have time right now but I will be happy to call back tomorrow, I want to get hold of them. Consumer was informed about the timings of Pfizer Drug Safety as 24 7.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a non-contactable consumer. This consumer reported events with the same suspect vaccines for herself and her husband. This is the second of two reports (referred to the consumer husband). This 74 year-old male patient of an unspecified ethnicity received a single dose of PREVNAR 13 and FLU SHOT, both via an unspecified route of administration on 03Nov2014. Relevant medical history and concomitant medications were unknown. It was reported that on 07Nov2014 after vaccinations he experienced arm, shoulder and neck pain. At the time of the report the patient was getting better, with events outcome reported as improved. No follow up attempts possible. No further information expected.
Mom states on 10/31/12 she noticed redness, swelling and warmth on left leg where shot had been given. The swelling extended all the way to the back of the leg. No fever. MD diagnosed with cellulitis and was put on an antibiotic and improved.
Fever, Chills, Shakes, Achy Muscles and Joints, Headache, Injection Site inflamed, Emotional Sadness, Nightmares, Night Sweats, Extreme Fatigue, Chest Congestion, Loss of Appetite
mild aches and pains; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (mild aches and pains) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PAIN (mild aches and pains). At the time of the report, PAIN (mild aches and pains) had not resolved.            No concomitant medications were reported.  Treatment information was not provided.
Three days later, I noticed a ringing in my head/tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date 09Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "Three days later, I noticed a ringing in my head/tinnitus". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient want to share his coronavirus vaccine experiences and asked for help to bring attention, and hopefully Start a tinnitus support group for people like him, who are suffering in silence because of the side effects of the coronavirus vaccine and this newly discovered dilemma. He was not asking anyone, or any institution for money. He was prepared to pay for local television, radio, and print advertising. Patient was simply asking for a partnership and guidance that will lead to establishing a tinnitus support group that will be able to utilize medical professionals as presenters to help keep the community more informed about the development of tinnitus and the connection to taking the coronavirus vaccine. On 22Mar2021, patient was seen by a physician at withheld ENT and Allergy. Patient was given a hearing test, and tympanometry exam. Afterwards they tried to sell him a hearing aid and explained there was nothing they could do to help him. Patient learned of the connection between being vaccinated and developing tinnitus. On 20Apr2021, He was seen by withheld physician Dr. withheld who told him the exact thing the physician at withheld ENT and Allergy told him, 'No cure, and Patient would have to learn to deal with it.' Patient found this to be disheartening coming from a world-renowned medical university physician. Patient researched the condition, and believe the vaccine saves lives, but He also believe the public should have been made aware of this horrible side effect. A sudden on-set of tinnitus can lead to depression and suicide in some cases. In my research He discovered there are over 10,000 people who have reported the onset of tinnitus to the Centers of Disease Control shortly after taking the coronavirus vaccine. This past Aug, Johnson & Johnson added tinnitus as a potential side-effect to their vaccine, but Pfizer and Moderna have not. This condition is real, and He had certain there are many people in withheld, and throughout the nation who will agree, this condition came about from being vaccinated for COVID -19. The problem is, we are suffering in silence.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced hot and cold flashes, stabbing chest pain, arm pain, body aches and passed out on his bedroom floor
This spontaneous report was received from a nurse practitioner regarding an 11 year old female patient. There was no information regarding concomitant medication and historical medication. On an unknown date in August 2015, the patient was vaccinated with GARDASIL dose 1 and dose 2 in mid-October 2015. Approximately on 12-APR-2016, 3 days ago patient was vaccinated with GARDASIL 9 in the left arm (interchange of vaccine products and wrong drug administered) and also got vaccinated with tetanus toxoid was administered. The outcome of pain in extremity was reported as recovered/resolved. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information is not expected as reporter dose not wants to get contacted.
Headache, Myalgia, Fever & NauseaVomiting Narrative:   Other Relevant History:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-JAN-2014 the patient was vaccinated with a dose of ZOSTAVAX with an expiry date of 17-JAN-2014 (lot number unknown) (route and dosing regimen unknown). No adverse events were reported. The action taken with the therapy with ZOSTAVAX was unknown. Additional information has been requested.
had a headache afterwards; the side of his face was hurting; This is a spontaneous report from a contactable consumer (patient's grandmother). A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown) 1st dose, via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunization and received meningococcal vaccine (MENINGOCOCCAL VACCINE) (formulation, lot number unknown and expiration unknown) via unspecified route of administration, on an unspecified date for an unspecified indication. The patient medical history and concomitant medications were not reported.  Patient took received the Pfizer BioNTech COVID vaccine and had got the meningococcal vaccine 10 days ago. Had headache after the vaccine and the side of his face was hurting but she was alright at the time of reporting. After got his Pfizer shot and the nurse did asked reporter have patient had any vaccine in time of 14 days, she told her yes but it haven't been 14 days it's just been 10 days. Reporter thought it was the last of his shot that the one for cancer, meningococcal vaccine. The outcome of the event was recovered.  Information on the batch/lot number has been requested.
nausea; fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 44N5L, expiry date 13th September 2021) for prophylaxis.   On 24th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the patient experienced nausea. On an unknown date, the outcome of the fever and nausea were recovered/resolved.   It was unknown if the reporter considered the fever and nausea to be related to Shingrix.  Additional details were provided as follows: Reported batch number 44N5L pertains to Shingrix adjuvant. On 24th May 2019, either the same day or the next day, the patient developed an intermittent fever. It lasted off and on for 10 days which was resolved till the time of reporting.  The patient also had nausea that developed later on and was resolved. The reporter consented to follow up.
Client given Adacel on 7/17/06. She called the next day 7/18/06, c/o sore left arm, not red, but had difficulty lifting it. Also c/o being pale, weak and dizzy. Stated she had to spend the day in bed.
Patient was administered ROTATEQ orally. A couple minutes later patient was given PEDIARIX, PREVNAR, and Hib. Immediately following injections patient began to cry intensely and his face became bright red. Patient then suddenly stopped crying and became very pale and still. Nurse blew in patient's face to motivate a breath from patient. Patient was breathing but very still. Doctor was called in room to evaluate patient. Patient was kept for observation for 45 minutes. "Shivering" and paused breathing observed. Pulse ox and heart rate were within normal limits when check 15-20min after event. After 25-30 minutes, patient's color returned to face and body but child was still very sleepy. Mother informed to observe child throughout the evening and night.
feeling foggy, woozy, a little dizzy and nauseated, racing hearthard to swallow
patient stated that her period started the day after she received the 2nd moderna vaccine which was early for her and cycle is normal now with 28 days in between.
Swelling in all joints elbows, ankles, feet swollen, hands have swollen burning on her buttocks. All joints very hot to touch. Can't walk without help.
cough, body aches, pleuritic chest pain and fever and she performed a home Covid test which was positive, x-ray which was abnormal,