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 had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 13-year old female patient, who had a diagnosis of autistic disorder and had no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the first dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the right arm, route not reported), on 24-JAN-2014 at 10:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient was going to be revaccinated at no charge. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown. 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.
There was moderate bleeding at the injection site (right deltoid muscle) when the vaccine was administered.  Approximately two hours after the injection severe burning pain was noted radiating down the right arm, up the right side of the neck and down the right side of the back.  This severe pain lasted approximately 48 hours then gradually decreased over about 4 weeks.  Weakness in the right arm was noted when performing certain activities or when the arm was held in certain positions.  Severe discomfort of the right arm was noted when lying on the right side; so uncomfortable as to be unable to sleep lying on the right side.  There was soreness at the injection site but no redness or bruising was noted.  No fever developed and no other unusual symptoms were noted.  The pain was treated w/Ibuprofen 400-600mg per mouth Q&H for approximately 48 hours and then two times pm.
101.4 F fever at 11am, day after injection. The following day was 99.4 F degree temperature. Use of Tylenol managed to lower the fever. Swelling at injection site, limited mobility in arm due to soreness and swelling, which has recovered. Swelling has gone down. Arm soreness has gone down but not entirely faded.
Narrative:  2 days after patient received his first covid vaccination, pattient experience a rash on both forearms
starting around 5pm 2/9 there was some soreness at the injection site. if I applied pressure it was very painful. overnight and the next morning the pain got a little worse but its tolerable. the pain increases when i lift my arm. if I keep my arm down by my side there's no pain.
Patient received Pneumovax23 Saturday morning, but her left arm (distal from the injection site to the crease of the elbow, wrapping around the whole upper arm) started to feel warm to the touch and become very red and swollen. Patient experienced feeling warm, but did not take her temperature. She took Tylenol to help with the pain and potential fever; patient stated this did not change much from before. Patient presented arm Monday morning to the pharmacist. She stated it slightly improved, but overall it had not changed much since Saturday evening. Patient related it hurt to move her arm, but was not physically unable to move it. Pharmacist recommended taking Benadryl to help with the swelling and redness and to take ibuprofen for the swelling, pain, and fever; pt was also counseled to use cold compresses to help with swelling. Patient was also referred to Urgent Care or PCP if does not improve by tomorrow (Tuesday).
TOOK SECOND DOSE ON DAY 4; This spontaneous case report was received from a nurse (PVX2019-162) on 17-Jan-2019. The report describes a 30-year-old adult female consumer who "took second dose on day 4". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took the second dose on day 4. The doses were taken on Sunday (13-Jan-19) and Wednesday (16-Jan-19), respectively.  The action taken with Vivotif with respect to the event "took second dose on day 4" was not applicable.  The clinical outcome of the event "took second dose on day 4" was unknown.  Company's Comment: The causality of the event "took second dose on day 4" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose on day 4" was considered as not applicable.
Severe pain and discomfort of upper arm the evening/night of vaccination.  This persisted for several days and extremely large hematoma developed on inner aspect of arm.
flushing; light headed; heart racing; heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Lot number: EW0150) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "muscular dystrophy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM]; CLONAZEPAM; DULOXETINE [DULOXETINE HYDROCHLORIDE]; VARENICLINE; BACLOFEN; TIZANIDINE. The following information was reported: FLUSHING (non-serious) with onset 07Apr2021, outcome "recovered", described as "flushing"; DIZZINESS (non-serious) with onset 07Apr2021, outcome "recovered", described as "light headed"; PALPITATIONS (non-serious) with onset 07Apr2021, outcome "recovered", described as "heart racing"; PALPITATIONS (non-serious) with onset 07Apr2021, outcome "recovered", described as "heart palpitations". Therapeutic measures were not taken as a result of flushing, dizziness, palpitations, palpitations.  Additional information: Caller is a female consumer who states she had a reaction with both doses of the Pfizer Covid 19 vaccine. It was thought at the time that it was a phycological reaction to the injection. When receiving the second dose she informed the nurse of her previous reaction and they stated it was probably a reaction to the needle but patient reports not having a problem with needles. She relays that almost immediately after the injection the same symptoms began as well as she described it to when you have a CT scan with iodine and you feel flushed and warm. She states that she nurse said she was red. She waited at the doctor for 1 hour after injection. Reaction lasted about 45 minutes. Her nurse practitioner did not recommend that she get any further doses. The doctor stated that since they did not have baseline vitals prior to the injections to compare her post injection vitals to that they cannot made the decision on if she should or should not receive a booster dose after these reactions. Her neurologist does not recommend her to receive a booster dose. On 28Apr2021 second dose confirmed. No prior vaccination within 4 weeks.  No follow-up attempts are possible. No further information is expected.
he had so many side effects after that dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (he had so many side effects after that dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (he had so many side effects after that dose). At the time of the report, VACCINATION COMPLICATION (he had so many side effects after that dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-320740 (Patient Link).   Reporter did not allow further contact
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-FEB-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength 0.5 mL, lot # L027282, expiration date 21-SEP-2017, dose and route were unknown). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion six times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first excursion was 72, 29 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 24, 34 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the third excursion was 16, 33 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the fourth excursion was 112, 32 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the fifth excursion was 208, 31 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the sixth excursion was 112, 30 and R. This is one of several reports received from the same source. Additional information has been requested.
Felt very sick. Fever, chills and the sweats for 24 hours. Feet and whole body felt very heavy.
Pt. mom called the office on 3/28/19 stating that ever since Patient received his DTP vaccine on 3/22/19 around 6-7pm every night he goes into a screaming fit for 1-2 hours. Dr. saw the patient in follow-up on 3/29/19 and advised the mother to observe the symptoms and give TYLENOL and gripewater routine over the weekend. Pt. mom instructed to call Tuesday 4/2/19 with an update on patient symptoms.
Pain in some muscles in leg; Itching throughout body; Headaches; Chills; Dizzy at times; Pain in joints; This is a spontaneous report received from a contactable consumer. A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) as a single dose via unspecified route of 1st dose on 26Feb2021 at 8 AM for COVID-19 immunization. The patient's medical history included prostate cancer low grade, penicillin allergy and sulpha allergy. He was allergic to Gadolinium when he had it for an MRI or Cat Scan. He broke out into a rash for a few days. Concurrent medical condition and concomitant medication were not reported. Patient did not test positive before vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient believe he had COVID in Mar2020 on and off until Aug2020 but did not had any trouble breathing or fever. On 27Feb2021 20:00, the patient experienced chills, dizzy at times, pain in joints, runs, headaches and so on. Actually his normal temperature dropped from 98.4 to 96.4. When he had BNT162B2, 8 days later (06Mar2021) he had pain in some muscles in his legs and then had major itching throughout his body for about 36 hours. He took strong doses of B12, B, C, D3, Zinc, olive leaf extract, baby aspirin, Dandelion root tea. Clinical outcome of all the events were reported as recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After the 2nd vaccine (4/11/21), during early hours of 4/12/21 around 3-4 am, woke up in sweat fever body hurting, felt like throwing up but only  saliva was coming out, headache. After 2 days on Wednesday 4/15, was felling better went to work temperature was less than 100.4. Was felling ok very tired, sweating but not a lot. On Thursday 4/16 felt a little cough and tired. By Friday morning the cough was more, while working I started to get cold sweat.  Called doctors same Friday, they told me to wait until Monday unless it worst and call them. Through out that weekend I had cold sweats, headache, felling like throwing up, chills temperature up to 104.6. This lasted about 2 weeks until 4/27. During this time was taking Tylenol and Mucinex. Also got two rapid test and a cpr test for COVID and all 3 came back negative
Information has been received from a registered nurse concerning a 19 year old female with allergy to cefaclor (CECLOR) who on 22-NOV-2006 was vaccinated with the first dose of HPV vaccine (yeast). Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING),  lansoprazole (PREVACID) and minocycline HCl.  On 03-JAN-2007, the patient had a cervical (PAP) smear.  The patient tested positive for Papilloma viral infection (HPV). On 11-JAN-2007, the patient was vaccinated with the second dose of HPV vaccine (yeast).  (Lot # 655617/1447F). The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient recovered.  Additional information has been requested.
Patient was given a concentrated dose of vaccine.  I diluted with dosage and gave 2 doses out of this vial. it was 6pm and very hectic.   I reached out to both parents, but only spoke to one.  The parent was very upset.  I explained side effected and to keep his son hydrated.
Patient admitted for acute encephalopathy and COIVD positive. Vaccinated July 2021.
Patient presented to the ER with shortness of breath found to be in Afib with RVR.
Weakness 5 days after vaccine, Leg pain & swelling 5-6 days after vaccine.
Expired Shingrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number C3455, expiry date 3rd February 2023) for prophylaxis.   Previously administered products included Shingrix (first dose was received on 3rd November 2022).   On 6th February 2023, the patient received the 2nd dose of Shingrix. On 6th February 2023, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-Feb-2023 Reporter comment: The nurse reported that the patient was administered a dose of Shingrix vaccine, which had an expiration date of 3rd February 2023. At the time of reporting, dose had not been repeated.  The reporter consented to follow up.  Additional supportive information: The patient was received an expired second dose of Shingrix, which led to expired vaccine used.
Frequent periods, every two weeks. Irregular menstruation. Severe cramping and abdominal pain with bleeding
Day after immunization her arm became red and itchy at the injection site. The area of inflammation grew to about a 8" circle and continued to itch. No treatment was required. Patient came into the pharmacy on 4/27 and the redness and itching is subsiding.
Severe forehead and scalp itching 1h after vaccination; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had severe forehead and scalp itching, 1 hour after vaccination. The pharmacist gave the patient Benadryl and it cleared up. The pharmacist followed up with the patient and the patient was not having any more issues. He just wanted to know if the patient should get the second dose after the event. The outcome of the event was recovered on unspecified date.Information on the lot/batch number has been requested.
pt recvd vax 2 days following vax pt had a confluent generalized erythema & then an apneic episode; eval @ ER & transferred to hosp included cranial n/s: enlarged ventricle; EEG; Nl;
Patient developed cough, sneezing, runny nose, sore throat the following day (suspected viral infection vs allergic) progressing into asthma flare requiring hospitalization.
Approx 5 days post had vaccine had change in pain of Lt arm @ injection area; that same pain persists; using Ibuprotin, at hapizal KETAPROTN given.
Approximately 44 hours after my shot I noticed a hard, red, slightly itchy, painful to the touch rash or splotch on my arm a ways below the injection site.  The way it felt reminded me of a spider bite, itchy but too  tender to scratch.  It started out as a big splotch, morphed later in the day into a larger semi-circle/smile shape, and now today (3rd day after vaccine) it is much larger but appears to be diffusing a bit.  It's not as hard as it was, and the borders are less defined.  It is covering the entire front side of my arm from side to side, and taking up the middle 3rd of my arm from elbow to shoulder.  Still itchy and uncomfortable to touch or lay on.
Had her 2nd dose on 2/18 in the morning. on 2/19 the injection site started itching. On 2/20 the site became irritated, red, and swollen. Symptoms were getting worse over time. She came into the clinic 02/25 for an appointment with the doctor
mom states that pt began crying the next day p/vax cried constantly;pt would not take anything (food);pt taken to MD-who felt pt was having side-effects from vax but they were wearing off & will recv vax from MD next time;fever also
Dizzy spells, feeling room was spinning. w/ physical activity, the dizziness would lead to tension headache (back, middle of skull). Dizziness lasted 2-wks at least.
Late miscarriage at 18 weeks gestation. Fetal demise.; This is a spontaneous report from a contactable nurse.  A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for COVID-19 immunisation.  The patient medical history was not reported.  There were no concomitant medications.  The patient experienced late miscarriage at 18 weeks gestation. fetal demise on 11May2021 12:00.  The mother was 18 weeks pregnant at the onset of the event.  The mother was due to deliver on 10Oct2021.  The mother delivered the pregnancy on 11May2021. Patient had Nasal swab (NP and rapid) on 17May2021 and the result was negative. Treatment: Delivery of fetus, D&C of remaining undelivered placenta. Event resulted to doctor or other healthcare professional office/clinic visit, prolongation of existing hospitalization (vaccine received during existing hospitalization), life threatening illness (immediate risk of death from the event). The outcome of the event was recovering.  Information about the Lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to event late miscarriage at 18 weeks gestation. fetal demise cannot be excluded based on temporal association and available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Authorities, Committees and Investigators, as appropriate.
she experienced a minor adverse reaction when she got her dose; This spontaneous report as received from a representative from the physician's office via a company representative and refers to a non-pregnant female patient of unknown age. The patient's concurrent condition, concomitant medication and medical history were not provided.    On an unknown date in December 2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date in December 2020 (reported as when she got her dose), the patient experienced minor adverse reaction. It was unknown what adverse reaction she had experienced. The outcome of adverse reaction was unknown.        The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Pt was given the Tdap in left arm.  Turned to expose his right side and was given the menveo and gardasil 9.  Pt stated that he felt fine and was ready to return to the waiting room.  Upon returning to the waiting room he fainted and fell forward.  A pt in the waiting room was able to catch him and help him to the floor.  This nurse then joined him in the waiting room and found him to be lying prone on the floor.  He was observed to be pale in color and felt clammy and hot to the touch.  Cool compresses were applied.  He stated that he hadn't felt well before having the shot.   He also stated to feel light headed, nauseous, and tired.  He laid on the floor for several minutes before he was moved to a near by chair.  he remained on his knees on the floor with body bent over chair.  Water and sucker were offered but patient stated he was nauseous.  After several minutes, the pt stated that he would like to lay down.  He was moved to an exam room and laid supine on the exam table.  He then was able to drink some water and have a sucker.  At this time his BP was 108-60 and pulse was 66 bpm.  Pt stated that he was beginning to feel better, color was returning to normal.  Pt stated that he felt fine and was moved to a sitting position.  He then ate an granola bar and drank more water stating that he felt fine.  Vitals at this time were 114/70 and 68 bpm.  Mom felt she was able to take him home and stated that she felt comfortable with his care.  Pt was released and walked out on his own.
Suspected vaccination failure; I got my shot and still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got my shot and still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-JUN-2023 The case was received from the patient interactive digital media. The patient got shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.