chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, and unspecified number of patients received doses of improperly stored ROTATEQ (lot # L042215, expired 02-JUN-2017) (dose and frequency were unknown). The vaccine was exposed under 33F for 15 hours. There was no previous exposures. No adverse effect was reported.  Additional information has been requested.
dx GBS admission on 9MAY95 to hosp placed in ICU; addtl info will be available only if pt signs & release form;
In December of 2021 he had an asthma attack that caused my son to cough until he threw up. We went to Urgent Care three times, the Emergency room once and had a telehealth visit once as we were out of town when he had the asthma attack.  In March of 2022 he had another asthma attack we visited his doctor twice. In May of 2022 he had another asthma attack we had another doctor consult and visit, that resulted in a change in medication.
Itching began on scalp and now have rash and itching on back of neck, upper back and upper chest.  Moves around, not always in same place.  Inside of ears hot/itchy.
After approximately 12 hours after the second vaccine dose, Experienced significant muscle pain in right arm, enough that it was challenging to move, pressure or contact with right arm, back, and legs caused significant discomfort, even with Tylenol. Approximately 18 hours after the second vaccine dose, experienced severe migraine symptoms: severe headache, sensitivity to light, sensitivity to sound. Other side effects such as fatigue were noted.  Symptoms subsided approximately 28 hours after second vaccine dose.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age who at about a month ago (approximately in November 2012) was vaccinated subcutaneously (SQ) with a single dose of ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that at about a month ago (approximately in November 2012), the patient developed redness, warmth, and pain at the injection site after administration of ZOSTAVAX "about one month ago". The symptoms resolved within 1 week (unspecified date in the 2012) without requiring medical treatment. The patient went to the pharmacy for medical attention. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Site: Pain at Injection Site-Mild, Systemic: Fever-Mild, Systemic: Headache-Severe, Systemic: Tachycardia-Medium, Additional Details: Patient's heart rate is typically in the 80's. After vaccination, night of and morning after, patient's heart rate went up to 113.
nerve pain down her left leg; sciatic pain on the left side of her lower back; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-FEB-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 22-FEB-2023, 2 days after receiving Shingrix, the patient experienced nerve pain (Verbatim: nerve pain down her left leg) and sciatica (Verbatim: sciatic pain on the left side of her lower back). The outcome of the nerve pain and sciatica were unknown.   It was unknown if the reporter considered the nerve pain and sciatica to be related to Shingrix.     It was unknown if the company considered the nerve pain and sciatica to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2023 Pharmacy Intern called to ask if sciatica and nerve pain were expected side effects of SHINGRIX. She stated that the patient came to the pharmacy today to receive her 2nd SHINGRIX dose, and asked if it was likely to happen again. She stated that "about two days" after her first dose, she experienced sciatic pain on the left side of her lower back, and nerve pain down her left leg. Consented to follow up. Permission to follow up with pharmacy intern.
Fever, chills, body aches, joint pain, rapid heartbeat, upset stomach, restlessness, fatigued
The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (NORGESTIMATE & ETHINYL ESTRADIOL) for Oral contraceptive.    On 24-Jan-2022 at 9:20 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-Jan-2022 at 9:20 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Polymerase chain reaction: tested positive for covid-19 (Positive) tested positive for COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date. Per Moderna, the vaccine will maintain the necessary effectiveness against COVID-19. There is no further follow up needed with the patient.  No treatment drugs were reported   This case was linked to MOD-2022-472156 (Patient Link).   Reporter did not allow further contact
Approximately 3.5 hrs after the shot, I began to feel slightly nauseous. As I was making my way upstairs to my bathroom, it became difficult to move as if all my strength was fading. By the time I made it to the bathroom, I was so disoriented that I sat down on the floor. I had this overwhelming sensation go through my entire body that made it impossible to move and I felt like I was going to black out. It was as if all of my nerve endings and muscles were "alive". I don't recall how I made it, but I ended up lying down in my bed on my side. It took me several hours to regain enough strength in my body to get up and move around.
Within 48 hours: High fever, irritability, drowsiness, loss of appetite, rash (Fever 102.3 Tmax). For 72 hours: Interference with limb movement (shaky walking only after 48 hours).
Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced RASH PRURITIC (Itchy rash). At the time of the report, RASH PRURITIC (Itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Sarna lotion to relief itch.
24 weeks pregnant due 5/11/21, unknown birth weight Symptoms started as sharp stomach pains around belly button which I believed to be constipation or gas due to pregnancy. I began to feel nauseous around 6-6:30 on the night of 1/21/21 (vaccine administered on 1/20/21). I then began vomiting until approximately 8:00 pm. The nausea persisted until some point in the night, but I fell asleep so I?m unsure when. Stomach pain persisted the same as the nausea.. woke up next morning feeling much better, but dehydrated. Still unsure if stomach pain is related, but positive the nausea and vomiting was from vaccine.
1st and 2nd Pfizer dose series given as a booster instead of the Pfizer Bivalent Booster
VACCINE LEAKED BETWEEN THE NEEDLE AND SYRINGE, PATIENT GOT PARTIAL DOSE; This spontaneous report received from a pharmacist 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 admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced vaccine leaked between the needle and syringe, subject got partial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine leaked between the needle and syringe, patient got partial dose was not reported. This report was non-serious. This case is associated with product quality complaint-90000173093.
Information has been received from a physician, via a company representative, concerning a female, aged 18 to 26 years, who on an unspecified date was vaccinated with the first dose , 0.5 ml, of Gardasil (lot # not specified).  Subsequently the patient experienced a "swollen hand at the injection site."  At the time of this report, the patient had not recovered.  Additional information has been requested.
Patient was injected with the vaccine instead of being given oral; This case was reported by a other health professional via call center representative and described the occurrence of wrong route of administration in a 6-week-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 27th April 2021, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 27th April 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of administration 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 details were provided as follows: The health care professional called to report the administration of the Rotarix vaccine that was injected instead of being given oral, which led to wrong route of administration. The reporter did not consent nor deny follow up.  No further events were reported. The reporter did not consent nor deny follow up. No further events were reported.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Weakness-Mild
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L047305 with expiration date 23-MAY-20`7, lot  # L051098 with expiration date 17-JAN-2017, dose and route unknown). The vaccines were stored under 6.6 F for 20 minutes without previous excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced stinging.  The patient received a dose on an unspecified date.  The reporter noted that PREVNAR hurts more than other vaccines.  The outcome was not specified.  The reporter was unable to specify the number of patients who experienced this event.  Additional reports will be generated when identifying information is provided.  No additional information was available at the time of this report.
Pt is seen about 36 hours after vaccinated. Left thigh had erythema approx 125 cm x 19 cm (was tender without significant edema. He was given Benadryl 25 mg, Zyrtec 5 mg qd PRN.
Patient had fainted almost immediately after giving the Fluarix dose, managed to catch the patient and prevent them from further sliding down the chair. Patient woke up within several seconds, and reported by dizzy and needing to sit down. Told patient to sit down for 15 minutes. Patient sat down in front of the pharmacy counter and then left after some time.
PATIENT STATES THAT HE GOT SHINGLES FROM THE 1ST VACCINE
Second day after vaccine I had chills, then very tired, the next day chills and on day 6-7 I was tire, and day 9 I was tired and on that evening the injection sire started itching. there was a large pink area and armpit mildly tender but no swelling, it started off round then became elongated. On day 10 I felt warm and armpit was slightly tender. On 15th day still tired and tender under arm. It eventually got to be 4inch square, on 16th it was more itchy and more sore, on the 17th the pink was less but you could see the demarcation on the edges. On the 19th I put a topical ointment on it. Today the redness is still there but less.
H1N1 vaccine 10.27. Tues, Wed -10/28 - numbness upper Rt arm, lip and fingers. Thurs - shoulder Rt temple, rt cheek, rt side, chin, under rt ear-sm lump, sensitive to chew rt side teeth. 10-30 called MD, home care. Vaccine # to ref anyone else having reaction. Set 10-31 doctor office. dx with Shingles? VATTREXIL-sleep 1-2 -ENT- eustachian tube involvement. PREDNISONE, NASONEX. 11-3 itch, tired. 11-4 nose numbness going away, 11-5-drying up face. 11-6 neck nodule almost gone.
On 9/13 he woke up at 11pm with stomach pain and nausea, wheezing. All night vomiting and stomach pain stating felt like he had to have a BM, unable to have a BM. Last vomited at 7:30am. Temp 98.2 at 8am, unable to eat all day- 3:30 cough - temp 99.2 - stated he was cold/chills, wheezing - 7:30 99.8 temp gave Tylenol and inhaler.
3 hours after shot I felt like I couldn't breathe. I had to use my asthma inhaler a lot from 830pm to the next morning. I got a 101 fever about 8pm that has lasted for 14 days now. It still hasn't gone away. I've been getting severe headaches every day since. My bloodsugar has been really really high and I've had to increase my insulin amounts. 3 days after vaccine I started getting random hives all over my body. It was one or 2 raised red itchy bumps at a time in random places, like on my leg, chest, arm, face, back. Those lasted for 5 days.
fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), lot no. El3428, via an unspecified route of administration (right arm) on 03Feb2021 16:00 at a single dose for COVID-19 immunization. Medical history included acid reflux and known allergies to erythromycin and azithromycin (ZITHROMAX). No covid prior to vaccination. Concomitant medication included lansoprazole. The patient previously first dose of BNT162B2 (brand=Pfizer) for COVID-19 immunization on 15Jan2021 03:15 PM (lot no. El3428, right arm). No other vaccine in four weeks. On 04Feb2021 09:00 AM, the patient had fever and chills and headache on Thursday and Friday after her vaccine. No treatment received for the events. No covid test post vaccination. The patient recovered from all events on 05Feb2021.
J AND J VACCINE ADMINISTERED TO 12 YEAR OLD. CHILD'S FATHER REQUESTED IN HOME VACCINATION DUE TO CHILDS SEVERE AUTISM AND PHOBIA OF INJECTIONS. AFTER CONFIRMING NKDA AND NO PAST ALLERGIES TO VACCINES, AND RECIEVING PARENTAL CONSENT, NURSE ACCIDENTILY ADMINISTERED J&J VACCINE.
Patient received vaccine 11/17/16 approximately 4pm. Evaluate in my office for rash. Rash appears to be a viral exanthem 5th's disease. Timing of rash after vaccine of interest.
Pt recv vax on 11/3/98; on same day pt exp red/swollen/sore area, unable to raise rt arm above shoulder
PATIENT STATES HE HAS HAD SHOULDER PAIN SINCE TIME OF INJECTION. WAS DIAGNOSED WITH RIGHT SHOULDER BURSITIS IN ED ON 9/17/2017.
COVID arm - red itchy began 5 or 6 days after the injection (was first COVID vacc)
Severe fatigue, brain fog, chills , fast heart beat,  nausea, pain in lower back, can?t get full air in my lungs, dizzy
had very bad reaction for those two injection/had a very bad reaction; for three days they have swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had very bad reaction for those two injection/had a very bad reaction) and VACCINATION SITE SWELLING (for three days they have swelling) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had very bad reaction for those two injection/had a very bad reaction) and VACCINATION SITE SWELLING (for three days they have swelling). At the time of the report, VACCINATION COMPLICATION (had very bad reaction for those two injection/had a very bad reaction) and VACCINATION SITE SWELLING (for three days they have swelling) had resolved.            No concomitant medication information was provided.  It was reported that the patient had two shots of the Moderna COVID 19 vaccines and had very bad reaction for those two injections and wants to take the booster on the hip or somewhere else on that is not the arm, because they had a very bad reaction, for three days they had swelling and was very concern, but it went away. Treatment information was not provided.   This case was linked to MOD-2022-528827 (Patient Link).
Seen 11/13 for 4yr ckup and vaccines. Fine x 24 hours w/o fever, however 11/15/07 while at babysitter had generalized seizure, eyes rolling back, tonic clonic movements of both arms and legs decreased LOC, no respiratory compromise or color change. Lasted 10 min. 911 called, taken to ED.
PT SEEN IN CLINIC TODAY WITH LOCAL REACTION TO THE FLU SHOT, L ARM RED AND WARM TO TOUCH. REDNESS MEASURED BY PROVIDER 7.75 CM. PROVIDER ADVISED PT TO APPLY ICE AND TO TAKE IBUPROFEN. DENIES HA NO FEVER
Fever 101.9 at 18 hours, body aches, headaches, chills, tight chest/throat post 48 hours.  Fevers and chills back at 48 hours with headaches again.
Chills, fever, body aches, headache, fatigue.  Chills and fever went away after about 2 hours from onset, body aches about 8 hours, and finally the headache and fatigue lasted about 24-36 hours from time of onset.  I started getting symptoms about 8 or 9 hours after the shot.
Patient received first dose of SHINGRIX in right arm intra-muscularly. After the injection he said he did not feel well. His wife said he wasn't really a fan of needles. I then told the patient to sit back in the chair (he was turned sideways so I could inject in his right arm, we were both left-handed).  The patient and his wife spoke for about 2-3 minutes about what she was going to do while he sat and in the pharmacy area to see if he would feel better. After approximately 3 minutes patient's  head dropped down. His wife called his name and grabbed his arm but he didn't respond. His head then went back and his eyes rolled back into his head. His body became somewhat stiff and rigid vs. loose as if he fainted. I immediately picked up the phone and call 911. The patient was breathing but his coloring had gone pale, almost green, and his heart rate was rapid. Before I had finished the call with 911 patient regained consciousness and had no recollection what had just occurred. He was extremely sweaty. The paramedics came took all his vitals, which were normal.  They recommended he be seen at the hospital due to his coloring and the amount of sweat he was producing. Patient said he felt fine and did not want to go.
Client states a lymph node in her left armpit became increasingly swollen and painful, peaking on Saturday, July 19th, 2014.
This is a spontaneous report received from contactable consumer or other non-HCP (patient). An 81-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0161), at the age of 81, in right arm, on Apr 12, 2021, single dose, for COVID-19 immunisation. Medical history included atrial fibrillation (unspecified if ongoing). The patient's concomitant medications not reported. Vaccination history include the flu shot. The patient developed a headache (head discomfort/felt like a pressure headache), onset Apr 2021, with outcome of unknown. The action taken for BNT162B2 unknown. Additional information: Head discomfort was minor and only lasted an hour. It was like a pressure headache. She had no arm pain at all. The patient wanted to know what to do about getting the second COVID-19 shot. She did not want to get it before the ablation, and did not want to get it a day or two after the ablation. It would be possible to get it the following week after the ablation either Mar 10, 2021 or May 11, 2021. She did not know if the pharmacy would still even have the COVID-19 shot. That would make the second shot 8-9 days later. She possibly could get it on Mar 8, 2021, but doesn't know. She did not receive any prior vaccinations within 4 weeks. No follow-up attempts possible. No further information expected.
Shortness of breath, tenderness at site, erythema and hot at site along with swelling and raised area. Patient also reports tingling down right arm and muscle aches.
Patient reported that she has a feeling in her throat and headache as well.. the headache cleared... throat cleared weeks after... after the second vaccine she had serve headaches and very thirsty had swelling and redness at the injection site.. also had hives on her body and the itching in her throat came back ...
She had awful smell; Awful taste in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (She had awful smell) and TASTE DISORDER (Awful taste in her mouth) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 031A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE BESILATE (NORVASC), BACLOFEN, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), CARBAMAZEPINE (TEGRETOL), CELECOXIB (CELEXA [CELECOXIB]), HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) and VALACICLOVIR for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PAROSMIA (She had awful smell) and TASTE DISORDER (Awful taste in her mouth). At the time of the report, PAROSMIA (She had awful smell) had not resolved and TASTE DISORDER (Awful taste in her mouth) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received on 10-Jun-2021 contains significant information where the outcome of the event parosmia changed from unknown to not recovered.