chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt collapsed 13 minutes after receiving the vaccine. This vaccine was her first COVID19 Shot. According  to pt, she couldn't see anything just before collapsing. Her spouse was with her at the time, so he caught her just before she could hit to floor. Pt was still waiting for the required 15 minutes wait after vaccination . Pt  regained consciousness in a few seconds then started talking. She denied any shortness of breath, or sign and symptoms of anaphylaxis. She however, complained of feeling anxious after gaining consciousness. she was made to sit while we wait for paramedics to arrive, she was  given water to drink. Paramedics arrived in about 5 minutes, examine pt and took her away from the pharmacy to be in their ambulance to monitor her for a while.
After the 1st dosage, I started getting severe Vertigo. Every time I change position my head starts spinning.   I have seen a number of specialists in order to resolve the issue without any success.  I am currently receiving physical therapy to deal with the issue.
plunger actually burst/defective RSV vaccine which is the Abrysvo/plunger is defective; Couldn't mix the diluent with the active ingredient; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 14Nov2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group, Program ID: .  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HL9687, Expiration Date: Mar2025) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), described as "plunger actually burst/defective RSV vaccine which is the Abrysvo/plunger is defective"; DEVICE USE ISSUE (non-serious), described as "Couldn't mix the diluent with the active ingredient".  Additional Information: It was initially reported that reporter was calling in regards to a defective RSV vaccine which is the Abrysvo. He mentioned that the plugger is defective. Reporter stated that there was no patient involvement, it was not administered. It's being reconstituted and the plugger actually burst. So, reporter couldn't mix the diluent with the active ingredient. No patient involvement. Reporter have the product on the site so when if reporter do get a mailer, reporter will mail it and then get reimbursed or credit or replacement.  Causality for "plunger actually burst/defective rsv vaccine which is the abrysvo/plunger is defective" and "couldn't mix the diluent with the active ingredient" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Symptoms: right sided facial droop and numbness CN VII weakness (decreased strength with closing eye, smiling, and blowing out cheeks; preserved eyebrow raising). Numbness; inability to hold liquids in mouth. Preserved strength in upper and lower extremities. This started with numbness on 09/17/2021, weakness noticeable on 09/18/2021
14:40 Started reaction throat and tongue numbness, I drank 2 glasses of water. 15:00 lost my voice, my eyes puffed up a bit and my face was not well, lungs wheezing, Epi administrated by PA vaccination clinic. 15:32 UC for observation. Administered Decadron 10 MG injection. Blood Pressure 150 /80- HR 88.
Localized reaction to (L) thigh, red, swollen area approx. 4x6".
Vaccination adverse reaction; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
High fever (104) that night, the next day was 103 for 24 hours dropped to 102 then was 101.8 for several days. Myalgia, diarrhea for 24 hours and arm soreness at vaccination site . 1 week to recovery.
Had hep A #2 on 12/20/01. 12/24/01 broke out in welts and rash al over body, itching. Gave Benadryl. Rash and welts gone in 12/25/01 morning but welts returned to arms and face 12/26/01. Continued on Benadryl. Eyes puffy rash and welts diminished. Had a slight cold when shots given. Is coughing now on cough syrup.
Approximately 2 hours after vaccine, patient complain of increased hives on back of legs.  Then became painful.  Patient exercised at gym for 1 hour and then noticed swelling of both hands/wrists.  Vomited at 2100.  Took BENADRYL,  by mouth at 2300, as per phone order by private medical doctor.  Next am, patient woke up with increased hives and feet swelling.  Then went to hospital emergency room.
Mild arm pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild arm pain) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Mild arm pain) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Mild arm pain) and FATIGUE (Fatigue) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to US-MODERNATX, INC.-MOD-2022-623799 (E2B Linked Report).
Patient woke with a very sore arm and swollen lymph nodes in her axilla area. She applied a heat pack and returned to sleep. By morning her arm was without indication of an injection site reaction, but the lymph nodes under her arms were still enlarged and sore the entire area under her arm and around her shoulder was swollen and tender to the touch. Patient did not feel it required any treatment, she just wanted to report that it had occurred. She stated if the reaction did not resolve in a few days, she would return to see the physician.
I gave patient the Afluria vaccine at approximately 5:10 PM.  The patient waited nearby as I then gave his father the same vaccine. Patient then starting looking down thru some isles in the store.  The father went to leave and came back to get me about 5 minutes later stating that patient had fainted. I informed my technician to call 911.  I ran over to the patient to assess the situation.  Patient's skin was pasty and flushed.  He had shallow breathing but was conscious. I checked his pulse it was weak.  He then started regaining color back and his breathing rate picked back up.  I had him remain on his back and keep his feet elavated.  He said he was very thirsty.  Some one brought water and he sipped it.  The EMT's arrived and took the situation over.
Informatino has been received from a healthcare worker referring to an 11 year old male patient. On 24-AUG-2015 the patient was inadvertently vaccinated with ZOSTAVAX instead of VARIVAX (Merck) (Wrong drug administered). No adverse effects reported. The outcome was unknown. Additional information has been requested.
Dizziness 10-15 min post im injection; injection site pain for 2 days following im injection
I woke up in the middle of the night about 02:00AM 03/20/2021 with swollen hands and itching under breasts and all around to back. I never had a rash. I texted him the next morning 03/21/2021 and he called in a prescription for Prednisone. It did clear up but he advised me not to get anymore. He thought I would be ok but because of that reaction, he thought it might be a worse reaction the next time. I do have some fatigue but that is getting better.
Had a severe allergic reaction after a previous dose; ringing in the ear; feeling of pressure in the ear; arm hurt; joint pain; armpits hurt; muscle pain; bones hurt; super tired and fatigued; This is a spontaneous report from a contactable consumer or other non hcp.   A 36-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 at 12:30 PM as single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that, patient reported that got his first dose of the Pfizer COVID-19 vaccine April 13th and was due for his follow up second dose on May 4th. Stated that vaccine card information was handwritten and the NDC/EXP were not provided on there. Caller stated that got a lot of the normal things, like his arm hurt, he had joint pain, his armpits hurt, he had muscle pain, and his bones hurt a little bit and reported that 5-6 hours after getting the vaccine he had ringing in his ears and that lasted a bit but then it went away, then the next day it came back, and not had the ringing since then. Stated that had slight pressure in his ears that is still there, but the ringing only happened the first two days. The pressure feels like an ear infection, no treatment for the ear ringing or pressure, but called his primary care provider and they told him to wait a bit and also said he could come in or he could try over the counter ear ringing medications, but they recommended calling to report it to Pfizer and get their opinion on it, she doesn't see any reason he could not get the second dose. Stated that his armpit hurting and things only lasted a couple hours, didn't take anything for the other pains either. Stated arm felt like an anvil for days, was super tired and fatigued. Still muscle and joint pain lasted a couple days after or lasted a day or two, main reason he called was because of the ear ringing and pressure. The outcome of the events was unknown.  Follow-up (PRD 04May2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included the information.  Follow-up actions are closed. No need of further information.
Pregnant at time of vaccination. Est due date was 9/5/21, making me approx 1 mo pregnant at time of 1st vaccine.  Baby boy born 8/19, with small for gestational age (weight 4lb 12oz), small VSD (also PFO, PDA), and large porto-systemic shunt of liver.   had repeat covid (pfizer) 1/26/21
skin lesion- vesiculobullous rash - Information has been received from a registered nurse concerning a female patient who on 06 May 2000 was vaccinated with a dose of varicella virus vaccine live.  subsequently, the patient developed  a generalized rash, about 20 lesions in number, none vesicular.  There were no systemic manifestations.  The patient sougth unspecified medical attention.  Additional information has been requested.
20 min after receiving vaccine, paresthesia felt in left arm. Spread to left half of face and left leg 3 days later. Two weeks after that, paresthesia spread to whole body. 3 days post-vaccine, chest pain, abdominal pain, nausea, and weakness began. 9 days post vaccine, abdominal bleeding began.   Chest pain resolved in 1 day.  Abdominal bleeding resolved in 2 days. Nausea lasted two weeks.  Weakness and paresthesia continue 3 weeks post vaccine.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Verbatim: other medical history: No. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: anti viral details. product: COVID 19 Treatment, brand: Paxlovid. Treatment start date: 12Jun2022,; treatment stop date: 19Jun2022, indication: Treatment of COVID-19   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a Licensed Vocational Nurse (L.V.N) refers to a 64 year old female patient. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD recombinant human albumin (rHA) (lot M044022; expiry date 01-MAY-2018, dose and route of administration were not reported) reconstituted with a sterile diluent. No adverse effect was reported. Additional information has been requested.
Uncontrollable itchiness / on the area she receive the vaccination; Rash on her arm, on the area she receive the vaccination; This case was reported by a nurse via sales rep and described the occurrence of injection site itching in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced injection site itching and injection site rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site itching and injection site rash were unknown.   It was unknown if the reporter considered the injection site itching and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced uncontrollable itchiness and rash on her arm, on the area she received the vaccination.  Benadryl was administered to this patient. No further details were reported. This case linked with US2020146794, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020146794:same reporter
Pharmacist realized later in the afternoon that the Pfizer pediatric  vaccine was undiluted and the patient received 0.2ml dose.  The pharmacist was able to notify the mother of the patient of the error and they stated that the patient did not experience any side effects from the vaccination at the time.
5/6/08 given VARIVAX; 5/8/08 seen with 9x4.5 cm area induration/erythema (wheal like) on upper arm; treated with ice & observation with improvement.
22 patients received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The date of vial initially stored in the refrigerator was unknown. Dates of administration of vaccine were reported as 2 doses on 05-Apr-2022, 13 doses on 06-Apr-2022, 2 doses on 07-Apr-2022 and 4 doses on 08-Apr-2022.  The patient received his Second booster in his right arm. The vial did not undergo any temperature excursions.  No treatment information was reported.
fell, did not have strength to get up, had to crawl; OVERALL WEAKNESS; HIP BONE HURT; NECK WAS STIFF AND SORE; NECK WAS STIFF AND SORE; LEFT ARM HURT; TENDER INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell, did not have strength to get up, had to crawl), ASTHENIA (OVERALL WEAKNESS), MUSCULOSKELETAL DISCOMFORT (HIP BONE HURT), MUSCULOSKELETAL STIFFNESS (NECK WAS STIFF AND SORE) and NECK PAIN (NECK WAS STIFF AND SORE) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced FALL (fell, did not have strength to get up, had to crawl), ASTHENIA (OVERALL WEAKNESS), MUSCULOSKELETAL DISCOMFORT (HIP BONE HURT), MUSCULOSKELETAL STIFFNESS (NECK WAS STIFF AND SORE), NECK PAIN (NECK WAS STIFF AND SORE), INJECTION SITE PAIN (LEFT ARM HURT) and INJECTION SITE PAIN (TENDER INJECTION SITE). On 26-Feb-2021, FALL (fell, did not have strength to get up, had to crawl), ASTHENIA (OVERALL WEAKNESS), MUSCULOSKELETAL DISCOMFORT (HIP BONE HURT), MUSCULOSKELETAL STIFFNESS (NECK WAS STIFF AND SORE), NECK PAIN (NECK WAS STIFF AND SORE), INJECTION SITE PAIN (LEFT ARM HURT) and INJECTION SITE PAIN (TENDER INJECTION SITE) had resolved.            No treatment was provided by the reporter. No concomitant medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Followup was received. No significant information was received.
I had scratchy throat; cough; cold-like  symptoms; and fever for about 5 days and  I took Tylenol.
Pt woke up on May 18th with severe headache. No improvement with Motrin. Also had nausea. Had lightheadedness when standing.  Had photophobia. Headache described as squeezing on top of head/band around head. No blurry vision. Lasted for 4 days. Went to the ER around 3AM the day after it started. Diagnosed with tension headache and sinusitis. Had negative Head CT. Was given a Z-pak and some "headache medicine" which sounded like vicodin or other narcotic. The meds helped but he required the pain med for the 4 days. He had anorexia. The smell of food made him vomit. Pain worse with sitting up. Was essentially incapacitated for 4 days. Had some hot and cold spells and sweats. Never got temperature reading. No diarrhea. No sore throat, no myalgias or arthralgias. Had fatigue. Feels totally fine now (5/29/07).
History of epilepsy associated with SCN1a mutation in childhood but reportedly no seizures in 10 years. Patient and family report changes within 24 hours that have been interpreted as probable seizures, recurrent for 4-5 months after vaccination. As of 1/31/2022 all has resolved.
2/12/2021 Slight headache Fatigue 101.2 fever Started feeling fatigue in morning also slight headache fever by afternoon and all evening
CONCERNED ABOUT AUTOIMMUNE DISORDERS DUE TO THAT EXPERIENCING SOME THINGS; BILATERAL EAR INFECTION (INNER AND OUTER EAR); DIARRHEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown), dose was not reported, 1 total, administered on 14-JUN-2021 into left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-JUL-2021, the patient experienced tinnitus, bilateral ear infection (inner and outer ear), diarrhea. The patient was generally a healthy person and did not get sick. On an unspecified date, the patient was concerned about autoimmune disorders and due to that patient had experienced some things. On 10-JUL-2021, the patient saw a physician who gave antibiotic (amoxicillin) for the ear infection. The physician was surprised since the patient was not exposed to anything that would cause the side effects.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bilateral ear infection (inner and outer ear), and diarrhea, and the outcome of concerned about autoimmune disorders due to that experiencing some things was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210726085-covid-19 vaccine ad26.cov2.s-concerned about autoimmune disorders due to that experiencing some things. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Initial and follow-up information has been received from a physician and nurse concerning a 17 year old female who on 01-NOV-2007 was vaccinated with a first dose of Gardasil (lot# unknown) injection.  On 27-DEC-2007, the patient was vaccinated with a second dose of Gardasil (lot# 659439/1267U) 0.5 mL injection.  On 27-DEC-2007 the patient experienced low blood pressure.  The patient's blood pressure dropped from 110 to 80 (also reported as 80/60), her skin was "hot" to the touch and she felt nauseated.  Medical attention was sought.  The patient went home after the recovery on 27-DEC-2007.  Additional information has been requested.
Every couple of days I get muscle spasms at the shot location.  It's been going on for 7-8 months now.