chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose on 12Feb2021, 2nd dose not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose pre-covid on 12th February 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 16-Sept-2022 Reporter's comment: The reporter reported that 1 dose of Shingrix pre-covid and reported asked that did they need to start over or was one more shot sufficient. The reporter consented to follow-up via postal. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Over the course of a week started getting more tired, aching, head aches.  By end of 2nd week sleeping all the time, joint pain stiffness, headaches, stomach ache, chills can't work. By 3rd week Sleeping 16 to 20 hours per day extreme stiff, aching in muscles and joints losing weight, general ill feeling.
Patient hospitalized. Patient died after testing positive for COVID-19. Admitted to hospital 4/2/2021 for right flank pain. Tested positive on  4/1/2021. Died 4/29/2021
Localized rash, itching, redness and pain starting the day following vaccination. This lasted for 3 days, during which pt developed pain shooting down her arm to her wrist from vaccination site. Progressed to wrist pain and weakness that is gradually improving after 10 days.  Also c/o some aches and pains to legs but no weakness.
Left upper arm and shoulder swelling, redness, pain and warm to touch 1 day status post vaccine administration.
red area at injection site x 5 days, rash on chest and leg, blister on hand; tx with Benedryl
1st dose on 27Apr2021/2nd dose on 14May2021; After his 2nd dose, he never became well and continued to be ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65 year-old male patient received bnt162b2 (COMIRNATY), administration date 14May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "HTN" (unspecified if ongoing); "CLL (Chronic lymphocytic leukemia)" (unspecified if ongoing), notes: He is not taking any medication for his CLL (no immunosuppressants); "COVID" (unspecified if ongoing), notes: Before he got his 2nd dose, he got in contact with someone with COVID. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 27Apr2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14May2021, outcome "unknown", described as "1st dose on 27Apr2021/2nd dose on 14May2021"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "After his 2nd dose, he never became well and continued to be ill". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected. The lot/batch number is not available despite the follow-up attempts made.
My wife contracted COVID-19 over the weekend. She tested positive on 03/12/2023. On the evening of 03/15/2023, I noticed my nose was running, I felt puny, I was fatigued, and achy with a headache as well. I slept pretty well, but when I woke up, I had a headache and was achy. My nose was bothering me, and I had a cough. I took an at home COVID-19 test and it was brightly positive. I started taking 200mg of ibuprofen every 2 hours to treat the symptoms. I contacted my physician as well to get a prescription of PAXLOVID. I began the PAXLOVID that the night of 03/16/2023. I never got a fever, and my headache was getting better. Once I started the PAXLOVID, I switched to acetaminophen extra strength every four hours. My doctor also advised that I stop taking the tadalafil and sildenafil that I normally take while taking PAXLOVID, so I followed his advice and did not take them for the course of the prescription. I started feeling better fairly quickly. By Saturday, I was feeling 85-95% and by Sunday, I was almost completely better and was able to work out again. I did still feel a bit winded, but not bad. I finished the last of the PAXLOVID on 03/21/2023.
Pt recvd vax on 12MAR92 & on 12MAR92  & pt devel hives on neck & face, & pain in lt arm radiating to hand;
PATIENT COMPLAINED OF REDNESS/SORENESS, SILVER DOLLAR AT INJECTION SITE, WARM UNDERNEATH ON 11/21/19 AT 9:30AM.  THE PHARMACIST ON DUTY AT THE TIME ADVISED THE PATIENT TO CONTACT HER DOCTOR.
Menstrual Spotting beginning 3 days after vaccine, continuing every two days through today?s date.
Within hours of the flu vaccine I developed a severe headache, burning, red, itchy, swollen eyes, tight feeling in lungs, all over ache.  *I do have problems with allergies, although this seemed worse than usual.   I also have asthma but had been fine all throughout the day.  My husband had been not feeling well over the weekend, as well.   I'm not sure if it was related to the vaccine, but when a friend told me she had a very simliar reaction after receiving the shot I thought I'd report it.
lymphatic nodes were swollen; right knee swollen; cannot walk yet; Leg pain; other specified soft tissue disorders.; leg bumps/or swelling; This is a spontaneous report from a contactable consumer (patient).   A 45-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 16:30 (Batch/Lot number was not reported),  at the age of 45-year-old at vaccination, as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.   The patient is not pregnant at the time of vaccination.  There were no concomitant medications.  The patient previously took NSAIDS and experienced drug hypersensitivity. The patient did not have COVID prior vaccination. On 09Mar2021 06:00, the patient woke up with her right knee swollen and had difficulty walking. She went to the Hospital in the afternoon and was told that her lymphatic nodes were swollen, and the diagnosis is Leg pain and swelling and other specified soft tissue disorders. The still have a swollen knee and cannot walk yet, 6 days after the vaccine. The patient still have leg bumps/or swelling in her leg. The patient was hospitalized for lymphatic nodes were swollen. It was also reported that patient has physician and ER visit. The patient was not tested for COVID post vaccination. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events which includes Codeine/paracetamol, RICE routine care for injury.  Information about Batch/Lot number has been requested.
developed a 10 cm area of redness on their arm.; This case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The patient developed 10 cm area of redness on the arm, after receiving the 1st dose of Shingrix. The patient visited the emergency room. The reporter consented to follow up.
Patient developed severe bilateral temporal pain as well as severe chills, photosensitivity, and nausea. Mom administered Ibuprofen and symptoms subsided within 2-3 hours.  Patient then went to bed and slept for 11 hours.  The following day, patient was complaining of malaise but had no pain or other symptoms.
Swollen lymph node on left side of neck; Initial information was received on 09-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp (healthcare professional).  This case involves female patient who experienced swollen lymph node on left side of neck (lymphadenopathy), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 19-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiration date were not reported) via unknown route in the right arm for prophylactic vaccination.  On 21-Oct-2020, the patient developed a non-serious swollen lymph node on left side of neck (lymphadenopathy), two days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown  at the time of reporting.  There will be no information on the batch number for this case.
c/o chills, lightheaded, hot flashes, fatigue and sweating after 1st vaccine on 12/30/20. Narrative:  Seen in Occ. Health for c/o chills, lightheaded, hot flashes, fatigue and sweating after 1st vaccine on 12/30/20. Afebrile. non-occupational illness. Returned for 2nd vaccine on 1/19/2021.
A 71 year old male received RSV Vaccine or Placebo and Influenza Vaccine on 10/14/02 and 243 days later died on 6/14/03. Patient obituary discovered in newspaper, the investigator will contact family in a couple of weeks. Signs/Symptoms/Diagnosis: No data at present time. The Investigator assessed the event as unrelated to the study product. Follow up on 07/08/2003: "A 71 year old male received RSV vaccine or Placebo and Influenza vaccine on 10/14/2002 and 243 days later died on 06/14/2003.  Patient obituary discovered in newspaper, the investigator will contact family in a couple of weeks.  Signs/Symptoms/Diagnosis: No data at present time.  The investigator assessed the event as unrelated to the study product.  Follow up information received 07/01/2003.  Investigator spoke with family members, regarding death.  They stated that subject died in bed.  Family physician thought cause of death was heart attack.  Autopsy was performed.  Results of the autopsy are not known yet.  Diagnosis: MI?.  The investigator site assessed the event as unrelated to the study product.  Further information is expected."  Follow up on 02/09/04: "Additional information received 02/02/04.  After multiple attempts, unable to obtain autopsy results."
DEEP VEIN THROMBOSIS  LEG; This spontaneous report received from a patient 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: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient developed deep vein thrombosis (DVT) on leg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep vein thrombosis leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210517421- COVID-19 VACCINE AD26.COV2.S  Deep vein thrombosis leg. This event is considered unassessable. The event 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.
Mother of child called clinic stated daughter had DTAP vaccine on left arm.  Mother noted left arm with redness, soreness, and swelling on left arm and hot to touch.  Mother took daughter to ER, child was given antibiotics, no fever at all.
Dizziness, Vertigo, Vomiting, Chills, Sore foot
Information has been received from a physician referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # M013636, expiration date 15-FEB-2018, intramuscular). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient received the flu vaccine first and she was fine, and then passed out immediately after giving the first dose of the HPV vaccine. MA was there to catch her. Patient lost consciousness for a moment and then came to it right away. MA laid her down right away after giving the vaccine. Once the patient came to it, she did not know what happened and asked if she passed out? Ma got NP right away after the patient came back to it. Took BP while she was lying down, and it was 110/68. Patient was shooken up after it happened but was no longer dizzy and felt fine. MA got water for patient. NP brought mom back into the room and let mom know what happened. Patient and mom stayed in the room for a bit after. Patient felt better and left 15 minutes after receiving vaccine. Advised the mom if she has any other severe reactions within the next 24hrs to call EMS or take her in right away. MA and patient were not injured.
Temperature of Storage Unit could not be verified for period of time.  Vaccine may have been effective.  No Treatment or adverse outcome
Patient contacted pharmacy on 8/16/18 reporting a large/raised red spot the size of a half dollar at the injection site from the vaccination received on 8/13/18. Site was warm to the touch. Patient reported no other symptoms. Recommendation was given verbally by the provider, to take oral Benadryl and to use topical Benadryl plus Hydrocortisone. Patient was to see provider if no improvement in 24hrs.
After her 1st dose, she had an allergy so bad; Swelling and hives all over body; Swelling and hives all over body; This is a spontaneous report from a contactable nurse, the patient. An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the arm on 23Jan2021 (at the age of 82-years-old) as a single dose for COVID-19 immunization. Medical history included the patient was on blood thinner therapy; allergy to a lot of medications, mold and cut grass; operation to remove clots in Nov2020 (two months prior to vaccination); thyroid disorder. Concomitant medications included unspecified thyroid pills and apixaban (ELIQUIS) as a blood thinner. The patient previously took moxifloxacin (AVELOX) and experienced allergy and rash and was in the hospital. On 24Jan2021 (the next day after vaccination), the patient experienced an "allergy so bad", swelling and hives all over her body. The patient went to the emergency room due to the events and was "hooked up" with intravenous (IV)s for an hour before she could go home. The reactions were assessed as related to the vaccination by the patient. The patient was scheduled for her second dose on 23Mar2021. She was not given the Pfizer-BioNTech COVID-19 Vaccine fact sheet for recipients and caregivers until after being administered the first dose of the vaccine. If she had been given the fact sheet for recipients and caregivers before being administered the first dose, she would not have gotten the vaccine because the sheet says not to get the shot if you are allergic to other medications or other reasons for allergies or on blood thinners. The patient questioned whether she should get the second dose as her physician said she should not get the second dose while on apixaban. The clinical outcome of "after her 1st dose, she had an allergy so bad" and "swelling and hives all over body" was unknown.  Information on lot number/batch number has been requested.; Sender's Comments: Based on temporal relation and known safety profile of the vaccine, a causal relation between events allergy to vaccine, swelling, hives and BNT162B2 cannot be excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
First symptom on 3/3/17 was pain and redness at the injection area. Pain was severe, could not move arm without pain. Gave ibuprofen. 3/4/17, very tired and still in pain, gave BENADRYL. 3/5/17. Left arm was numb at injection. Took to the ER. No medication given. 3/6/17-11:00 whole arm was numb to fingers. Chest pain in a pulsing manner. Took back to the ER, no medication was given. 3/6/17 7:30, chest pain is constant, redness at injection site has reappeared. Gave an Epsom salt bath. Left arm now is hurting in addition to being numb. Left toe and then half the foot felt like electrical pulses zapping it.
Headache, Myalgia, Fever, Angina, Chills, Tinnitus Narrative:
BlurredVision, Diarrhea,  no appetite Narrative:  Other Relevant History:
patient came in for routine counsel and stated that after vaccine he had arm pain at injection site and could not raise his arm above his head.  The pain radiated to his neck and eventually his other arm.
This is a spontaneous report received from a noncontactable other healthcare professional. A 25-year-old female patient (unknown if pregnant) received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FD7218), at the age of 25, on Jan 12, 2022, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown/not available/not provided to  at the time of report), for COVID-19 immunization. The patient had pyrexia/fever and nausea, onset Jan 2022, with outcome of unknown. No follow-up attempts possible. No further information expected.
Client signed consent for vaccines on 11-3-2022 per self. No s/sx noted, appears at baseline in use. Upon assessment post mass influenza vaccination clinic client had previous signed consent for self on 10-26-2022 to have high dose influenza vaccine. Client provided consent on both vacciens.  Notified Dr. Per Nurse will monitor client, client had body aches, chills, no fever. Will administer PRN Tylenol as needed. Will continue to monitor.
pt recvd vax & exp burning @ inject site following 2nd dose of Hep B vax 19JAN93;
chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped.  Limited range of motion noted on L arm, could not lift arm ROM more than  30 degrees   12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching.   Took Benadryl 25mg and feel asleep.  hives and itching was gone by the time she woke up.  Severe fever and body aches 22 hours after vaccine administration.  Temperature was 101.8.  Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg  and Vit C 2000mg and Vit D 10,000 IU  and Zinc 100mg.   Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.
Headache, Fever, fatigue, arm soreness, brain fog Narrative:  Headache, fever, myalgia, sore arm, fatigue, brain fog; tylenol, Advil.
superficial thrombophlebitis left greater saphenous vein with blood clot formation almost entire length of the vein
High fever for three days 101- 103. My regular temperature is 96 not 98. Nauseas/ vomiting. Headache. Painful muscles and joints. Cough. Excessive tiredness.
pts face twitched & then muscles relaxed & drolled; mom could not get pt to respond to voice or touch; stared for several minutes; eye rolling-immed went to peds MD; pt had episode of staring p/that time & eyes rolling;
Administered expired vaccine to the patient, Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, Dose administered after 30-day use by date or after manufacturer date of expiry) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator reported as unknown. Vaccine was expired on 07-Apr-2022.No  temperature excursion for the vials was reported. Total of 173 doses were reported with the lot number 070H21A.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up document was received and had  no new information.
After leaving vaccination station, patient started to collapse, was helped into a chair then to a wheelchair, taken to a gurney. Once on gurney he stated he "felt much better", Given water and juice. Patient felt "woozy" again after sitting up on side of gurney. so he laid down again. Slightly hypotensive at 96/46 first measurement. 101/44 for second measurement. Continued to report waves of dizziness.
This case was reported by a healthcare professional via a sales representative and described the occurrence of menstrual cramping/pain in a 11-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In February 2011 the subject received 1st dose of CERVARIX (unknown). Less than one year after vaccination with CERVARIX, and starting at some unspecified time prior to receiving the 2nd dose of CERVARIX on 28 April 2011, the subject developed painful menstrual cramps. The painful menstrual cramps continued following the 2nd dose of CERVARIX and were unresolved at the time of reporting. No further details were provided.
I did have a hard red lump at the site of the injection. The main reason I went for medical treatment, I woke up I believe the second day and had double vision.  I went to urgent care, and they thought maybe it was an eye infection and gave me medication.  I had the medication and did that for a few days and then I went to see an Optometrist and told me to take eye drops. I did that and it got better.   The I got the second shot and it happened it happened all over again. My doctor ran blood work and has extremely low white blood count.