chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slight anaphylactic reaction; This is spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation; amifampridine phosphate (FIRDAPSE, tablet, 10 mg, Lot number was not reported), via an unspecified route of administration from Feb2019 and ongoing, at 10 mg for Lembert-Eaton myasthenic syndrome (LEMS). Medical history included myasthenic syndrome. The patient's concomitant medications were not reported. On an unspecified date, after starting the product, the patient experienced a bad reaction to the covid vaccine, described as a slight anaphylactic reaction to Pfizer vaccine. Seriousness criteria was reported as important medical event. As on 10May2021, treatment with amifampridine phosphate continued, and the slight anaphylactic reaction had resolved. The action taken in response to the event for BNT162B2 was not applicable, for amifampridine phosphate was reported as unknown. The outcome of event was recovered on 10May2021.  Information about lot/batch number has been requested.
Shot given, and upon return home dizzy, vomited and rashy. Did resolve over several minutes. Then local reaction x 2-3 days.
Pt recv vax on 10/27/98; 1 hr later pt exp rash on face, upper chest, left side of body
Headache, Arthralgia, Fever, Diarrhea &  Nausea Vomiting
It started to be sore; Arm was swollen; Arm was red; Arm was hot/ hot skin; Arm was itching; Numbness; Tingling; Arm was burning; Arm was sore; Slight headache; Rash around area where i got the jab/ larger rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen), ERYTHEMA (Arm was red), SKIN WARM (Arm was hot/ hot skin), PRURITUS (Arm was itching) and HYPOAESTHESIA (Numbness) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis. Concurrent medical conditions included Anxiety, Crohn's since August 1984, Drug allergy (rash, itchy, hives) and Drug allergy (rash, itchy, burning, threw up, throat closed up, bumps hives). Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) for Anxiety, ENTYVIO for Crohn's.    On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen), ERYTHEMA (Arm was red), SKIN WARM (Arm was hot/ hot skin), PRURITUS (Arm was itching), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), BURNING SENSATION (Arm was burning), PAIN IN EXTREMITY (Arm was sore), HEADACHE (Slight headache) and VACCINATION SITE RASH (Rash around area where i got the jab/ larger rash). On an unknown date, the patient experienced VACCINATION SITE PAIN (It started to be sore). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC) from 14-Jul-2021 to 20-Jul-2021 for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (Benadryl) from 13-Jul-2021 to 20-Jul-2021 for Adverse reaction, at an unspecified dose and frequency; SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFAMETHOPRIM) from 15-Jul-2021 to 16-Jul-2021 for Adverse reaction, at an unspecified dose and frequency and NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN) 14-Jul-2021 for Adverse reaction, at an unspecified dose and frequency. On 20-Jul-2021, PERIPHERAL SWELLING (Arm was swollen), ERYTHEMA (Arm was red), SKIN WARM (Arm was hot/ hot skin), PRURITUS (Arm was itching), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), BURNING SENSATION (Arm was burning), PAIN IN EXTREMITY (Arm was sore), HEADACHE (Slight headache) and VACCINATION SITE RASH (Rash around area where i got the jab/ larger rash) had resolved. At the time of the report, VACCINATION SITE PAIN (It started to be sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: significant follow up- patient medical history, concomitant medications, treatment details and event onset, end date, outcome of events. On 29-Jul-2021: Photos attached.
MCIR website was down. So I had to look at the vaccine rec. for shots due. Did not notice DTaP-hib shots. I thought she was overdue for DTaP. Administered DTaP shot. Was told afterward by another nurse that children over 7 yrs old get Td not DTaP. Called mom told her she stated child was fine.
Pt. states that after receiving the 3rd Booster of Moderna 11/05/2021, started experiencing symptoms of itching in the Ears (Both), self-treated with Benadryl, continued to experience neck stiff pain, headache, back pain, fatigue, muscle aches, (Left)swollen at the injection site (4inches from elbow) with redness, and itchiness. No noted Primary visit/communications. Still experiencing symptoms of swelling in the arm.
Patient experienced pain upon injection which got worse within few minutes of vaccine administration. Patient as to take Aleve as well use cold pack.
Had immediate severe pain in arm, head rush, hives, dizzy, sick to my stomach.  Sick all week and missed 3 days of work.
cut his finger; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SKIN LACERATION (cut his finger) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013l20a and 015m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced SKIN LACERATION (cut his finger). The patient was treated with DOXYCYCLINE for Laceration of finger, at an unspecified dose and frequency. At the time of the report, SKIN LACERATION (cut his finger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient takes blood pressure medicines as concomitant drug.  Patient had to receive a tetanus shot as a week ago he cut his finger.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 57-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date unknown). The patient's past medical history included shingles (dates of previous outbreak unknown). On 26th March 2018 13:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 4th April 2018, 9 days after receiving SHINGRIX, the patient experienced shingles, vesicular rash and papular rash. On an unknown date, the outcome of the shingles, vesicular rash and papular rash were not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. The reporter considered the vesicular rash and papular rash to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced small bumps on the opposite arm of vaccination. By the next day, on 5th April 2018, the bumps also appeared on the ankle on the injection side. Within approximately 5 days from appearance, the bumps were raised and fluid filled. The patient had not visited a physician or other medical professional and no diagnosis had been made at this time. The patient, who had experienced a prior case of Shingles, felt that this might be a recurrence of Shingles. The healthcare professional was unable to provide the expiration date of SHINGRIX, as their system automatically defaults to one year after the administration date. The report lot number VY3X4) for SHINGRIX did not exist and was updated to ZY3X4, according to sales database. This case has been linked to US2018063409, reported by the same reporter.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient reported on 2/22/21 that he had been having recent episodes of syncope related to hypoxia. Hospice referral due to rapidly progressing emphysema on 3/17/21 after another syncope event. He later passed away on 3/20/21. Comorbidities include chronic hypoxemic respiratory failure, emphysema, pulmonary fibrosis, CAD, T2DM, HTN, HLD.
Other than soreness at the injection site, there were no adverse effects. I did, however, contract covid about 4 months later.
Swelling, redness, warm (temperature), itching approx. 7 inch swollen area of injection.
Immediately after injection, soreness, stiffness and range of motion issues ensued. After 3 weeks, primary care physician (PCP) was contacted. PCP said this was normal. Contacted PCP in May due to continuing issues and had visit on 5/18/21. X-ray taken and PCP referred to Physical Therapy (PT). 2/x week visits began 6/16/21. Icing and home exercises prescribed in between visits. Last visit 8/12/21 and referred back to PCP due to limited progress. PCP referred to orthopedic surgeon. First visit with surgeon on 10/4/21. MRI ordered and showed adhesive capsulitis and small tear. 2/x week PT ordered with first visit on 10/27/21. Continued PT. Underwent Platelet-rich plasma (PRP) injection 3/17/22 due to little progress PRP treament provided no additional relief or progress. ROM still limited. Continued 1/x week PT visits, home exercises and icing until last visit on 8/30/22. Due to not being able to progress further, PT determined their role to have ended. Was told that time may be what is needed to heal. PCP visit on 9/13/22 and was told that time is still needed to improve.
Fever of 100.8.Degrees Farenheight; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100.8.Degrees Farenheight), FATIGUE (Fatigue) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (Fever of 100.8.Degrees Farenheight), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever of 100.8.Degrees Farenheight), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown. Not Provided          No treatment information was provided.
Pt here for in office visit converted from virtual. He developed painful rash on Friday late morning 4/9. Bumps on his right side of forehead and pain traveling down front of his right ear and into lower part of his jaw. No tinnitus, hearing issues, pain inside ear. No eye issues such as eye pain, vision issues or blurriness, tingling. He had an eye exam 2 weeks ago. No facial paralysis, tingling or numbness. He has been taking tylenol. No hx of shingles. No hx of vaccine for shingles. Chicken pox as a child. He sees GI for UC. On medication last few years. He last saw his GI last year and is overdue to see him this year. He did get his janssen vaccine 2 weeks ago  3/17.
Information has been received from a pharmacist refers to a female patient of unknown age. The pharmacist reproted that on an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number: K009770; expiry date: 09-OCT-2015) (0.65 ml, subcutaneous) which was improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
At first I just had a sore arm, but then the sore arm did not go away.  It got worse. The  injection site was still hurting, then my shoulder and upper arm to the point where I had a hard time  moving it.  I thought this  was just temporary so I had not gone to the doctor. I sent an email to their office about it and they replied that it would be just temporary .  I cannot lift thinks with my left arm without it hurting. It still is sore at the  injections site.  I have trouble reaching behind me or stretching up or back.   I keep thinking it is going to go away, but it  hasn't.
Back muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "Back muscle pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
One day, post vax, pt developed erythematous maculopapular rash that started on trunk and spread to extremities, sparing palms and soles. Did not seem to be pruritic. No other associated symptoms. Treated with Benadryl. Rash resolved within 4 days of onset.
2nd dose of Hep-A given on 10/4/00. Pt developed a fever to 38.7C (axillary) per dad on 10/6/00 and still febrile to 39.3C (axillary) per dad on 10/7/00 through 10/8/00. No other symptoms.
Redness, warmth, swelling at injection site.  Body aches, fatigue, chills, nausea
I had a huge red rash from the top of my thigh to my knee that was hot to the touch.
Patient complained of heart palpitations while waiting for 15 minutes. EMS was called and attended to patient at store.
With in a week of receiving the vaccine I begin feeling a tightness in my chess and could feel something wasn't right with my heart.  I was unable to find a heart monitor available in the local stores and ordered on online.  The device indicated that I was likely in Afib. I made an appointment with the clinic and they gave me an EKG to confirm that was the case
Generalized hives, tightness in throat.  No wheezing on auscultation.
patient received ActHIB. Which was incorrectly reconstituted with a Merck diluent; Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from Other health care professional.  This case is linked to cases 2019SA036959 and 2019SA036960, same reporter.  This case involves a 4 months old patient (gender unknown) who received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patients past medical history and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL).  On 04-Jan-2019, the patient received a 0.5ml dose of suspect HIB (PRP/T) VACCINE lot UI914AA, expiry date 28-Nov-2018 via unknown route in the left thigh.  It was an actual medication error due to wrong solution used in drug reconstitution.  It was reported that patient received ActHIB. Which was incorrectly reconstituted with a Merck diluent.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
Blood sugar numbers through the roof. After 48 hours, low 300s despite aggressive treatment.
A male patient came to doctor's office to receive TD and MENACTRA vaccinations for admission to college.  Patient was administered TD IM/left deltoid (lot TD-181) and before doctor administered MENACTRA vaccination, patient fainted.  Patient was fine moments later.
Pt says she experienced weakness, shakiness, nausea, paleness and cold sweats. The symptoms started the morning after and lasted one day. She said she also felt shoulder soreness. This is her second dose in the series and she recalls now that she felt this way after the first dose as well. She did not indicate any prior adverse reaction to a vaccine when she filled out the consent form for the second dose.
tested positive after vaccination; tested positive after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Follow-up attempts are completed. No further information is expected.
Patient hope a Covid shot wasn't given by mistake with no AE; Initial information received on 03-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.   This case involves patient of unknown demographic for whom it was reported "hope a covid shot (COVID-19 VACCINE) wasn't given by mistake" while receiving INFLUENZA VACCINE (Wrong product administered).  It was unknown if the patient had any medical history, concomitant disease, or risk factor.  The patient medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to wrong product administered [Latency: on the same day].    There were no lab data/results available  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   There will be no information available on the batch number for this case.
Pt given MENINGOCOCCAL vaccine in right deltoid on Thursday 4/15/10 at 4 PM.  On Friday 4/16 in PM - noticed upper arm, red, swollen & hot.  Seen in clinic noon on Sat. 4/17.  Given cold compress, told to repeat & take TYLENOL if needed.
This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of rash pruritic (1st dose received in June 2018, refer case US2018214095). In September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced itchy rash. The patient was treated with hydrocortisone. On an unknown date, the outcome of the itchy rash was not recovered/not resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were reported as follows: The patient experienced an itchy rash after SHINGRIX. The 2nd dose of SHINGRIX was given at the end of September 2018 and the rash again began about a week later but was on the right arm and spread to the legs.  During the daytime, the rash was tolerable but it worsens after showering in the evening.   Hydrocortisone cream was being used with success but symptoms have not fully abated.   The reporter consented to follow up. The member of public adverse event collected by Medical Affairs Contact Center (MACC).
Stuffed nose, scratchy throat, pressure in head and sinus area.  Burning swollen mouth and nose.  Teeth feel gritty.
I suffer from mild tinnitus and high frequency hearing loss. Approximately 45 hours after receiving injection, my tinnitus and hearing loss in my left ear became significantly worse. I would say 20-40% worse.
Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 25-SEP-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by healthcare providers for herpes zoster. The pt claimed damages as a result of injury to themselves and economic losses. The outcome of shingles was unknown and the causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was considered related.
This is a spontaneous report from a physician through a Pfizer sales representative. A patient of unspecified age, gender and ethnicity received on unknown date PREVNAR 13 at single via an unspecified route of administration. Relevant medical history and concomitant medications were not reported. The patient experienced acute cellulitis and redness. It was red from elbow to shoulder for 10 days and doctor treated the patient with antibiotics. The outcome of the events was reported as unknown.
Pain, swelling, hard traveling towards elbow, under arm and inside armpit with body shakes, fever, whole body pain.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions /allergies and concomitant medication were not provided. On 24-MAY-2016, the patient was inadvertently vaccinated with and expired dose of PNEUMOVAX 23, expiration date reported as 05-MAY-2016 (strength, dose, route of administration and lot # were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
The next day 2/13 I started to have aches and pain over my body with every single joint as if I had arthritis and got a fever up to 102.0. I also got chills cold sweats. Felt ill for about 4 days and was not able to go back to work until 2/16. Menstrual cycle also became irregular.
Rehab admit date: 07/16/21 HX: dementia, urinary incontinence, pacemaker, and hypothyroidism. 09/26/2021 COVID-19 positive; patient passed away at facility 10/08/2021.