chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching; she has raised bumps on her skin and she peels the tops off; did not feel right; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 intramuscular, administered in Arm Right on 08Mar2021 10:15 (Batch/Lot Number: EN6204) as dose 1, single (age at vaccination 72-year-old) for covid-19 immunisation. Medical history included Known allergy: Penicillin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced did not feel right on 09Mar2021 and itching on 10Mar2021 while she has raised bumps on her skin and she peels the tops off on 10Mar2021. She had the Pfizer covid vaccine first dose on 08Mar2021. On 09Mar2021, she didn't feel right, and didn't feel sick, clarifies she did not feel good. She was not upset about it. On Wednesday and Thursday she started itching, she wanted to take finger nails and dig in her skin. On Friday she went to drug store and got Benadryl. She took two Benadryl on Friday, 2 on Saturday, and 2 on Sunday. She was thinking if the Benadryl was not doing anything, she does not know if she should be taking it since it makes her a little fuzzy. She was asking if there is anything she can do to help it. She tried Benadryl and nothing was working. She was scared since she was scheduled for second dose on 07Apr2021. She did not want to experience this with the second dose. She puts her glasses on. She cannot say she feels great, she does not feel sick, she just didn't feel right and it was just one day that the feeling lasted. Itching has worsened and since she has dug at her skin, she has raised bumps on her skin and she peels the tops off. It is worsened. She kept thinking it was going to better. She knows she was allergic to penicillin and she told the nurse that was administering the vaccine and was told it was not an issue. Therapeutic measures were taken as a result of events. The outcome for feeling abnormal was recovered on 10Mar2021 while rest was not recovered.   Product Complaint was added for Benadryl.   No follow-up attempts are possible. No further information is expected.
Patient received SHINGRIX vaccine on 12/07/18 and developed fever on 12/08 at 2 am which patient describes as being profound and highest temp noted was 101 degrees. Patient stated she had violent vomiting and was nauseous. No swelling of arm but tender to touch. Patient also developed red spots on face. Patient was advised by MD to report adverse effect.
p/vax pt fed & then found unresponsive; asystolic on arrival to hosp; unable to resuscitate; all sutures split in cranium
Vaccine given to a 16 year old age; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old age) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04IB2IA and 04IB2IA) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old age). On 19-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old age) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-288020 (Patient Link).
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient got really cold and passed out in chair. Immunizers laid her down on the ground. Patient told paramedics that this is a hereditary issue and that this happens every time she gets a vaccine/blood work done . She came back around immediately after passing out. Ambulance service was refused but mother drove her to hospital just in case.
First dose 56 days ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 56 days ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 56 days ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 56 days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided by the reporter No treatment information reported by the reporter
Hives all over the body Yellowish Discoloration under the eyes and Bridge of the nose. Cough
pt recv vax 10DEC96 & 10DEC96 pt exp swelling & redness in the area of the deltoid muscle @ inj site;
Right side of face tingly and numb around mouth and eye. General numbness in right arm and in fingers.
Some anxiety; Little dehydrated; a little nausea; Chills; Headache; Body pain; This spontaneous case was reported by a patient and describes the occurrence of ANXIETY (Some anxiety), DEHYDRATION (Little dehydrated), NAUSEA (a little nausea), CHILLS (Chills) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Motor vehicle accident. Concurrent medical conditions included Allergy and Pain. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ANXIETY (Some anxiety), DEHYDRATION (Little dehydrated), NAUSEA (a little nausea), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body pain). On 21-Mar-2021, CHILLS (Chills) outcome was unknown. At the time of the report, ANXIETY (Some anxiety), DEHYDRATION (Little dehydrated), NAUSEA (a little nausea), HEADACHE (Headache) and MYALGIA (Body pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient asked whether the vaccine exacerbated the pain she already experiences. No treatment information was reported
Reported that he began to feel dizzy after injection. Was taken to urgent care clinic for monitoring at 1100. Was noted to be hypertensive. Was given 0.1mg Clonidine PO at 1205. Was discharged with safe blood pressure at 1345
ITCHING INSIDE CHEST; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: fibromyalgia, and concussion, and other pre-existing medical conditions included: The patient had autoimmune issue and genetic issues, lump into fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported (dose number in series: 1), administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced itching inside chest (dose number in series: 1). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itching inside chest was not reported. This report was non-serious. This case, involving the same patient is linked to 20211203557.
had gotten GBS; This is a spontaneous report from a contactable consumer. This female consumer reported similar events for five patients. This is 2nd of five reports. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had gotten GBS (guillain-barre syndrome) on an unspecified date with outcome of unknown.  In reporter city of 30,000 people, 4 people have gotten GBS. One person was still in a wheelchair.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019264899 Same reporter/products/events, different patients
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 (Lot number: FL3198) at the age of 46 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "she does not have a thyroid" (unspecified if ongoing); "needed glasses" (unspecified if ongoing), notes: she needed glasses prior to getting the vaccines; "seasonal allergies", start date: 2012 (unspecified if ongoing), notes: She just takes medication for seasonal allergies. This began about 10 years ago; "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 2017 (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Lot EN6208, expiration is unknown. Injected in left arm), administration date: 12Mar2021, when the patient was 45 years old, for Covid-19 immunisation; Bnt162b2 (Dose 2, Lot EW0151, expiration unknown, injected in left arm), administration date: 09Apr2021, when the patient was 45 years old, for Covid-19 immunisation. The following information was reported: HYPOAESTHESIA (non-serious) with onset 04Jan2022, outcome "not recovered", described as "Caller reports experiencing numbness at the injection site that spread upwards to her- neck and side of her face". Relevant laboratory tests and procedures are available in the appropriate section. Follow-up attempts are completed. No further information is expected.
Mother wrote on the form that his birthdate, the same as her sister and therefore making them twins.  Before vaccinating, the vaccinating pharmacist double-checked with the mother about his birthday and then wrote down "DOB verified by mother."  It was not until later when trying to update his information into Immunization Registry System did we find that his birthdate was different, making him 4.  The mother misinformed us in order to get her son a pediatric Pfizer dose before it was approved for his age group.
heart pulse was racing; dizzy; This is a spontaneous report from a contactable consumer (patient herself). A 66-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6203, expiry date: unknown) via unspecified route of administration, in left arm on 26Feb2021 14:30 (age at vaccination: 66-years) as dose 1, single for Covid- 19 immunisation. Facility type vaccine was public health clinic/veterans administration facility. Patient was not pregnant at the time of vaccination. Patient was not diagnosed with covid prior to vaccination. She was not tested for covid since vaccination. Patients medical history included asthma, thyroid and known allergies of citrus and mold from an unspecified date and unknown if ongoing. Concomitant medication included flu vaccine as single dose on 10Feb2021 (in 4 weeks of covid vaccine), for unspecified indication. On 26Feb2021 2:30PM, immediately after receiving the Covid 19 vaccine, her heart pulse was racing, and she started to feel dizzy. The patient underwent lab test for heart rate on 26Feb2021, with results as racing. No treatment was given as a result of the adverse events. The outcome of event was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Case number PHEH2016US008637, is an initial spontaneous report received from a nurse on 05 Apr 2016. This report refers to a 17 years old male patient. Past medical history and concomitant medications were not reported. This patient under the age of 18 was vaccinated with FLUCELVAX (batch number: 174087A) intramuscularly on 15 Oct 2015 instead of FLUARIX (batch number: 9JX2N, expiry date: 16 Jun 2016). No adverse event was reported following this maladministration. Follow up report from nurse received on 22 Jun 2016: Suspect drug FLUARIX and its details (dose and route) updated event coding as (wrong vaccine administered) from inappropriate age at vaccine administration.
Red, 16x14in area at site of injection, fever to touch of area, swollen (Tdap).
Patient stated he had not received the Covid vaccine before. Patient was given first dose of Pfizer vaccine on 06/24/2021. In Right deltoid at 1:15pm. When documenting the vaccination, CAIRS information was populated that the patient had received the J&J vaccine in march.
Patient developed mild redness and itchiness at site of injection w/in 1 hour of getting dose. When seen patient was scratching area of injection site on left upper arm. I went over VIS and explained redness and itching are common side effects and usually last 1 to 2 days. I told her not to scratch, but she kept clawing injection site. Next morning seen by MD and developed swollen arm and bacterial infection inclusion "cellulitis" and given AUGMENTIN.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 38-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, Covid-19 from 30Sep2023 to 04Oct2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300322298 same patient, different drugs and events;
Woke up with at 3:30am with extremely sore throat, swollen uvula, could not swallow, multiple scattered petechiae on soft and hard palate. Afraid of angioedema or delayed acute anaphylaxis. Paramedics called. Treated at Facility with IV dexamethasone,  diphenhydramine, Pepcid. Swelling resolved in 2 hours. Petechiae still present.
Developed severe pain at site of injection (left shoulder). Several days after, seen at Urgent care 12/31/16, (x-ray), primary doctor 1/13/17 and Orthopedic doc 1/13/17. Prescribed pain killers, anti inflammatories and Physical Therapy (5 weeks). Pain is still severe and limiting.
Fever, aches, fatigue for approx 30 hrs.-treated with sleep, fluid, and ibuprofen. Fever was low grade 99.5-100 degrees. This child has rarely had fevers. He's usually <98.6 degrees. I'm fairly confident he had a mild reaction to the vaccination.
The patient stated approximately 1-2 hours after getting the influenza vaccine at our office 10/20/08  8:45 a.m.  Soon after, he began to get hives in the bend of the right arm at the site of a venipuncture he had received earlier that morning. Then his groin, and thigh areas started whelping up with hives and itching along with his hands becoming red and swollen. He was still unable to wear his rings on either hand. No respiratory problems reported. He was seen 10/21/08 in our office for appointment regarding the above symptoms. Patient was given an injection of Kenalog 40mg/ml 1ml IM in his L Dorsogluteal area.  The patient tolerated this well. Patient also given prescription for Atarax 25mg 1 po tid prn itching.
day of vax, discomfort @inj site,pt didn't want to walk on it;day p/vax firmness & erythema @ site;2d p/vax area of whiteness around site,surrounded by erythema;able to run/jump;no fever;sl tender to palpation;erythema;scaling 3 weeks later
Swelling at the injection site along with pain. Site is warm to the touch. No fever ~ temp is 97.5. Side effect was noticeable roughly 8 hours after injection.
Pt had flu shot at 1435, Hx: asthma, came to nurses room in ER c/o chest tightness, urticaria, itching gave epinephrine 0.3 ml SQ (L) arm 1636.
w/in 24 hrs of vax pt exp redness, warm to touch, tenderness & swelling @ inject site; office visit following day; react 4cm in diameter w/2cm cental area of bright redness-afebrile; dx cellulitis-rx'd w/Augmentin x 5 days;
Febrile seizure for 10 seconds required mouth-to-mouth resuscitation.  Seen in ED and discharged home.
Patient became lightheaded and remained in chair for 20-30 minutes.  She requested water.  She kept her head lowered to help with lightheadedness.  She reported itching especially on her head.  We gave 50 mg PO Benadryl and symptoms improved in 30-40 min. Her husband took her home.  We made a follow up call to patient early afternoon next day and she said she was fine.
Patient complained of severe Headache, nausea, vomiting, feeling "foggy". Came into doctor office for eval.
tendonitis (severe pain in the opposite arm of the injection); A spontaneous report was received from consumer, concerning herself, 56 year old female patient who received Moderna's COVID-19 vaccine and experienced tendonitis.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On 11-Feb-2021, prior to the onset of the event, the patient received the first of their first planned doses of mRNA-1273 (lot number 007M20A) in the left arm for prophylaxis of COVID-19 infection.  On12Feb2021, the patient experienced severe pain in the opposite arm of the vaccination, went to the hospital, and and was diagnosed with tendonitis.  The patient was treated with Tylenol.  Action taken with the mRNA-1273 was not reported.  The outcome of the event, tendonitis, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
39 Y/O MALE C/O SWELLING AND ITCHING TO HIS RIGHT ARM AFTER 4TH ANTHRAX VACCINE ADMINISTERED 3 DAYS AGO.
This spontaneous report as received from a 36 years old female patient refers to herself. The patient was vaccinated SC, with 3 doses of GARDASIL (lot number not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The patient stated that her mother who was nurse gave her the second dose 3 months after the first dose, and the third dose 2 months after the second doses. She had no side effects. It was unknown if the patient had sought medical attention. Additional information is not expected.
Currently taking Macrobid for a UTI; This case was reported by a consumer and described the occurrence of urinary tract infection in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced urinary tract infection. The patient was treated with macrobid (nos) (Macrobid). On an unknown date, the outcome of the urinary tract infection was not recovered/not resolved.   It was unknown if the reporter considered the urinary tract infection to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient was currently taking Macrobid for a urinary tract infection. The patient's last dose of Macrobid was 2nd April 2020. The patient second Shingrix vaccine was due by April 24th to be in the 6 months second dose guidelines. The drug information  received from the pharmacy on the Macrobid said do not have any immunizations/vaccinations while using the medication. The reporter wanted to know when is it safe to take the Shingrix vaccine. Also, what was the last date the patient could receive the second dose of Shingrix and not risk the effectiveness of the vaccine.
Sore arm: began 2 hours post vaccination and completely went away 48 hours post vaccine  Chills: began 12 hours post vaccination, lasted 15-20 minutes, relieved with warm heating blanket  Fatigue: general fatigue and sluggish feeling 24 hours post vaccine, resolved 48 hours post vaccine
Starting on 06/11/2022, I developed a head cold (some congestion and runny nose) and a cough due to the drainage, and a sore throat. I was on vacation when I contracted COVID. We returned on 06/12/2022 and I tested positive on 06/13/2022. My wife and I contacted our Dr. that day and she ordered Paxlovid. I started that on Tuesday Morning and started feeling a little better that afternoon. No fever. As of today, I am feeling almost back to normal, just had a runny nose when I woke up but nothing now. As of today I am on day 3 of the Paxlovid Treatment.
Patient presented to clinic to receive Pfizer booster dose of COVID vaccine. Vaccine order has been placed per standing order. Consent form signed, COVID vaccine card, EUA Fact Sheet, and V-Safe information given. Patient tolerated procedure well.  After receiving vaccine, patient was instructed to wait 15 minutes minutes in waiting room and report to the front desk with any symptoms and/or questions.  Patient advised they may leave if no symptoms occur and have no further questions after recommended wait time.    I followed appropriate precautions, and wore proper PPE during this patient encounter.    Received verbal attestation from patient that she received Pfizer but after injection administration, upon trying to reconcile the health maintenance, nurse sees that patient has documentation of Moderna as first two doses, not Pfizer. Immediately returned to patient and verified which COVID vaccine she previously received. She states that she is 95% sure it was Pfizer but she does not have her card with her today.    After some more thought, she realizes that she thinks she mixed up her husband and her cards and she truly did receive Moderna. Patient apologizes for the mix up and understands that her verbal attestation was incorrect. Incident report filled out and supervisors contacted for help with documentation.
angioedema, diarrhea, lt eye swollen, redness, swelling around inject site; Susphrin, DPH, Epi approx 2 days;