chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Has multiple auto immune diseases; This is a spontaneous report from a Pfizer sponsored program. A non-contactable female consumer reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection; Lot number and expiration date were not reported) via an unspecified route of administration, on 24Mar2021 as single dose for COVID-19 immunization. The patient had multiple auto immune diseases. Patient was wondering if they had any data on people with having auto immune diseases and getting vaccine. Also is there any testing they should do to make sure vaccine worked, like IDG or IGM testing. HCP wasn't sure advised to call them. Relayed PMI number and transferred. They would fax into DSU not clarifying if had auto immune disease before or after covid vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
swollen lymph nodes in clavicle region; This spontaneous case was reported by a non-health professional and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes in clavicle region) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes in clavicle region). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes in clavicle region) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
pt recvd vax;pt became feverish & had some v;swelling from shoulder to elbow w/ redness, hot to touch;
Round, raised, puffy, red, itchy rash at injection site with fever and body aches and chills.
Pentacel liquid portion administered without lyophilized component with no reported adverse event; Initial information received on 21-Dec-2021 regarding an unsolicited valid non-serious case from a other health professional via Agency (Reference number- 00907136).  This case involves an unknown age female patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], (Product preparation issue).  The patient's past medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error case due to Product preparation issue (latency on same day).  It was reported Nurse practitioner reports patient was given Pentacel liquid portion without the lyophilized component.  At time of reporting, 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.
Approximately two months post 2nd vax received on 5/6/99, the pt experienced swollen hands, feet, and elbows, had discomfort and joint pain and had decreased hand strength and grip. The pt reported that she "was not able to use the small muscles in her hands." Rheumatologist performed "blood tests" which revealed rheumatoid arthritis and Sjogren's disease. According to the pt, her physicians believe the Lymerix triggered those events. She now takes Relafen and needs monthly monitoring for the ongoing events.
Started COVID-19 symptoms on 18Apr. Tested positive with rapid (18Apr) and PCR (19Apr) testing.; Started COVID-19 symptoms on 18Apr. Tested positive with rapid (18Apr) and PCR (19Apr) testing.; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3, (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Moderate asthma" (unspecified if ongoing); "latent TB (treated)" (unspecified if ongoing); "allergies" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE; SYMBICORT; FAMOTIDINE. Past drug history included: Codeine, reaction(s): "Drug allergy", notes: known allergies: codeine, ibuprofen, azithromycin; Ibuprofen, reaction(s): "Drug allergy", notes: known allergies: codeine, ibuprofen, azithromycin; Azithromycin, reaction(s): "Drug allergy", notes: known allergies: codeine, ibuprofen, azithromycin. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27Apr2022, 9 days after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant) with onset 27Apr2022, 9 days after the suspect product(s) administration, outcome "not recovered" and all described as "Started COVID-19 symptoms on 18Apr. Tested positive with rapid (18Apr) and PCR (19Apr) testing.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive; (18Apr2022) Positive. Therapeutic measures were not taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Patient received a flu vaccine (FLUZONE QUAD) on the left arm on 10/27/18. Patient came in to the pharmacy on 12/06/18 to let us know that she has experienced bruising (size of a nickel) and pain, resulting in the use of a MEDROL DOSEPAK and NORCO. Patient stated that she's on the 3rd day of the steroid and is feeling better.
"started to notice myself feeling itchy"; "I got home from work, changed out of my work clothes and noticed a rash in several locations on my body where I was itching"; normal sore arm at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Medical history included peanut allergy, allergy to nuts, allergy to grains (sesame seeds and corn) and mite allergy (dust mite allergy). The patient did not receive any other medications within two weeks of vaccination. The patient previously took amoxicillin and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 12:00, the following day after the second dose of vaccination, the patient started to notice himself feeling itchy. He did not think too much about it until he got home from work, changed out of his work clothes and noticed a rash in several locations on his body where he was itching. Other than that, just the normal sore arm at the injection site but that had gone away. He was not sure if he should take any antihistamines or something to reduce the itching and to see if it would go away on its own after a few days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the adverse events. The clinical outcome of the event "started to notice myself feeling itchy" and "I got home from work, changed out of my work clothes and noticed a rash in several locations on my body where I was itching" was unknown. The clinical outcome of the event normal sore arm at the injection site was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Day 1 of taking the vaccine, I had some slight itching  Day 2 of the vaccine- I had palpitation, weakness, diarrhea, trembling, headache, and slight tingling sensation to my tongue.
Tinniitus - Ringing in ears:  Annoyance level varies daily and hourly.  Maximum level in left ear 5 out of 10.  Maximum level in right ear 3 out of 10.
Patient reported numbness throughout her body shortly after receiving vaccine. No treatment was given. Patient refused further medical care.
My daughter received her 2nd inoculations of GARDASIL 9 and BEXSERO PFS and went to bed within 3 1/2 hrs of the vaccinations. She got up for school at 5:25 AM, precisely 12 hours after the inoculation. She felt nauseated and disoriented, turned to go back to bed and fainted. I heard something hit the floor and a minute later, heard noises. I listened for about 10 seconds to ascertain whether it was laughing or crying. It was 5:27 AM when I entered her room and found her on the floor. She had hit her head and elbow and had an extreme headache. She sustained a concussion, her third in 2 1/2 years. I sent her back to bed. Upon arising at 9 AM, she started seeing black and rushed to lie down. She felt nauseated, had a low-grade fever, headache, slight swelling and soreness at the site of the inoculations. We called the doctor. She advised rest, ADVIL and to watch the symptoms. My daughter's nausea subsided once she had eaten, but she's had headaches on and off ever since (most likely from the concussion). Three days later, she fell and bumped her chin on the floor hard enough to cause a bruise and hear her neck crack with the impact. Again, she had a severe headache, so we thought it best to visit the ER.
5-6cm reddened area noted on lt deltoid surrounded by large amt of edema; area warm to touch; c/o very tender painful to touch;
temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions,pertinent medical history and concomitant medications.  On 06-APR-2021 the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX)  and patient was asymptomatic (lot number T028303 and expiration date 20-AUG-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported  and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002751:
first night of shot(1-25-07) dereks throat started feeling irratated and he was sounding hoarse and was clearing his throught constantly,he started running a fever. second day a bad cough developed and continued to have fever, gave motrin for fever it worked untill dosage time ran out then fever would be back coughing increased and then wheezing,paleness and loss of appetite followed and had a noticeable loss of energy.
sick; pain; This case was reported by a consumer via (facebook) interactive digital media and described the occurrence of sickness in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced sickness and pain. On an unknown date, the outcome of the sickness and pain were recovered/resolved.   It was unknown if the reporter considered the sickness and pain to be related to Influenza vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Flu shot and got a little sick and pain for about 2 days. The follow-up would not possible as no contact details were available. The case had been linked with US2021AMR171208 reported by the same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR171208:same reporter
I had epileptic seizures 6 days later and they haven't stopped. Never had seizures in my life
Employee stated that 2 days after the injection she noticed some redness, itching, and small raised area around the injection site. On day 3 she reported to medical informing them of a possible reaction. The area is warm and light red in color approximately 1.5 inches in diameter. Employee has had no treatment measures at this time instructed to take a benadryl and apply some hydrocortisone to site.
vaccine into the posterior side of her left arm, in the fatty tissue in error. It was SC and not IM.; vaccine into the posterior side of her left arm, in the fatty tissue in error. It was SC and not IM.; Initial information received on 14-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 31 years old female patient who received 0.5 ml vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6273AA (Expiry date 24-Apr-2021) via subcutaneous route into the posterior side of her left arm, in the fatty tissue in error, on 09-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate route of vaccination and vaccine administered at inappropriate site.  It was reported that vaccine into the posterior side of her left arm, in the fatty tissue in error. It was SC and not IM.  At a time of reporting no adverse effect 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 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.
Was given wrong dose of Covid vaccine. 3 other siblings in room and this child was given higher dose vaccine. No adverse reaction. Follow up call to mom with phone interpreter, no answer and voice mail asking mom to return call next business day, to schedule appointment. Call to mom with use of interpreter, on Monday, Mom states child is ok and not able to come to appointment today. Appointment scheduled, next day, Tuesday. Error was immediately reported to clinic manager.
Pt recvd vax on 28AUG92 & on 11SEp92 exp pain & swelling of joints & 2 fingers, as well as elbow & arm that recvd inject in; dx arthritis;
On 12/4/13 child vomited 3x, had lg bout of diarrhea. Followed by 4 more bouts of unusually colored diarrhea.
Myalgia, Fever,  H/A, body aches, fever 101  Narrative:
93kg 63 yo M was given varicella zoster vaccine 0.65ml SC in right deltoid on 6/20 @ 1025.  Within 5 minutes before leaving clinic, pt complained of itching and buring at injection site.  Onset of symptoms within 5 minutes of injection.  Redness and hives noted to injection site.  No other symptoms.  BP WNL.  MD notified.  MD provided prescription for 25mg diphenhydramine PO q6hprn itching.
After shot #1, my period cramps caused meto nearly pass out from the severity of the pain; After shot #1, my period cramps caused meto nearly pass out from the severity of the pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jun2021 as dose 1, single (Lot number: EW0196) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known Allergy: gluten" (unspecified if ongoing), notes: Known Allergy: gluten; "Known Allergy: sulfa-based antibiotics" (unspecified if ongoing), notes: Known Allergy: sulfa-based antibiotics. The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Known Allergy: Ibuprofen". The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), DYSMENORRHOEA (non-serious) all with onset 25Jun2021 at 11:00, outcome "recovered" and all described as "After shot #1, my period cramps caused meto nearly pass out from the severity of the pain". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2021) Negative, notes: Nasal Swab; (23Jun2022) Negative, notes: Nasal Swab; (05Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of loss of consciousness, dysmenorrhoea.  Clinical course: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of other medications the patient received within 2 weeks of vaccination were Muro 128, elderberry, magnesium, vitamin d, Tylenol. Patient got the COVID vaccine shot #1 and shot #2 right before her period. Her cramps were so much more horrible than normal. After shot #1, her period cramps caused her to nearly pass out from the severity of the pain. After shot #2, her period cramps caused her to vomit from the severity of the pain. There were no other obvious changes in her medications, work, sicknesses, diet, exercise, stress, etc. that could have affected her cycle. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. At dose 3 with suspect vaccine Pfizer Bio N tech, lot# FJ5683 and expiration date 03Mar2022 in right arm, having active substance COVID-19 , no relevant medical history and concurrent conditions noted. At dose 2 with suspect vaccine Pfizer Bio N tech, lot# EW0198 and expiration date 15Jul2021 in right arm, having active substance COVID-19 , no relevant medical history and concurrent conditions noted.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200932052 same patient, same drug, different dose/event;
fever post vax blood & spinal fluid cultures grew Neisseria Menigitidis w/in 24-48 rhs post DTP;
COVID-19; drug ineffective; Tired; lips and tongue were numb; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4272790-00.  A 47 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 17Apr2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 2018 (ongoing) (Lot number: 1153257). The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: SUSPECTED COVID-19 (medically significant) with onset Dec2021, outcome "unknown", described as "COVID-19"; DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", described as "drug ineffective"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "Tired"; HYPOAESTHESIA ORAL (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "lips and tongue were numb". The action taken for adalimumab was dosage not changed.  Additional information: Solicited report  by a consumer of a 47-year-old female with events of non-serious tired after getting off working the night shift, lips and tongue were numb and Covid-19 with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced tired after getting off of working the night shift. On an unknown date, lips and tongue were numb resolved. Pfizer Biontech Covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Causality for Humira (Adalimumab) the reporter's causality for the events of tired getting off of working the night shift, lips and tongue were numb and Covid-19 was not provided, and Action taken with drug for all events dose not changed.  The reporter's assessment of the causal relationship of the event with the suspect product Pfizer Biontech Covid-19 Vaccine (Tozinameran) BNT162B2 was probable at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events fatigue, hypoaesthesia oral, drug ineffective and suspected COVID-19 cannot be totally excluded.
arm redness and swelling initially on day 2 that resolved by day 4 and presented again on day 7 with worsening now on day 8.  The redness and swelling on days 7 and 8 is accompanied by warmth as well