chrisvoncsefalvay/vaers-outcomes huggingface dataset:
myocarditis; nervous; experienced numbness in their shoulder, neck and jaw; This is a spontaneous report from a contactable consumer (Patient's wife) reporting for her husband. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 26May2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced myocarditis (medically significant), nervous, experienced numbness in their shoulder, neck and jaw on an unknown date in 2021. Caller stated that she and her husband got their first dose in 26May2021. Both of them are kind of nervous and has experienced numbness in their shoulder, neck and jaw. It took 5 hours to go away. Her husband had developed a heart issue. They were told by their Doctor that it was not normal and it advised not to take the vaccine yet. It has been 99 days since they got their first dose. Caller stated that she lost two friends from COVID and her husband has myocarditis which he didn't have before getting the vaccine. Caller stated that she was just afraid to get the second shot with all of this misinformation circulating out there. The outcome for all events was unknown.   Information on Lot/Batch number has been requested.
This spontaneous report was received from a Certified Medical Assistant (CMS) referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 28-AUG-2018, the patient was inadvertently vaccinated with an expired dose of M-M-R II lot # M034857 expired on 27-JUL-2018, for prophylaxis (dose, frequency and route of administration were not reported). Concomitant therapies included sterile diluent. No adverse effects were reported.
pt recv vax 17DEC96 & that same day pt c/o of a lump on lt upper arm w/redness;no itching & soreness;pt was seen by a NP & tx w/ATB
All 4 doses were administered to both of them, and got covid after that; All 4 doses were administered to both of them, and got covid after that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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 "All 4 doses were administered to both of them, and got covid after that". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: got covid after that. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- answered by consumers husband who said that he was not able to swallow the pill as it was too big, he did not chew it, his wife was taking the medication (PAXLOVID), she did not experienced any symptoms. All 4 doses were administered to both of them, and got covid after that.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200075122 same reporter/drug/event, different patient;
Chills in the morning, worse right after taking a bath. Feeling extremely tired with headache all day.
Mild Vaginal cramping with significant spotting. Period is not due to start for 2 weeks and there is no chance of pregnancy. Symptoms started at 05:07. It is now 07:47 and I am still spotting.
Wheezing Fever Headache  Chills Nausea Vomiting  Burning in throat  Im urgent care- Albuterol and ipatropium bromide - Breathing treatment  Dexamethasone  shot  Prescribe for home- Albuterol Prednisone  Iprat-albut
Pt recvd vax on 17AUG92 & 18AUG92 pt awoke w/joint pain, h/a, nausea, fatigue also warm to touch;
vasovagal symptoms -- lightheaded, cold sweats, nausea, diarrhea, extremely low blood pressure and heart rate for ~30 minutes
Light menstrual-like bleeding starting the day after the second dose, out of synch with regular menstruation schedule, and persisting constantly for several months.
pt recv vax 18ARP96 & 28MAY96 & pt failed to seroconvert;
Rash and redness on the arm and it was tender to the touch; Rash and redness on the arm and it was tender to the touch; Rash and redness on the arm and it was tender to the touch; Golf ball size swelling at the injection site; This spontaneous case was received on 21-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04047) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in Oct-2020, reported as within the last week from initial reporting, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: arm and route of administration: not reported) for prevention of seasonal influenza. The batch number reported was 283852 and expiration date 30-Jun-2021.  On an unspecified date in Oct-2020, an unknown amount of time after receiving Flucelvax QIV, the patient developed a golf ball size swelling at the injection site on arm. The patient also developed a rash and redness on the arm, and it was tender to the touch. The reporter stated it was not life threatening.  The outcome of the events was unknown.  The reporter assessed the events to be related to Flucelvax QIV. Pharmacist reported 4 patients who had an adverse event to Flucelvax Quad MDV.  This case is linked with cases 202005388, 202005389 and 202005390 (due to same reporter).  Additional information received on 05-Nov-2020 from pharmacist via Med Communications (SEQW20-04786): Reported provided causality. Causality changed from not reported to related. New reference number added. New reporter added. Narrative amended.  Company comment: A patient of an unreported age was administered Flucelvax QIV vaccine. The patient developed tenderness, erythema, rash and vaccination site swelling. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related for all events.; Reporter's Comments: Pharmacist reported 4 patients who had an adverse event to Flucelvax Quad MDV.; Sender's Comments: A patient of an unreported age was administered Flucelvax QIV vaccine. The patient developed tenderness, erythema, rash and vaccination site swelling. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related for all events.
doctor inadvertently ordered the patient to receive a dose of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA765A, expiry date 31-DEC-2023) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   On 09-APR-2023, the patient received Menveo. On 12-JUL-2022, the patient received MENACTRA. On 09-APR-2023, an unknown time after receiving Menveo, the patient experienced interchange of vaccine products (Verbatim: doctor inadvertently ordered the patient to receive a dose of Menveo). The outcome of the interchange of vaccine products was unknown.   Additional Information: GSK Receipt Date: 10-APR-2023 The nurse reported that the 11 years old patient received a dose of Menactra on 12th July 2022.   The patient went for a check-up and the doctor inadvertently ordered the patient to receive a dose of Menveo which was administered 9th April 2023. The Menveo dose was administered from lot number AMVA765A and expiration date 31Dec2023. The reporter consented to follow up. The patient received a dose of Menactra and Menveo, which led to interchange of vaccine products.
pt recvd vax 15FEB94 & devel general discomfort, chest tightness & extreme viral sx w/fever & chills; pt presented to MD; 01MAR94 sx had completely resolved; No further details were provided;
Moderna COVID-19 Vaccine EUA Patient hospitalized for Moderna vaccine induced thrombocytopenic purpura for which she received prednisone and IVIG. Patient discharged and presented again with recurrent thrombocytopenia and received rituximab.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2016, the patients were vaccinated with ZOSTAVAX (dose and route of administration were not provided, lot # M028798 with expiration date 18-AUG-2017), which were improperly stored (temperature excursion 6.8 F for 6 hours on 28-OCT-2016 and 6.44F for 4 hours and 30 minutes on unspecified date). No adverse experiences were reported. Data logger was involved. This is one of several reports received. Additional information has been requested. Sender's Comments: US-009507513-1612USA006421.
Pt to ED 2/17 c/o cough, chest congestion, chest tightness for the past 2 days. COVID positive upon admission, rx remdesivir for 3 d only on 2/17, not on oxygen. 2/18 reported no acute issues overnight. CXR showed COPD, right basilar scarring. Denied chest pain, c/o shortness of breath, no abd pain, no fever or chills. 2/19 pt has aches and pain, but not on O2, and tolerating activy. Pt is A&Ox4, cooperative and pleasant. Pt discharged 2/21.
8"x6" swelling of lt deltoid area;red, warm to touch;recv vax on 14OCT97;tx ceftin x 5 days to prevent;cellulitis;DPH;swelling had dec less warm to touch;
Patient developed multiple firm cutaneous nodules surrounded by erythema on the neck b/l as well as on the forarms.  First lesion noted on day 9.
Pt experianced discomfort at inject site & fibrotic encapsulitis * pain in the left shoulder /p Cholera vaccine. A seventy % loss of mobility of the arm observed
Patient had redness, swelling to site after 1 week of administration date.  Mom states patient had a red ring.
Constant cough; This is a spontaneous report from a contactable consumer. This contactable 15-years-old male consumer (patient) reported himself that he received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was mentioned that the patient was not diagnosed with covid-19 prior to vaccination and did not get tested for covid-19 since vaccination. The device date was 05Jun2021. On an unknown date patient reported that he had constant cough. The outcome of event was unknown.  Information about lot number/batch number could be requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in an elderly female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient has had flu vaccines often in her life and they hurt at injection site. The reporter did not consent to follow up and the patient did not want to provide any details. For tolerance of SHINGRIX refer case US2019004829.
60 yo patient with PMH significant for T2DM, HTN, HLD, neuropathy in hands and feet called in to this institution on 5/3 to request a COVID-19 test. Patient received her Pfizer COVID-19 vaccination: first dose on 3/12 and second dose on 4/2. Only new symptoms reported include congestion/runny nose. COVID-19 test resulted back positive on 5/3.
An 11 year old patient was vaccinated. Patient presented to a vaccination clinic at a high school with her father. Procedures for the vaccination clinic required the parent or legal guardian to complete a prevaccination checklist. This checklist required the date of birth of the patient to be written and the parent/legal guardian signed a statement that certified that the individual receiving a vaccine was "at least 12 years old on this day" and that they offer their consent for the patient to be vaccinated. The father wrote the patient's date of birth as 2008 and the patient was vaccinated. The last step in the vaccination clinic involved entering the vaccination into the state immunization registry. Upon looking up the patient it was discovered that the patient's date of birth was 2009 not 2008. At this time the individual working on the registry notified the pharmacist. The pharmacist then retrieved the signed prevaccination checklist and questioned the parent about the responses. The parent admitted to falsifying the patient's date of birth so she could be vaccinated. The pharmacist informed the patient and her father that she would not be able to receive the 2nd dose until she turns 12 in November (or the eligibility is expanded further).
About 5 to 10 minutes after receiving his vaccine, the patient's eyes were excessively teary. He waited around for 45 minutes and they were still more watery than usual, but there were no other signs of allergic reaction. The patient said that it wasn't watery to the point of blurry vision and went home.
Swelling in ankles, rash all over body, blisters on lips.  Swelling in joints in hands, sore joints, swollen glands in throat.
LOCALIZED RXN TO MMR/PREVNAR--- > LEFT THIGH  TYLENOL / WARM COMPRESSES
Tested NAAT positive for COVID 8/7/21. Symptom onset 8/5/21.
Pts mom c/o red rash dn pts face and back onset 2 days ago, vaccine given 11.30.09
Lasting several days:  Distended abdomen; slowed or improper motility in intestines; tenderness below sternum; very loud stomach gurgles  Lasting about 3 months: Loose stools, loud stomach gurgles, occasional tenderness on surface of abdomen, burping
Fever; Swollen lymph node; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 26Mar2021 at 15:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as oodles of them (unspecified). The patient had unspecified known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 05Mar2021 at 15:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 27Mar2021 at 09:00, the patient had normal immune system responses that lasted 12 days after the second shot including fever, swollen lymph node, diarrhea and others. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, swollen lymph node and diarrhea was resolved on 08Apr2021.   No follow-up attempts are needed. No further information is expected.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: She said she had this with the past 3 Pfizer doses, was instructed previously to take Allegra, Benadryl and Pepcid before getting vaccine & patient said she did pre-medicate. Primary doctor is aware and authorized patient to take 4th booster
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown demographics. On an unknown dates (time frame: 21-DEC-2015 to 05-JAN-2016), the patients were vaccinated with improperly stored doses of GARDASIL lot # K011325, expiry: 08-APR-2017. No previous temperature excursion reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
On March 27,2007, patient woke up from his nap around 3 pm with a bulging fontanel. He was happy, alert, and not fussing in any way, nor had he been. His fontanel remained large for around 3 hours then started to go down. It has not happened since.
He got his vaccine, he had general soreness in the area and marked immobility of the shoulder itself.  He treated it with ice and anti-inflammatories and the soreness went away, and then he is left with a particular motion that he cannot make.  He has had that treated with steroids, physical therapy, MRI done through an orthopedist.  There were findings that appeared normal aging process for his frozen shoulder.  He is continuing to be treated for the limitation that he has.  He did not have this before the vaccine.    The Orthopedist said that the next thing would be surgery, and he does not want that.
acute onset of nerve III palsy; This is a spontaneous report received from a contactable consumer (patient). A 25-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration in the arm left on 09May2021 at 16:00 at age of 25-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Medical history was none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included estradiol (ESTROGEN, reported as low estrogen birth control prescribed for 8 yrs) which was received within 2 weeks of vaccination. Two weeks after vaccine on 24May2021 at 02:00 PM, patient had acute onset of nerve III palsy. CT and MRI was negative for aneurysm, tumor, multiple sclerosis (MS), etc. Event still has not resolved, working to neurologist. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. There was no treatment for the event. Event was reported as serious as disability. Outcome of the event was not recovered. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 on 24May2021 by Nasal Swab which was negative.  Information about batch/Lot number has been requested.
Flu like symptoms; Plaque psoriasis small breaks on outside of left thigh/psoriasis flare-up; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PSORIASIS (Plaque psoriasis small breaks on outside of left thigh/psoriasis flare-up) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PSORIASIS (Plaque psoriasis small breaks on outside of left thigh/psoriasis flare-up) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown and PSORIASIS (Plaque psoriasis small breaks on outside of left thigh/psoriasis flare-up) was resolving.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was provided. No treatment medication was provided.
Redness, welting, itching in a patch about 6"x3",  8 days after injection.  Tender.
This is a spontaneous report from a contactable pharmacist.  A 67-year-old female patient received PREVNAR 13 (lot M77339 Expiry Date Jul2017, NDC  00005197105) intramuscular at 0.5 ml, single on 02Aug2016 at 00:03 for immunization at Pharmacy. The patient medical history was not reported. Concomitant medications  included: amlodipine besilate (NORVASC) oral 5mg 1 po qd form 2013 and ongoing for HBP, atorvastatin calcium (LIPITOR) oral 40mg 1 po qhs form 2015 and ongoing for cholesterol, losartan potassium  (COZAAR) oral 50mg 1 po qd from 2013  and ongoing for HBP. No other vaccines were given on same date along with suspect vaccine. No other vaccinations were given within four weeks prior to date of vaccination The patient experienced tingling and burning sensation down to her fingers on 02Aug2016 with outcome not recovered. The AEs did not require an emergency room or physician visit. No specific tests and/or treatment were required. The Pharmacist stated that the patient did not provide to him/her information regarding the reported adverse events with the use of the suspect. The Pharmacist considered there was not a reasonable possibility that the event is related to suspect product.  The Pharmacist was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts are completed. No further information is expected. Follow-up (05Oct2016): New information reported from a contactable Pharmacist included:  Concomitant medications;  course of events; no lab tests; reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
During the 15 minute observation time post vaccine on January 25, 2021, my eye lids were itchy (this is a typical allergic reaction for me). Reaction reported to Nurse.  On Sunday, January 31, 2021, 4:00 pm, my face became red and blotchy, eyelids slightly inflamed. On Monday, February 1, 2021, 6:00 p.m., eyelids were swollen, area around the eyes were red, irritated and itchy. Hydroxyzine Pamoate 25 mg taken Monday evening would normally alleviate any signs of allergic reaction.  On Tuesday, February 2, 2021, upon waking and throughout the day the area around the eyes were red, irritated, itchy and  eyelids swollen with red blotchy skin on forehead and cheeks. Possible consumption of small amounts of soy lecithin (a known allergen) present in baked goods consumed on February 1 at 12:30 pm.  Normally, I do not have an allergic reaction to small amounts of soy.