chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen arm; underarm/lymph nodes; dose number=3; dose number=3; This is a spontaneous report from a non-contactable other hcp (patient). A 36-years-old non-pregnant female patient received third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ew0191) via an unspecified route of administration on an unspecified date (age at vaccination 36-years-old) as dose 3 (booster), single for COVID-19 immunization. The patient's medical history was not reported. The patient concomitant medication included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date as dose 1, single; and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 12Jan2021 (age at vaccination 35-years-old) as dose 2, single for COVID-19 immunization. No COVID prior vaccination. No COVID tested post vaccination. Patient had no known allergies. On an unspecified date, the patient experienced Swollen arm, underarm/lymph nodes, and dose number=3. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Passed away from a heart attack after receiving the COVID 19 JOHNSON AND JOHNSON vaccination.
ADMINISTRATION ERROR : Pt. states that he had received the Phizer 1st dose 07/23/2021 and then for his 2nd dose received the Moderna 08/13/2021. Administrator by employee. Communations with Health Dept. Supervisor. Pt. states symptoms of a "splitting headache" continuing.
The day after receiving flu vax, pt felt weak and had muscle aches. On 11/6/01, pt fainted and "lost control of limbs" (arms and legs paralyzed). She was admitted to ICU. She remains in ICU at time of report. Ataxia, Dysarthria. The discharge summary states ataxia, dysarthria, paraparesis, and conversion disorder. The discharge summary states seizure disorder.
Severe fever, chilling, sore throat and severe fatigue starting 6/3. Sunday 6/4 severe pain in neck where unable to move neck side to side. starting on one side then progressing to both sides. Also knee joint pain. Redness over lateral anterior elbows and knees. Warm to touch with slight swelling. Lasting 2 days. Amoxicillian treatment started and feeling better.
Pneumonia; Pneumonia; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age (73 unknown unit) received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration in Oct2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient indicated that she did not engage a doctor, health care professional or pharmacist to get vaccinated in the past 3 months, since she was vaccinated while hospitalized in Oct2019 for 2 types of pneumonia. Although she suffered pneumonia despite being vaccinated, vaccines were not 100% effective, and there were still other 'bugs' out there, and harassment from people that she's stupid to keep getting vaccines because she still got the disease did not discourage her. The outcome of events was unknown.   Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.  Information on the Lot/batch number has been requested.
Seven days after my first Pfizer vaccination I came down with a rash on my neck that turned blistery which progressed and spread on my neck and into my scalp on the right side over the next 3-4 days. This was an itchy, burning painful rash that produced the blistery welts. I saw my dermatologist who confirmed I had the Shingles virus. I was provided oral medication and a topical steroid cream. I do not know if this has anything to do with the vaccination, but given my age to be diagnosed with Shingles thought it best to report. I did have the chicken pox virus when I was a child.
Patient reported large red circle around injection site along with itching and redness--also reactivated prior shingles in vaginal area with large red welts and circle of redness around vaginal area
Contractor presented for Dose 1 of Moderna Covid Vaccine.  At 1100, contractor reported headache.  PMH: undiagnosed hypertension, heart palpitations. VS 1100 BP 129/67 HR j55 02sat 99% RA VS 1118 BP 138/83 HR 55  02sat 99% RA 1215  BP 148/75 HR 53 02sat 100% RA  1144  Headache resolved, reports lightheadedness 1155  Reported nausea 1215- all symptoms resolved.  Contractor left observation area accompanied by his supervisor.
Information has been received from a licensed practical nurse concerning a 10 year old female with seasonal allergies and no pertinent medical history who on 17-DEC-2001 was vaccinated subcutaneously with a first dose of 0.5 ml VARIVAX (Merck) (lot# 639434/0788L). On 28-JAN-2008 the patient was vaccinated subcutaneously with a second dose of 0.5 ml VARIVAX (Merck) (lot# 659533/1594U). There was no concomitant medication. On 12-DEC-2010 the patient experienced pain in her right arm. On 13-DEC-2010 a zoster rash developed on the back of her shoulder and patch on her triceps. She had about 20 lesions. At the time of the report, the patient was not recovered. No diagnostic laboratory tests were performed. The patient sought unspecified medical attention. Additional information has been requested.
Vomiting; diarrhea; "not feeling well"; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced vomiting, diarrhea and feeling unwell. On an unknown date, the outcome of the vomiting, diarrhea and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the vomiting, diarrhea and feeling unwell to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received dose 1 of Shingrix and developed vomiting, diarrhea and was not feeling well immediately after the dose.  He stated these symptoms lasted for two days and then resolved. The reporter consented to follow up.
induration & lt radial neuritis (inject site) following 3rd Hep B vax;
Fever day of shot up to 101.5F, developed seizure for 1 minute, 6 hours, post vax.
This is a spontaneous report from a contactable consumer who reported for himself. A 70-years-old other ethnic group male patient received PREVNAR 13 , via an unspecified route of administration in Mar2015 at 0.5 ml, single for immunisation.  The patient medical history was not reported.  The patient took many unspecified concomitant medications.  The patient experienced broke out in hives with outcome of recovering and was photosensitive on an unspecified date about 18 or 20 hours after vaccination with outcome of unknown.  The patient underwent lab tests and procedures which included blood test on unspecified date, no results were provided. The patient went to a dermatologist he prescribed prednisone, fexofenadine hydrochloride (ALLEGRA), hydroxyzine ointment; betamethasone dipropionate and  ulobetasol propionate (HALOBETASOL PROPIONATE) Cream, later received ranitidine (ZANTAC) and experienced heartburn so took aluminium/magnesium hydroxide (MAALOX).
Graves disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Lot number: EW0172) as dose 2, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: EW0179, Route of administration: Intramuscular), administration date: 24Jul2021, for COVID-19 Immunisation, reaction(s): "trouble sleeping/got out of bed at 2:30AM in the morning and she was wide awake at 4:00AM and not feeling tired, she was wide open", "mood swings up and down, mad, sad, happy", "feels like the wheels in her head are constantly spinning, mind doesn't stop", "headache", "runny nose", "crying", "mood swings up and down, mad, sad, happy", "moodiness", "Wheels in her head are turning", "shaking of the hands and legs", "When confirming side effect with caller, she just added a description stating that the shaking was like if she was nervous". The following information was reported: BASEDOW'S DISEASE (medically significant), outcome "unknown", described as "graves disease". The patient underwent the following laboratory tests and procedures: investigation: graves disease.  Clinical course: This report was not related to a study or programme. Caller states that after taking the Pfizer BioNTech covid 19 vaccine she was diagnosed with grave's disease, Patient asked if they have any reports of this side effect? Caller asked if there was somewhere she could report her side effects. Caller displayed frustration that she had been on the phone for 25 minutes and had to listen to a recording for 5 minutes. Consumer stated that she need to find out if there is any reporting of people getting Graves' disease after they had the COVID shot (Pfizer COVID-19 vaccine), as she just recently was diagnosed with Graves' disease. Consumer stated lot number for the second one was EW0172 (clarified and captured in tab), first one EW0179 (confirmed). Product details (Expiration date, NDC and UPC) and other details could not be probed as consumer was unwilling to share further information. Hence further probing could not be done. Limited information available over the call. On follow up, patient clarified that Lot, stated, "The first one is EW0179 and second one is exactly the same except there is 0172 (EW0172)." Consumer was unwilling to complete the report. Further probing could not be done. Hence, limited information available over the call.  No follow-up attempts are possible. No further information is expected.
vaccinated and had COVID; vaccinated and had COVID; lost his smell and his taste; lost his smell and his taste; he was about as sick; felt like crap; This is a spontaneous report from a Pfizer sponsored Program via a contactable consumer or other non-healthcare professional (patients aunt). A 40-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as singe dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated and had covid, lost his smell and his taste and he was about as sick. The reporter mentioned that her 40-year-old nephew, who was vaccinated, was as sick as she was with COVID and she doesn't know why. First his wife got COVID, she was unvaccinated, then his teenage daughter who was 17-year-old got COVID and then (her nephew) got it. The patient lost his smell and his taste and he was about as sick as the reporter was, he had 10 days where he felt like crap. The reporter mentioned that her nephew was vaccinated and had then tested positive for COVID. This report was related to a study or program. Reporter seriousness for vaccinated and had COVID was reported as unspecified. On an unspecified date, the patient underwent lab tests and procedures which included COVID-19 Test: positive. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
veins in her arm have become pronounced/ also the veins in her other arm and a little bit on her throat; Orange spot appeared on my hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 91 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Lot number: EL9267) at the age of 91 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; LOSARTAN; BABY ASPIRIN. The following information was reported: VEIN DISORDER (non-serious) with onset 2021, outcome "unknown", described as "veins in her arm have become pronounced/ also the veins in her other arm and a little bit on her throat"; SKIN DISCOLOURATION (non-serious) with onset 2021, outcome "unknown", described as "Orange spot appeared on my hands". Therapeutic measures were not taken as a result of vein disorder, skin discolouration. Additional information: The course of events was described as follows: The patient had the first Pfizer COVID vaccine shot about three weeks ago and was due to have second shot on 04Mar2021. She was just within the last 4-5 days; she developed the veins in her arm have become pronounced and also the veins in her other arm and a little bit on her throat. The patient was querying if she should have the second shot. The patient hasn't treated the events since it didn't bother.  No follow-up attempts are possible. No further information is expected.
Body aches, fatigue - The next morning there were blisters present near the site of injection and low grade fever.  Area was sore, red, and warm to touch.
Fever; Feeling sick; Difficulty breathing; This is a spontaneous report from a contactable consumer (patient himself). A 69-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0167; Expiration Date: Aug2021) via an unspecified route of administration, administered in Arm Left on 04May2021 09:00 (at the age of 69-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Family medical history relevant to AE(s) was reported as none. History of all previous immunization with the Pfizer vaccine was none. Additional vaccines administered on same date of the Pfizer Suspect: reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient had received the first dose of the COVID vaccine and when he retired that night on 05May2021 he woke up about 1:00AM with a fever, feeling sick and difficulty breathing. He took an aspirin and stayed awake for about two hours. He finally felt better. The next morning, he called the clinic where he got the first dose of the COVID vaccine and canceled his appointment for the second dose of the COVID vaccine. He was not going to go through that again. He had also called the FDA, and CDC to report his symptoms. His fever, feeling sick and difficulty breathing all lasted for about two hours. AEs did not require a visit to: emergency room or physician office. Therapeutic measures were taken as a result of AEs as patient took aspirin. The outcome of all events was recovered on 05May2021.  No follow-up attempts are needed. No further information is expected.
pt was experiencing extreme anxiety prior to vaccination today, high bp following initial dose with dizzy spells, pt is alert and stable, resting comfortably, pt bp returned to wnl after spending time in the observation tent, observed pt walking- pt is steady, no dizziness, pt felt comfortable to drive herself home.
ADMINISTRATION ERROR:  Nurse manager reports that the patient received her first dose on 7/28/22, and the 2nd dose should have been on 8/18/22 but instead she received it on 8/12/22.  She did not have any adverse reaction to the vaccine, just needing to report it.
7JUN93 puncture wound lt foot from wooden dock; DTP given in morning; 3PM mom phoned t102.3, arm red, hot, swollen w/pain;
Was at home, felt Dizziness,fainting,fever,strong headache,fatigue,cold sweat,body ache,clammy skin,nausea, short of breath ,dry mouth ,dehydrated, very bad I though Iwas going to pass out at any time,weak.
This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-JUNE-2021, the patient took a blood test to check that he had generated antibodies and the result was the following: Immunoglobulin G (IgG) antibodies: 0.018 Negative - 0.018 index (S/C) [Assay results were reported as an index value of the ratio of specimen to calibrator absorbance (S/C or S/CO)], Immunoglobulin M (IgM) antibodies: 1.17 Positive - 1.17 index (S / C) Given this result, the antibodies that protect against the virus had not been generated after 60 days of application of the vaccine (confirmed immunological vaccine failure). The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000182752. The suspected product quality complaint has been confirmed to be non-voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210628716-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Started experiencing chills, headache, vomiting, loss of eyesight and have started to wear glasses. I went to the ER and was treated with IV fluids. Next day was moved to a HCF after experiencing jaundice and was put on the liver transplant list I was then admitted for a total of 8 days. Currently on bed rest and restrictive diet.
Blotchy rash started on extremities & then progressed to entire body; both wrists swollen, no pain, no fever; family MD thought erythema multiforme but MD dx as urticaria resolved w/high dose Pred & antihistamines;
4/14-Resident c/o not feeling well and  declined scheduled dialysis. c/o bilateral shoulder pain and fatigue. AP- 44, BP- 80/45, c/o headache, no chest pain and no SOB.  Sent to ER- patient deceased on 4/14/2021.
01/26/2022 - Patient presents for evaluation of cough congestion Raynaud's and sore throat. History of physical exam this is a viral type illness. Patient is overall well appearing afebrile with unremarkable vital signs. Patient has  been vaccinated blue suit against Covid-19. Chest x-ray performed shows no acute pathology. Quad screen testing obtained is positive for Covid-19. Patient was consented for monoclonal antibody therapy and had agreed. Patient was administered monoclonal antibody therapy without competitions. Patient has no hypoxia no current indication for admission at this time. Will discharge with treatment and patient will be followed up by high risk team. Patient was given strict return precautions. 02/27/2022 - Briefly, patient with paraplegia and multiple care needs recently tested positive for COVID-19. He lives by himself and his family is refusing to come care for him. His home health care person also did not come today because she was told by her boss that she should not come to the house if he is positive for COVID-19. We spoke with social work and they attempted to work with his home health company or find placement for him for six hours. Ultimately they were unable to secure placement. Doctor then spoke with alternate Doctor who accepted patient for admission. 02/01/2022 - Patient discharged from hospital following complicated UTI/ Covid-19 +.
Within 15 min of vaccine, headache, woozy dizzy feeling.  Lightheaded.  That night, fatigue and arm pain.  Next day tender warm swollen lymph nodes left supraclavicular nodes and (much less axillae.).  3rd  day.  Extreme fatigue. Fever 103. Could not get out of bed.  Nausea diarrhea. Malaise.  Felt like the flu.   Painful lymph nodes worse and arm pain worse.
Information has been received from a physician concerning a 5 month old patient who on 28-SEP-2006 was vaccinated PO with first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) with no adverse effect. It was unknown if medical attention was sought. No further information is available.
Pt broke out with chicken pox-severe case. Had varicella in 2/12/99.
Fever; Chills; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and PAIN (Soreness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN (Soreness). On 20-Jan-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and PAIN (Soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol
Approximately 1 week after getting BV vaccine, all long COVID symptoms disappeared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: Aug2021 (unspecified if ongoing), notes: If COVID prior vaccination: Yes, long term covid symptoms, including fatigue, brain fog.; "COVID-19" (unspecified if ongoing), notes: long term covid symptoms, including fatigue, brain fog. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single , Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single , Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Single , Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4, Single , Manufacturer unknown), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Sep2022, outcome "unknown", described as "Approximately 1 week after getting BV vaccine, all long COVID symptoms disappeared". Therapeutic measures were not taken as a result of therapeutic response unexpected.  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.