chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-MAR-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX, is intended to prevent. During July 2016, the patient was treated by a physician for symptoms of a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Diarrhea and my purps smell terrible; Stomach issues; Vomited; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea and my purps smell terrible), ABDOMINAL DISCOMFORT (Stomach issues) and VOMITING (Vomited) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2020, the patient experienced DIARRHOEA (Diarrhea and my purps smell terrible), ABDOMINAL DISCOMFORT (Stomach issues) and VOMITING (Vomited). At the time of the report, DIARRHOEA (Diarrhea and my purps smell terrible), ABDOMINAL DISCOMFORT (Stomach issues) and VOMITING (Vomited) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided
Small skin rash and minor itching began 5 days after receiving first shot. Each day for 5 days, the rash and itching increased and was a bit warmer than the rest of the arm. On the 6th day, the itch subsided and the rash color diminished but has not gone away (it's been 4 more days now). Rash area is about 3 inches across and about 2.5 inches long and appears below the injection site.
When she had first two Pfizer COVID vaccine shots in Feb2021, it was just an itchy arm.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2021 (Lot number: EL8982, Expiration Date: Mar2021) at the age of 75 years as dose 1, single and administered in arm left, administration date 10Feb2021 (Lot number: EN5318, Expiration Date: May2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "upper respiratory nasal drip" (unspecified if ongoing), notes: Over the last 5 years, she has developed the upper respiratory nasal drip; "irregular heart beat" (unspecified if ongoing), notes: Why was the patient taking Concomitant Products Amlodipine (Verbatim): irregular heart beat. Family history included: "Diabetes", start date: 1995 (ongoing), notes: Mother had diabetes and it seems to run in family. Concomitant medication(s) included: HUMALOG BASAL taken for diabetes mellitus; METFORMIN [METFORMIN HYDROCHLORIDE] taken for diabetes mellitus; PRAVASTATIN taken for blood pressure measurement; AMLODIPINE taken for heart rate irregular; EZETIMIBE taken for blood pressure measurement; ASPIRIN [ACETYLSALICYLIC ACID]; LOSARTAN taken for hypertension. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "When she had first two Pfizer COVID vaccine shots in Feb2021, it was just an itchy arm.".  Additional information: Received call from consumer who provided her middle initial. She had her Booster shot of the Pfizer Covid vaccine last Wednesday, 20Oct2021. She had the two previous ones in February and then space and got another one. He had no effects from the others at all except an itchy arm.  No follow-up attempts are possible. No further information is expected.
pt exp local rxn site lt thigh-swelling; t105.0; went to ER for tx of event duration of illness 1/2day; pt recovered;
Body aches, fatigue, chills, headache 24 hrs after vaccine. Tachycardia and SOB Day 2 & 3 after vaccine. HR up to 120.
pt recv vax; not consolable for 4 hr, screamed, leg swollen fr knee to hip, also red;
-stood on his tiptoe and that made him black out and fall down  -sat at a computer and his feet went numb, count move feet for 20 mins  -was on a 10 foot ladder and blacked out and feel off the ladder  -went to hospital and was given a walker, was experiencing nausea, face swelling and he said his forehead felt like he has a block on his head -was laying in a bed and at 2 am his face swole up and forehead felt like he had a 50 pound bag on his head
First time Shingles: slight irritation noticed on 4/14; by 4/16 progressed to blisters mid-line torso on the right-side; on 4/16 Dr. prescribed Valacyclovir HCL 1 gram T 1 tablet by mouth every 8 hours for 7 days
Booster dose was given together with  high-dose quadrivalent preservative free influenza vaccine. My father experienced temporary muscle weakness with paralysis. He described the event as not being able to feel his legs and not being able to walk. Episode lasted for approximately 1 hour then spontaneously stopped.
Information has been received from a registered nurse concerning a 72 year old male physician who in 2006 was vaccinated with Zostavax (Oka/Merck). On 01-DEC-2007 the patient developed pain in his neck with "blisters that went from his side all the way down to his bottom". The nurse reported that the patient had trouble sitting down, and was subsequently diagnosed with shingles. At the time of reporting the shingles persisted, and were considered to be disabling. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
hemifacial spasms on the right side of face; weird sound in the ear; pulsating in the neck; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 29-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the left arm on 30Dec2020 10:00 (lot number and expiry date unknown) at single dose for Covid-19 immunization in a workplace clinic. Medical history included hidradenitis suppurativa. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included unspecified other medication. The patient received first dose of hepatitis vaccine in the left arm on 15Dec2020 (29 years old) for immunization which was within 4 weeks prior to the COVID vaccine. On 07Jan2021 07:15, the patient experienced hemifacial spasms on the right side of face. The right side of face tightens to the point her eye closes, mouth pulls up and cheeks pulls up as well along with a weird sound in the ear and pulsating in the neck. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included CT scan: unknown results in Jan2021. The patient has not been tested for COVID-19 since the vaccination. The patient received treatment of muscle relaxer, medrol dose pack. The outcome of the events was not recovered. The reporter considered the events serious as disabling/incapacitating but did not results in death, not life threatening, did not cause/prolong hospitalization, no congenital anomaly/birth defect.  Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the hemifacial spasms and other reported events  due to temporal relationship  Additional information is needed to better assess the case, including complete medical history, diagnostics including results of Head CT scan, EMG and chemistry panel, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
LEFT EAR ACHE; HEART PALPITATIONS; DRY COUGH; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included heart stent, and other pre-existing medical conditions included the patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced left ear ache. On 24-MAR-2021, the subject experienced heart palpitations. On 24-MAR-2021, the subject experienced dry cough. On 24-MAR-2021, the subject experienced fatigue. On 01-APR-2021, Laboratory data included: EKG (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 26-MAR-2021, and had not recovered from left ear ache, heart palpitations, and dry cough. This report was non-serious.
Two weeks after vaccine, (R) arm shoulder with moderate soreness and severe when arm raised, the next day left arm shoulder with same pain, unable to raise arms. 4 days later both arms still sore with numb/tingle in hand, jaw soreness 4th day.
On January 6, 2009, 2.5 weeks after vaccine adminstration, Macular rash on chest neck and back, vesicular lesions on back, number less than 10. Client reports feeling feverish at night... No fever noted when checked by MD.
This report described the occurrence of joint pain and swelling in the face in a female patient who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received her first dose of LYMErix "in June of 2000. Subsequent vaccination dates are not known by the client." On 03 September 2003, the patient's attorney alleged that the patient "suffered joint pains, swelling of her ankles, knees, hips, shoulders, elbows, wrists, fingers and jaw. The onset of her symptoms is unclear at this time." Treatment and outcomes of the alleged events were not reported. The following information was provided via medical records. The patient's medical history included a tick bite in June 2000. The patient's grandmother had arthritis. The patient received her initial LYMErix vaccination on 26 June 2000, and her second LYMErix vaccination on 28 July 2000. In December 2000, the patient presented with complaints of ankle and foot pain; however, x-rays revealed normal findings. On 12 October 2002, the patient presented with left knee inflammation that was hot to touch, and right thumb pain and swelling. Diagnostic tests on that date revealed an elevated rheumatoid factor. Between 05 November 2002 and 19 June 2003, the patient was evaluated by an arthritis specialist for chronic arthralgias that occurred intermittently, usually in just one or two joints at a time, with most of the peripheral joints involved at one time or another. The patient complained of joint swelling in the wrists, fingers, and knees, with episodes lasting one to two days at a time. Impressions included intermittent arthralgias/arthritis assessed to be probable palindromic rheumatism, with antinuclear antibody negative lupus less likely a possibility. Treatment included Naprosyn. In January 2003 Plaquenil was prescribed although the patient did not initiate the medication. On 22 December 2002 the patient injured her left angle and was diagnosed with an acute ankle sprain accompanied by swelling and tenderness. Following the reported onset of joint pain and swelling, the patient experienced left ear erythema, and elevated platelet count, blood glucose, and total bilirubin. The patient had no history of chicken pox, and on 08 July 2003, diagnostic tests were positive for varicella zoster virus antibody (IgM). These were not reported as adverse events due to vaccine administration, but were found during the course of review of the patient's medical records. Therefore, they are not listed as adverse events. The most recent information received on 08 December 2003 did not provide the outcome of joint pain/ joint swelling.
The pt received the DT booster in left deltoid. The next morning the pt had a reddened area around the injection site the size of a fifty cent piece. It was reported to the office 4 days later when the red area covered the from the side of the arm from shoulder to elbow.
Client had Pfizer vaccines x 2 in June, 2021 at the appropriate intervals.  Client developed Covid symptoms on 8/27/2021  (fever x 1 day, nasal congestion) and tested PCR positive for Covid on 8/30.  Reported as case of breakthrough Covid in a fully vaccinated person.
Bad reaction; Initial information was received on 21-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (unknown demographics) who had bad reaction (adverse reaction) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry not reported) (formulation: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious bad reaction (adverse reaction) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "I am on the fence about getting a flu shot this year. last year I got one in September, had a bad reaction to it and went to Emergency Room (ER) the next day. So scary!"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
tingling lips, itchy red cheeks - on the way home Saturday muscle aches from neck to ankles - during the night Saturday to Sunday  stuffy nose, dry cough, fatigue, chills (no fever), nausea, sore arm - Sunday and Monday on third day the only thing remaining are chills sought no treatment
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 15Apr2021 as dose 2, single (Lot number: ER8737), in left arm, on 02Nov2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 28Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Non Hodgins Lymphoma survivor" (unspecified if ongoing); "Chemo" (unspecified if ongoing), notes: Chemo 10Jul to 4Aug then 20-days of radiation.; "Hypothyroidism" (unspecified if ongoing); "GERD" (unspecified if ongoing), notes: GERD from a flap that doesn't always close correctly.; "Herpes virus" (ongoing), notes: also have the Herpes virus living in my spine that I take acyclovir daily for. Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR] taken for herpes virus infection, start date: 01Jan2010 (ongoing); SYNTHROID, start date: 01Jan2012; OMEPRAZOLE, start date: 01Jan2018. Past drug history included: Leviquin, reaction(s): "rip up my stomach"; Bioxin, reaction(s): "rip up my stomach". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive for Covid in the ER; (28Feb2023) Positive, notes: initially tested positive; (08Mar2023) Negative, notes: was negative and felt fine. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient was treated with Paxlovid.  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-202300109979 same patient, different drug/event;US-PFIZER INC-202300111511 same patient, different drug/event;
fever; bad cold / full blown cold; body aches; cough; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 4th December 2021, the patient received Shingles vaccine. On 6th December 2021, 2 days after receiving Shingles vaccine, the patient experienced general body pain and cough. On 8th December 2021, the patient experienced fever and cold. On an unknown date, the outcome of the general body pain and cough were recovered/resolved and the outcome of the fever and cold were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, cough, fever and cold to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient reported that he/she had the shingles vaccine on Saturday afternoon (from the day of reporting) felt fine on Sunday but developed body aches and a cough on Monday and Tuesday. Woke up today (on the day of reporting) had a fever and a full blown cold. The patient wanted to know if it was normal 4 days after vaccination. The follow-up would not be possible as no contact details were available.
I had dry cough and scratchy throat two days later I developed a sore throat as well. I then did a home test on July 13 and it was positive. I then went to urgent care and got a prescription with Paxlovid. I was around someone that was sick, so I was on high alert when I developed these symptoms. I started my medication and after the 3rd day of the medication I started to improve. Then I retested 2 days after I finished the medication, and I was still slight positive (the line was visible but faint). Two days after this reading I tested again, and it was negative.
TINGLING IN INJECTION ARM AT PALM Narrative: 0731 vs taken for tingling in palm 121/84 75 100% RA 0706 vs 122/87 69 100% RA tingling resolved. D/C stable
Herpes simplex cold sore outbreak- worst I have ever had, 6 sores on lip/in mouth/ on tongue.  One week later and still in significant pain, lip bleeding, and more sores breaking out.  Have been using Abreva topically but it isn't helping.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that 4 vials had been used and 1 punctured and about half used, five vials remain unpunctured.The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1  vial was used per day between the hours of 8:00am to 4:00pm. No concomitant medications were reported. No treatment medications were reported.
pt recvd vax & was flushed w/urticaria to legs, lower abd & arms; ears very red & sl edematous; no resp problems;
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 26-SEP-2018, the patient was vaccinated with PEDVAXHIB (lot # N003698 with expiry date 31-OCT-2019, dose, strength, route, vaccination site unspecified) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 47 degrees Fahrenheit (53.37 F) for 3 hours and 46 minutes, as recorded by a data logger. No previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010362: Original Case: 1903USA004795; US-009507513-1903USA010363: Original Case: 1903USA004795; US-009507513-1903USA010364: Original Case: 1903USA004795; US-009507513-1903USA010361: Original Case: 1903USA004795; US-009507513-1903USA010360: Original Case: 1903USA004795; US-009507513-1903USA010365: Original Case: 1903USA004795; US-009507513-1903USA004795: Original Case: 1903USA004795; US-009507513-1903USA010359: Original Case: 1903USA004795.
pt experienced an MI the day after his second dose of Covid vaccine and had cardiac cath and stinting x2 of coronary artery.