chrisvoncsefalvay/vaers-outcomes huggingface dataset:
autoimmune disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: unknown, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune disease". Clinical course: Withheld called in asking where to get a prescription Paxlovid or a list of doctors who's prescribing it. She also mentioned that she, her husband and son have all been vaccinated and boosted and that her husband has cancer and heart disease and her son has an autoimmune disease. She also said she managed to get Covid even after being vaccinated.   The lot number for bnt162b2 was not provided and will be requested during follow up.
10SEP92 t104 ax 2AM following vax 16 hrs a/DT; vomiting p/APAP; slept alot;
27 y/o previously healthy male received 3rd dose of Moderna "booster" on 9 June 2022. Full body urticaria without angioedema developed on/around 13 June 2022 and has continued since then. Not improved with prednisone or oral antihistamines.
Covid Arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (Covid Arm) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced VACCINATION SITE PAIN (Covid Arm). At the time of the report, VACCINATION SITE PAIN (Covid Arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No Treatment medication was reported.
Pain at injection site days 1-3, subsided. On day 8, pain at injection site resurfaced at night.  Then in morning of day 9, itchy red rash appeared near injection site.
no adverse effect; improperly stored vaccine administered; varivax was administered intramuscularly; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-NOV-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), intramuscular route for prophylaxis (# lot S010297, expiry date 03-APR-2021, dose, strength, vaccination site unspecified). Concomitant medications included sterile diluent (lot# S002638, expiry date 31-OCT-2021). The vaccine varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent at a temperature of 15 degrees Fahrenheit to 46 degrees Fahrenheit for a time frame of 16 hours. There was no previous temperature excursion. No digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Woke up with headache, chills, and vomiting. Diarrhea.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive, notes: testing positive for the last 7 days; (Aug2023) Positive, notes: testing positive for the last 7 days; (Aug2023) Positive, notes: testing positive for the last 7 days; (Aug2023) Positive, notes: testing positive for the last 7 days; (Aug2023) Positive, notes: testing positive for the last 7 days; (Aug2023) Positive, notes: testing positive for the last 7 days; (Aug2023) Positive, notes: testing positive for the last 7 days. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Information has been received from a mother concerning her 7 year old son with tuberous sclerosis and penicillin allergy who on 12/13/1995 was vaccinated with a dose of Varivax (site unknown). Concomitant therapy includede Lamictal (75 mg) (T.I.D) and Inderal (OD.). On 02/19/2002, the patient developed varicella confirmed by a physician.  The patient sought unspecified medical attention. Additional information has been requested.
Patients husband reports a half dollar size raised red mark.  Patients husband called on Monday, vaccine was given on friday. Said that they have iced it 3 times a day since then.
COVID -19 Pfizer Vaccine 3mcg/0.2ml Diluted  with 1.2 ml of 0.9% sodium Chloride in stead of 2.2ml by mistake. Pt was given dose on 0.2ml. Pt mother made aware of error.
2 days p/vax mom noticed a red, hot raised area & brought pt to MD;pt was treated w/rx & compresses;
Pt recvd 1st dose of Engerix-B 24APR91 & exp an abscessed tooth 16MAY91; pt recvd 2nd dose of Engerix-B on 28MAY91 & again exp abscessed tooth (same tooth as w/1st shot); tooth was extracted;
slept all day; fatigue; chills; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HYPERSOMNIA (slept all day), FATIGUE (fatigue), CHILLS (chills) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 13-Apr-2021, the patient experienced HYPERSOMNIA (slept all day), FATIGUE (fatigue), CHILLS (chills) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), HYPERSOMNIA (slept all day), FATIGUE (fatigue), CHILLS (chills) and HEADACHE (headache) outcome was unknown.
When the needle went in my arm I was perfectly still however the needle seemed to have made contact with a nerve which gave me an involuntary spasm. Left Arm -more than normal pain 1 hour after injection went to sleep and then woke up the next morning with partial paralysis could not lift arm up outwards at all my arm was basically stuck in raptor like position for several weeks. It also hurt to move my arm and hurt in general when not moving. Pain and muscle spasms continued after I gained back full movement of my left arm after about 60 days and have been persistent toil present day. Currently upon writing this there is sharp stabbing pains in my left arm. dated 1/18/2020.
Varicella vaccine breakthrough. Pt developed rash 5/26/06 on trunk, extremities and palate. Had fever of 104 by ear for 12 hrs on 5/26/06. Seen in our office 5/30/06 with over 100 pinpoint vesicles and diagnosed by MD with atypical varicella.
A report has been received from a Health Professional concerning an 8 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. On 02-Dec-2013, the patient received FLUMIST QUAD that expired on 25-Nov-2013. The outcome of the event of administration of expired product was unknown. The report was considered to be non-serious.
human leukocyte antigen (HLA) sensitization subsequent to vaccination;   This literature marketed report has been received from authors of the literature article entitled as stated above and refers to an unspecified pediatric patient waiting for kidney transplant. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), varicella virus vaccine live (oka/merck) (manufacturer unknown) and hepatitis a vaccine, inactivated (manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) all for prophylaxis. On an unknown date after vaccination, the patient's anti-HLA antibody test was positive; the patient experienced human leukocyte antigen (HLA) sensitization subsequent to vaccination. The outcome of the event was unknown. The authors considered the event to be related to suspect vaccines.  This is one of five reports derived from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2209USA001761: US-009507513-2209USA010290: US-009507513-2209USA010291: US-009507513-2209USA010293:
Reported to pharmacy 1/19/16 patient reports bruising beginning approximately 1 day after vaccination and has lasted about 1 month. She also reports residual arm pain/shoulder pain (side of vaccination) when she raises arm (90 degrees); such as performing, tennis strokes, pushing out of bed. Began after vaccine and continues.
Patient reported back to the clinic today reporting high fever since the day after the vaccine was administered as well as body aches, headache, and localized redness and swelling as well as small bruising at and around injection site. Redness measures 11cm W x 8CM L. Temperature 99.2 today 2 hours after taking Tylenol.
Pt. came back few days after receiving treatment with a big red itchy patch so I recommended to go visit the Dr.
The next day I noticed a measles like red spotty rash all over my arms legs and torso.  This rash at first did not itch but later itched mildly and intermittently this rash continues today, May 5th 2021.  Furthermore I've suffered what I can only describe as brain fog that has left me discombobulated, absent mind, stumbling for words.  Also my mood is significantly altered as I am suffering from anxiety and a short temper.
Primary series: Pfizer Vaccinated: 11:25AM Reaction: 11:30AM Patient complained of flushed/dizziness, felt slightly nauseous 5 minutes after vaccination Vitals: @11:27: 85/66, 52, 12 -> @11:32: 89/48, 71, 12 -> @11:40: 94/53, 71 HR -> @11:45: 87/48 -> @11:47: 95/53, HR 71 -> @11:50: 103/58 Patient reported feeling much better and released from vaccination site at 11:50AM
5 minutes post vaccination client had vision changes, lightheadedness, mild nausea, sweating. Symptoms resolved after 10 minutes. Client's treatment was elevating legs, applying cold packs to neck and staying close to client and not allowing client to leave until he was 100% normal per client's report of normal.
Elevated heart rate (blood pressure and pulse); Elevated heart rate (blood pressure and pulse); Severe headache; Leg pain; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 11Apr2021 at 09:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid issues - only left lobe and known allergy to Sulfa. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included ergocalciferol (VITAMIN D2) 50,000 IU and doxycycline (MANUFACTURER UNKNOWN); both for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Apr2021 at 15:00, the patient experienced elevated heart rate (blood pressure and pulse), severe headache and leg pain. On the same day, the patient underwent blood pressure and the result was found to be elevated and also the patient underwent pulse rate and the result was found to be elevated. On 18Apr2021, the patient underwent nasal swab and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department visit or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events elevated heart rate (blood pressure and pulse), severe headache and leg pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sudden jump in blood pressure, from lifelong normal of 125/80 to daily average of 175/95 for several weeks. Plus brain fog, loss of focus, irregular heartbeat. Recent BP tests showing gradual decline to averages of 150s to 140s. Negative COVID test 12/23/2021.
The patient received Fluzone HD which is indicated for patients age 65+. The patient is 59.
Pt vaccinated with DTP/OPV/Recomb developed fever of 103, convulsions, fine tremor.
Two weeks after booster, I started breaking out in hives multiple times a day all over my body (I.e. chest, neck, arm pits, hands, wrists, knees and thighs)
This spontaneous report was received from a pharmacist refers to a 57 year old female patient. Her relevant medical history and past drug history are unknown. On 10-SEP-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, lot # J003798, expiry: 28-JUN-2014 (reported as 20-JUN-2016) subcutaneously. Concomitant therapies included DILTIAZEM ER. On 13-SEP-2013, the patient experienced redness 7cm wide, around the site of injection. Patient's relevant laboratory data was unknown. As of 14-SEP-2013, it was unknown if the patient would continue to take ZOSTAVAX or if she continues to experience redness around the injection site. Additional information has been requested.
On 8/01/2019 patient came to pharmacy and talked to pharmacist about  redness  - not around  the injection site but on left arm at different area , pharmacist gave her recommendation to take Benadryl and keep eye on it, as it got severe for redness ,nausea and pain she went to see doctor on 08/02/2019, doctor told patient that it might be vaccine related or cellulitis , gave her rx for ranitidine, ibuprofen, zofran odt . She started to get fever and more swelling so she went to doctor again  on 8/3/2019 , doctor told patient that reaction is vaccine related , gave her keflex.
On the day I received the first Pfizer shot, my blood pressure went into the 160s/100s and has remained there since 3 Nov 21. It has never been sustained high for more than a few hours.
MILD SORENESS IN ARM; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced mild soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild soreness in arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210219 and 20211210428.
Very swollen leg, red and irritated skin that continued to grow and get worse, bruising and brown skin that grew to cover large portion of the thigh, started showing cold like symptoms, extreme irritability, interruption in sleeping patterns
This was my second booster dose, 6 months after 1st booster.  I experienced a large size (like an orange-size circumference) and maybe one inch raised, a lump/swollen gland, under my right armpit, between my armpit and my breast.  This appeared the morning of the 29th, whereas my shot was on the late afternoon of the 27th.  I have has side effects of swollen glands in my neck/shoulder area but not this large and not under armpit.  It is tender, but already reducing in size.
overall muscle soreness and extreme lethargy, slight nausea lasting for a day and a half
Chest tightness, sore throat, headaches, conjunctivitis, cough, oculo - respiratory 12/02/09  Medical record received for DOS 09/02/09. Telephone call from patient, reporting reaction to flu shot. Oculo-respiratory symptoms. Took Tylenol, feels better. DX: Allergic reaction to flu shot
Patient received Pfizer booster vaccine and about 5 minutes later she was seen throwing up, complained of itching, hives were seen on her arms bilaterally. She complained of feeling faint and weak and later complained of her throat feeling like it was closing up and difficulty breathing/speaking. Patient was given two separate doses of epinephrine while the nurse called EMS to report the SAE.
Pt recvd vax 18AUG92 & became very tired & hot & exp achiness; pt recovered on the same day; No further details were provided;
pt recvd vax & felt lightheaded, n, eyes blured & watery nose; pt became limp & fell convulsions; hospitalized -d/c, still limp & lightheaded;
Patient was on nursing schedule to come in for 2nd SHIGNRIX injection, Patient's name was one list for 2nd injection, vaccine set aside for patient with name on it in refrig. Patient brought into room, confirmed with patient that she was here for 2nd SHINGRIX vaccine, patient said yes, verified patient, allergies, current meds, visits. SHINGRIX given with no problems or concerns. Documented in chart, when documenting, realized it was patients 3rd SHINGRIX vaccine. She had received the other two vaccines on 7/13/18 and 2/7/19. Tried to call immunization staff, unable to reach anyone, tried to call staff, no one available, was given the name of from Health Dept, spoke with him about it and he recommended what to do. Dr. Immunization Provider know, called and spoke with patient husband. Primary care provider, Dr. notified on 3/15/19. On 4/15/19 called patient to check in with her, no adverse effects or concerns.
Left arm fell asleep; uncontrollable nausea and vomiting; gradually got more nauseous; I was hyperventilating; Woke up with a headache; Had extreme vertigo with headache; body aches; disorientation; very tired; This is a spontaneous report received from a contactable consumer (Patient). A 38-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: WAG6975), via an unspecified route of administration, administered in Arm Right on 08Apr2021 14:00 (at the age of 38-years-old) as single dose for covid-19 immunisation. Medical history included anxiety and DVT in lower leg 7 years ago from surgery. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC DUO). Patient had no known allergies. Patient did not receive any other vaccines in four weeks. Patient was not diagnosed with covid-19 prior to vaccination, and she was not diagnosed with covid -19 since vaccination. On 18Apr2021 08:00, patient experienced left arm fell asleep, was hyperventilating, woke up with a headache, gradually got more nauseous, had extreme vertigo with headache, uncontrollable nausea and vomiting, body aches, disorientation and very tired. It was reported that she ended up in the ER 10 days after vaccine. Woke up with a headache then gradually got more nauseous. Had extreme vertigo with headache and uncontrollable nausea and vomiting. Left arm felt asleep, and she was hyperventilating. Couldn't stop vomiting until the Er gave her an injection and pills. Had body aches later that day and the next day and disorientation and very tired. No fever. Patient received Iv fluids, injection for nausea RX for vertigo as a therapeutic measure to treat adverse events. The events were recovered with sequel.  Follow-up attempts are possible. Further information is expected.
admitted to hospital with platelet count of 8,000; petechiae; This is a spontaneous report from a contactable physician. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) via Intramuscular on 18Jan2021 into left arm at a single dose for covid-19 immunization. Medical history included hypothyroidism and neomycin allergies. The patient did not get covid prior vaccination. Concomitant medications included calcium, levothyroxine sodium (SYNTHROID), trazodone, tocopherol (VIT E) and no other vaccine in four weeks. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9261) via Intramuscular on 28Dec2020 into left arm at a single dose for covid-19 immunization. 24 hours after injection she developed petechiae and was admitted to hospital with platelet count of 8,000 on 20Jan2021 22:00, the patient has ITP with baseline platelet count of 60,000. All events lead to hospitalization for 5 days (PENDING CLARIFICATION) and received IgG and oral Dexamethas as treatment. On 20Jan2021, the patient did Sars Co V 2 RNA test via Nasal Swab and result negative. The outcome of the events was recovering.; Sender's Comments: Based on a close chronological association, a causal relationship between events petechiae and thrombocytopenia and  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The case will be reevaluated should additional information become 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.