chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gradually increasing weakness and pain in the leg; Gradually increasing weakness and pain in the leg; liver hepatic enzymes were elevated; Aldolase elevated; This is a spontaneous report from a contactable physician reported for a patient via medical information team. A 48-year-old male patient BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: Unknown), via an unspecified route of administration on unknown date as 1st dose, single dose and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: Unknown), via an unspecified route of administration on unknown date as 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Consumer sated that they had a patient who was in the hospital who had both doses of the Pfizer-BioNTech COVID-19 vaccine and they were tracing his symptoms. Patient experienced a gradually increasing weakness and pain in the leg. They did not find an infection and the final cause of these symptoms. They conducted a muscle biopsy and no result provided. Aldolase and liver hepatic enzymes were elevated. Consumer wanted to know if there have been similar reports and how are patients treated and what could be done. Response: There are no information regarding how the vaccine affects test results or liver enzymes, and antipyretic. Also, pain relieving medications were used on the clinical trials, but Pfizer cannot give medication recommendations. The outcome of the events was unknown.  Information about lot/batch has been requested.
Redness, swelling, heat and induration of area where vaccine was administered. Small hive-looking blotches appeared 7 days after vaccination some 2-3 inches from vaccination site.
4/6, 6pm I started developing hives, a lot of hives, extremely itchy, they started on my forehead, then neck then chest, then everywhere, some small some as large as a 50 cent piece. They itched beyond control. Then I started feeling week, lethargic, and my throat started to swell.  I called a friend to take me to the ER, I was unconscious twice on the 5 mile trip to the hospital.  Upon arrival, around 7:45pm, I had to be wheeled in I could not stand on my own, I had an intake blood pressure of 70/40.  they immediately started  IV lines, with prednisone, benadryl and saline (others too?) i was moved to a bed, and kept on the IV's.  They took a lung x-ray, it was fine. Then a chest Xray, then EKG, was fine. My Lactate was 4.4, so i had to stay on the medicine and IV until it dropped to a lower level.  They released me
With the first 3 doses she usually gets a bump on the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 3 (booster), single (Lot number: FP4554) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disease" (unspecified if ongoing); "hard to walk" (unspecified if ongoing); "hands go numb" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Prednisone, reaction(s): "inflammation disease". Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot: FF8839; Anatomical location: Left arm), administration date: 29Sep2021, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "With the first 3 doses she usually gets a bump on the injection site"; BNT162b2 (DOSE 2, SINGLE; Lot: FF2593; Anatomical location: Left arm), administration date: 21Oct2021, when the patient was 57-year-old, for COVID-19 immunization, reaction(s): "With the first 3 doses she usually gets a bump on the injection site". The following information was reported: VACCINATION SITE MASS (non-serious) with onset 2022, outcome "not recovered", described as "With the first 3 doses she usually gets a bump on the injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that, the patient had attacks where it was hard to walk and use her hands because they go numb. The patient Sed. rate and C-reactive proteins were high. The patient was told it was inflammation disease. She was on prednisone for 2 years. Had test after test. Does not know the name of her disease. The patient was not on Prednisone anymore. Does not know if the prednisone helped whatever it was as she was able to walk and use her hands now. The patient did not receive other vaccines within four weeks prior to COVID vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201268928 same reporter, patient. Different dose and events.;
pt recvd DTP/HOBC on 14JAN93 & w/in 12 hrs p/vax, pt was found dead @ home; transported byEMTto local hospital & pronounced dead on arrival; autopsy scheduled;
Information has been received from a physician concerning a 59 day old male who on 05-NOV-2007 was vaccinated with a dose of Rotateq.  There was no concomitant medication.  On 08-NOV-2007 the patient  developed diarrhea 7 to 8 times a day, and a severe diaper rash.  The patient came into the office on 12-NOV-2007 because the diarrhea still did not stop.  At the time of the report the patient was recovering.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
A report was received from a health care professional on 11/04/2003 concerning a 6 month old male vaccinee who inadvertently received Fluvirin on 10/10/2003. The vaccinee had not experienced any adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. See Ref.: PJP200300984 and PJP200300985.
I had local soreness in the arm after receiving the vaccine for about a day. I began not feeling well with a stuffy nose, scratchy throat and fatigue. I tested positive for COVID-19 in 03/2023.  I contacted my doctor via the patient portal, and I got the prescription Paxlovid. I tolerated the medication without any difficulty. As of today, I still have a dry cough.
1) ongoing palpitations - started 4 p.m. Day 1 and continuing, it is now Day 5 2) chills - lasting 72 hours starting with vaccine day (Day 1) 3) extreme arm pain - starting on day after vaccine (Day 2) that lasted for 24 hours; pain went from ear to wrist 4) general arm pain - continuing, it is now Day 5 5) heavy menstrual bleeding - I am in perimenopause and haven't had any heavy bleeding in over six months. Heavy bleeding started on Day 4
10/25/2021  When I laid down at 11 pm my heart started pounding I'd wake up in the night sweating, still pounding,  even harder it seemed. I'd sit up and it would calm down but I wasn't feeling well I had weakness and difficulty breathing this happened for several days im still not right. On the second day my blood pressure was 199/98 and I'm always around 130/55 area. Its Nov 4 2021 so that's 10 days and I still don't feel right and the way I feel I will never get this brand flu shot again if any.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Jan2022 (Batch/Lot number: unknown) at the age of 69 years as dose 3 (booster), single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Anatomical location: Left arm, No problem), administration date: Jun2021, when the patient was 68 years old, for Covid-19 Immunization, reaction(s): "No Problem"; Bnt162b2 (Dose:2, Arm Left), administration date: Jun2021, when the patient was 68 years old, for Covid-19 Immunization, reaction(s): "So tired"; Bnt162b2 (Dose:2), administration date: Jun2021, when the patient was 68 years old, for Covid-19 Immunization, reaction(s): "stiffness and soreness especially on knees and hips", "stiffness and soreness especially on knees and hips", "little shortness of breath", "Fatigue", "stiffness and soreness especially on knees and hips". The following information was reported: ARTHRALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 2022, outcome "recovering" and all described as "Soreness in knees and hips"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "extreme fatigue"; ECZEMA (non-serious) with onset 2022, outcome "unknown", described as "Eczema on top of hands"; DECREASED APPETITE (non-serious) with onset 2022, outcome "unknown", described as "does not want to eat"; DYSPNOEA (non-serious) with onset 2022, outcome "unknown", described as "shortness of breath"; ANGER (non-serious) with onset 2022, outcome "unknown", described as "makes her angry"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "tired"; PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "itches especially at night"; FRUSTRATION TOLERANCE DECREASED (non-serious) with onset 2022, outcome "unknown", described as "frustrating"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "exhausted"; DEPRESSED MOOD (non-serious) with onset 2022, outcome "unknown", described as "super depressed". Additional information: Booster shot was on 07Jan2022. She does not have her vaccine card to produce a lot expiration or date for the first two vaccines or this booster dose. She confirmed that all 3 were Pfizer COVID vaccines. She noticed getting back to normal after 3-4 months after getting it. She got the flu shot and it was somewhere between the 2nd vaccine and booster. She does not have a date, manufacturer, lot or expiration for it. Patient was taken hydrocortisone and Neosporin for the treatment of eczema. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (COVID arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes (PME includes diabetes) since an unknown date. Concurrent medical conditions included Penicillin allergy (Allergies include penicillin). Concomitant products included ACETYLSALICYLIC ACID, METFORMIN and MULTIVITAMIN & MINERAL for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced DERMATITIS ALLERGIC (COVID arm). On 22-Jan-2021, DERMATITIS ALLERGIC (COVID arm) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Loss of hearing in left ear; tinnitus/echoing; numbness around area of left ear; This is a spontaneous report from a contactable health care professional (patient). A 46-year-old male patient received the second dose BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: El3248), via an unspecified route of administration, administered in the left arm on 18Jan2021 as a single dose for COVID-19 immunization.  Medical history included Hashimoto's disease, high cholesterol and is prediabetic all from an unknown date and unknown if ongoing. The patient has no known allergies. The patient did not have COVID prior to vaccintion and has not been tested for COVID post vaccination. Concomitant medications included empagliflozin (JARDIANCE); levothyroxine (manufacturer unknown); metoprolol (manufacturer unknown); rosuvastatin (manufacturer unknown) and fish oil (OMEGA 3 [FISH OIL]), all taken for an unspecified indication, start and stop date were not reported.  The patient previously received the first dose of bnt162b2 (lot number: Es1685) on 28Dec2020 at 12:00 PM via intramuscular route on the right arm for COVID-19 immunization. The patient experienced loss of hearing in left ear, tinnitus/echoing and numbness around area of left ear all on 22Mar2021 at 12:00. The ENT prescribed prednisone 10mg as treatment for the events. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded. 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 RAs, Ethics Committees, and investigators, as appropriate.
Only injected the liquid portion of Pentacel/no AE; Initial information received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from a Physician, other health care professional and consumer via Medical Information- 00823022.  This case involves a 4 month-old female patient who was only injected the liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included PNEUMOCOCCAL VACCINE 13V and HEPATITIS B VACCINE.  On 21-Oct-2021, the patient received 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via intramuscular route in the right thigh for prophylactic vaccination.  Batch number and expiry date of diluent was reported U6945AA and 09-Sep-2021 respectively.  It was reported "Stated that she has a question on the Pentacel. Only injected the liquid portion. Can the HIB component be mixed with saline and injected? HCP reports that today, a 4 month-old girl received only the DTaP-IPV portion of her indicated PENTACEL vaccine".  It was a case of an actual medication error due to inappropriate reconstitution technique (latency was on same day).   At the time of report, no adverse event reported.   Second dose of Act-HIB would be administered as corrective.  Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for Pentacel.
Hard red lump at injection site, increased from 5 cm up to 7 cm or slightly more over the course of the day. Very warm to the touch, not bumpy, just hard lump.
Pt. came in for a nurse visit for HPV #1 - noted both Rt. and Lt. deltoids were red and raised. Area cool to touch, both w/itching. Rt. delt approx. 8 x 9 cm reddened, raised area; Lt. delt. approx. 5 x 3 cm reddened, raised area. Informed FNP, she assessed areas. Instructed to apply ice packs to area and ordered BENADRYL to take Q 4-6 hrs as needed. HPV #1 was deferred x 1 month. Pt afebrile.
Pt admitted w/ respiratory distress, altered mental status due to basilar artery thrombosis causing brainstem and bilateral thalamic stroke.
Immediate: intense pain spread in arm. First Week: chills & aches, swollen tongue & throat, can't breathe deep, cough, chest pain. 2nd & 3rd Weeks: gradually worse. 19th night: heart attack, to ER in time, angioplasty, remove clot, stent, intensive care. Following Month: very gradual improvement (not all gone).
multiple outbreaks of herpes zoster; post herpetic neuralgia; vision problems; balance problems; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for the prevention of shingles (herpes zoster).  On an unspecified date, shortly after receiving the vaccine, the patient suffered multiple outbreaks of herpes zoster, post herpetic neuralgia, vision problems and balance problems. As a direct and proximate result of the plaintiff's symptoms had resulted in physical limitations not present prior to using the vaccine. Plaintiff also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), plaintiff sustained severe and permanent personal injuries. Further, as a tragic consequence of Merck's wrongful conduct, Plaintiff suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Patient got the expired Covid vaccine (vaccine expired on 02/12/22). No ADEs is reported. Called Pfizer medical rep and she said there is new data that Covid vaccine ( purple cap) is stable in the fridge for 45 days. Advised patient to call doctor if the new data is acceptable. if not, revaccination is required
itching, difficulty breathing, lips swelling, red face. About 10 minutes after vaccines were give dad noticed above symptoms patient was still in clinic. Dr evaluated 2.5mg neb of albuterol was given and 10cc of benadryl was given.
patient was given 0.3ml  pfizer bivalent 5years-12years not diluted. no adverse reaction or signs and symptoms of allergic reaction noted.
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 70-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 19-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805512 was crossed linked to original case 201804863 due to same reporter.
Information has been received from a consumer who knew of a 77-year-old female who was vaccinated on an unspecified date with a dose of ZOSTAVAX (product circular# 9815604). Subsequently, on an unknown date, the patient developed shingles. No additional information about the patient was available. No product quality complaint was involved. Additional information has been requested.
Information has been received from a physician concerning a 25 month old male patient who on 19-SEP-2008 was vaccinated with his first dose of VAQTA (lot# and manufacturer unknown), 50U/0.1ml in another country. It was reported that on an unknown date, the patient developed an intermittent rash which lasted for a year after administration of his first dose of VAQTA. The patient had sought medical attention via office visit and was diagnosed with Gianotti-Crosti syndrome after a skin biopsy (detail unreported). The patient "currently" had hyperpigmented marks on his skin. At the time of report, the patient was recovering. Follow up information has been received from the physician concerning the child who developed Gianotti-Crosti syndrome after receiving the first dose of VAQTA on 19-SEP-2008 in another country. Relevant diagnostic tests and laboratory data were done in another country (result unspecified). The patient was hospitalized and recovered (date unspecified). Additional information has been requested.
blisters and redness on bilateral forearms/ diagnosed with herpes zoster, varicella-like rash and drug dermatitis; blisters and redness on bilateral forearms/ diagnosed with herpes zoster, varicella-like rash and drug dermatitis; blisters and redness on bilateral forearms/ diagnosed with herpes zoster, varicella-like rash and drug dermatitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or around 23-OCT-2017, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date, shortly after receiving zoster vaccine live(ZOSTAVAX), the patient suffered blisters and redness on bilateral forearms and was diagnosed with herpes zoster, varicella-like rash and drug dermatitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered all events to be disabling and related to Zoster Vaccine Live(ZOSTAVAX).
On 2/10 about 2 hours after the shot, my arm was too sore to move and I was extremely thirsty.  I had trouble sleeping because of the pain in my arm. On 2/11 I was exhausted, still thirsty, had muscle aches (especially in my calves) and dull headache.. On 2/12 I felt better in the AM. but by afternoon all symptoms returned, lower back ached, I was queasy. On 2/13 I felt better but was very tired.   After that I felt more like myself for the next 5 days.  Today, 2/18 at 3PM I developed a rash at the injection site.  It was very itchy.  I used calamine lotion to calm the rash, which helped.