chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her mother tested positive for COVID-19 after being vaccinated with the Pfizer COVID-19 vaccine and this happened about a month after her second dose; her mother tested positive for COVID-19 after being vaccinated with the Pfizer COVID-19 vaccine and this happened about a month after her second dose; This is a spontaneous report from a contactable consumer. This consumer (daughter) reported for a female patient (mother). A female patient of unknown age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) on 13Apr2021 via an unknown route at single dose on the unspecified anatomical location for COVID-19 immunization. First dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) on 23Mar2021. Relevant medical history and concomitant medication were not reported. On an unspecified date, a month after her second dose the patient was tested covid-19 positive after being vaccinated with the Pfizer COVID-19 vaccine. Consumer stated that she filed a report for herself, however, she did not file an official report for her mother. She did confirm that she informed them about her mother's AE. Vaccine is not providing as much protection as thought since my mom got COVID after being fully vaccinated with the Pfizer covid vaccine for a month. If her mother wants to call she can do a report and reporter declined to complete report at this time on her mother. Outcome of the event is unknown.  Information on lot number/batch number has been requested
A severe cough started five days after my 10/23/2004 flu shot. I also had a severe cough starting three days after a flu shot on 10/20/2003. In both cases, the intermittent cough continues for many weeks.
Patient had a reaction 1 week after receiving the vaccine she had nerve pain that went down from her arm to below her breast
Narrative: Patient is a 70 year old old MALE who received the 1st dose of COVID vaccine 3/3/21. Spoke w/pt today RE: adverse reaction related to the vaccination.------------------------------------------------- ----------------SYMPTOMS: Fever No If yes temp: n/a Fatigue No Myalgia Yes Arthralgia No Rash/Hives No SOB No Bell's Palsy No Injection Site Reaction No Other Yes If yes describe: muscle aches and dizziness 24 hours after vaccine. Muscle aches resolved with OTC Tylenol.
yeast infection; This is a spontaneous report from a contactable healthcare professional (reported for herself). A 36-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL0140; expiry date: not known), intramuscular on 18Dec2020 and second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3246; expiry date: not known), via an unspecified route of administration on 08Jan2021, both in the right arm at single dose for COVID-19 immunization, administered in hospital. There was no medical history. No known allergies. The patient is not pregnant. Concomitant medications included ibuprofen (ADVIL), dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL), and valaciclovir hydrochloride (VALACYCLOVIR) (medications received in two weeks). The patient had no COVID prior vaccination and not tested post vaccination. The patient experienced yeast infection on 19Dec2020. This event got by the patient for both doses. No treatment received for this event. The outcome of the event was recovered on an unspecified date.
Patient complained of palpitation and hypertension ~20minutes post 2nd Pfizer COVID vaccine.
had a breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  An 8-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFECTION (non-serious), outcome "recovered", described as "had a breakthrough infection".  Additional information: The patient had a breakthrough infection 2 weeks after completing full vaccination for COVID-19 her symptoms were mild and short lived.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Admitted 8/27/2022 for SOB, fever, cough, chills, nausea, fatigue, weakness, and myalgia, and malaise; reason for visit.  Discharged 8/29/2022
FEVERISH AND FEVER LIKE SYMPTOMS; SHAKING; SWEATING; FELT COLD; POUNDING HEADACHE; FELT TIRED; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included prothrombin gene mutation - increased risk for blood clot (predisposition), amoxicillin allergy, occasional alcohol use, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) .5 ml, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced feverish and fever like symptoms. On 03-MAY-2021, the subject experienced shaking. On 03-MAY-2021, the subject experienced sweating. On 03-MAY-2021, the subject experienced felt cold. On 03-MAY-2021, the subject experienced pounding headache. On 03-MAY-2021, the subject experienced felt tired. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish and fever like symptoms, shaking, sweating, felt cold, pounding headache, and felt tired on 04-MAY-2021. This report was non-serious.
Moderate to severe pain in arm, shoulder, back started about one hour after shot. Lasted until next morning. No medication taken. Moderate headache lasting through next morning, general grumpiness for 2 days, brain fog beginning following morning - forgetfulness, depression. Still continued through today (Monday, March 1, 2021). Symptoms are not severe, but are acute enough that they are impacting quality of life.
Headache, dizziness, body aches, redness, soreness and swelling of injection site. Pt evaluated by P.A. and was told to ice inj site and take an anti-histamine and call us if streaking/worse.
While preparing vaccines for administration at 9:36am on 5/24/18, the RN inadvertently pulled MENACTRA vials instead of the Sterile Diluent vials from the vaccine fridge. The MENACTRA vaccines were documented in place of the diluent. The MMR and Varicella vaccines were reconstituted with 0.5ml of MENACTRA each. Both vaccines were administered to the patient subcutaneously as documented. Error was discovered at the end of day on 5/24/18 - MD in office notified; ordering physician notified patient's parents the morning of 5/25/18. No adverse signs or symptoms reported at that time.
She developed entire upper body redness like a slight sunburn. No itching. No rash. No difficulty breathing. She had the vaccine on 09/25/18 sometime in the morning and woke up on 09/26/18 with this redness. She applied lotion with aloe. No medications taken. No medical treatment required. I saw her in the employee health clinic on 09/26/2018 that morning. She was given a dose of flu vaccine that was from a multidose vial. She did mention that in the past she has problems with using contact solution which caused redness and itching of her eyes. I saw her after lunch and the redness was subsiding. I spoke with her via phone today 10/01/18 and she stated that the redness had subsided by the following day and that she was fine.
Sore arm dose 1 Flu like symptoms, extreme joint pain and body aches, Headache, fatigue  dose 2. And lasted 4 days
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 02-OCT-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 912 hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Received MMR on 4/5/06. On 4/11 spiked temp of 103.3 after 2 days of being tired and low grade temp. Next morning had developed scattered red, raised bumps on face, scalp, arms, legs, neck, back and buttocks. Denies they were fluid filled: only raised bumps. Disappeared by day 12 or 13. Was placed on Zithromax for sinus infection after rash appeared.
18OCT95 mom called & reported pt recvd vax 17OCT95 & noticed sl rash in legs PM p/vax; took pt to lifeline & saw MD said thought there was no rxn from the shots but to call clinic;
Subsequently the pt experienced a breakthrough rash with less than 50 lesions. Unspecified medical attention was sought.
pt recv vax LMP 7JUN98 not aware of pregnancy @ time of vax 15JUL98 began spotting & went to see MD;pt was told on this day was pregnant (5wk) but was threatening spontaneous abortion;
SMALL NEEDLE IN THE HEART AND IT WAS PAINFUL, HEART PAIN WAS STILL HAPPENING THOUGH IT GOES ON AND OFF; CRAMP IN HER LEFT CALF (OUTER SIDE OF THE LEG); This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cat allergy, and lot of unspecified allergies, and other pre-existing medical conditions included: The patient was athletic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 14-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On JAN-2021, (7 month ago) Laboratory data included: Blood test (NR: not provided) Everything was perfect.  On 14-AUG-2021, within 15 minutes after received vaccine, the patient experienced small needle in the heart and it was painful, heart pain was still happening though it goes on and off. The patient never experienced anything like that before. It lasted 1 minute and went away. On the same day, 20 minutes after getting the vaccine, the patient experienced cramp in her left calf (outer side of the leg). Then it went away in a few minutes. Then she got these two symptoms 4 or 5 hours later that night. It was reported that the heart pain was still happening though it goes on and off. The patient did not contact any Doctors. She was waiting to contact a cardiologist The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cramp in her left calf (outer side of the leg), and had not recovered from small needle in the heart and it was painful, heart pain was still happening though it goes on and off. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210857265.; Sender's Comments: V0: 20210857104-COVID-19 VACCINE AD26.COV2.S- small needle in the heart and it was painful, heart pain was still happening though it goes on and off. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
sore arm; This is a spontaneous report received from a contactable reporter (consumer) from Medical Information Team. The reporter is the patient. A 73-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 30Mar2021 at 14:00 as dose 2, single (lot number ER8733) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "cirrhosis from hepatitis C" (unspecified if ongoing); "hepatitis C", start date: 1981 (unspecified if ongoing), notes: got this from a hospital 40 years ago (from 2023); "car accident" (unspecified if ongoing); "encephalopathy" (ongoing); "didn't know own name or name of president" (unspecified if ongoing). Concomitant medications included: XIFAXAN taken for encephalopathy, start date: 2020; ZINC; GENERLAC taken for hepatic cirrhosis; LACTULOSE taken for hepatic cirrhosis. Past drug history included: ammonia, reaction: "goes into the brain, messes your brain up". Vaccination history included: BNT162b2 (dose 1; lot number EN6199), administration date: 06Mar2021, for COVID-19 immunization, reaction: "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Mar2021, outcome "recovered" (2021), described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: For medical history hepatitis C, the patient got this from a hospital 40 years ago. She was in a car accident and they didn't screen the blood for hepatitis C, they didn't even know hepatitis C existed yet. When she got this, it kind of messed up her liver, so she got cirrhosis. If not for Xifaxan and Generlac she would probably be in a home, because she ended up in hospital; couldn't figure out how to go to bathroom. She knew she had to go, couldn't figure out how to do it, didn't know her own name or the name of the president. They just loaded her up with Generlac and that was about it. Xifaxan really, really helps, she wouldn't be able to function without it. It has to do with gut, kills bad bacteria, that's why it works. On 30Mar2021 the patient experienced just a sore arm; usually just a little sore when she slept on that side, a little uncomfortable; no other side effects whatsoever. The sore arm recovered completely a couple of days later. She has not required any treatment or medical interventions.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300073682 same patient/product, different vaccine dose/event;
Initial information received on 11-Dec-2018 regarding an unsolicited valid serious case received from a health professional. (Pharmacy Director). This case is linked with case 2018SA388771 (same reporter). This case involves a 36 years old female patient who experienced neuropathy on her arm, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided. On 02-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1817 via unknown route. On an unknown date, the patient developed a serious neuropathy on her arm 2 weeks following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant as per Important medical event. No lab test was reported. Final diagnosis was neuropathy on her arm. It was not reported if the patient received a corrective treatment. Outcome of the event was not reported. List of documents held by sender: none. Sender's Comments: Patient presented with peripheral neuropathy after vaccination with FLUBLOK QIV. Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information, the role of vaccine cannot be assessed.
Inappropriate Sinus Tachycardia, shortness of breath, and near syncope on first day of symptoms  IST has continued for 2+ months in sporadic moments, sometimes paired with physical exertion, other times at rest
vaccination was given in the evening. the following AM she had a rash on face and over torso
Irregular periods, extreme heavy periods, extremly late periods. I have been on a regular cycle my entire life. Now everything has changed
morning after first dose woke up with Shortness of breath,i was shaky and struggled to basic tasks. i had basic vital equipment so i took my vitals.mind you i previously discussed orthostatic hypotension with my primary care provider  before my vaccintion.my vitals that day were 139/108 my pulse being 132. my ekg was irregular. i had tachycardia. my er provider told me it was a vaccine reaction and it should go away om its own within a few weeks,it didnt.i later saw my primary care provider and he wasnt able to put me on medication due to my previous history with love blood pressure. today,over nine months later i stil have bouts of high blood pressure.just getting a package off my porch it was 130/95 pulse 131
The vaccine did not prevent shingles; persisitent strain of herpes zoster, also known as shingles/ blistering vesicular outbreak diagnosed as severe herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose #, route and anatomical location were not specified) for routine adult health maintenance for the prevention of shingles. On an unspecified date, the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, 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. The outcome of vaccination failure and herpes zoster was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). Additional information has been requested.; Sender's Comments:  US-009507513-0506USA02718: US-009507513-0510USA07841:
This spontaneous report as received from a physician via company representative, refers to a currently 83 year old female patient. The patient had a medical history of shingles. On approximately January-2012, reported as approximately two years ago, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route, lot and expiration dates were not reported) for shingles prevention. Co-suspect or concomitant therapies were not reported. Since approximately January-2012, the patient had had recurring bouts of shingles on unspecified dates after being vaccinated with ZOSTAVAX. The patient reported that the shingles outbreak after vaccination followed the same dermatome as the shingles outbreak prior to being vaccinated. Also stated to had ongoing pain and neuralgia with the current outbreak of shingles and felt that the symptoms of the shingles virus had not lessened in severity and/or duration after having been vaccinated with ZOSTAVAX. The outcome for shingles was unknown at the time of the report. The patient was treated with Acyclovir and an unspecified topical cream on unspecified dates. This is one of two reports from the same source. Additional information has been requested.
Two days after vaccine administration I began having severe vertigo, where it has been difficult to walk. It has been four days since I was vaccinated, and I am still having episodes of vertigo, when I turn my head or get up too quickly. I have not gone to the doctor for this, as I had an episode of vertigo years ago, and it went away on its own. I am not sure if this current episode is related to the vaccine, but I think it may be, which is why I am reporting it.
This case was reported by a healthcare professional via a sales representative and described the occurrence of not responding to therapy in a 14-year-old female subject who was vaccinated with Hep B (manufacturer unspecified). On 20 November 1997 the infant subject received the final dose to complete the Hep B vaccination series. Years later, at the age of 14, serology showed that the subject did not have protective antibodies. It was reported that the subject did not convert or had not responded to therapy. No additional details were provided. This event occurred in 4 separate subjects. Linked cases are A0941135A, A0941136A and A0941137A.
back pain; Left leg it keeps shaking alone; This is a spontaneous report from a contactable consumer (patient's mother). A 17-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Apr2021 09:30 at 17-year-old at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter (caller) calling about her daughter. Asked if these were normal symptoms and should be worried. Caller reported that her daughter took her first vaccine dose at 0930 this morning. She reports that her daughter has never had a flu shot or vaccine of this kind. She reports that they waited the recommended 15 minutes after getting the vaccine. They got home and about 30 minutes after the vaccine (15Apr2021 10:00) her daughter started having back pain, slight back pain and her left leg it keeps shaking alone. She reports that when she stands up it shakes, and it comes and goes. She asks if this is normal or should she be concerned. Caller reports that she already spoke with safety, no reference number for that encounter. Caller reported that she wanted to end the call so she could call her doctor, she did not provide any additional information at this time. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Administered an expired dose.; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 11th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comment: The reporter was a clinic supervisor. The reporter asked for information regarding the administration of an expired dose of Twinrix to a patient. The reporter wanted to know about the information regarding revaccination. The reporter did consent to follow up. Additional supportive information: The patient received a Twinrix which was already expired, which led to expired vaccine used.
Information has been received from a female nurse who reported that "every time she administers ROTATEQ she develops diarrhea. medical attention was not sought. The outcome was not reported. No product quality complaint was involved. Additional information has been requested.