chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my right cheek began feeling numb/ travelled up to my left temple, then later to my right temple and across my forehead. Later that night went across the top of my head; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 23Feb2021 17:45 as dose 1, single for covid-19 immunization at pharmacy or drug store. The patient medical history included high BP, thyroid. Concomitant medications included atenolol, l-thyroxine [levothyroxine], calcium carbonate (CALTRATE [CALCIUM CARBONATE]), all taken for unknown indications from an unknown date. Other medications received in two weeks included atenolol, L-Thyroxine, Caltrate, supplements. The patient previously took codeine and experienced allergies. The patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid. Post vaccination, the patient has not been tested for covid. It was reported that, on 23Feb2021 at 18:30, within 1 hour of dose her right cheek began feeling numb. She liken the feeling to right after Dentist gave a shot of Nova Caine, that first numb feeling. The numbness remained in the cheek for approx 2 hours, travelled up to her left temple, then later to my right temple and across her forehead. Later that night went across the top of her head. It was gone the next morning, she would say it lasted 5-6 hours. No treatment was received for adverse event (AE). The outcome of the event was recovered on an unspecified date of 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vaccine expiration 06/31/2022 from manufactory date of October 2021. Patient was given an injection 1 day after expiration. Patient reported no problems when contacted.
Patient approached pharmacy on 4/6/23 around 11:15 am stating that ever since she had her updated booster shot in November that her arm has been sore, almost feeling like it was bruised, but that there was nothing visible there.
Generalized itching; Inappropriate Schedule of Vaccine; Shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced shingles in January and March 2018). Previously administered products included Zostavax (received when it was first marketed).   On 20th July 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In September 2019, 14 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced generalized itching and incomplete course of vaccination. The patient was treated with cetirizine hydrochloride (Zyrtec), cetirizine hydrochloride (Cetirizine) and valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles, generalized itching and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles and generalized itching to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Nurse for her mother. The reporter stated that the patient developed generalized itching two weeks post injection. The patient was treated with prescription for Zyrtec and Cetirizine. In September 2019, patient was confirmed with a case of Shingles by her primary care physician. The patient was treated with 2 weeks of Valacyclovir. Till the time of reporting patient did not receive the vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow up.
6-inch, raised, warm, itchy rash on arm for several days; body aches; tired; headache and nausea.
weak and tired, cannot get out of bed/hard to raise her head she is so weak; weak and tired, cannot get out of bed; slight shortness of breath; body aches but they have been worse; This is a spontaneous report from a contactable nurse. This 82-year-old female nurse (patient) reported.  An 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8734), dose 2 via an unspecified route of administration, administered in Right arm on 31Mar2021 (at the age of 82-years-old) as dose 2, single for covid-19 immunisation. Medical history included rods in back from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6206), dose 1 via an unspecified route of administration, on 10Mar2021 (at the age of 82-years-old) as dose 1, single for covid-19 immunisation and felt her arm was going to explode, Tired and shortness of breath after first dose of vaccine, she had a rotator cuff in her right arm that needed to be repaired which was an issue prior to the vaccine, and that was probably why it hurt so badly and had gotten better. Exact details were not provided. On an unknown date in Apr2021, the patient experienced weak and tired, cannot get out of bed, slight shortness of breath and body aches but they have been worse. The reporter stated that she had her shots last month, clarifies the Pfizer Covid vaccines, states 31Mar2021 was her second dose, first dose was 10Mar2021, states she felt fine until this past weekend. On an unspecified date on Apr2021, the patient stated that she has slight shortness of breath, is very tired and weak, cannot stay out of bed, has a hard time getting up. Her appetite is great, no nausea or vomiting or anything. States her symptoms started this week, no exact dates provided. The reporter stated she has rods in her back so maybe that is why she cannot get out of bed, she needs help, states it is hard to raise her head she is so weak, has to use her hands, states she typically deals with body aches but they have been worse this week. The reporter states that all of her symptoms have just been persisting since they started this week. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous case, initially received from the pharmacist on 03-Nov-2017, concerning a 60-year-old adult female patient. It was reported that, the vaccine seems to be clear white looking with many very small fiber looking particles. Reported that, the product was agitated for 10-15 seconds, where some of the particles were dissolved after agitation. The vaccine was stored in temperature of 41 degrees, where no temperature excursions was noted. It was reported that particulate was found when it was preparing to administer. The PTC number was 452078. On an unspecified date, the patient was administered with AFLURIA QUADRIVALENT PFS (pre-filled syringe) with the presence of particular matter (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XF33108 and expiry date: 30-Jun-2018).
pt was inadvertently immunized w/DTAP SC on 24SEp92 following day exp inject site react of swelling & induration; As of 1OCt92 local reaction, size of a quarter & pt feeling very tired;
Mother states that patient has a itchy rash on the back of his hand although vaccine was administered in his thigh. Advised her to call the pediatrician for follow-up. We called the pediatrician and notified them of her concerns.
Within 30 minutes post vax pt experienced generalized muscle aching which resolved. 3 days later, pt experienced flu like symptoms, fever, general body aches and back pain. No diagnostic tests were performed to evaluate the pts back pain. The right lumbar back pain is ongoing. A doctor visit was required and the pt was treated with Naproxyn from 07/31/2000 to 08/09/2000 at a dose of 250 mg bid. As of 08/24/2000 the outcome of the event is ongoing.
Info has been received from a physician concerning a 9 year old male with no medical history who on 6/22/59, at 3 years of age, was vaccinated, SC, with a 0.5 mL dose of varicella virus vaccine live (Lot 629901/0116J). There was no illness at the time of vaccination. The physician reported that on 8/18/05, the pt presented to the office with chickenpox characterized by lesions all over his body. No lab/diagnostic tests were performed. As of 8/22/05, the pt was noted to be recovering as his lesions persisted, but he had no fever and felt fine. Additional info has been requested.
Patient inadvertently injected with undiluted Pfizer vaccine.  Treatment: Observation, ice application to injection site Symptoms: Tender deltoid muscle
Achy, light headed @ 3 a.m....went to kitchen to take  Tylenol , took it & then passed out on the kitchen floor.   I landed on my bottom & then I was aware of what happened.  Only happened once, & was feeling  somewhat better by around 11.  Husband was concerned, so this is why I'm sending this your was
Breakthrough case of COVID-19:  I had congestion, sneezing, coughing, body aches, fatigue. I am currently positive for COVID-19 and isolating.
Patient given vaccines at end of visit, Mom & patient left and went across the street for something to eat - Mom noticed hives & redness with itching - returned to office & was given BENADRYL 7.5 ml, Sat 98%, ORAPRED 30 mg given, patient watched for 60 min - patient was better sent home with instructions.
pt c/o tenderness, pain, redness & swelling in upper lt arm;redness & swelling proximal to inj site;states pain & hardness in arm & has increased daily to make it difficult to raise arm;referred to MD
RN consulted me about 5-10 minutes after her injection  in her left deltoid.  Upon observation, it was obvious that she was developing a small hematoma that was slightly raised about the size of a nickel, however she denied any pain on palpation.  We recommended that she sit in our observation area for 30 minutes and I had our RN observer place a cold pack on her deltoid.  I checked on her again in 20 minutes and the hematoma had appeared to reduce in size.  I reviewed strict return precautions with her, and reminded her to come back to the ED should this site start to swell again in size and become painful.  She planned to return home and will keep the arm elevated and keep a cold compress on this site.
A full body rash that was hot, itchy, and very painful. Unable to sleep for 3 nights from 2/23-2/25/21 MD prescribed 6 day course of prednisone and Zyrtec
Does not move as fast as she used to; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization; Bnt162b2 (Second dose), for Covid-19 immunization. The following information was reported: BRADYKINESIA (non-serious), outcome "unknown", described as "Does not move as fast as she used to".  Additional information: She stated she does not move as fast as she used to when going to get something to write with. The patient stated that she had not experienced any adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician, as part of a marketing research program conducted by Market Research Agency, refers to a 63 year old male patient.  On an unknown date in 2013 the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (manufacturer unknown) (route, lot number and expiration date not reported). There was no concomitant medication reported. On approximately 01-NOV-2013 (beginning of November 2013) the patient had to be hospitalized because of neutropenia. The outcome of neutropenia was reported as recovered/resolved on 01-DEC-2013. The reporter considered neutropenia to be related to Pneumococcal Vaccine, Polyvalent (manufacturer unknown). Additional information is not expected.
stomach cramps; Tingling in hands; This is a spontaneous report from a non-contactable consumer. A 79-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 27Feb2021 10:00 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation. Patient received the first dose of vaccine intramuscular on 06Feb2021 10:00 (Batch/Lot Number: EM9810) for covid-19 immunization, and experienced numbness in hands/arms, excruciating cramps in stomach. Medical history included ongoing diabetes, ongoing high blood pressure (BP), ongoing high cholesterol. None concomitant medication. The patient experienced stomach cramps on 03Mar2021 AM with outcome of unknown, it required visit to Physician Office, doctor stated lack of H2O but didn't receive treatment. Patient also experienced tingling in hands on 03Mar2021 with outcome of unknown. The events were reported as non-serious.  No follow-up attempts are possible. No further information is expected.
This case was reported by a physician via sales rep and described the occurrence of swelling in a child male patient who received MENVEO (batch number M16172, expiry date unknown). On 17th April 2018, the patient received MENVEO .5 ml. In April 2018, less than a week after receiving MENVEO, the patient experienced swelling, erythema and feeling of warmth. On an unknown date, the outcome of the swelling, erythema and feeling of warmth were recovered/resolved. It was unknown if the reporter considered the swelling, erythema and feeling of warmth to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe swelling, redness and warm and went to ED on 19th April 2018. The events were resolved shortly after ED visit.
Started with an itchy head. Next day had neck rash. Developed into rashes that move all around my body- full back, abdomen, arm, calf, chest.  Sometimes start itchy then I scratch them and get dermatographia and many of the scratches turn to welts. The redness and welts usually go away on their own after 20 minutes. Sometimes the rashes appear and I don?t feel them.  I continue to get these daily.  Today was another bad day- full abdomen(especially where my clothes touch) and both arms.  Some days I will have 10 rashes and some days 2- varying in intensity.
Vaccinated with two days prior expired vaccine; Inappropriate schedule of vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated with two days prior expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Biontech Covid-19 vaccine (Dose 2) and Pfizer Biontech Covid-19 vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer Biontech Covid-19 vaccine and Pfizer Biontech Covid-19 vaccine.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated with two days prior expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Vaccinated with two days prior expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   30 days expiry date was on 3-Jan-2022.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.  Patient had no other adverse reaction.
BLOOD CLOTS; BACKACHE/BACK PAIN; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included backache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included oxycodone for backache/back pain.  On MAR-2021, the subject experienced blood clots. On MAR-2021, the subject experienced backache/back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots, and the outcome of backache/back pain was not reported. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jun2021 as dose 1, single (Lot number: BW0168), in left arm, on 14Aug2021 as dose 2, single (Lot number: EW 0168), in left arm, on 09Dec2021 as dose 3 (booster), single (Lot number: FJ8757), in left arm and on 21Jul2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 53 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: LOSARTAN taken for hypertension, start date: 01Jun2016; VENTOLIN [SALBUTAMOL] taken for inhalation therapy, start date: 01Jun2016. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8733), in left arm, on 16Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 21Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 39 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE MAGNESIUM]; ZYRTEC [CETIRIZINE HYDROCHLORIDE].  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (09Sep2022) Positive, notes: Rebound COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with Paxlovid from 31Aug2022 to 05Sep2022.  No follow-up attempts are possible. No further information is expected.
Developed a fever and fatigue six days after vaccination (10/6/2020). Fever resolved by 10/13/2020 but took about 6 weeks until his mood and energy were back to baseline.
Fever; body ache; a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm), PYREXIA (fever) and MYALGIA (body ache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 immunisation.  No Medical History information was reported.  On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (a sore arm), PYREXIA (fever) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, PAIN IN EXTREMITY (a sore arm), PYREXIA (fever) and MYALGIA (body ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-068507 (Patient Link).
Patient stated feeling dizzy and had syncopal episode witnessed by nurse for 1 minute Patient provided water and seen by medical team The medical team advised patient to be seen in the hospital but patient refused medical transport and signed AMA form Patient agreed to stay in monitoring longer, patients symptoms resolved and was able to ambulate independently with no dizziness
10/23 Left arm swollen, hot and extremely painful to touch; 10/24 less painful to touch and decrease in edema; 10/25 no edema; pink from mid-bicep inner aspect above elbow to deltoid.
Swelling, pain, redness elbow to shoulder and 3-4 inches across upper back
After ~ 10 minutes, I had a metallic taste in my mouth.  Upon leaving the facility after sitting for 30. minutes, I had lip/tongue/roof of mouth prickly feeling exactly the same as initial reactions in food allergies that I have developed over the past two years.  The reaction worsened and I pulled over and drank some water.  I did not have an epipen or benedryl.  After about 10 minutes, I proceeded home, took a benedryl and called my PCP for advice.  There is no instruction or guidance  for allergic reactions  to the vaccine that do not require an epipen so I do not know whether to have a second dose. It is well known with food allergies that such a reaction can worsen with exposure.
Pt had itching that continued 1 week after immunization. She said that she has some redness since she was scratching it but no other reactions.
Flare up of migraine headache, fever, burning type radiation from injection site up left shoulder and left side neck, left arm erythema / inflammation.  Patient took Claritin and 800mg Ibuprofen which seemed to help sx. Symptoms subsiding at time of f/u appt 5/25/19. Has f/u with PCP in 1 week for re-eval.
Within less than 24 hours of taking the vaccine, I was rushed to the ER and diagnosed as having a stroke.
This spontaneous report as received from a pharmacist via a field representative refers to 3 patients of unknown age and gender. Relevant medical history and concomitant medication were not provided. On an unknown date the patient was vaccinated with ZOSTAVAX. Lot number, dose, route and frequency were not provided. On an unknown date the 3 patients experienced large rashes in diameter, swollen and warm to touch, kind of look liked cellulites. The outcome of large rashes in diameter, swollen and warm to touch, kind of look liked cellulites was reported as recovered/resolved. The reporter causality was unknown. Additional information has been requested.
Headache, fatigue, muscle aches, dizziness, nausea and vomiting started 6-8 h after vaccine and was maximal at 40 hours.   Pancytopenia with WBC  of 2.2, platelets to 150,000 and anemia of 9.8
Patient arrived to urgent care one day after getting the third covid jab booster because she is feeling awful. Body pain, terrible headache and very bad cough. Pain in chest that radiates to the back.