chrisvoncsefalvay/vaers-outcomes huggingface dataset:
massive stroke; This is a spontaneous report received from a non-contactable consumer or other non hcp for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient (unknown if pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Dec2021 (Batch/Lot number: unknown) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Dec2021, outcome "unknown", described as "massive stroke". Caller mentioned that she was involved in the situation where she got massive stroke twice after taking the COVID-19 vaccine 2 weeks ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a delayed response to Covid 19 vaccine by one week, March 13th 2021. I had a bright red rash on hand, thighs, buttocks, with small blisters in between fingers and inside upper and lower lips. Also, had hives, welts, and swelling of these areas. Severe itching that did not subside. On March 14th I went to urgent care, by Tuesday March 16th it was worse, went to see Doctor and she increased Pepcid and prednisone dosage that I was given at urgent care. She increased my Zyrtec that I was taking from home and added Singulair. She did labs at this time. I was much better the week of March 21st and advised to see an allergist. Saw him on March 23rd, and he advised no more vaccines until her could test me. So far, April 1st there is no Pfizer vaccine available for test. I'm making another virtual appointment for April 20th.
Received Vaccine on 02/26/2021 and on 03/06/2021 around 10:00 AM started having double vision, thought it was due to contact lenses so took them out put on glasses but double vision continued. Could not do anything without closing one eye, so called eye doctor and had appt. Eye exam was done and  was told that one of the eye muscles was inflamed, stated would need to use a temporary prism on glasses, wanted to see if inflammation would go away on its own. Double vision started to slowly get better and by the end of March it was gone, then as soon as vision cleared started to get Vertigo, which lasted all through April, and by May no longer had any symptoms and was back to normal.
no adverse effects reported; the patient inadvertently received a dose of VARIVAX via intramuscular route; This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about patient's concurrent conditions or pertinent medical history. Concomitant therapy included sterile diluent(MERCK STERILE DILUENT).     On 29-MAR-2019, the patient was inadvertently vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) via intramuscularly, lot number N034559, expiration date 05-DEC-2019, for prophylaxis. No adverse effects were reported.
fever; chills; nausea; increased heart rate; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (Pfizer-BioNtech Covid-19 Vaccine, Solution for injection), via an unspecified route on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced fever, chills, nausea and increased heart rate. Patient wanted to know if it was safe to take the second dose. The patient underwent lab test and procedure which included increased heart rate. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a spontaneous report from a contactable nurse. A 17-year old male patient received TRUMENBA, (lot number: S26985, expiration date: 31Jan2019) intramuscular on 13Aug2018 at 0.5 ml, single for pre-college admission. The patient was not suffering from any other medical conditions and was not taking any other medications. On 13Aug2018, the patient had fever and body ache for about 24 hours right after taking meningococcal group b rlp2086. The patient did not undergo any lab work or blood test. Therapeutic measures were taken in response to fever and body ache which includes ibuprofen. The patient recovered from fever and body ache both on an unspecified date in Aug2018. The reporter considered fever and body aches related with meningococcal group b rlp2086.
Experienced significant improvements in Multiple Sclerosis symptoms; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EL9264 Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 18Feb2021 at 19:45 (at the age of 58 years old) as second dose, single for COVID-19 immunisation. The facility where the vaccine was administered was reported to be "other". Medical history included multiple sclerosis, restless leg, alopecia, lymphedema and venous insufficiency stasis, all from an unknown date. Patient has known allergies to interferon Beta-1A (REBIF), amoxicillin and hydrochlorothiazide on an unknown date.  The patient was not pregnant at the time of vaccination and prior to vaccine the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number: EN5318), via an unspecified route of administration, administered in right arm on 28Jan2021 at 05:00 PM (at the age of 58 years old) as single for COVID-19 immunisation. Concomitant medications included baclofen, furosemide, levothyroxine, mirabegron (MYRBETRIQ) and bupropion hydrochloride (WELLBUTRIN), all taken for an unspecified indication, start and stop date were not reported. On 19Feb2021 at 06:00, the  patient experienced unexpected therapeutic effect further described as significant improvements in multiple sclerosis symptoms including extreme reduction in inflammation. The patient was able to move her hands and feet freely, which are always stiff and difficult to move, and unable to make a fist with her hands. No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
TWO BREAKTHROUGH COVID-19 INFECTIONS; SUSPECTED CLINICAL VACCINATION FAILURE; PAIN RADIATED DOWN THE ARM; This spontaneous report received from a patient concerned a 42 year old female of unspecified race. The patient's height, and weight were not reported. Patient was not pregnant or breastfeeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 10-JUL-2022) dose was not reported, 1 total, administered on 16-DEC-2021 at left arm for prophylactic vaccination. Concomitant medications included cyanocobalamin (Vitamin B12) and salbutamol (blue inhaler). On an unspecified date, the patient experienced chest pains, pain radiated down her arm, heart palpitation, shortness of breath, rapid heart rate and had two breakthrough COVID-19 infections ever since she received the JNJ vaccine and had suspected clinical vaccination failure. Patient went to her PCP who advised her to go home and relax. Laboratory data included: Heart rate (NR: not provided) 117 beats/min even when she stood still. Patient stated that she monitored her heart rate and said that it went even higher when she moved around. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough covid-19 infections, had not recovered from pain radiated down the arm, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000222820.; Sender's Comments: V0: 20220342279-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure . The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related. 20220342279-Covid-19 vaccine ad26.cov2.s- Two breakthrough covid-19 infections. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Back of throat hurting, painful, inflamed lips, tongue red, headaches, swelling in throat.
An initial report was received from a nurse on 17.Aug.2012 and concerns a male patient in his 50's, who on 13.Sep.2012 received the first dose of VIVOTIF orally (batch no.: 3000132). The patient's medical history and concomitant medications were not reported. On 13.Sep.2012, following administration of the vaccination, the patient experienced chills, nausea and fever. At the time of reporting, the patient had not yet recovered from the event. The events were considered non-serious.
Neck stiffness a dat after vaccination, then dizziness. with vertigo, blurry vision, nausea and vomiting,
19-year-old patient received an adult dose; 19-year-old patient received an adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number TB3KN, expiry date unknown) for prophylaxis.   On 4th April 2022, the patient received Engerix B adult. On 4th April 2022, unknown after receiving Engerix B adult, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 05-Apr-2022 Reporter's comment: Nurse reported that a patient received an adult dose of Engerix-B, which led to overdose and inappropriate age of vaccine administration. The reporter consented to follow-up.
Slight pain in left axillary and noticed swelling in armpit, more noticeable when left arm raised up.
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the shingles the shot this year and experienced shingles for two weeks. This case was considered as suspected vaccination failure since the details regarding completion of primary schedule and laboratory confirmation was not known.
Shot #1:  Swollen glands under chin on right side (like mumps), sore when pressed
PATIENT INADVERTENTLY RECIEVED A CHILD PFIZER DOSE INSTEAD OF A  MODERNA BOOSTER.
Vaccine was administered on 4/10/07 and on 4/14/2007 mother noticed "spots" on child. In ER he was found to have thrombocytopenia(plts count of 6000). Blood test performed on 4/10/07 showed 190000 plts. Patient was hospitalized and given IV IGG and also prednisone last plt count was 53000. 06/06/07-records received from facility for DOS 4/14/-4/18/07-DC DX: Idiopathic thrombocytopenia. Sinusitis. Posthemorrhage anemia. C/O nose bleed and petecchia all over the body. CT head extensive sinus opacification. Treated with IVIG.
I was given a flu shot on Wed 10/29/08 about 5:00 pm. That evening, I started to get a sore throat. I gargled with Listerine and took Cold EEZE. My throat improved but I had some fever and for two weeks I was fighting much nasal and bronchial congestion and aching. This is 11/13 and I'm a lit better but still have hangover phlegm. Also bought more Cold EEZE and Cold Flu Relief.
the maladministration of Rotarix via IM; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate route of vaccination in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 422GF, expiry date 24-FEB-2025) for prophylaxis.   On 13-JUN-2023, the patient received Rotarix lyophilized formulation (intramuscular). On 13-JUN-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate route of vaccination (Verbatim: the maladministration of Rotarix via IM). The outcome of the inappropriate route of vaccination 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: 14-JUN-2023 The reporter reported that the maladministration of Rotarix to patient. The healthcare professional wanted to know how to proceed with this patient. The reporter consented to follow up. The Rotarix vaccine was administered via intramuscular route, which led to inappropriate route of vaccination.
On 3/17/23 client was given a first dose of Moderna 12+ monovalent vaccine, which expired on 3/12/23. Per CDC guidance Moderna was contacted. Moderna conducted stability testing on lot #071B22A and found that the vaccine was stable at time of administration an repeat vaccination was not required.
had focal sz on one hand;followed by blank stare;over past 2yr has had more sz;EEg w/multi focal spikes;on variety of anti-convulsants;Annual follow-up dated 11/21/00 provided no additional data.
9 X 9 cm irregular area to left delt.  Nt, slightly warm
Hives or Redness on upper center of chest and red flushed looking cheeks. Claims throat may have been slightly scratchy. Administered Diphenhydramine 50mg and observed for an additional 30 minutes. This resolved after the diphenhydramine dose and they were able to leave and return home.
Severe chills , no fever, body aches , brain fog,lack of appetite   Had COVID diagnosed 10 - 27 - 2020.                                Should be told at time of injection possible worse side affects if had COVID previously also need to inform of possible brain fog
No additional AEs were reported; The physician reported that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX (u024221   8/4/2023) Temperature: -12.5C Time frame:; This spontaneous report was received from a physician and refers to a patient of unspecified age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 12-SEP-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # u024221, expiration date 04-AUG-2023 (dose, route of administration and anatomical location were not reported). Administered vaccine was improperly stored in temperature of -12.5 degrees Celsius (product storage error, temperature too high) for 1 hour. There were no previous temperature excursion reported. No additional adverse events were reported.
she inadvertently administered PREVNAR 20 instead of GARDASIL-9 due to product confusion; no adverse event; Nurse calling to report that she inadvertently administered PREVNAR 20 instead of GARDASIL-9; This spontaneous report was received from Other Health Professional (nurse) and refers to an unknown age male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUN-2023, the nurse inadvertently administered pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) (strength, formulation, lot #, expiry date, route of administration, and indication were not provided) instead of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) to the patient (Wrong product administered) due to product confusion. The patient had already received his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) previously and this was supposed to be his second dose. On an unspecified date in June 2023, the patient came back to the office and received his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #u029033, expiration date: 13-MAR-2024 (strength, route of administration, and indication were not provided). The patient has no symptoms (no adverse event).   The causality between all the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
she felt pretty ill and had to take a sick day from work after second dose/ feeling poorly; after the second shot, her arm started to hurt,aches; after the second shot, her arm/shoulder started to hurt; Fever; horrible headache that lasted for about 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she felt pretty ill and had to take a sick day from work after second dose/ feeling poorly), MYALGIA (after the second shot, her arm started to hurt,aches), ARTHRALGIA (after the second shot, her arm/shoulder started to hurt), PYREXIA (Fever) and HEADACHE (horrible headache that lasted for about 12 hours) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A; and 025L20A) for COVID-19 vaccination.     No medical history was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced MALAISE (she felt pretty ill and had to take a sick day from work after second dose/ feeling poorly), MYALGIA (after the second shot, her arm started to hurt,aches), ARTHRALGIA (after the second shot, her arm/shoulder started to hurt), PYREXIA (Fever) and HEADACHE (horrible headache that lasted for about 12 hours). At the time of the report, MALAISE (she felt pretty ill and had to take a sick day from work after second dose/ feeling poorly), MYALGIA (after the second shot, her arm started to hurt,aches), ARTHRALGIA (after the second shot, her arm/shoulder started to hurt), PYREXIA (Fever) and HEADACHE (horrible headache that lasted for about 12 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2021, SARS-CoV-2 test: positive for covid-19 (Positive) positive for COVID-19.         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.        Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
The vaccine refrigerator went out which compromised the MMR vaccine at time of administration. No adverse effects were reported. Patient to be revaccinated.
pt reports nerve like pain in upper arm shoulder area. pt is unable to tolerate sleeping on this arm.
Less than 24 hours after vaccine admin. pt had stiff neck, fever to 100F and body aches.
12/28/20 EE received 1st COVID vaccine; 1/4/21 EE began feeling increased fatigue with dry cough; COIVD(-)
Dizziness, vertigo - bedrest, continue but diminishing.   Facial swelling, rapid heartbeat - diminishing. Headache , nasal congestion. Fatigue.
Sharp pains and Limited movement.  Restless sleep awakened at night.  Difficulty dressing.
Her left arm was sore and she woke up in the middle of the night and put an ice pack on it. Her arm was swollen and hot and this lasted through Sunday night. She had a temperature Saturday 101 F but was gone on Sunday. Saturday she had a tightening in the chest lasted into the night and then Sunday morning she did not have chest tightness. Tuesday night she is now fine no problems.
NUMBNESS AND WEAK GRIP FOR TWO DAYS AFTER INJECTION; STILL HAS NUMBNESS AND LEFT ARM FEELS HEAVY FROM ELBOW TO FINGERTIPS. LEFT AREM IS PAINFUL AT INJECTION SITE; NO REDNESS OR SWELLING AT INJECTION SITE NOTED.
Patient came in to treatment room for 4 year old vaccination update.  I gave patient MMRV, D tap, Polio.  I documented and realized patient had already received 2 varicella vaccinations.   I discussed with pediatrician she stated patient had received an extra dose of varicella and that there was no harm done.  I proceeded to call patient's mother advised patient received an extra dose of varicella.  Mother stated patient was doing  fine and it was ok.
sore throat; woke up with chills and fever; Body aches; woke up with chills and fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN, PYREXIA, PAIN, and CHILLS in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN, PYREXIA, PAIN, and CHILLS. The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Ache, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN, PYREXIA, PAIN, and CHILLS had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Problem with her mood; Problems waking up; Very bad fatigue; Had alot of joint pain; This spontaneous case was reported by a consumer and describes the occurrence of AFFECTIVE DISORDER (Problem with her mood), SOMNOLENCE (Problems waking up), FATIGUE (Very bad fatigue) and ARTHRALGIA (Had alot of joint pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced AFFECTIVE DISORDER (Problem with her mood), SOMNOLENCE (Problems waking up), FATIGUE (Very bad fatigue) and ARTHRALGIA (Had alot of joint pain). At the time of the report, AFFECTIVE DISORDER (Problem with her mood), SOMNOLENCE (Problems waking up) and FATIGUE (Very bad fatigue) had not resolved and ARTHRALGIA (Had alot of joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
tinnitus, occurring at random times, and random severity. I have had perfect hearing all my life, with not tinnitus of any type.