chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sleepy or drowsiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (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: SOMNOLENCE (non-serious), outcome "unknown", described as "Sleepy or drowsiness". Additional information: The patient wanted to know how long the vaccine was effective for.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse reaction per parent after 4th dose.   Dose series dated:  2/16/22, 4/13/22, 6/15/22 and 7/13/22
This spontaneous report as received from a Medical Assistant (C.M.A.) (also reported as nurse) refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a doses of M-M-R II dose number, lot# and expiration date was not reported, which underwent a supported temperature excursion. No adverse effects reported. Follow-up information has been received. On 04-FEB-2015 several telephone attempts were placed to the certified medical assistant however she was unavailable at the time of calls. This one of several reports from the same reporter. Additional information has been requested.
received the first dose of Shingrix. After this dose, the patient received radiotherapy for the treatment of multiple myeloma; This case was reported by a pharmacist via call center representative and described the occurrence of multiple myeloma in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced multiple myeloma (serious criteria GSK medically significant). The patient was treated with non-drug therapy (Radiotherapy). On an unknown date, the outcome of the multiple myeloma was unknown.   It was unknown if the reporter considered the multiple myeloma to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. A pharmacist reported that five to six months before this report, a patient received the first dose of Shingrix.  After this dose, the patient received radiotherapy for the treatment of multiple myeloma.  The pharmacist does not know if the diagnosis of multiple myeloma was before or after dose one of Shingrix. The reporter consented to follow up.
Patient experienced swelling and pain at this injections site. The arm is warm to touch. The patient also has been having severe headache starting 2 hours after the shot.
Right arm hot, red and itching at the injection site; Right arm hot, red and itching at the injection site; Right arm hot, red and itching at the injection site; A spontaneous report  was received from a consumer concerning a 82-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events right arm hot, red and itching at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the events right arm hot, red and itching at the injection site.  Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events right arm hot, red and itching at the injection site was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a physician concerning an approximately 17 year old female with penicillin allergy and clindamycin allergy who on 22-OCT-1998 was vaccinated with a first dose of VARIVAX (Merck). On an unspecified date the patient was vaccinated with a second dose of VARIVAX (Merck). Concomitant therapy included Hep A (unspecified) in the other arm. On the day after the vaccination, the patient developed a big lump at the injection site. The lump was 2"X3" and lasted 5 days. It was treated with BENADRYL and ice. The physician "knows" that the big lump was the result of VARIVAX (Merck) because "she has had other patients with the same reaction." The patient sought medical attention by mentioning it to a doctor. Subsequently, the patient recovered. This is one of two reports from the same source. Additional information has been requested.
Severe Headache; Muscle ache; Abdominal pain; lost his appetite; had a horrible feeling in his stomach, almost like the stomach flu; cold and had trouble maintaining his body heat; significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week; Felt like Flu Coming On; Sore Arm; Runny Nose with Mucous; This is a spontaneous case is received from a contactable consumer or other non hcp (patient). A 61-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Lot Number: EN6206) as dose 1 single (at the age of 61-years-old ) for covid-19 immunisation. Medical history included diabetes mellitus from 2009 and ongoing Verbatim: Slightly Diabetic. The patient's concomitant medications were not reported. The patient experienced sore arm on 10Mar2021, runny nose with mucous on 10Mar2021, severe headache on 07Apr2021, muscle ache on 05Apr2021, on 02Apr2021 felt like flu coming, abdominal pain, lost his appetite, had a horrible feeling in his stomach, almost like the stomach flu, cold and had trouble maintaining his body heat, significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs over a week. The outcome of the event sore arm was recovered on an unspecified date Mar2021 and rest of the events was recovering.  No follow-up attempts are possible.No further information is expected.  Follow-up (12Apr2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. This report included that: Caller was a male. Patient gender "Male" retained as previous.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable pharmacist. An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Feb2021 as a dose 1, single for COVID-19 immunization. No medical history and concomitant medications were reported. It was reported that the patient was not able to get the 2nd dose because he got hospitalized due to Pneumonia on an unspecified date in 2021. The event was Serious (Medically Significant and Hospitalization). The reporter stated that a patient was interested to receive his second dose of the Pfizer BioNtech Covid-19 vaccine today (01Jul2021), however his first dose was last 01Feb2021 and wanted to know if there was a need to start over the Pfizer BioNTech Covid-19 Vaccine series from the first dose if a patient had exceeded the allowable second dose schedule. The outcome of the event was unknown.  Information on batch/lot number had been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pneumonia and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Menses stopped immediately; Skin rash on upper and lower extremities; This is a spontaneous report from a contactable healthcare professional (patient herself). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 02Apr2021 11:30 (Batch/Lot number was not reported) at the age of 52-years as dose 2, single for COVID-19 immunisation. Medical history included intermittent migraines which I take preventive medication. Patient had no other health issues, no known allergies. Concomitant medication included topiramate taken for migraine received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 11:30 AM on the left arm at the age of 52 years as dose 1 for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that "menses stopped immediately." She had skin rash on upper and lower extremities. Never had a skin issue ever and never went to see a dermatologist in her life. Rash appeared a few days after the vaccination and she was in her home not around gardens, parks, grass, etc. She had no pets and lived alone working remotely. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included prescribed cream for rash, but rash has not diminished. Outcome of the events was not recovered. The case was reported as serious. The patient had not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal association there is possibility of causal association between the event amenorrhea and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
1 cm hive and 3 cm rash at site on left arm at vaccination site.   2 cm rash on Right arm at vaccination site. Administered 7.5 ml liquid Benadryl.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 19-DEC-2014, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. In December 2014, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
Parent paged me after hours, 8 hours after vaccine administered, because her son had severe headache and body aches and sore throat, tactile fevers, with acute onset.
Patient experienced extreme tiredness and a red area around the site of the shot. Red area is large and very hot to the touch 3 days later.
Tolerated the injection well, but about 45 minutes after developed severe inflammation of neuropathy in my feet that lasted for well over 24 hours. I have neuropathy from chemotherapy about 6 years ago, but this was a severe exacerbation of the pain and burning for almost 24 hours, but calmed down late the next day back to baseline.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies.  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 left arm on15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient received the Janssen COVID 19 Vaccine on 15-MAR-2021, He didn't have any side effects after vaccination. On 19-APR-2021, he went to get tested for COVID 19 antibodies. On 21-APR-2021, The test results came back negative for SARS-COV2 antibodies (coded as confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210446599-Covid-19 vaccine ad26.cov2.s- Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
A lot of vertigo after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (A lot of vertigo after booster dose) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 006B21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (she gave birth to a healthy baby on 19APR2021) from 2020 to 19-Apr-2021 and Normal birth (Patient delivered a child(Boy)) on 19-Apr-2021.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced VERTIGO (A lot of vertigo after booster dose). On 31-Dec-2021, VERTIGO (A lot of vertigo after booster dose) had resolved.            No concomitant medication reported. Patient received Moderna COVID-19 booster vaccine after her child was born. Patient did not breastfeed at all No treatment medication reported.   This case was linked to MOD-2022-546451 (Patient Link).
Initial report was received from a health care professional on 12 September 2012. A 24-year-old female patient received dose one of an intramuscular injection of ("the rabies series") IMOVAX Rabies, sanofi pasteur SA, H1091-1 (indication and site and side of administration were not reported) on 11 September 2012. According to reporter, the patient did not have any reactions when she went home. The next day, it was reported that the client died during the night. Exact date of death was reported as unknown, either 11 September 2012 or 12 September 2012, as reported "during the night". The medical examiner was called to verify the death, and details were not available at the time of the report. No information was reported at this time on if an autopsy was performed. The patient's outcome was fatal. Documents held by sender: None.
6 doses administered neyond the expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 doses administered beyond the expiration date) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 doses administered beyond the expiration date). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (6 doses administered beyond the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Vials were taken out of freezer on the same day doses were administered (08-Nov-2021). Patient had received booster dose. No side effect reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Non-significant follow up appended.Contact information added. On 12-Nov-2021: Patient demographics and vaccine information were updated.
The flu like symptoms dissipated very quickly. I was sent to the Foot Hill Presbyterian ER after a trip to urgent care. They took an X-ray and blood work. They ruled out myocarditis. I think my heart was elevated for 2 days after that. It would skyrocket for 120-130bpm. My heart rate would respond oddly depending on sitting down or laying down. No stimuli and it would still be odd numbers. I was getting weird readings each time I looked up my heart rate. I thought it was normalizing. I have been getting these tachycardia heartbeats as I am sitting down. It will be up to 120bpm after 2 hours. Now it stays at 90-100 bpm and palpitations keep happening. Sometimes when I get up, it will start skyrocketing. My BP jumped to 150/120 and my ER doctor prescribed me beta blockers (metoprolol 25mg). I am scheduled to see a cardiologist on Monday. I have had multiple EKG readings. I have noticed a strange cycle pattern for the past few days and no reason for it. It's almost like its playing its own beat.
"A mother reported that her 4 month old daughter received Rota shield, Hib-Titer, IPV (Aventis-Pasteur SA) and hepatitis B (manufacturer unknown) on 07/12/99. The next day, the infant developed diarrhea (up to 13 watery stools/day), colic and was "cryin a lot"." From follow-up #1 correspondence, information received on 04/19/01, it was reported that the patient did not develop blood in her stool as previously reported. "Reviewed, no additional information at this time." Mailed additional correspondence from 04/31/01 stated the patient recovered from this experience. No further information available regarding the patient of this case. This case is closed.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender, who on unspecified dates were administered the improperly stored GARDASIL (doses and routes not reported) lot # 0555AE exp: 14-DEC-2014. The reporter stated that a satellite office had experienced an ongoing temperature excursion from December of 2012 through September of 2013. During this temperature excursions GARDASIL was not supported and was affected. This is one of several reports received from the same source. Additional information has been requested.
Pt received ADACEL on 9-8-08 in LA - We received a TC from Pt's husband on 9-11-08 AM. With  Pt c/o local Rx at inject site - warm red swollen - also pt with mild fever and stomach hurting. Pt subsequently came in for O.V. on 9-12-08 and was diagnosed with severe reaction to ADACEL 10+ cm of Erythema, central induration, blister, flu like Sx. - Rx Pred-
child was given 0.2ml of undiluted 5-11 yr old Pfizer vaccine.
I was briefly  hospitalized for covid19 in early December of 2020. Vaccine side effects included ALL of the  symptoms of the real thing. Fatigue, head ache, muscle and joint pain, slight nausea, fever of 100 degrees.  I would like to know if the second vaccination is necessary.
Fever 101-104 after 24 hours, chills, sweating, extreme fatigue, dizziness. After 48 hours, fever, chills, sweating, lightheaded, vomiting, diarrhea
Mother reported onset of 103.8 F. temperature.  Tylenol given and temperature 98.7 within two hours. Temperature remained with in normal limits.
12/20/21 APN's note: "Patient is a 80 y.o. female with a past medical history noted below presents from ED with c/o productive cough x 2 weeks from nursing home.  Per ED, pt also confused but upon interview is alert oriented x4.  Denies sore throat, fatigue, fever, chills, N/V, CP, changes in bowel nor bladder habits.  States she in currently staying at nursing home after recent leg fracture sustained last month and hopes to go back home soon.  Denies any leg pain, numbness nor tingling.  Has been vaccinated against COVID x 2 doses.     In the ED: COVID PCR positive, febrile at 102, HR 116/109, 02 sat 89% on RA >95% on 5L nasal cannula.  CXR negative.  Given decadron and IVF in ED".
pt returned to desk c/o thickness in throat & having a funny feeling; nausea; diaphoresis, SOB; dx anaphylaxis to pneumovax;
Employee seen for HBV #2. She felt dizzy, lightheaded within 10-15 min then better but "off" x an hr. Midmorning had difficulty concentrating/focusing. About 4:45 PM - weak, dizzy, pale "world spinning" because nauseated, pulse faint thready. 5:20 PM EVAC to ER. Released about 11 PM. Weak, dizzy next day.
vaccine doses of mRNA-1273 (Lot number: 027A21A), intramuscularly, on her left arm, for prophylaxis of COVID-19 infection.  The expiration date of the vial was reported as 22-Aug2-022.  On 11-MAR-2021, the vaccine was administered from a vial punctured more than 18 hours ago. Treatment for the event was unknown.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, vaccine administered from a vial punctured more than 18 hours ago, was considered resolved on 11-Mar-2021.; Reporter's Comments: This report refers to a case of Expired product administered for mRNA-1273, lot # 027A21A, with no associated AEs.
nausea, chills fatigue,  headache, generally feeling unwell.  very swollen arm and covid  rash  around injection site;  advill and rest until subsided.  about  1  week.  First shot the worst.  Second shot, not too much.
Vaccine #1 given on 10/14/2021. Given at health clinic; Pfizer. Lot: 301308A. Exp 11/30/2021. Given IM in site unknown
slightly hoarse and raspy voice, approximately within a few days developed hives and sore throat- used antihistamine and rest
felt really super dizzy; Fatigue; This is a spontaneous report from a contactable consumer 8patient).  A 65-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at 09:00 at single dose in left arm for COVID-19 immunisation. Lot number was EL3247. Medical history and concomitant medications were none. On 27Jan2021 at 11:00, the patient experienced feeling really super dizzy (used walker of wife to get around) and fatigue; the patient had to go to sleep after that, he could not walk around, he was so dizzy and tired, he went to bed after 11AM and did not wake until 3PM. Then, the patient recovered from the events on 27Jan2021.
Patient developed upper body shakes/tremors.  She called 911, ambulance arrived. Patient decided not to go to the hospital and went to her family physician who administered Benadryl to stop symptoms.