chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US011954, is an initial spontaneous report received from a pharmacist on 18 Jun 2015. This report refers to a 6 year old female patient. Historical conditions was not reported. She was vaccinated with BEXSERO (batch number: not reported) intramuscularly on 12 Jun 2015. No adverse event was reported following this maladministration.
This spontaneous report was received from a physician referring to an unspecified number of male patients of unknown age. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with doses of GARDASIL 9 for prophylaxis (dose, route, lot # and expiration date were not reported). The reporting physician stated that she had been informed by an unspecified person "a report that stated that GARDASIL 9 could make males sterile so they should not received". At the time of reporting the outcome of infertility male was unknown. A product quality complaint was not involved. The causality assessment between Infertility male and GARDASIL 9 was not provided.
This spontaneous report as received from a male patient of unknown age regarding himself without drug reactions/allergies. The patient's medical history included shingles (no other pertinent medical history). On an unknown date the patient was vaccinated with ZOSTAVAX. Concomitant therapies included Nexium, Restasis, Metoprolol, and Klor-Con, aspirin (manufacturer unknown and Furosemide (manufacturer unknown). It was reported that the patient received ZOSTAVAX after previously having shingles and developed another case of shingles on an unspecified date approximately one month after he received ZOSTAVAX. The patient treated with acyclovir and lidocaine patches. There were no lab diagnostics studies performed. At the time of reporting, the patient was not recovered. The patient sought medical attention by office visit. Additional information has been requested.
Rash, redness and fever started the next day and blister. Diagnosed as cellulitis.
Pt developed a papular  rash around the injection site about an hr after vaccination took place. Family noticed that it quickly spread upwards on both legs and spread to chest/abdomen/trunk but stopped at the neck line. Mother consulted with examiner and administered a dose of Benadryl. Rash stopped spreading but has not resolved yet. No respiratory compromise reported or GI symptoms
PATIENT CAME IN TO RECEIVE 3RD COVID VACCINE AND FILL OUT PAPERWORK. REGISTRATION DESK ENSURED THAT MODERNA WAS WRITTEN ON THE PAPERWORK AND VACCINE CARD WAS GIVEN. VERBAL COMMUNICATION WAS ALSO ALERTED WHEN PAPERWORK WAS HANDED OFF TO PHARMACIST THAT IT WAS A MODERNA DOSE. PHARMACIST VERBALLY VERIFIED MODERNA DOSE WITH PATIENT BUT ACCIDENTLY GAVE PFIZER. DRAWN MODERNA DOSES ARE KEPT IN THE COOLER SEPARATE FROM THE PFIZER DOSES TO AVOID VACCINATION ERRORS.  PATIENT WAS OKAY AFTER MONITORING PERIOD AND LEFT.
Throat tightness, able to swallow & breathe. Feels like something in the back of her throat.  Has not taken anything for sxs. Advised to take benadryl & seek in-person care.
Diarrhea, vomiting, stomach ache, fever.  the vaccine date listed is the first date taken: subsequently taken 1/27, 1/29, 1/31 as per instructions.  I was given a tetnus shot in my left arm on 1/24 in PM (the system won't let me out even though I tried to delete so I'm picking a manufacturer & type that may not be correct).
Prolonged vax reaction. Started 02/14 with fever, rash on 02/16, irritable on 02/17, and fever on 02/18. ER visit and lab work to rule out Kawasaki. Finally normal 02/21/00. Although is know to have positive RAST to egg, negative result from skin test and eats egg. Allergist okayed the vax.
Information has been received from a female consumer who was vaccinated with a dose of GARDASIL (Lot# not reported).  The patient reported that she developed a fever after receiving a dose and then she was fine the next day.  The patient's outcome is recovered.  No further information is available.
This spontaneous report was received from a health professional referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On 15-FEB-2016, the patient was vaccinated with an expired dose of VAQTA expiration date: 15-JAN-2016 (Lot#, dose and route of administration were not reported). No adverse effects were reported. There was no product quality involved. Additional information has been requested.
site swollen, hard lump, would not move lt leg x 1/2 day, fever, unable to sleep w/o being held otherwise cries very intensely x 3 nights
11-18-06 child developed red spots on face and hands 6 hrs after getting flu shot. Face rash has calmed down, blanches was itchy. Temp 95.1. Eating and drinking ok. Mother called our office after hours. Advised to monitor. Give baking soda or oatmeal baths, may try Benadryl 10 mg every 6 hours Prn.
Information has been received from a physician concerning a female (age not reported) who on 26-NOV-2006 was vaccinated with the first dose of Gardasil and on 31-JAN-2007 was vaccinated with the second dose of Gardasil. Concomitant medication was not reported. On approximately 26-NOV-2006 the patient experienced headache after the first dose of Gardasil, which lasted about one month. The outcome and causality of the headache was not reported. On 07-FEB-2007, about 7 days after the second dose of Gardasil, the patient developed a "lump," redness and pain in her arm, at the injection site. The physician reported that the injection site reaction was approximately one half centimeter which was extremely tender and painful. On an unspecified date, the patient sought unspecified medical attention. The patient's events persisted. Additional information has been requested.
I experienced a stroke at work, that started with problems in my vision, dizziness, difficulty standing, and I became incoherent. It was diagnosed as a stroke at the hospital and I was placed on a treatment regimen.
This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On 19-JAN-2015, the patient was vaccinated with expired dose of ZOSTAVAX (expiration date was 19-OCT-2014, lot number, dose and route of administration were not provided). No adverse events were reported. Additional information is not expected because the reporter did not wish follow up contact.
Information has been received from a physician concerning a male who was vaccinated with zoster vaccine live (Oka/Merck). The physician reported that the patient experienced a itchy rash all over their back that looked like shingles. Additional information has been requested.
Patient called pharmacy the day after receiving the vaccine and reported feeling sick, muscle aches, fever, and redness around injection site the size of a baseball.
Burning stomach sensation. 9 out 10 in term of strength followed by diarrhea. Took OTC Tums and GasX. In 45min, symptons reduced and 2h no more signs of side effect
ER f\up. Was seen on 8/22 at clinic, given routine TDaP. Pt was seen on 8/25 at facility for adverse reaction to vaccine. Records unavailable at time of visit. Right upper arm red, swollen and painful. Had fever up to 103 before being evaulated in the ER. Swelling is improving. No medications. Per pt report normal WBC in ER, no abx were indicated.
Achiness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness) and CHILLS (Chills) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced PAIN (Achiness) and CHILLS (Chills). At the time of the report, PAIN (Achiness) and CHILLS (Chills) had resolved.            It was unknown if patient was enrolled in a COVID-19 vaccine trial. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Hives on body ( face neck abdomen chest back both arms, ) for 4 days
bad cough; runny nose; sneezing; cold like illness; This is a spontaneous report from a contactable consumer or other non hcp.   A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced bad cough, runny nose, sneezing and cold like illness. The patient wanted to reschedule the second dose, he stated that he had running nose and he was advised to call vaccine provider or the site for assistance and he also wanted to know if there was a specific waiting period he needs to wait after cancelling the appointment or a timeline. The outcome of the cough, rhinorrhoea, sneezing, nasopharyngitis was unknown.  Follow-up attempts completed. No further information is expected.
10/17/2021 it was a rash on the upper body, and I still have it. Not as bad but it is somewhat better and saw my doctor. I was given Benadryl and cortisone for a week, and it got worse. She prescribed me prednisone
Runny nose; Fever; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (054550).  A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "ER POSITIVE" (unspecified if ongoing); "NEOPLASM OF THE BREAST" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D3. Past drug history included: Enbrel, reaction(s): "Allergy:ENBREL"; Humira, reaction(s): "Allergy:HUMIRA"; Keflex, reaction(s): "Allergy:KEFLEX"; Levaquin, reaction(s): "Allergy:LEVAQUIN". The following information was reported: RHINORRHOEA (medically significant), outcome "unknown", described as "Runny nose"; PYREXIA (non-serious), outcome "unknown", described as "Fever".Clinical comment: She had a runny nose, and fever, this was also after obtaining the covid vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, a causal association between the reported events rhinorrhea, pyrexia and the suspect BNT162B2 cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Rash appeared 2/3/05 and progressed, red papular rash of various sizes some with fluid on arms, trunk.
migraine; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), NAUSEA (nausea) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced MIGRAINE (migraine), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, MIGRAINE (migraine), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
pt rcvd vax; pt was found to be surface antigen & antibody pos & had a slightly elevated SGOT following vax w/ 2nd dose of hepatitis;
fever 101.3, rash: no change in soaps, detergents, clothes, or foods;tx w/DPH PRN;
Headache, Anaphylaxis, fatigue, "hives/anyphylaxis reaction to covid vaccine" Employee reported fever, headache, muscle pain and fatigue occurred 1/10/2021. Employee reported hives/anaphylaxis occurred 1/12/2021 through 1/17/2021 and reoccurred 1/29/2021 through 1/31/2021. Employee reported "hives/anaphylaxis reaction to COVID vaccine: ER visit 1/12/2021 and multiple M.D. visits". "Symptoms resolved on 1/17/2021 but came back 1/28/2021 which prompted another M.D. visit." Resulted in unable to work 1/11/2021 through 1/15/2021 and 1/31/2021.
Additional Vaccine given is described as the following: Patient was mistakenly given both Pentacel, and Pediarix by the Medical Assistant. CDC  was contacted in regards to the error which we were told that the combination of the vaccine will not harm the patient. Provider has contacted the patients parents to notify them in regards to the error which the provider has additional care plans in place to ensure the patients safely. A vaccine error report has been also generated in regards to this incident. MA Supervisor 6/7/2019
Swelling in the bags under the eyes, 3 times as the normal size; Rash on cheek and forehead, both temples, then down bridge of nose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on cheek and forehead, both temples, then down bridge of nose) and PERIORBITAL SWELLING (Swelling in the bags under the eyes, 3 times as the normal size) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL, SIMVASTATIN, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), ALLOPURINOL, BOSWELLIA SERRATA RESIN, COLECALCIFEROL, COLLAGEN (OSTEO BI-FLEX EASE) and VITAMIN D NOS for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced RASH (Rash on cheek and forehead, both temples, then down bridge of nose). On 25-Feb-2021, the patient experienced PERIORBITAL SWELLING (Swelling in the bags under the eyes, 3 times as the normal size). At the time of the report, RASH (Rash on cheek and forehead, both temples, then down bridge of nose) and PERIORBITAL SWELLING (Swelling in the bags under the eyes, 3 times as the normal size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment to the events not provided.
passed out; upset stomach; vomiting; got dizzy; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4201755-00.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Dec2021 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "had boils that formed on her body", start date: Oct2021 (unspecified if ongoing), notes: In Oct2021, the patient had boils /she was prescribed antibiotics in Nov2021. The patient's concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 14Dec2021, outcome "recovered" (Dec2021), described as "passed out"; ABDOMINAL DISCOMFORT (non-serious) with onset 14Dec2021, outcome "recovered" (Dec2021), described as "upset stomach"; VOMITING (non-serious) with onset 14Dec2021, outcome "recovered" (Dec2021), described as "vomiting"; DIZZINESS (non-serious) with onset 14Dec2021, outcome "recovered" (Dec2021), described as "got dizzy". The action taken for upadacitinib was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Reporter's causality was not reported for suspects. The case would be managed as per company assessment.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Loss of consciousness, abdominal discomfort, vomiting and dizziness and 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.
Hives all over her body/hives were very itchy and almost like welts; didn't feel great; Crazy Fatigue; Headache; Severe Arm Pain; couldn't sleep it was that bad; This is a spontaneous report from a contactable consumer (patient).  A 28-year-old female patient received  (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. There were no medical history and no concomitant medications. There were no prior vaccinations within 4 weeks and no Family Medical History Relevant to adverse events. The patient states she got the first vaccine on 16Apr2021 around noon and she did develop pretty bad symptoms. The patient had crazy fatigue, headache, severe arm pain, couldn't sleep it was that bad and didn't feel great on 16Apr2021, 2-3 hours after she left the site. She has hives all over her body. She doesn't know if it has anything to do with it or not. The patient stated that the hives were very itchy and almost like welts. The hives started to develop last night (20Apr2021) and today (21Apr2021) they were way worse. She hasn't taken any BENADRYL yet, she wanted to make sure that was okay to take and wants to know if that is a normal reaction to the vaccine. There were no additional vaccines administered on same date of the Pfizer. The patient received TYLENOL as treatment. The adverse events did not require a visit to Emergency Room or Physician Office. The outcome of event Crazy Fatigue and didn't feel great was recovering, of event headache was recovered on 19Apr2021, of event severe arm pain, couldn't sleep it was that bad was recovered on 20Apr2021, of event Hives all over her body/hives were very itchy and almost like welts was not recovered.   No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
severe arm pain for 5 days throbbing and piercing pain in the area from shoulder down to elbow unable to lift arm without pain for 5 days now moderna covid-19 vaccine EUA
Post vax, pt had scattered hives, crying throughout. Oral Benadryl was given, no respiratory symptoms. Looks fine and is resolving and playing. Pt went home with family.
Local reaction, 6 cm x 6 cm induration, discoloration, pain and swelling.
Covid19 breakthrough.  1st Vaccine on 03/02/2021.  69 y/o with recent history of Covid + on 12/27/2021, received Monoclonal Antibodies on 12/28/2021.  Pt now presents with 2 week history of no appetite, worsening c/o weakness, cough, SOB, mylagias.  Room air sat 86%, pt arrived on 15L NRB.  CXR diffuse infiltrates.  Pt started on IV steroids and Remdesivir.
Acute right-sided congestive heart failure. She was referred to hospice service at the time of discharge. ED visit to hospital admission within 6 weeks of receiving the COVID Vaccine.
BRAIN BLOOD CLOT; This spontaneous report received from a consumer via media via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced brain blood clot. It was reported that "my friend died 3 of a brain blood clot 3 weeks after getting this vaccine". On an unspecified date, the patient died from brain blood clot. It was unknown if the autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event brain blood clot was fatal. This report was serious (Death).; Sender's Comments: : V0. 20220210873-covid-19 vaccine ad26.cov2.s -Brain blood clot . 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).; Reported Cause(s) of Death: BRAIN BLOOD CLOT
4 x 4 area red, warm. No pain or burning. Not getting any larger. More red area w/in 4 x 4 area about size of 1/2 dollar. No other symptoms. Pt instructed: if increase in size or severity to go in.
Traumatic experience; Lethargic/Not motivated; got very sick; Fever 100.5F; Chills; Pounding headache; swelling in the arm (Injection Site); Sweating; Trembling; This spontaneous case was reported by a health care professional and describes the occurrence of HYPERHIDROSIS (Sweating), TREMOR (Trembling), INJURY (Traumatic experience), LETHARGY (Lethargic/Not motivated) and ILLNESS (got very sick) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 15-Jan-2021.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating), TREMOR (Trembling), LETHARGY (Lethargic/Not motivated), ILLNESS (got very sick), PYREXIA (Fever 100.5F), CHILLS (Chills), HEADACHE (Pounding headache) and VACCINATION SITE SWELLING (swelling in the arm (Injection Site)). On an unknown date, the patient experienced INJURY (Traumatic experience). At the time of the report, HYPERHIDROSIS (Sweating), TREMOR (Trembling), INJURY (Traumatic experience), LETHARGY (Lethargic/Not motivated), ILLNESS (got very sick), PYREXIA (Fever 100.5F), CHILLS (Chills), HEADACHE (Pounding headache) and VACCINATION SITE SWELLING (swelling in the arm (Injection Site)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: 100.5f (High) 100.5F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment details were not provided.