chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm sore and swollen started on 10/11/13 pm. Using hot and cold pack, started taking TYLENOL extra strength pain medication. Left arm is still sore and swollen. Feeling much better since started taking pain medication 10/21/13.
Local reaction - red welt over injection sight with leg swelling. TYLENOL was taken for pain & ice used to reduce swelling in leg.
she ended up passing away in the hospital, her diagnosis there was hypoxia and acute CHF; she ended up passing away in the hospital, her diagnosis there was hypoxia and acute CHF; hypotensive; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Mar2021 (Lot Number: EL9269; Expiration Date: 01May2021) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient sent to the ER hypoxic, hypotensive, short of breath, she ended up passing away in the hospital, her diagnosis there was hypoxia and acute CHF (Congestive heart failure). Serious: No. The patient died on an unspecified date.  It was not reported if an autopsy was performed.; Sender's Comments: Based on the information available, a causal association between BNT162B2 and the reported events cannot be excluded. However, details on the patent's age, medical history, drug-event temporal relationship, clinical course of the event and relevant test results would allow for a meaningful medical assessment. 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: she ended up passing away in the hospital, her diagnosis there was hypoxia and acute CHF; she ended up passing away in the hospital, her diagnosis there was hypoxia and acute CHF
Hives started next day - lasting 5-6 days - ORAPRED, ZYRTEC - referred to allergist.
Pt was experiencing decreased control of left side of mouth, left arm, and left eye. Also left eye kept tearing. Pt went to MD a few days later and followed up Kw/ ophthalmologist and both diagnosed her with Bell's palsy. Both MD were not sure if coincidental or not?
viral infection; repeated respiratory viral infections; feel like they have a fever and are both congested; feel like they have a fever and are both congested; cough is terrible; feeling chills and cold; feeling chills and cold; generally not feeling well; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 59 year-old male patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Lot number: ED6201) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Lot Number: EL9126 (reporter was guessing on the LP or it could be EL9126)), administration date: 27Jan2021, for COVID-19 Immunisation. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "generally not feeling well"; VIRAL INFECTION (non-serious) with onset 22Oct2021, outcome "unknown", described as "viral infection "; RESPIRATORY TRACT INFECTION VIRAL (non-serious) with onset 2021, outcome "unknown", described as "repeated respiratory viral infections"; PYREXIA (non-serious), NASAL CONGESTION (non-serious) all with onset 2021, outcome "unknown" and all described as "feel like they have a fever and are both congested"; COUGH (non-serious) with onset 2021, outcome "unknown", described as "cough is terrible"; CHILLS (non-serious), NASOPHARYNGITIS (non-serious) all with onset 2021, outcome "unknown" and all described as "feeling chills and cold". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, pyrexia, nasal congestion.  Additional information: Reporter is Wife of the Patient. Reporter stated that her husband and son should go again to be tested, since they are both having symptoms again, they both are generally not feeling well. Other Products and Patient History: Not Provided. Reporter stated that between the 5 of them, they have tested about 5 times in the last 12 days. Patient's cough was terrible, last episode lasted 10 days. Patient got tested when the symptoms ran. Now her husband (patient) is experiencing symptoms again since the 11th.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a consumer (patient's mother) and refers to her daughter, a female patient of unknown age. Concurrent conditions and medical history was not reported. On an unknown date, the patent was vaccinated with MMR II injection (route, dose and lot number were unknown), but the facility did not record the first vaccination. On an unknown date, the reporter stated that her daughter received MMR II twice. No concomitant medications were reported. On an unknown date her daughter's blood titers were positive for measles and rubella, but was negative for mumps. The outcome of the event was unknown. Causality assessment was not reported. Product quality complaint was not reported. No additional adverse event information was provided. Additional information has been requested.
Diagnosed with Achalasia shortly after shot. My head has not been the same: dizzy, get spells where I can't focus for periods of time, orange spots, lose balance often.
Reports dizziness, light headeded, heaviness on top of head 10 minutes after injection.  No sob, chest discomfort, palpitation or weakness. AAOx3. VVS. States that she worked last night and did not eat breakfast yet, also ran two miles prior to getting vaccine.she was given fluids and was closely monitored. Symptoms mildly improved after about 30 Minutes but continues to keep the heaviness. States that she is likely very sleepy and tired. No acute distress. Instructed to contact clinic/ED/PCP if symptoms worsen or persist.
Swelling and sensitivity around eyes. Eczema flare up around eyes. Mild dizziness and general malaise.
first 3 days- fatigue, low grade fever, poor activity tolerance, winded, sweats/ chills, poor sleep, arm pain, joint pain, muscle pain, day 5- severe headache and nausea/vomiting
pt got hives 2 days later, MD gave DPH & told to see or call MD the next day if not better;afeb the next day;
Bandaid at the injection site was itching; stopped when she took the Bandaid off; they hit a blood vessel and blood squirted out; they hit a blood vessel and blood squirted out; bruise; This is a spontaneous report from a contactable consumer, the patient.  A 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, EL9262), via an unspecified route of administration on 26Jan2021 at 16:30 (at the age of 81-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included an upper bowel blockage with hospitalization on an unspecified date reported as "two years ago." Concomitant medications were not reported. The patient was administered the vaccine at a facility clinic. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that she got her first dose of the Pfizer vaccine and they hit a blood vessel and blood squirted out. It left a bruise (3-4 inches) on her arm.  It has not bothered her and it's healing up, but it's in her left arm. She would like to get it on this arm again to keep it moving. The bruise is a size of a baseball.  She inquired as to if it is safe to get the second  shot in the same arm. She also mentioned that the Bandaid at the injection site was itching; it stopped when she took the Bandaid off. The clinical outcomes of the events wrong injection technique, vaccination site bleeding and contusion were reported as recovering. The clinical outcome of vaccination site itching was reported as recovered on an unspecified date.
This case was reported by other health professional via call center representative and described the occurrence of sickness in a patient who received SHINGRIX. On 2nd March 2018, the patient received SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. On 6th March 2018, the patient came with sick symptoms. The other healthcare professional did not have time to provide any additional information. The follow up information was requested.
INADVERTENTLY VACCINATED BEFORE AGE 12. ERROR IN DATA ENTRY MADE CONTACT IMPPOSSIBLE.
Client verbalized itching to the right deltoid at vaccination site.  Client was evaluated by Paramedics.  Client was observed for additional 10 minutes.  Per paramedics, client doesn't need further evaluation.  Client exited the facility.
bilateral pulmonary embolism; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 66 year old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose No:1), for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "not recovered", described as "bilateral pulmonary embolism". Caller reported an adverse event following the second dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap). Caller stated that I am calling on behalf of a patient who received her primary series of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) and within a week of her second dose she developed bilateral pulmonary embolism. The patient would like to receive her booster dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap). The reporter questioned Do they had any information of post-authorization reports of patients that received a subsequent dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) after developing bilateral pulmonary embolism. Caller requested escalation on her specific question: "Post-authorization reports of patients that received a subsequent dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) after developing bilateral pulmonary embolism", as this information is needed to make a medical decision on whether the patient can safely receive her booster dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap).  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the event pulmonary embolism and suspect drug BNT162B2 cannot be 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.
No symptoms reported; Unspecified number of patients have recieved improperly stored ROTATEQ on unspecified dates; This spontaneous report was received from a nurse, referring to a 12 weeks old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 26-NOV-2019, the patient was vaccinated with the improperly stored only dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number S004251 with expiration date: 22-SEP-2020; dose, strength and route of administration were unknown) for prophylaxis (product storage error). No symptoms reported. It was reported that the patient was not administered rotavirus vaccine, live, oral, pentavalent (ROTATEQ) on 28-MAY-2019.  Administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent temperature excursion of 46.9 degrees Fahrenheit (F) for 55 minutes. Data logger was involved. The previous temperature excursion was 34.9 F for 25 minutes and 48.6 F for 25 minutes.  This is 1 of 4 reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA007560: US-009507513-1911USA004865: US-009507513-2005USA007562:
After pt. received vaccine, pt became faint, eyes rolled, arms had jerky movements for 30 sec.  Pt lost consciousness.  Vitals checked.  Pt c/o nausia, servere headache.  A&O x 4, called, pt sent to hospital per ambulance
2/26/03 Skin lesions times 2, vomiting; Cutirate and diagnosed with eczema or fine corporis; given Phenergan. 3/2/03 Skin abscess left thigh; Keflex; Cutirate vs. eczema. 3/11/03 Nephrotic syndrome; hospitalized out of town and then to local hospital. The 60 day follow up received on 12/31/03 states pt has been exposed to active varicella and did not develop any response. We are assuming that all live vaccines are contraindicated in this child. If this is incorrect, please update our office. The discharge summary received on 1/28/04 states nephrotic syndrome. 7/7/04: came down with sore throat and stuffy head, virus. 7/11/04: urine was 2000+ w/protein started on 45mg. Prednisone/calcum carbonate, 2 ml of 500mg/5ml
This case was reported by a nurse and described female pt who did not respond to the hepatitis B vaccine (unknown manufacturer).  The pt's medical history and concurrent medications were not reported. The nurse reported that the pt had received her vaccination series prior to 1999.  At an unspecified date in 2003, a hepatitis B surface antibody titer was "negative".  On follow-up received 12/10/03, the nurse reported the pt was determined to be "negative." The pt was also found to be pregnant and "on the advise of her physician declined the booster until a later date."  At the time of followup the pregnancy was ongoing.
Headache, pain/swelling at site, h/a, body aches x day 3 dose. Narrative:
Patient was mistakenly administered Haemophilus b Conjugate Vaccine; no adverse events were reported by the patient.
approx 10 mins p/administration of vax pt had generalized clonic/tonic activity for 1-2 mins; resp depressed but w/o apnea; post ictal state noted BP 116/60, P72;
Got really sick about 12 hours after first dose then have been extremely tired ever since. I used to wake up at 5:00 am every morning and go workout but since the covid shot I can not get out of bed and I have not been able to workout since March, weakness in legs, shakiness. This has not gone away, Loss of appetite. I lost 12 lbs over 7 weeks. I was given two rounds of Steriods a 5 day pack around 4/3 and and a 10 day pack around 5/7. Did not help. I've had this eye infection, Punctate Keritasis, since March and has still not cleared up. I couldnt drive for a month and can not still see to drive at night. We did drops, ointment, Protective lenses then finally my left eye needed a medicated patch with a protective L lense. Having to use expensive OTC eye drops every hour on the hour. 7/20 I had a bladder infection that was treated with antibiotics.Then around the end of July beginning of Aug I started getting cysts all over my groin. I went to my gynogologist and she said it was some gland that was draining. I went back again and they said the same thing. Still have the cysts. Then shortly after the i started noticing all these ingrown hairs along my face and body and cysts all over my body. I went to the dermatologist to find out I had a staph infection on 8/24. Was given Antibiotic oinment and antibiotics, still fighting that. I am pulling these extremely long hair like things from my body that I can feel coming out throughout my body that disapte into water. I still don't feel like my normal self. I'm tired, I'm depressed, i can't work out like I have for the past 5 years like I have 6 days a week becos I am too tired and weak. It also threw my thyroid into hyperthyroidism. Bloodwork was done and my thyroid meds needed to be lowered after being on the same dose for nearly 3 years. I only had one dose and never got well enough to get the second dose.
This patient got the VARIVAX vaccine on 5/30/2008. On 06/11/08 in the evening the patient developed a fever, body aches, fatigue and generalized maculopapular vesicular rash.
9/27 flu shot, 9/29 soreness in thighs, 10/2 numbness, 11/2 Dr. for weakness, & numbness. 11/6 fell & went to ER - diagnosed Guillain Barre Syndrome, given IVIG & Plasmapheresis, 11/27 sent to rehab, 12/27 legs still paralyzed & arms failing & sent to clinic, diagnosed CIDP, given IVIG & steroids, 1/6 sent to rehab, 1/18 some leg movement & able to raise arms over head.
BEFORE HER FIRST DOSE PATIENT HAD UTI AND AFTER THE SECOND DOSE SHE WAS IN BETTER HEALTH/IMPROVED HEALTH; This spontaneous report received from a female patient of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: UTI (Urinary Tract Infection)- time unspecified. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient reported that, she was very happy that she was able to get first and booster dose of Janssen COVID-19 vaccine. The patient reported that, before her first dose she had UTI which she believed was her fault, but after the second dose she was in better health (improved health) (coded to unexpected therapeutic benefit) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of before her first dose patient had UTI and after the second dose she was in better health/improved health was not reported. This report was non-serious.
Pt describes that after dose #1 of Hep-B on 10/3/00, that once she got home, she experienced red, botchy palms, that itched bilaterally and shortness of breath, lasting 1 hour in duration.
Had measles like rash over body after the first dose, this lasted 5 to 7 days.; This spontaneous case was reported by a consumer and describes the occurrence of RASH MORBILLIFORM (Had measles like rash over body after the first dose, this lasted 5 to 7 days.) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included IRBESARTAN (AVAPRO), APIXABAN (ELIQUIS), METOPROLOL, SPIRONOLACTONE and DILTIAZEM for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MORBILLIFORM (Had measles like rash over body after the first dose, this lasted 5 to 7 days.). At the time of the report, RASH MORBILLIFORM (Had measles like rash over body after the first dose, this lasted 5 to 7 days.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-416103 (Patient Link).
Pt was given expired Moderna Vaccine. Vaccine expired on 7/13/22. Nurse manager drew vaccine from vial and provided us with syringe's with vaccine. Nurse manager notified us at approximately 1411 by text & voicemail at 1412 informing us of vaccine being expired per Director of Nursing Services for Public Health region, and "Do not give vaccine." Spoke with Nurse manager who was going to speak with Dr. regarding next steps in process since vaccine had already been administered. Contacted patient on 7/21/22 informing them of expired vaccine and offered to provide new vaccine if wanted. Patient refused vaccine at this time stated we will just wait for the next booster.
tired; Approximately 18.5 hrs after the 2nd vaccination, the patient had a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Nov2021 19:00 (Lot number: FK5618) at the age of 7 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: XYZAL. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Left, Vaccine Administration Time: 07:00 PM, Route of Administration: Intramuscular), administration date: 09Nov2021, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 01Dec2021 13:30, outcome "recovered" (Dec2021), described as "tired"; HEADACHE (non-serious) with onset 01Dec2021 13:30, outcome "recovered" (Dec2021), described as "Approximately 18.5 hrs after the 2nd vaccination, the patient had a headache". Therapeutic measures were taken as a result of fatigue, headache.  Additional information: Patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination: Xyzal day of and Allergy shot 7 days prior. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Patient reported: at 5:30 on 10/15/2008, fever 99.8, felt cold and had soreness at inj. site. 10/16/06: swelling at site and 2" below down to her elbow. at 0830 arm "tight as drum". She called the ER, Recommend ice and Ibuprofen: 10/17/08: Dr visit says Lymphangitis with allergic reaction to vaccine. Treatment Keflex and Periactin.
Patient received Moderna vaccine on 2/12/21 at 3pm. She sat in our waiting area under observation for 15 minutes (she reported no allergies, prior issues with vaccination such as fainting/anaphylaxis). Once she was home, she started feeling nauseous (and vomiting), severe joint and body pain, headache (reports feeling like, "her head is going to explode). These issues were worst over Friday/Saturday but improved over Sunday and today, Monday. Patient stayed home over the weekend and did not contact emergency services. Patient contacted her doctor on Monday to report the events of the weekend. At this time, her doctor has not recommended any treatments or issued prescriptions, and their plan is to have the patient follow up with the office should things worsen or change.
Malaise, muscle pain, headache, shivering, nausea, rash on upper torso.
Information has been received from a physician concerning a 24 year old female who on 11-FEB-2008 was vaccinated with the first dose of GARDASIL (Lot# not provided). Subsequently the patient experienced numbness in feet and toes and tingling in feet and toes. The patient's numbness in feet and toes and tingling in feet and toes persisted. No further information was provided. Additional information has been requested.