chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. An 80-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis reaction". Therapeutic measures were taken as a result of anaphylactic reaction.  Clinical course: On 01Dec2022, it was reported that an (ethnicity withheld) patient started treatment on an unspecified date in Jan2021 with Pfizer BioNTech COVID-19 Vaccine at an unspecified dose/frequency for COVID-19 immunisation. It was reported the patient had an anaphylaxis reaction and she had to get "the epi pen." No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Gave zoster vaccine on 7/5/23 after expiration date of 7/1/2023. PT did not have symptoms at time of vaccine given.
received a booster dose out of a vial that had a needle left punctured; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (received a booster dose out of a vial that had a needle left punctured) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (received a booster dose out of a vial that had a needle left punctured). On 02-Nov-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (received a booster dose out of a vial that had a needle left punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications were reported.
became "sick as a dog"; chills; very uncomfortable; flu-like symptoms; awful congestion; headaches; vomiting; aching; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (became "sick as a dog"), VACCINATION COMPLICATION (very uncomfortable), INFLUENZA LIKE ILLNESS (flu-like symptoms), NASAL CONGESTION (awful congestion) and HEADACHE (headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION COMPLICATION (very uncomfortable), INFLUENZA LIKE ILLNESS (flu-like symptoms), NASAL CONGESTION (awful congestion), HEADACHE (headaches), VOMITING (vomiting) and MYALGIA (aching). On an unknown date, the patient experienced MALAISE (became "sick as a dog") and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN 81) at an unspecified dose and frequency. At the time of the report, MALAISE (became "sick as a dog"), VACCINATION COMPLICATION (very uncomfortable), INFLUENZA LIKE ILLNESS (flu-like symptoms), NASAL CONGESTION (awful congestion), HEADACHE (headaches), VOMITING (vomiting), MYALGIA (aching) and CHILLS (chills) outcome was unknown.      Action taken with mRNA-1273 in response to the events was not applicable      No concomitant medications provided
Sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in an unspecified number of patients who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, couple of days after receiving Influenza vaccine Quadrivalent unspecified season, 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 Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that their friend had taken his family to get their flu shots and a few days later, they were all sick. The reporter suspected that maybe they all got the sickness from someone getting their shot.
Veteran was administered vaccine that did not meet the necessary storage requirement. Freezer malfunctioned and reached a temperature of ~89 degrees at least once. Symptoms: & no reaction.
LOCALIZED LEFT ARM REDNESS, SWELLING, PAIN, HEAT. ONSET 2 DAYS AFTER INJECTION. HAD CHIROPRACTIC MANIPULATION OF SHOULDERS AND ARMS 1 DAY AFTER INJECTION.
Swollen node on top of collar bone; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 07Jul2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Jul2021, the patient experienced swollen node on top of collar bone. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen node on top of collar bone was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient accidentally thought second shot was 2 weeks after first shot and came 1 week too soon for second Pfizer shot. Nurse helping store administered vaccine and didn't catch. Company ran and caught on report today 10/6/21 and patient was notified. No repeat dosing needed per guidelines at this time.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 06-APR-2016 and 10-APR-2017, the patient was vaccinated with Oka/Merck VARIVAX (lot # L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
Left upper extremity felt numbness and tingling to Right Chest. Pt experienced some  diaphoresis to face, denies dyspnea. Pt has hx of a vaccine reaction three years s/p 3 years.
One day after injection a red rash developed just below the injection site and spread down to my elbow.  The itching, burning, and aching associated with this rash interfered with my sleeping for two nights.  The injection site itself turned black.  Both of these problems began to clear up after 4 days.  The rash is faint pink now, and the injection site bruise is now yellow in color. The only other symptom I had was a severe headache for 2 days which was resistent to Tylenol.  The headache has cleared up.
Heart palpitations, headache, shortness of breath continue at this time per pt. for palpitations, pt. made appt. with cardiology for evaluation.
Her breast cancer come back after being cancer free for 11 years; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER RECURRENT (Her breast cancer come back after being cancer free for 11 years) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER RECURRENT (Her breast cancer come back after being cancer free for 11 years) (seriousness criterion medically significant). At the time of the report, BREAST CANCER RECURRENT (Her breast cancer come back after being cancer free for 11 years) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
sudden return of migraines that were dormant for over 3 years.  Auras, migraines and vertigo started less than a month after 2nd vaccine and continue to present day.
Inappropriate schedule of vaccine administered; Interchange of vaccine products; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 30-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  The treatment information was  not provided.  It was reported that total five patients who were immune compromised, and took Moderna third dose on 30-Aug-2021.They got their two shots  of Pfizer previously, one of them got second Pfizer shot on 25-AUG-2021 and took Moderna Booster after five days.   Reporter did not allow further contact
Pfizer 8/27/21, 9/17/21. Positive on 2/25/22
Experienced L sided visual changes, including decrease in visual field and inability to focus eyes. No intervention, recovered 30-40 minutes after it began.
The patient is a 69-year-old male who, it turns out, has a prior history of an adverse reaction to influenza vaccine manifesting as fever and myalgias. He received the Prevnar 13 vaccine on September 18, 2015. The next day he had the onset of fever followed by a bullous rash in the mouth and on the hands and on the feet accompanied by night sweats and joint symptoms. I was contacted by Dr at the time and suggested that he be seen by Dermatology. He was seen by Dermatology and started on doxycycline for possible cellulitis. He has been on doxycycline now for a month. The vesicular rash has resolved, as has his fevers. He has not had any fever since early October. He still has some mild joint symptoms at the base of his ring finger and had some sore ankles a couple weeks ago, but in general he is improving. He was seen in the emergency room on October 9 where it was noted that he did not have a fever for one week. His workup included negative Lyme serology, tick panel, culture of the lesion, CBC, comprehensive panel, RPR and blastomyces EIA. Provider states: it is most likely that he had an immune reaction to his Prevnar 13 given the temporal sequence of events. It is possible that he had a hand, foot and mouth disease syndrome due to a coxsackievirus, though based on the temporal association with the Prevnar 13 administration and his prior similar reaction to an influenza shot I think an autoimmune reaction to his vaccine is most likely.
This spontaneous report was received from a nurse refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. Since 05-JAN-2015, the patients was vaccinated with PROQUAD (Merck) (strength, dose, lot # were not reported) which were exposed to supported temperature excursion. Concomitant therapy was not reported. No adverse effect was reported. This is one of the two reports from the same source. Additional information has been requested.
Every muscle started aching; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Every muscle started aching) and PYREXIA (Fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to allopathic drugs (Allergic to Lisinopril).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced MYALGIA (Every muscle started aching) and PYREXIA (Fever). At the time of the report, MYALGIA (Every muscle started aching) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
joint stiffness; nausea; diarrhea; sore throat; Temperature of 101. 4 degrees Fahrenheit; Bad feeling all over; No appetite; Temperature of 101.4 degrees Fahrenheit; Booster; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 73 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown.), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Dec2021, outcome "unknown", described as "Booster"; ASTHENIA (non-serious) with onset 28Dec2021, outcome "unknown", described as "weakness"; JOINT STIFFNESS (non-serious), outcome "unknown", described as "joint stiffness"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Temperature of 101. 4 degrees Fahrenheit"; MALAISE (non-serious), outcome "unknown", described as "Bad feeling all over"; DECREASED APPETITE (non-serious), outcome "unknown", described as "No appetite"; PYREXIA (non-serious), outcome "recovering", described as "Temperature of 101.4 degrees Fahrenheit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional Information: According to agent, caller is a consumer inquiring about the adult formulation Pfizer BioNTech Covid-19 vaccine. Caller would like to know if any of the following side effects have been reported after receiving the vaccine, weakness, joint stiffness, nausea, diarrhea, sore throat and a temperature? Caller has a follow-up question and he would like know if the effects mentioned are also associated with the Covid-19 virus? further context: The patient was calling about the Pfizer Covid 19 booster shot, states he took the booster shot on Tuesday. The patient states by the evening, he was weak, and could not get up to his bed and he was so weak he had to crawl up the stairs. He states he had a bad feeling all over, his joints were stiff by Wednesday, he had an episode of nausea, no appetite, diarrhea, sore throat temperature of 101.4 degrees Fahrenheit, and he took some Theraflu and he was feeling better now. The patient decline to complete a report. He thought the vaccine gave him the Covid virus. He read a long list of side effects on his vaccine information sheet. He asks could his symptoms be the Covid virus? have other people reported his symptoms and asking if these symptoms could possible lead to getting the Covid virus.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
PALMS AND FEETS AND FACE OBSERVED SOME BLUISH PATCHES; LIGHT HEADED; RIGHT HAND NOTICED AT THE BASE OF INDEX FINGER'S KNUCKLE SOME DEEP RED AND BIG BLUE COLORED CIRCLE WHICH LOOKED LIKE A BRUISE; COULD NOT STAND UP; BOTH OF HANDS BACK SIDE BRIGHT RED COLORED; FELT CHILLS; HEADACHE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced palms and feets and face observed some bluish patches. On 12-APR-2021, the subject experienced light headed. On 12-APR-2021, the subject experienced right hand noticed at the base of index finger's knuckle some deep red and big blue colored circle which looked like a bruise. On 12-APR-2021, the subject experienced could not stand up. On 12-APR-2021, the subject experienced both of hands back side bright red colored. On 12-APR-2021, the subject experienced felt chills. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand noticed at the base of index finger's knuckle some deep red and big blue colored circle which looked like a bruise on APR-2021, and the outcome of felt chills, palms and feets and face observed some bluish patches, headache, fever, nausea, light headed, could not stand up and both of hands back side bright red colored was not reported. This report was non-serious.
The patient has achy muscles, burning eyes, headache, and chills. Treatment: Nyquil Employee has multiple allergies: Food testing planned for 1/01.
Information has been received from an investigator concerning a 10 week old female who on 8/11/99 was vaccinated, IM, in the right anterior thigh, with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). Concomitant vaccination, the same day, included a dose of poliovirus vaccine inactivated (manufacturer unknown) (lot N0956) given SC, in the left anterior thigh and a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (manufacturer unknown) (lot 7388AA) given IM, in the left anterior thigh. This report was part of a post-marketing surveillance program. On 8/22/99, the pt developed a fever and viral (presumed) gastroenteritis and was hospitalized. It was reported that the pt was treated with antibiotics and did well. The pt was hospitalized for 3 days and subsequently recovered. The investigator reported that the pt's adverse experiences were "possibly related" to therapy with the study vaccine. No further information is available.
Lower back pain started 5/5/03 at approx. 1700 hours. Pt experienced increased fatigue for the next 2 days. Fever began the evening of 5/7-101.5F at home and 99.5 upon presentation to ER. Hospitalization on 5/7 for increased WBC and fever. Has been hospitalized for 1 day as of 5/8/03. Pt has hisotry of splenectomy 1988.
Weakness/difficulty getting out of bed. Likely reaction to COVID booster. Infectious disease was consulted and was concerned that her weakness was more likely related to an inflammatory reaction to the COVID booster. Possible community acquired pneumonia. ED visit and hospital admission.
SICKENESS WIPED OUT; VOICE WAS COMPLETELY GONE; COVID-19 INFECTION; HOARSE VOICE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included significant weight loss, and concurrent conditions included chest congestion. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:20 for prophylactic vaccination. Concomitant medications included dextromethorphan polistirex for chest congestion, and cough, camphor/eucalyptus globulus oil/juniperus virginiana wood oil/menthol/myristica fragrans oil/pinus nigra oil/thymol, ibuprofen, and paracetamol.  On 14-APR-2021, the subject experienced hoarse voice. On 17-APR-2021, the subject experienced covid-19 infection. On 17-APR-2021, the subject experienced voice was completely gone. Laboratory data included: COVID-19 virus test (NR: not provided) postivite. On 18-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.1 C. On 19-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.4 C. On 20-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.5 C, 100.8 C. On 21-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.3 C. On 22-APR-2021, Laboratory data included: Fever (NR: not provided) 99 C. On an unspecified date, the subject experienced sickeness wiped out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hoarse voice, and the outcome of voice was completely gone, sickeness wiped out and covid-19 infection was not reported. This report was non-serious.
This spontaneous report as received from a physician via a company representative refers to a 61 year old female patient. Information regarding her pertinent medical history, drug reactions/ allergies and concomitant medications was unknown. On an unknown date in 2016 (reported as "about a year ago"), the patient was vaccinated with ZOSTAVAX for the prevention of shingles (the dose, dosage number, anatomical location, route of administration, lot # and expiration date were unknown). Subsequently, on 01-FEB-2017, the patient experienced an itchy rash around her right eye. She sought medical attention by contacting her physician. The physician was unsure if the itchy rash was shingles or not. An unspecified treatment was nevertheless prescribed for the event. It was unknown if any laboratory diagnostic studies had been performed. The outcome of the event, at the time of reporting, and the causal relationship between the event and the vaccine were unknown. Additional information has been requested.