chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vestibular balance issues; Wrecked her truck when a bought of vertigo came on; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VESTIBULAR DISORDER (non-serious), outcome "unknown", described as "Vestibular balance issues"; VERTIGO (non-serious), outcome "unknown", described as "Wrecked her truck when a bought of vertigo came on".  Additional information: The reporter was the brother of patient. The reporter stated he has had a serious and intense reaction that he can only trace back to the 2nd dose of the vaccine. It started with a lot of different symptoms. While competing a report on himself, caller stated that after his sister (the patient) got the vaccine she also experienced vestibular balance issues, but he doesn't know the manufacturer of the vaccine the patient received. The patient had an incident where she wrecked her truck when a bought of vertigo came on. The Caller declined to complete the report because he couldn't give detailed information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
dry lips; Intense pain on injection site; Elevated temperature (100.5F); Wriggling sensation on face; This spontaneous case was reported by a consumer and describes the occurrence of LIP DRY (dry lips), VACCINATION SITE PAIN (Intense pain on injection site), BODY TEMPERATURE INCREASED (Elevated temperature (100.5F)) and PARAESTHESIA (Wriggling sensation on face) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030MZ0ALLD073121 and 036ALIN) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced LIP DRY (dry lips), BODY TEMPERATURE INCREASED (Elevated temperature (100.5F)) and PARAESTHESIA (Wriggling sensation on face). 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Intense pain on injection site). At the time of the report, LIP DRY (dry lips), VACCINATION SITE PAIN (Intense pain on injection site), BODY TEMPERATURE INCREASED (Elevated temperature (100.5F)) and PARAESTHESIA (Wriggling sensation on face) outcome was unknown. Not Provided
Had a headache saturday night, woke up with terrible headache sunday, body aches, fever, and pain in arm on sunday. Monday had pain in arm and fever. Tuesday no fever but pain in arm got worse and a large red rash developed. Rash continued to grow daily and became hot to touch. Saw my doctor on Thursday I drew a circle under the rash and it grew outside the circle, doctor prescribed prednisone and antibiotics as a precaution in case not an allergic reaction but possible infection at the injection site.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 31-DEC-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Patient presented with both arms with swelling around the deltoid, hot to touch, and a bit uncomfortable but he said he felt no pain. He was well and alert in office.
Headache, Myalgia, Arthralgia, Fever,  CoughWheeze, Chills, fatigue Narrative:
Pt. received TDAP. Approx 20 min later pt. complained of lightheadness, feeling warmth all over body. Pt. placed on supine position evaluated by 2 physicians, 1 RN. Pt has involuntary movement all over body, with O2 sat of 71%. Placed on 2 liter O2 and transported to ER for further evaluation.
PATIENT RECEIVED FIRST DOSE OF PFIZER COVID 19 VACCINE. AT APPROXIMATELY MINUTE 15 POST VACCINATION PATIENT STATED THAT SHE WAS HOT AND FELT JITTERY. PATIENT WAS GIVEN WATER AND A BANANA AND HAD SEVERAL COUGHING SPELLS, SAID THAT SHE FELT A LOT OF MUCUS IN HER THROAT AND THAT SHE WAS ASTHMATIC. PATIENT HAD RESCUE INHALER WITH HER BUT NEVER USED IT. PATIENT REPORTED FEELINGS OF ITCHINESS AND WAS OFFERED BENADRYL BY RPH. PATIENT TOOK BENADRYL FROM EMERGENCY SUPPLY KIT. AFTER MINUTE 45 PATIENT WAS FEELING BETTER AND WAS RELEASED FROM OUR CARE.
Left deltoid (TDAP) 4.5cm x 5cm red, hot to the touch slightly raised at injection site (fever 6/24/10 per mother).
Congestion; Weakness; Coughing; cold; This is a spontaneous report from a contactable consumer (patient).   A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot EN6207) on 17Mar2021 at 12:00 pm in arm and second dose (Lot ER8729) on 10Apr2021 at 11:00PM in left arm, both at age of vaccination 49 year old, via an unspecified route of administration at single dose for COVID-19 immunization. Medical history and concomitant medication were unknown. On 13Aug2021, patient experienced cold, congestion, weakness and coughing. No treatment received. Outcome of events congestion and cold was recovered, of event weakness and coughing was recovering. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 on 13Aug2021 ( COVID test nasal swab with unknown results).  Follow-up attempts are completed. No further information is expected.
Narrative:  Hospitalization: COVID-19 fully vaccinated, found to be COVID-19 positive upon admission after presenting to ER after a fall and reported AMS
Severe rash over 80% of body; eczema-like in nature.; This is a spontaneous report from a contactable consumer, the patient. An 88-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the right arm on 24Feb2021 (at the age of 88-years-old), as a single dose for COVID-19 immunisation. Medical history included left bundle branch block in heart. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) and rivaroxaban (XARELTO); both for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration on an unspecified date in Feb2021 at 09:00 (at the age of 88-years-old), as a single dose for COVID-19 immunisation. On 04Mar2021 at 08:00, the patient experienced severe rash over 80% of body and it was eczema -like in nature. This appeared 8 days after the second dose. The patient was treated with unspecified cream for eczema type symptoms. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of eczematous rash was not recovered.  No follow-up attempts are needed. No further information is expected.
Narrative:  Pt called COVID-19 Vaccine ADR hotline on 2/11/21 to report experiencing dizziness following the second dose of the Moderna vaccine on 2/10/21. Per chart review, the patient self-presented to community emergency facility reporting "dizziness and giddiness."
Vaccines administered on 1/6/14, patient presented to office on 1/9/14 with generalized macula papular rash, pain/burning on bottom of feet. No treatment. Coming back for additional follow up on 1/16/14.
Varicella vaccine given 4/19/2007 (2nd dose) (+) pregnancy test on 4/25/07.
Patient was adminsitered vaccine at 230pm on 6/19, and stated reaction started that evening around 6pm. Patient had her arm and leg on ONLY the left side of her body swell up. Patient followed up with the physician on Monday 6/22, by which time the swelling had almost completely gone away.
Background: pharmacy received 49 vials of Pfizer COVID vaccine (Lot number EN6199) on 5 March 2021 and stored them in the pharmacy refrigerator.   The doses were labeled with an expiration date of 10 March 2021 at 0701.   Since starting the COVID-19 vaccine program, the medical office has always used the doses before they approached the expiration date. This time, there were 16 vials of the Pfizer vaccine that had not been used and set to expire. The labeled expiration date and time were clearly present on the outside of the bag containing the doses. On the morning of 10 March 2021, a pharmacist retrieved 1 vial at 0754 and 7 vials at 1138 from that allocation and provided them to nursing for the day?s administrations.  The pharmacy placed those doses in a new amber bag and did not label the bag with an expiration date and time.   The nursing team received the vials, diluted and drew up 20 doses that were administered to patients before 1230.    The charge nurse did not question the expiration date until after 20 patients had been vaccinated.  At that time she messaged the pharmacist to verify the expiration date.  The pharmacist indicated that the label did not state am or pm and misinterpreted the expiration time for the doses as 7:01 PM rather than 7:01 AM.  There was not a defined double check at the time of distribution from the pharmacy to nursing  The remaining 11 vials were quarantined.  The pharmacy manager contacted the manufacturer.  According to Pfizer it?s recommended to use the thawed vaccine within 120 hours, but can be used up to 144 hours.  The doses in question were administered before 125 hours after they were thawed.  The remaining expired vials will be wasted and appropriate notifications sent.  Assessment: Twenty patients received Pfizer COVID vaccine 5 hours passed the labeled expiration date and time.  While exceeding the manufacturer?s recommended beyond use dating, the doses were within the acceptable 144 hours post thaw period and still safe for patient administration.  There was misinterpretation of the labeled expiration time by the dispensing pharmacist, the container of COVID vaccine vials provided to nursing was not labeled with an expiration date or time, there was not a double check on hand off, the nursing team did not double check the expiration date/time before dilution or administration.  Recommendation:  When repackaging COVID Vaccine vials for distribution to vaccination centers, a label including the expiration date and time should be placed on the new container.    When COVID vaccine is transferred from one location or department to the next, a double check of the product, quantity, integrity and expiration date and time may prevent a recurrence of this situation.
headache; arm soreness under injection; This is a spontaneous report from a contactable nurse (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685), intramuscular on 28Dec2020 12:00 in left arm at single dose for COVID-19 immunization. Medical history included depression, osa (obstructive sleep apnea syndrome) and obesity from an unknown date and unknown if ongoing. Concomitant medication included escitalopram oxalate (LEXAPRO), lansoprazole (PREVACID), clarithromycin (CLARITIN [CLARITHROMYCIN]) and losartan potassium (COZAAR). The patient had arm soreness under injection and slight headache on 28Dec2020 21:00 and took Tylenol and aleave as treatment. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect. The outcome of the events was recovering.
received the 2 vaccine and still got shingles / Suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 16-JUL-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The reporter stated patient received 2 doses of Shingles vaccine, however still got shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset was not known and laboratory test confirming shingles were unknown at the time of reporting.
A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicated that a 1 year old female was inadvertently administered Fluvirin IM on 18Nov02.  The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854,PJP200200855, PJP200200856,PJP200200857,PJP200200858, PJP200200859, PJP200200805, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.
Elevated heart rate; chest pounding following first dose.; This is a spontaneous report from a non-contactable consumer or other non-health care professional (Patient). A 45-year-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176 and expiration date was not reported), first dose via an unspecified route of administration, administered in arm right on 11Jun2021 17:00 (at the age of 45 years) as single for covid-19 immunisation. Patient also received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176 and expiration date was not reported), second dose via an unspecified route of administration, administered in arm right on 02Jul2021 17:00 (at the age of 45 years) as single for covid-19 immunisation. Patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccines within 2 or 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 11Jun2021 18:00 the patient experienced Elevated heart rate, mild sensation of chest pounding following first dose. This persisted for the three weeks until 2nd dose and continues to date. The outcome of the events was not recovered.  Follow-up attempts are needed. No further information is Expected.
moderate muscle pain, headache, shivering, anxiety and not sleeping well, frequent restroom trips overnight --six or seven times
Client states his upper arm has been sore ever since he received the Typhim vi injection in his left arm. He feels the soreness when he raises his left arm above his head or behind his back. He has not had any treatment.
No additional adverse event.; The patient inadvertently received an expired dose of MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.   On 21-JAN-2020, the patient inadvertently received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA) (strength, route, dose, frequency, and anatomical location were unknown) with lot # R001659 and expiration date on 17-JAN-2020, reconstituted with sterile diluent(MERCK STERILE DILUENT) for prophylaxis. No additional adverse event were reported.
Pt recvd 3 doses of Hep B, time of 3rd dose was MAY89; pt exp arthralgia;
After 2 days of fever (about 48h), suddenly found dermatitis around some parts of body. Including face skin, ear  skin and skin of  private parts.
Breakthrough case admission after four vaccines: Pfizer 2/24/21 Lot# EN6202; Pfizer 3/17/21 Lot# EN6204;  Moderna 11/6/21 Lot# 051F21A; Moderna 4/1/22 Lot# 066K21A.
Right arm- where she received SHINGRIX: right eye and bottom lip swell, had hives all over the body inclulding chest and trunk. Left arm- where she received flu shot: arm was swollen.
Shingles that ended up causing Transverse Myelitis I was in the hospital for a week and still have a lot of health issues associated with the Myelitis.
Shot received aprox. 12:30p.m. and by 6:30p.m.  raised area at injection site. then feeling tired. Then early a.m.  of  5/25/21 woke with muscle cramps in right calf. As the day progressed, I had the following symptoms: fever ,chills, burning sting/watery eyes, muscle aches, severe head and neck ache, congestion in left cheek and brow bone(general feeling of the flu).  On 5/26/21 still having feeling of muscle cramps, exhaustion, headache, and cloudy thinking/judgment.
a nurse may have given an expired IPOL vaccine/no AE; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves female patient (of unknown demographics) who received an expired dose of IPV (VERO) [IPOL] (lot unknown, of Expiration date:14-Nov-2019) via unknown route at an unknown administration site for prophylactic vaccination (expired product administered).  It was an actual medication error due to expired vaccine used.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication.  Information on the batch number is requested.
Right anterior thigh 18mmx12mm oval area of erythema and induration. 40mmx38mm nodule underlying the area of erythema.
Client passed out after giving vaccine, pale, dizzy but alert when coming to, client laid down for a few min. Gave water, BP 102/76, O2 98%, HR 81.
Tested positive for Covid on 12/26/2021 after receiving 2 Covid vaccinations and a booster vaccination several months before. No treatment required at this time.
A non-serious, spontaneous report of lower back pain, fever, nasal congestion, and cough had been received from a registered nurse concerning a six-year-old male patient, subsequent to H1N1. The patient's medical history and concomitant medications were not provided. The patient received H1N1 on 20-Oct-2009. On 20-Oct-2009, the nurse reported the patient came into the office with flu-like symptoms. The patient had a fever, lower back pain, nasal congestion, and cough. A nasal swab was performed and the test came back positive. The event outcomes were not reported.
Patient presented to the ED with epistaxis on 5/1/2021. Patient had second vaccination on 5/22/2021. Patient presented to the ED and was subsequently hospitalized on 6/21/2021 for acute pancreatitis. These visits are within 6 weeks of receiving COVID vaccination.
Itchy vesicular rash - per parents with elevated temp 100-101 4/20/03 - 4/25/03.  Seen 4/28 office, scattered lesions on scalp, back resolving.
received Flublok and experienced left facial numbness; numbness started at the top of cheek to the corner of mouth; Initial information received on 29-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 35 years old female patient who experienced left facial numbness; numbness started at the top of cheek to the corner of mouth after receiving vaccine Influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Sep-2022, the patient received 0.5 ml total dose of suspect Influenza quadrivalent recombinant vaccine(strength, formulation: unknown) (lot QFAA2225, 30-Jun-2023) via intramuscular route in the left deltoid for immunisation.  On 28-SEP-2022 the patient developed a left facial numbness; numbness started at the top of cheek to the corner of mouth (hypoaesthesia) following the administration of Influenza quadrivalent recombinant vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered / Resolved on 28-Sep-2022 for the event.
Post first and second vax, litigation alleges the pt experienced arthritic-like symptoms in various joints of his body. The newspaper article quotes the pt as developing the same form of arthritis that afflicts his wife after getting vax. Pt has test HLA-DR4 positive and is positive for Lyme disease. He is being treated by MD for these events. The litigation states that the pt has suffered great pain, discomfort and emotional distress as well as the events have severely limited his employment options and opportunities. The litigation alleges that pt Lyme disease and arthritic symptoms associated with his HLA-DR4 positive status were triggered by his vax with Lymerix.
A week after vaccine (after initial soreness was gone) my arm began to hurt a lot. Vaccine site became stiff and developed rash/large bump. The day after this occurred the bumps went down but the area became inflamed, red, and warm to touch. The entire upper arm is still in a lot of pain.
screwed my stomach; Initial information regarding an unsolicited valid non-serious case received from a consumer via social media and transmitted to Sanofi on 09-Dec-2020.  This case involved an unknown age patient who experienced screwed my stomach (Abdominal discomfort), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported.  On unknown date, (latency unknown) patient reported the last time patient got a flu shot it totally screwed stomach up, patient stomach hasn't been right ever since would never allow another shot to be stuck in arm for any reason (Abdominal discomfort).  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.