chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-JAN-2011, the patient was inoculated at a medical plaza with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-FEB-2014, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The patient was prescribed acyclovir, prednisone, and gabapentin for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Soreness at injection site (3 days) Swollen lymph glands (2 days) Lethargy (2 days) Fever spikes (day following shot) Brain fog (2 weeks) Achiness in shoulders & neck (2 days) Diarrhea (2 weeks - ongoing)
Inadvertently received a booster dose of Moderna vaccine  that expired on 4/06/2022 (2 weeks prior)
revived during game; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case was received from a consumer/non-hcp (non health care professional) via social media.  This case involves a 17 year old and unknown gender patient who revived during game while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  It was reported that the patient was a soccer player and on an unknown date the patient revived during game (loss of consciousness) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (revived during game).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event revived during game.; Sender's Comments: Sanofi company comment dated 07-Feb-2022: This case concerns a 17 year old patient of unknown gender who had revived during game after vaccination with vaccine Influenza Vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Further information such as condition at the time of vaccination, medical history and concomitants would be needed to rule out alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.
About a week after the Booster I noticed I had an itchy feeling different parts of body, feet, legs and arms, chest and back not torso. No rash developed, but when I scratched it welted up. Shower made it worse. If I would get warm it would make it worse.
seizures; Fever; vomiting; This is a spontaneous report from a non-contactable healthcare professional. A adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm right on an unspecified date (Batch/Lot number was not reported) as dose 2, single, dose 1 via an unspecified route of administration, administered in arm right on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient was not pregnant. Medical history included depression, anxiety. No other vaccine in four weeks. No other medications in two weeks. The patient's concomitant medications were not reported. The patient experienced seizures, fever, vomiting on 14Aug2021 03:00 with outcome of recovering. The patient was hospitalized for these events for 3 days. Therapeutic measures were taken as a result of events included Put on a breathing machine and given anti seizure medicine. Events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). No Covid prior vaccination. No Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Seizures, Pyrexia and Vomiting cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
SHORTNESS OF BREATH ISOLATION-INFECTIOUS DISEASE SIRS (systemic inflammatory response syndrome)  Hypokalemia Hypomagnesemia  Lactic acid acidosis Hypoxia Transaminasemia Generalized weakness Abdominal pain, unspecified abdominal location Suspected COVID-19 virus infection
He received 3 doses of Pfizer vaccines on 3/13/21, 04/03/21, and 12/18/21. On 5/25/22, he presented at ER for one week of generalized weakness, cough, and falls. He was tested for covid, positive prior to ER arrival. He was admitted to the hospital same day for further treatments. He received Remdesivir and Steroids. He was originally febrile and given supplemental oxygen. He was discharged home on 5/29/22 without home oxygen therapy.
She Fell into a very deep sleep, we were unable to wake or stimulate to wake her for up to 8 hours. She was grunting and trying to wake but would never open her eyes. Kept falling back into deep sleep. This went on for hours. She could not drink from bottle during this time. During the first 6 hours after her vaccines. We thought she was just sleeping longer than usual but once we realized she was having trouble waking the Situation went on for the remainder of the night. Unsure of brand of vaccine so I listed unknown- but she was given Hep B, DTaP, polio, rotavirus, and HIB - ALL AT ONCE.
drive through monitoring area. Nurse practitioner approached the client in her car she was here for 15 minute post vaccination injection.  When I asked her how she was doing, she said she was feeling numbness and tingling in her fingers and seeing white spots in her eyes. She was  sitting in the car in the sun for the past five minutes or so I got her a bottle of water and moved car into the shade I asked her if I needed to call the paramedics.  We initiated the code green and turned over care to the paramedics.    Evaluated by paramedics and released. Patient?s husband drove the patient
Severe upper abdominal pain slightly to the right of center, tenderness, radiating through to back, worse after drinking water, approximately 12-14 hours, would not resolve with OTC medications.
redness that is increasing in size; warm; feel pain; covid arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (covid arm), ERYTHEMA (redness that is increasing in size), FEELING HOT (warm) and PAIN (feel pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE REACTION (covid arm), ERYTHEMA (redness that is increasing in size), FEELING HOT (warm) and PAIN (feel pain). At the time of the report, VACCINATION SITE REACTION (covid arm), ERYTHEMA (redness that is increasing in size), FEELING HOT (warm) and PAIN (feel pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
Thigh with significant edema, erythemia and warmth the day after receiving vaccine.  Continued to progress for next few days, finally treated with antibx.
My headfeels like a truck hit it; nothing worst then having a badflu type of thing; This is a spontaneous report from a contactable consumer or non health care professional (Patient). This is a report received from a Pfizer sponsored program. A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiration date was unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiration date was unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient mentioned that the first shot was really easy but the second one that one was a doosy. He was kind of still reeling from that one a little bit. His head felt like a truck hit it. The day of the second shot was not too bad but the day after was really bad. The patient heard that it was very common the second shot gives you a bad reaction, nothing worst then having a bad flu type of thing. It was not pleasant but the outcome was what we are all going after. The outcome of events was unknown.  No follow-up attempts were needed. No further information was expected.
Had a fever is high as 100° cold chills bodyaches joints hurt had a 48 hours after that it disappeared. Stayed in bed for two days.
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 years old female patient who experienced 17 year old girl who received an extra dose of MENACTRA, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6016AA in left deltoid. It was a case of actual actual medication error due to extra dose administered. 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 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 error.
Fever 102, headache, nausea, chills, malaise, brain fog lasting 2 days. Patient had COVID in March 2020 and recovered.
Fever; Body aches; Fatigue; This is a spontaneous report from a contactable other healthcare professional (hcp reporting for self). A 57-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL 3247, expiry date not reported), via an unspecified route of administration on 27Jan2021 14:45 at a single dose in the right arm for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. The patient had no known allergies. Patient had no covid prior to vaccination. Concomitant medications included atorvastatin calcium (LIPITOR); ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER); and fish oil. The patient had no other vaccine in four weeks. On 28Jan2021 22:30, patient had fever, body aches, and fatigue. No treatments received in response to the events reported. The patient was not tested for covid post vaccination. The patient recovered from the events fever, body aches, and fatigue in Jan2021.
Heart aches and pains; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE), dose 1 at vaccination age of 43-year-old via an unspecified route of administration in the left arm on 24Apr2021 13:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included heart disease family history. The patient was not diagnosed with covid prior vaccination. The patient has no known allergies. There were no concomitant medications. The patient received the vaccine in a public health clinic. The patient did not receive other vaccine in four weeks. On 30Apr2021, the patient had heart aches and pains, and shortness of breath started within 2 weeks after her first dose at a public facility. The patient did not received treatment for the adverse event. The patient had a nasal swab on an unspecified date with negative results. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in an 87-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 07-Apr-2022. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2022: Follow up received reporter address updated.
After injection the initial side effect was only a sore arm.  By 9:15 the next morning (Friday) body aches began to set in, with sore joints.  At 10:30 when I took my temperature, it was 101 and chills set  in.  For the remainder of the day I alternated with tylenol and advil.  Aches and fever remained the rest of the day.  By Saturday morning, fever was down and it was only 99.8.  The only side effect on Saturday was a sore arm and headache.  All symptoms were gone by Sunday morning.
This spontaneous report was received from a patient of unknown age and gender who refers to him/herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2014, reported as four years ago, the patient was vaccinated with a dose of ZOSTAVAX vial (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis. The patient received a first dose of SHINGRIX in approximately May 2018, reported as six weeks ago, for the prevention of shingles. No adverse effects were reported. According to the current prescribing information for ZOSTAVAX, the need for revaccination had not been defined. The outcome of the event and causality assessment were not provided.
This spontaneous report as received from a registered nurse refers to an unspecified patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# were not reported) which this single dose was exposed to -1C for 22 days. The nurse stated that she was not sure if dose may have been administered to the patient. No adverse effects reported. This is one of several reports from the source. Follow-up information has been received from the registered nurse and refers to a 55 year old male patient. On 14-MAY-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were not reported, lot # K003074, expiration date 13-MAR-2015) that was stored improperly. The diluent was exposed to lower than 2C for more than 15 days, the lowest temperature was -1C for 5 days. No symptoms were reported. No PQC (product quality complained) involved. The reporter asked if the patient had to be revaccinated. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 6 month old patient of unknown gender. On 03-MAR-2014, the patient was vaccinated with an expired dose of properly stored ROTATEQ (lot # H012252, expiry date 29-JAN-2014), 2 ml, oral. This dose was the third dose in ROTATEQ series. No adverse events were reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
mild right sided tear through swelling where dermal filler has been used; mild right sided tear through swelling where dermal filler has been used; received BNT162B2; first dose on 18Dec2020 15:00 and second dose on 06Jan2021 20:45; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899 and expiry date unknown) via unspecified route of administration on 06Jan2021 20:45 at left arm for Covid-19 immunization in a workplace clinic. Medical history included covid prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medications was none. Historical vaccine included first dose of BNT162B2 (lot number EJ1685) on 18Dec2020 15:00 at right arm for Covid-19 immunization. On 08Jan2021 18:30, the patient experienced mild right sided tear through swelling where dermal filler has been used. The patient was not covid tested post vaccination. The outcome of the events mild right sided tear through swelling where dermal filler has been used was recovering. The reporter considered the event non-serious; which did not result in death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating and no congenital anomaly/birth defect.
This spontaneous report as received from a pharmacist refers to an almost 65-year-old female patient. The patient's pertinent medical history included diabetes. No information regarding the patient's drug reactions or allergies was provided. On 16-SEP-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 plaque-forming units (PFU) (0.65 ml in the right arm; lot # L007222, expiration date: June 2016) for a doctor recommendations. Concomitantly she took unspecified diabetes medications. On an unknown date in September 2017, an unspecified amount of hours after the vaccination, the patient experienced numbness and tingling on the right side of her head. The patient sought a medical attention and talk with the pharmacist on the phone about the event. No treatment was given for the adverse events and no laboratory diagnostic studies were performed. The numbness and tingling on the right side of her head was unknown. The relatedness between the adverse events and ZOSTAVAX was not provided.
Feeling lightheaded; Sensitivity to light; Headache; This case was reported by a pharmacist via patient support programs and described the occurrence of light headedness in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced light headedness, photophobia and headache. On an unknown date, the outcome of the light headedness, photophobia and headache were unknown.   The reporter considered the light headedness, photophobia and headache to be related to Shingrix.  Additional details were reported as follows: The pharmacist reported the patient was feeling lightheaded, sensitivity to light, headache from last few days.
MINUTES AFTER IMMUNIZATIONS GIVEN, CHILD BROKE OUT IN RASH OVER FACE, TRUNK, AND LEGS.
18 hours after the 1st vaccine shot... healthy female while in the shower....blacked out, couldn't  see, called for mother who she knew was not home, passed out, and was not coherent, felt dizzy,  had a bad headache, and face was swollen, Called her doctor's office, told them about the vaccine and the incident,  they said to go to the emergency room. Went to emergency room. She had a full list of tests.  Was given a saline drip, hydration unit. Level V emergency code. Name vasovagal syncope, reaction to vaccine, electrolyte abnormalities,  dehydration,  dysthymia
X-XX-09 Error: Unnecessary MMR given. Narrative: 13 year old child came into clinic for immunizations shots. Nurse looked at the form the school filled out on what they thought was needed. The nurse gave the shot without checking the child's medical record. The nurse discovered her error when she went to chart the shot. The Dr. was notified and he said the child should have no ill effects.
Information has been received from a registered nurse concerning a male who on 12/26/99 was vaccinated with a 3rd dose of Hepatitis B vaccine recombinant. Concomitant therapy included a 2nd dose of Hepatitis A vaccine. On 12/26/99, the patient experienced arm soreness with radiation of pain lower into the arm. There were no objective signs or symptoms. It was decided the patient had "either tendinitis with accidental nick of tendon sheath or coincidental tendinitis". NSAID's were recommended. Subsequently, the patient recovered. It was noted he "had two vaccine together in same arm previously with no problem". No further information is available.
This spontaneous case reported by a consumer (patient's mother), describes the occurrence of vaccination complication (side effects from the Moderna booster ten days after) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (side effects from the Moderna booster ten days after). At the time of the report, vaccination complication (side effects from the Moderna booster ten days after) outcome: unknown. Reporter stated her daughter had side effects from the Moderna booster after ten days. No concomitant medication or treatment information provided.