chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna lot# 016M20A 0.5ml given at 1008 am. 1019 am client complained of swelling in her throat without other symptoms. Lips & tongue with minimal swelling noted. Denies respiratory distress or any other symptoms. 1021 EPI 0.3mg administered left thigh. 1022 BP 130/90 left arm with large cuff & pulse 84 & regular. Talking without difficulty & in full sentences. EMS activated stat. Ambulated to the front entrance of the building without difficulty. EMS arrived 1024am. 2 children accompany her. Denies history of anaphylactic reaction but later remembered a reaction to Iron infusion & witnessed per EMS. Refused ER visit & signed against medical advice per EMS.
PATIENT CAME IN TODAY WITH A PARTNER FOR A SCHEDULED APPOINTMENT FOR A HEPATITIS A AND AN INFLUENZA VACCINE. HAVRIX WAS ADMINISTERED IN THE RIGHT ARM IMMEDIATELY FOLLOWED BY FLUCELVAX ADMINISTERED IN THE LEFT ARM. WITHIN 30 SECONDS POST-VACCINATION THE PATIENT REPORTED FEELING LIGHTHEADED AND DIZZY. I ADVISED PATIENT TO REMAIN SEATED AND MONITORED HER SYMPTOMS. SHE IMMEDIATELY BECAME PALE AND BEGAN TO PERSPIRE AND STATED THAT SHE FELT LIKE SHE WAS GOING TO FAINT. THE PATIENT THEN BEGAN CONVULSING, HER PUPILS DILATED AND SHE HAD A SHORT 20-30 SECOND SEIZURE. I ADVISED HER PARTNER TO CALL 911 AT THIS TIME. WHEN THE PATIENT CAME TO SHE WAS VERY ANXIOUS, COMPLAINED OF TINGLING IN HER EXTREMITIES AND NAUSEA. SHE COMPLAINED OF SHORTNESS OF BREATH AND APPEARED TO BE MILDLY HYPERVENTILATING. PARAMEDICS ARRIVED WITHIN 5 MINUTES FROM PLACED 911 CALL. PATIENT WAS TRANSPORTED TO THE HOSPITAL DUE TO NO HISTORY OF SEIZURES IN THE PAST AT THE RECOMMENDATION OF THE PARAMEDICS
-nausea for 1 week -body aches and chills lasting one week -headache for 3 days -loss of appetite for 5 days -hyperglycemia and insulin resistance -pain in arm radiating to shoulder/ wrist, persistent, lasting over 9 days
37 yo obese dependent female with severe vasovagal reaction after a 30 minute wait time someone walking by noticed patient was not looking well and informed the observation staff. Nurse called for assistance and began talking with the patient.   Provider arrived and patient was pale, slumped in chair but conversive. Upon assisting patient to the floor she became unconscious and we laid her down. EMS was requested. Over the next few minutes had 3 episodes of LOC with brief ~5 seconds of breathing cessation and seizure like activity with significant head shaking sometimes involving upper torso followed by coughing and retching without actual vomiting. Due to this she was placed in left lateral recumbent position with the first episode. Each time she awoke she appeared confused but was able to answer questions. Oxygen was applied with pulse oximetry but unable to obtain BP during this time. After the third episode she suddenly asked what happened and mentation returned to normal.   Upon Fire/EMS arrival was conversing normally on the floor on her left side. Reported multiple food/environmental allergies and metformin allergy. History of suspected seizure but nothing proven.   Reported before her vaccine that last time she experienced a brief LOC hours ~12 hours after her first vaccine. She had arranged for someone to stay with her tonight in case she felt faint again.
Local swelling, warmth and induration around injection site (9x7cm). Suspected cellulitis: tx with Bactrim (pt has hx MRSA).
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 19-MAY-2016, the patient was vaccinated with an expired dose of VAQTA lot # L018498, expiration date on 28-APR-2016 (strength, dose number, route and anatomical location were not provided). There was no concomitant medication described. No adverse effects were reported. Additional information has been requested.
Information has been received from a registered pharmacist (R.Ph.) concerning a 20 month old patient whose approximately 60 year old grandfather on 30-APR-2010 was vaccinated with a first dose of ZOSTAVAX (Merck) subcutaneously (Lot number unknown). The pharmacist stated that the patient's grandfather received his dose of ZOSTAVAX (Merck) and subsequently visited his grandchildren. On 05-MAY-2010 "5 days after the visit", the 20 month old granddaughter developed a case of chickenpox (approximately 15 lesions in her upper chest and face according to the grandmother). The pharmacist stated that the recipient of the vaccine never developed a rash on his body. At the time of the report, the current status of the 20 month old granddaughter is unknown. The patient did not seek medical attention. Follow up information has been received from a registered pharmacist. It was reported that the female patient, whose grandfather was vaccinated with the first dose of ZOSTAVAX (Merck) (lot number 665515/1373Y) in the left arm on 22-MAY-2010 after noon, developed mild case of chicken pox 30 days after exposure to her grandfather (on 21-JUN-2010). The patient's grandfather had no reaction to ZOSTAVAX (Merck) (no rash developed at the injection site). At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. No further information is expected.
swollen tongue; Sleepiness; swollen tongue, with raised white puffy lines; vaccination complication; Rash; This spontaneous case was reported by a patient and describes the occurrence of SWOLLEN TONGUE (swollen tongue), SOMNOLENCE (Sleepiness), TONGUE DISCOLOURATION (swollen tongue, with raised white puffy lines), VACCINATION COMPLICATION (vaccination complication) and RASH (Rash) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for Prophylactic vaccination.    No medial history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   In 2009, the patient received dose of INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) (unknown route) .5 milliliter. 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 SWOLLEN TONGUE (swollen tongue), SOMNOLENCE (Sleepiness), TONGUE DISCOLOURATION (swollen tongue, with raised white puffy lines), VACCINATION COMPLICATION (vaccination complication) and RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, SWOLLEN TONGUE (swollen tongue), SOMNOLENCE (Sleepiness), TONGUE DISCOLOURATION (swollen tongue, with raised white puffy lines), VACCINATION COMPLICATION (vaccination complication) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
1/20/16 PENTACEL, PREVNAR 13 and ROTATEQ. She was a little more tired 3 hr nap but excessive. No irritability T100.6 that night. No excessive crying. 1/25/16 First episode of "startle" 1/26/16 Tues morning a cluster of infantile spasm 8-10 (4 spasm recorded on video). 1/26/16 a few spasm at night. 1/27/16 EEG hypsarhythmia a few episodes of the spasm B6 administer - no improved 1/28/16 ACTH-1st dose.
Loss of sensory waist down. Numbness and tingling waist down.  Weakness in legs, heaviness in the legs. Bladder and bowel problems - urinating frequently, urinary incontinence and constipation.
Friday afternoon, felt hard lump in both arms at sites of injection. Left arm improved with time. Right arm subq area was hot to touch, firm and red. Painful. Did not see PMD.
Information has been received from a doctor of pharmacy concerning a 69 year old male patient who on 03-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669538/1390Z). The doctor of pharmacy stated that in February 2011, the patient developed localized redness and swelling which resolved on its own in February 2011. There was no treatment given for the events. It was unspecified if the patient sought unspecified medical attention. Follow-up information has been received from the doctor of pharmacy, who reported that the female patient (previously reported as a male) with unknown illness and unknown pre-existing allergies birth defects, at the time of vaccination was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot # 669538/1390Z), SQ, 13:00 on 03-FEB-2011. The doctor of pharmacy stated that the patient experienced Localized reaction, including redness and swelling. There were no laboratories diagnostics performed. The doctor of pharmacy stated that the patient did not want to be contacted. At the time of the report the patient had recovered. It was also reported that the patient had no adverse event follow prior vaccination. No further information is available.
fever and cramping beginning approx 5 hours after vaccination, preterm labor diagnosed. T max 101.1. 32 weeks 6 days pregnant, EDD March 20, 2021. Labor was stopped, delivery has not occurred. TDAP was received 16 days after 2nd dose of Pfizer Covid19 vaccine.
Started with left arm sore and not able to move very well, moved to right arm, then to neck. States he just felt pain. Mom gave Tylenol. Started to complain on Saturday that legs/knees were very painful and was not able to get around very well, then moved to groin area.
Dizziness, Headache, Myalgia, Fever,  injection site reaction Narrative:  Pt received 3rd (booster) dose of Moderna vaccine on 11/12/21 in the afternoon and by the following morning (11/13/21) began experiencing symptoms of fever (102 F), chills, dizziness, body aches, headaches, and fatigue. On 11/15/21, pt was denied entry into facility due to complaints of chills and body aches. Also reported injection site itching, redness, heat, and hardness the size of a tangerine. Advised to see PCP. On 11/16/21, fever was reduced to 100 F, still complaining of body aches and injection site swelling, hardness, redness, and heat. Did not see PCP yesterday. Advised again to see PCP or present to urgent care. On 11/18/21, pt states saw PCP on 11/16/21 evening and was diagnosed with cellulitis. Was prescribed antibiotics (unknown drug, dose, frequency, duration). Reported fever steadily improving. Reports did NOT have this same reaction with previous 2 doses of vaccine.
Severe abdominal cramps/pain accompanied by 4 bouts of very watery diarrhea.  Lasted approximately 90 minutes.  No treatment. (This is similar, although much more intense, to symptoms I experience on accidentally ingesting gluten).
Boostrix given to a 19-month-old; Boostrix given instead of DTaP; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number KP547, expiry date 29-NOV-2024) for prophylaxis.   On 13-FEB-2023, the patient received the 4th dose of Boostrix. On 13-FEB-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix given to a 19-month-old) and wrong vaccine administered (Verbatim: Boostrix given instead of DTaP). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-MAR-2023 A nurse called to inform that the patient was supposed to receive the 4th dose of the DTap series however dose of Boostrix was administered. The reporter consented to follow up. A 19-month-old patient received a dose of Boostrix instead of DTap vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Leg pain, Back pain , Developed shingles 5-6 days after the leg and back pain started. (April 11-12th.)
Client reported a friend noticed a large bruise on the back of her left arm around one day after MMR shot received. Area became sore/ sensitive over the next 24 hours with increasing redness and warmth noted. Client presented to clinic on 7/8 at 1:45 to have PPD read and showed her left arm. Observed. 2.25 inch blackened bruise around 2" above elbow, surrounded by reddened area around 2.5 inches in diameter. No treatment. Patient advised to contact physician if continued discomfort or concerns.
headache/Headache was reported as worsened; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. A 27-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) on her right arm, via an unspecified route of administration on 19Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included migraine in 2016 and on Birth control.  Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) for Birth control and paracetamol (TYLENOL). It was reported that the patient received the Pfizer COVID 19 vaccine yesterday and started to have a headache last night (19Jan2021). She noticed the headache last night and now it is worse than last night. The outcome of the event was not recovered.
Collapsed; Lost her vision; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Collapsed), BLINDNESS (Lost her vision) and FATIGUE (Exhausted) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes.    On 26-Feb-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 SYNCOPE (Collapsed) (seriousness criterion hospitalization), BLINDNESS (Lost her vision) (seriousness criterion hospitalization) and FATIGUE (Exhausted) (seriousness criterion hospitalization). At the time of the report, SYNCOPE (Collapsed) and FATIGUE (Exhausted) outcome was unknown and BLINDNESS (Lost her vision) had not resolved.        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.  Based on the current available information and temporal association between the use of the product and the events though start date was not provided- reporter indicated event occurred after the first dose), a causal relationship with the events cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events though start date was not provided- reporter indicated event occurred after the first dose), a causal relationship with the events cannot be excluded
Pt received 3 doses of COVID-19 (Moderna) vaccine on 3/11/21, 4/8/21, & 11/12/21. These were confirmed. Pt presented to hospital on 12/27/21 with increased lower extremity weakness, a sensation of heaviness, and bowel/bladder incontinence. These symptoms are typical of her MS flares and she was started on therapy for such (high dose methylprednisolone IV). The patient tested positive for COVID-19 on 12/28/21, but was asymptomatic.
STARTING WITH SLIGHT TINGLING TURNED RED STRTED ITCHING GOT PUFFY AND SWOLLEN PRESCRIBED EYE OINTMENT NEOMIOCINE- POLY- DEXAMET HAS HAD TWO EPISODED
Shot given 4-18-2021 Fever, aches started within 6 hours of shot and arm swelling,  Arm swelling has not improved injection site is still red swollen and hot to touch as of 4-21-2021.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: Ep6955), on 12Apr2021 as dose 2, single (Lot number: Ep6955) and on 04Nov2021 as dose 3 (booster), single (Lot number: fh8027) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Apr2022, outcome "recovered" (2022) and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Woke up next mourning with sweats, mild fever,  moderate headache, body aches and some chest pains that lasted for 2 days and slowly subsided.
Blisters on lower lip; This is a spontaneous report from a contactable nurse. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the right arm on 08Apr2021 at 10:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis and polycystic ovarian syndrome (PCOS). The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 08:00, the patient experienced blisters on the lower lip showed up 3 days post vaccine. The patient had no history of lip blisters. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of blisters on lower lip was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reports 4 out of 10 - 7 out of 10 pain in upper left leg that radiates towards groin
Information has been received from a registered nurse referring to an unknown number of unspecified patients of unknown ages and genders. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date (reported as "starting on or after 20-AUG-2016"), an unknown number of unspecified patients were administered improperly stored doses of PNEUMOVAX 23 (dose and frequency unknown, lot # L031459, expiration date: 30-APR-2017; lot # reported as M022085, expiration date: 19-OCT-2017). The vaccines were stored in 31.5 Fahrenheit degree for 27.5 hours. There was no previous temperature excursion. The call was due to a "data logger". No adverse effect reported. This is one of three reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age, race/ethnicity and gender received TRUMENBA on an unspecified date, at single dose, for immunization. Medical history and concomitant medications were not provided. On an unspecified date after vaccination the patient experienced pain, swollen at the injection site. Events outcome was unknown. No follow-up attempts possible. No further information expected. Information about batch number cannot be obtained.
BLURRED VISION, PARTICULARLY FAR DISTANCE ON THE 7TH AND 8TH OF MARCH.  Might be temporary, I will wait and see if the problem does not correct itself.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 27-DEC-2017, the patient was vaccinated with an improperly storage dose of PROQUAD, lot # N023967, expiration date 28-FEB-2019, (dose number, dose, and route were not reported), for prophylaxis. Other suspect therapies included sterile diluent (MERCK), (Lot number N027626 Expiration date 20-MAY-2019). The PROQUAD and the sterile diluent (MERCK) was on a temperature excursion from 6 to 14 Fahrenheit Degrees during 1 hour and 18 minutes; and from 15 to 46 Fahrenheit Degrees during 34 hours and 29 minutes. Both products had multiple previous temperature excursions. The digital data logger was involved. No adverse effects or reactions had been reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA005276.
Patient received immunizations. She then was sitting on the examining table, jumped off, she stood, legs collapsed, patient fell to the floor. The nurse present in the room immediately attended the patient she was pale, breathing, eyes were closed. recovered after 5-10 mins.
Having real stabbing pain, mostly when I sleep and wake up for almost for couple of hours it stay like that, that time I won't be able to lift my hand or cannot lift anything.
Lyme disease; Patient has no appetite after 2nd shot; This is a spontaneous report received from a contactable Non-healthcare Professional on behalf of a patient. A non-pregnant adult female patient received bnt162b2 (Pfizer, Solution for injection), dose 2 via an unspecified route of administration on Mar2021 as single dose, via an unspecified route of administration on Mar2021 to Mar2021 for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took bnt162b2 for covid-19 immunisation first dose. The patient experienced lyme disease (Medically significant) and has no appetite after 2nd shot on Mar2021. Outcome of the events was unknown.  Information about batch/lot number has been requested.
Death  5/5/2021 Causes of death listed on death certificate: 1) cardiac arrest  2) unknown cause  Other: COVID 19, CAD, AKI needing HD
Vaccines were given in the same arm per patient request due to lymphectomy. They were given more than an inch apart. AFLUARIA on the right of the left arm and Pneumoncoccal on the left of the left arm. She stated that that evening her arm swelled up very large. The next day she went to the doctor and the swelling had increase to her elbow. Her diagnosis by the Doctor was cellulitis.
Pt reports the area he received the anthrax shot has become red, swollen and hard to the touch. He further states that he could not move his arm above shoulder level on 01/11/2016, but the pain is slowly going away and his ROM is improving. Pt does not feel that he should seek emergency care at this time.
feeling ackey all over; feeling very fatigued; This case was reported by a other health professional via sales rep and described the occurrence of general body pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received in November 2019 and felt fatigue, refer case US2020AMR017459).   On 29th January 2020, the patient received the 2nd dose of Shingrix. On 29th January 2020, less than a day after receiving Shingrix, the patient experienced general body pain and fatigue. On an unknown date, the outcome of the general body pain and fatigue were unknown.   The reporter considered the general body pain and fatigue to be possibly related to Shingrix.  Additional information was provided as follows: The patient received a dose of Shingrix on the left arm. The patient felt ackey all over and very fatigued. The patient thought it may be due to the vaccine. The reporter consented to follow up.