chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child was sleeping, woke up calling for mom...mom went over child felt warm, vomited then started seizing. Seizing lasted for approximately 45 minutes. Ambulance was called and patient was transported via ambulance to Hospital. Upon arrival patient was still seizing. Pt was intubated at Hospital, stabilized and transported to another hospital where she is currently an inpatient.  Lab work has been performed and chest xray has been done at hospital. 11/25/2009 MR and DC summary for 11/17-11/19/2009,Dc Dx Complex febrile seizure, Status Epilepticus  patient with a hx of neonatal meningitis with VP shunt presents with c/o's nausea, fever, tonic-clonic convulsion brought to ED in Status epilepticus, lasting 45-60 minutes. Tx: IV valium, intubated and admitted to PICU. Dc'd on Tegretol and Diastat
13 hours after the patient had had her 2nd covid-19 shot, she was found dead.  She had  indicated that she had no side effects after her shot.
a rash; red spot on my forearm; Arm hurt since then/Arm dull pain since then; 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 PAIN IN EXTREMITY (Arm hurt since then/Arm dull pain since then), VACCINATION SITE ERYTHEMA (red spot on my forearm) and RASH (a rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt since then/Arm dull pain since then). On 30-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spot on my forearm). On 01-Jun-2021, the patient experienced RASH (a rash). At the time of the report, PAIN IN EXTREMITY (Arm hurt since then/Arm dull pain since then), VACCINATION SITE ERYTHEMA (red spot on my forearm) and RASH (a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO treatment and concomitant medications were reported for mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.   Reporter did not allow further contact
The patient reports having pain in the back and side then passing out on an unknown date after receiving SHINGRIX. The patient was transported via squad to the ER but nothing could be found wrong with her. She has a history of orthostatic hypotension (self report). On 10-19-18 the patient continued to have pain so she went to clinic. They diagnosed her with Shingles, but didn't give her any medication. She then went to her primary care on 10/22/18 and the doctor gave her medication (she couldn't tell me what it was). The patient feels this was all due to the vaccine and wanted it reported.
This spontaneous report as received from a physician refers to a 9 months old (at the time of third vaccination) and currently 18 years old non-pregnant female patient. On 26-JAN-1995 the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 02-MAR-1995 and the third dose was administered on 28-SEP-1995. The reported stated that on an unknown date a titer for Hepatitis B were drawn and the titer resulted negative. No treatment was given for adverse event. The outcome of Hepatitis B titer negative was unknown. This is one of 10 reports from the same source. Additional information has been requested.
pt states she has had pain at the injection site for a couple of days after vax along with severe headache that has not subsided after taking Tylenol, Ibuprofen and now Naproxen.  pt also states having fatigue and brain fog.  Pt was prescribed Medrol 4mg to take for headache that will start taking today,.
Moderna COVID?19 Vaccine EUA  I am currently 24 weeks pregnant. About 2 hours after receiving the first dose of the Moderna vaccine, I experienced severe tachycardia (210 beats per minute). It came on suddenly, lasted for about 5 minutes, and then disappeared. Had no other symptoms (no lightheadedness, no shortness of breath, no nausea). Told my OB about it the next day at our routine visit; no other follow-up.
Patient found in cardiopulmonary arrest at home. 6/29/2009 Autopsy report received with COD Sudden Unexplained Death in Infancy.  Pt found face down in crib. Resuscitation unsuccesful.  Reportly had be lethargic and not sleeping at night since receiving vax at 3 month check up.  No anatomic, metabolic or toxicologic COD, therefore SUDI. ICD9: 798.4
Mother noted redness, swelling, and itching of child's right upper arm a day after receiving vaccinations. Called MD. Instucted to put ice on area and give age appriopriate dose of benadryl. Mother notes improvement.  10/6/09 PCP medical records, neurology consult, service dates 2/10/02 to 9/09/09. Assessment: Intractable epilepsy and static encephalopathy. Child presents with hx of generalized tonic-clonic convulsion in setting of high fever in Feb 01 dx febrile seizure. In Feb 02 was found limp and unresponsive, vomited twice, and slept for a period of time. convulsive seizure March 02 when ill with otitis media. Tonic stiffening, loss of consciousness, drooling, clonic movements. Similar seizures have continued to occur. Child has been agitated, agressive with hitting and biting, hyperactive, mood lability. Sometimes prodrome or aura. Chewing movements, c/o knees hurt, behavioral arrest, blank stare, stiffen and fall to floor. Bilaterally syncronous and symmetric clonic movements. Eyes roll up. Perioral cyanosis. Postictal confusion. Cognitively impaired. Limited speech. Not eating or sleeping as usual. Sore throat. Diarrhea. Bends back while walking.
Initial report received on 20 March 2009 from a health professional. A 42 year old female patient, with no medical history other than seasonal allergies, received the following vaccines on 20 March 2009: a first intramuscular injection of ADACEL (lot number C3098AA) in the left deltoid, an intramuscular injection of HAVRIX (GlaxoSmithKline, lot number AHAVB252AA) in the right deltoid, and an intramuscular injection of RECOMBIVAX HB (Merck, lot number 1040V) in the right deltoid. Immediately after vaccination, the patient developed a swollen, red, indurated area of 3.5 cm in diameter at the injection site (side not reported). Within five minutes, the area had decreased to 2 cm in diameter. The patient had no pain at the site. No other symptoms were reported. At the time of the report, the patient's recovery status was unknown. Follow-up information received 27 April 2009 from a health care professional. It was unknown how many Tdap vaccines the patient had received in the past; however the patient's last Td was likely more than 10 years ago. The reporter confirmed the reaction had occurred in the patient's left deltoid. Corrective treatments included intramuscular BENADRYL 25 mg, ice to the affected area, and Ibuprofen as needed for pain and inflammation. The patient reported that her symptoms fully resolved by the time she left the office and no additional treatment was necessary. The patient fully recovered from the event. Documents held by sender: None.
Died; A spontaneus report was received from a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and died.   The patient's medical history was not provided.  No relevant concomitant medications were reported.     On an unknown date, prior to onset of the event, the patient received their dose of mRNA-1273 (lot/batch number: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient died.  Action taken with mRNA-1273 in response to the event was not applicable.  The patient died on an unspecified date. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. The cause of death was unknown. Plans for an autopsy were unknown.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follow: The age at vaccination was not reported. The patient indicated that he was having an adverse event (not further specified) to SHINGRIX. No other information was provided.
This spontaneous report was received from a medical technician (reported as healthcare worker) referring to a 9 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies reactions were not reported. On 24-SEP-2014, the patient was vaccinated with a dose of VAQTA intramuscular, lot # K004856 and expiration date: 07-DEC-2016 (Strength and  dose were not reported) for prophylaxis (drug administered to patient of inappropriate age). No side effects were reported. Additional information has been requested.
Got shingles after Shingrix/Suspected vaccination Failure; Shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Got shingles after Shingrix/Suspected vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles).  The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-SEP-2023 The reporter reported that she was unaware that she should report an event of a patient who got shingles after received Shingrix vaccine. The reporter cannot recall which physician it was but she remembered having a conversation with a physician regarding a patient got a bad case of shingles after receiving Shingrix.  The reporter believed that she asked the physician if the patient had received both doses or only one dose and that the physician did not know.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter consented to follow up. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023127597:Same reporter US-GSK-US2023127594:Same reporter
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 17-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot # J004268 and expiry date 12-JUL-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
i feel like i have covid all over again since i got my injection; This spontaneous case was reported by a patient and describes the occurrence of SUSPECTED COVID-19 (i feel like i have covid all over again since i got my injection) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (i feel like i have covid all over again since i got my injection). At the time of the report, SUSPECTED COVID-19 (i feel like i have covid all over again since i got my injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
heacache, muscle pain, joint pain, burning, swelling at injection site, fatigue, fever
allergic to it; Initial information was received on 28-Jan-2021regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (age and gender unspecified) who had allergic to it (hypersensitivity), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications 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 not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was allergic to it (hypersensitivity), (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.   No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
within an hour, it my head felt like a had sinus pressure and had foggy "mind". Arm was sore but no more than any other vaccine. close to 4 hours later, headache started, felt hot and cold. Hard to sleep, sweating a lot during the night. Headache was so bad it felt like a combination of a bad flu with a hangover. felt very thirty. In the morning I was dizzy, hot, cold, temp 99.8, sick to my stomach, coudn't taste food very well, just like when you have the flu, nothing taste good. I spend the following day in and out of sleep, very tired, hard to focus. The sensation for being hot and cold continued. Took Imitrex to alleviate the headache/migraine . I did help, but not much. Hard to eat due to an upset stomach. Today is the first full day. I hope I'm better tomorrow
red spots on the inside of his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), on 12Oct2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hand surgery" (unspecified if ongoing), notes: Her husband had a surgery before on that same hand. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 immunization. The following information was reported: RASH MACULAR (non-serious) with onset 12Oct2022, outcome "unknown", described as "red spots on the inside of his arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On approximately 10/10/2000 the patient experienced apparent chickenpox with approximately 50 lesions on her trunk. Medical attention was sought. Follow up information provided by a physician indicated that he had never seen the patient. He heard about the case from the patient's father, who contacted him by e-mail. The patient was over 1000 miles away from the physician. The patient's father described about 50 chickenpox lesions a few days after the patient received the vaccine in approximately September 2000. The physician noted that he did some research out of interest. On 12/06/2000, the physician reported that the patient's father told him the patient was "better". She never got sick and the case resolved. No further information is available.
Sneezing, sore throat, headache, body aches, phlegmy cough, earache, sinus pain, fever.
COVID positive on 4/2; COVID positive on 4/2; This is a spontaneous report from a contactable physician. A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 13Mar2021 (Batch/Lot number was not reported) as single dose, and first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID 19. As reported, since the vaccination, the patient had been tested for COVID 19 on 02Apr2021 and the COVID test result was positive (COVID positive on 4/2). Test name was nasal swab. The COVID was tested post vaccination. The event was not resulted in death, Life threatening, causing/prolonging hospitalization, disabling/incapacitating or congenital anomaly/birth defect. The outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Wants to follow up on some experiencing that they have  experienced following the vaccine"I was a young 78 year old before the vaccine"; Aches of knees, elbows, hips and back; Joint aches of knees, elbows, hips and back; In beginning I noticed fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Wants to follow up on some experiencing that they have  experienced following the vaccine"I was a young 78 year old before the vaccine"), BACK PAIN (Aches of knees, elbows, hips and back), ARTHRALGIA (Joint aches of knees, elbows, hips and back) and FATIGUE (In beginning I noticed fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced BACK PAIN (Aches of knees, elbows, hips and back), ARTHRALGIA (Joint aches of knees, elbows, hips and back) and FATIGUE (In beginning I noticed fatigue). On an unknown date, the patient experienced VACCINATION COMPLICATION (Wants to follow up on some experiencing that they have  experienced following the vaccine"I was a young 78 year old before the vaccine"). The patient was treated with IBUPROFEN in 2021 for Adverse event, at a dose of 1 dosage form and VITAMIN D [VITAMIN D NOS] in 2021 for Adverse event, at a dose of 4000. At the time of the report, VACCINATION COMPLICATION (Wants to follow up on some experiencing that they have  experienced following the vaccine"I was a young 78 year old before the vaccine"), BACK PAIN (Aches of knees, elbows, hips and back), ARTHRALGIA (Joint aches of knees, elbows, hips and back) and FATIGUE (In beginning I noticed fatigue) had not resolved.            Patients states that before vaccination she used to do activities like hiking, jump over streams and over the past 6 weeks she's experiencing the events.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Include patient contact information updated, dose 1 and dose 2 details, concomitant medication information,treatment medication details and events occurred and outcome was updated.
At approx. 08:00 this morning,  the patient arrived to facility, was processed and screened for her 2nd dose of Antrax Vaccine in her left deltoid region. She sat in the waiting area for 20 minutes and was released without incident. She said approx. 12:00, she experienced chills & fever, nausea, dizziness, difficulty breathing, tightness in her chest, neck pain, pain in her right eye and right arm and uncontrollable jerking and twitching. She was assessed by Dr. Treatment: IV of Lactated Ringers, 02 via nasal cannula, and Phenergan 25 mg at 14:35hr. Pt was transferred at 15:00 to Hospital. 6/27/08-ER records received for DOS 6/17/08-Impression: allergic reaction to Anthrax vaccine. C/O diffuse body pain, sudden onset of chest tight, PE WNL. Treated with Promethazine, symptoms improved.
Patient had Prevnar injection on 5/22/07.  Mom phoned on 5/23/07 stating patient has red swollen leg down to knee stating it hurts to walk.  Advised to use warm packs, give Benadryl and advil.  If sx's persist needs office visit to recheck injection site
Swelling, redness and pain to touch that involved entire thigh that received DTaP. Required abx for possible cellulitis , NSAIDS, ice.
Arm became red, swollen, rash at injection site the afternoon after receiving vaccine in AM. Was painful/itchy. Took BENADRYL.
A quarter sized knot in the left axilla with erythema spreading toward the left hand and also swelling and pus exuding from the left middle finger of the left hand.
Pt recvd vax 19MAY90, 5JUL90 & 5DEC90 & it was determined that pt did not respond; 2 addtl boosters were administered 13DEC91 & 21FEB92; pt now has a post titer response;