chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suffered from a TIA post covid shot; This is a spontaneous report from a contactable consumer (reporter's family member). A male patient of an unspecified age (reported as 65 +) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient suffered from a transient ischemic attack (TIA) post COVID shot this morning on 19Apr2021 with outcome of unknown. He was doing well, but was warned her could suffer from another stroke up to 4 months after his vaccination. The outcome of the event was unknown.  Information about the Lot/batch number has been requested.
On the day after vaccines administered, patient had sudden onset of hypoxia and loss of consciousness. All tests have been negative including brain biopsy. Patient is in a semi-comatose state requiring tube feeding and total care.
Initial chest pain 1 month after vaccine, pain returned with increased severity  June 19th resulting in ER visit. Pulmonary embolisms have caused some permanent lung damage. Patient is currently taking Xarelto. Minor symptoms remain.
POSSIBLE ADMINISTRATION OF MODERNA COVID VACCINE ON 01/04/2021 AT CLINIC PRIOR TO TODAYS  PFIZER VACCINE, 07/9/2021.  CLIENT DENIES RECEIPT OF PREVIOUS VACCINE 0N 01/04/2021.  CLIENT DOES NOT HAVE ID WITH HER TODAY.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 64-year-old patient of unknown gender. Medical history, concurrent conditions and concomitant medications were not provided.  On or about 02-DEC-2016, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration and lot # were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date (reported as subsequently), the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX): herpes zoster. The patient claimed damages as a result of: injury to themselves. The outcome of the event was not provided.  The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Diabetes.  Pt. unable to move neck back and forth w/ pain. Pt. c/o stiffness in left side of neck after receiving the  Pfizer vaccine.  Unable to ROM.  Emergency Personnel notified and pt. was taken to Hospital for further evaluation
PVCs with compensatory pauses, postural orthostatic hypotension associated with chest tightness, shortness of breath, dizziness and blurry vision
Received Tdap at approx 3 PM on 9-24-07. Woke up next AM w/ the following S/S: headache, fever (106.2 F), nausea, tired, soreness at injection site but no redness or swelling. Tx: Ibuprofen 400mg. She states she does not think she needs to see a physician. 9-26-07 "Feeling much better". 10-2-07 "Full recovery in 24-48 hrs. Other family members had similar S/S.
Postmenopausal vaginal bleeding; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 17:30 (Lot number: FF3587) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: prior vaccination. Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE], reported as other medication in two weeks. No other vaccine received in four weeks. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 24Nov2021 14:30, outcome "not recovered", described as "Postmenopausal vaginal bleeding". The event "postmenopausal vaginal bleeding" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of postmenopausal haemorrhage. No covid tested post vaccination.
Patient states vaccine given to her on 10/15- arm was sore that day and pain became more severe. Patient lost mobility and it has been 2 weeks , her mobility has yet to be regained. Patient has a referral to  see orthopedic specilist. Patient states immunization was given to high up
diagnosed with pulmonary embolism; started having chest pain; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (diagnosed with pulmonary embolism) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Reflux esophagitis and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, FAMOTIDINE for Allergy and Reflux esophagitis, NADOLOL, LANSOPRAZOLE (LANZOPRAL), VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced CHEST PAIN (started having chest pain). On 25-May-2021, the patient experienced PULMONARY EMBOLISM (diagnosed with pulmonary embolism) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (diagnosed with pulmonary embolism) and CHEST PAIN (started having chest pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment product information was provided It was reported that patient is in generally good health and has never experienced anything like this, patient is not sure if it is connected to the vaccine and if other people have experienced the same reaction but patient wanted to report this adverse reaction to Moderna.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
This case was reported by a physician and described the occurrence of injection site nodule in a 18-month-old male patient who received INFANRIX. Concurrent medical conditions included aluminum (nodule caused by aluminium allergy). On an unknown date, the patient received INFANRIX at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced injection site nodule. On an unknown date, the outocme of the inejction site nodule was unknown. It was unknown if the reporter considered the injection site nodule to be related to INFANRIX. Additional information received: INFANRIX was given to a chils at 18 months of age. The developed a nodule at the injection site that lasted for several year. The HCP states that the nodule was caused by an Aluminum allergy. HCP states that the patient is now 4 years of age and wants to know what information we have on this topic. The HCP who called is an allergist, the vaccine was given at a different HCPs office. The allergist HCP is calling to determine if another vaccine can be given to the child.
got COVID; got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2022, outcome "unknown" and all described as "got COVID". clinical course: Is there a primary COVID vaccine in development for the fall? I haven't gotten my 2nd Pfizer booster yet because I got COVID in Mar. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
tested positive for Covid and have been very sick ever since; tested positive for Covid and have been very sick ever since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  An 80-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "not recovered" and all described as "tested positive for Covid and have been very sick ever since". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) positive, notes: One month later tested positive for Covid. Clinical course: One month later patient tested positive for Covid and had been very sick ever since. The patient was fully vaccinated and never had Covid.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300186615 same reporter/drug/event, different patient;
left shoulder joint pain; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 09Mar2021 23:30 (Batch/Lot Number: EN6198) as single dose for covid-19 immunization at a public health department. Medical history included diabetic and blood pressure. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the first dose, the patient had left shoulder joint pain for about 10 days. The event resulted in emergency room/department or urgent care visit and hospitalization. The event was not treated. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
I began having symptoms on Thursday night. I had a lot of chest pain. On Friday at 8am I had the same chest pain and I could not walk. I called my doctor and I went to his office. He did an EKG and I had a pulse of 124. He called the cardiologist so he could do an echocardiogram. He did a chest x-ray and it was fine. I went to the cardiologist and the echo was fine. They repeated an EKG and it was very different from the one in the morning. They said I had pericarditis. They put me on treatment of Colchicine 0.6 mg once a day for 3 months and Indomethacin 50 mg 2 capsules for 3-4 days. I have a follow up this week and he is going to do another EKG.
On the day of vaccination, just pain at the injection site. The next day, pain at the injection site, slight fever , body pain, tiredness
This spontaneous report as received from a registered nurse refers to an unspecified number of 4 years old patients of unknown gender. Since 15-NOV-2014 the unspecified patients were vaccinated with doses of VARIVAX (Merck), that were exposed to a supported temperature excursion, (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse effect has been observed. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 23JUN95 & was presented to ER 26JUN95 w/sudden onset of unsteady gait & falls; pt w/ h/o 3 day measles in early JUN85; stayed overnoc in hosp & was discharged w/minimal unsteadiness;  post infectious cerebellitis or cerebellits
On January 13, the third dose of Pfizer was administered to the patient and she present rash and itching in both upper limbs even taking Atarax and Claritin. The patient had presented the same thing in the second dose and was evaluated by the dermatology Doctor which ordered him to take Atarax and Claritin.
it was rpt fr MD concerning pt who was vax in jan99 & approx 2wks later the pt devel chickenpox. addl info requested
PATIENT GIVEN EXPIRED VACCINE EXP: 3/12/18 GIVEN 3/13/18.
Patient received moderna vaccine on 2/5/21, 3/9/21 and 12/10/21. Presented to ER on 1/16/22 and found to have COVID. Was given sotrovimab and was going to be discharged. Concern is for being able to get her safely home and arrangements made for additional home care tonight as she is normally independent and required additional assistance today.  Because of her generalized weakness and increased confusion show the kept for observation tonight with possible case management involvement and arrangements with the son in the morning. She never became hypoxic. COVID-19 symptoms were minimal.  She was found to have urinary tract infection is started on ceftriaxone.  Cultures positive for contamination only.  On day 2 she had some wheezing and so was kept in the hospital and treated with bronchodilator therapy and dexamethasone.  Did not require remdesivir.  By 01/20/2022 was tolerating usual level of activity and respiratory status was continued stable.  She did not require supplemental oxygen throughout her entire hospital stay.  Arrangements were made for home health to see patient at home.  Discharged on 1/20/22
Information has been received on 31-DEC-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around December 2012, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster.) Shortly after receiving the ZOSTAVAX, the patient suffered sudden hearing loss in his right ear. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. The patient has paid and has become liable to pay for medical aid, treatment, monitoring, medications and other expenditures and will necessarily incur further expenses of a similar nature in the future as a proximate result of ZOSTAVAX. The outcome of the events is not recovered. The causality of the events is related. Sudden hearing loss in his right ear was considered to be disabling. Upon internal review, sudden hearing loss in his right ear was considered to be medically significant. Additional information has been requested.
I  developed Shingles on the same side of my body as I got the vaccine on. The symptoms started 5 days after the vaccine.
pt stated that they felt weak 30 minutes after receiving vaccine. pt drank some water. Then after another 15 minutes pt complained of being cold. tried to move pt into vaccination room for privacy. pt was unable to stand on her own. checked with pt then called ambulance.
Shingrix administered to patient on 5/6/19. Patient called on 5/14/19 to report event. She states that on Wednesday or Thursday following the vaccination (5/8 or 5/9) she noticed red blotches on her arms and legs-they did not itch and were not bothersome. On Saturday (5/11), she noticed the areas appear more hive-looking as they were more swollen. They still did not itch. On 5/14 the swelling has resolved, but the spots are still there.
pt recv vax 4/30/98 & pt exp a fever for 3 to 4 days;the fever subsequently broke;pt exp a low grade temp from approx 5/4/98 until 5/11/98;5/10/98 pt devel a rash which looked like a rubella rash on face, chest & back;pt cranky;
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse).  An 101-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 100 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies Penicillin" (unspecified if ongoing), notes: known allergies Penicillin. The patient's concomitant medications were not reported. Past drug history included: Phenergan, reaction(s): "Drug Allergy:Phenergan".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; positive, notes: rebound positive covid 19 test via binaxnow, placed back on covid 19 isolation precautions and quarantine. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received paxlovid 300 mg oral treatment start date 09Jun2022, treatment stop date13Jun2022, Indication for Treatment of COVID-19, and had rebound positive covid 19 test via binaxnow, placed back on covid 19 isolation precautions and quarantine. ; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Patient had experience a reaction with dizziness and headache and had a tickle in her throat.  Had to have a nurse walk her out because she was so unsteady due to the dizziness. By the time she got home she was itching all over, felt like a sunburn without rash.  She said her where her clothes touched her skin felt itchy and sunburned. States she felt like a tickle in the throat with some shortness of breath.  She took benadryl and it stopped the itching.  1:15pm -5:30pm was the worst of it.
1 day p/vax pt noticed rash on both arms & hands which gradually progressed, arms were pink to purple in color, hands, swelled up, hands & wrists were painful, raised dry, rough rash up to elbow;some on face & back;
Muscle spasms in arm & forehead,  LUQ pain. Ekevated temp @ Arm pain at injection site.
Headache, Myalgia, Arthralgia, Fever, fatigue Narrative: 1st dose - 12/16/20 (NO SYMPTOMS THAT TIME) 2nd dose - 1/6/20 - Symptoms Listed Below (started 1/6 at 5p - ended 1/8 in AM) -Severe muscle pain (whole body) -Neck pain - Temp 100.0 most of day 1/7 - Headache - Fatigue (slept entire day 1/7)
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was  refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Information has been received from a third party claims administrator on behalf of a pharmacy concerning a female patient, who on 21OCT2013 was vaccinated with the PNEUMOVAX and a flu vaccine (Manufacturer not specified). The lot # for PNEUMOVAX was H016283 with an expiration date of 21FEB2014. The patient experienced an adverse reaction (not further specified). It is unknown at this time which vaccine the patient had the reaction to. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient fainted after first  dose of Pfizer. Called ambulance and they came to check him out. His blood pressure was very low do they took him to the ER.
Severe back pain, muscles (rather than spinal) all across my lower back and sides of my waist. Shoulder and neck aches. This is body ache as described in common side effects but it is so severe I couldn't put on my shoes or turn over in bed. Never had back ache before. Did not lift anything heavy or do anything to trigger this. No other side effects. This is my second moderna booster. Never had any side effects before.
Worst pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a 82-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Worst pain). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-JUL-2023 This case was reported by a consumer via interactive digital media. Worst pain the patient ever had as received 1st shot, but got them before could get the 2nd. The reporter suggested to get shot if someone haven't had them.
Low-grade fever, chills, exhaustion, sore back, sore arm (12 hours after shot until 30 hours after the shot, progressively less severe as time went on)
Patient received vaccination and became lightheaded. She was sat down on a stool and ended up fainting. She was out for a few seconds and then came to and seemed to be ok.
their bodies are magnetized; can stick a fork, paper clip, quarters, rings, lighters and its magnetized to their arms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (their bodies are magnetized) and VACCINATION COMPLICATION (can stick a fork, paper clip, quarters, rings, lighters and its magnetized to their arms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (their bodies are magnetized) and VACCINATION COMPLICATION (can stick a fork, paper clip, quarters, rings, lighters and its magnetized to their arms). At the time of the report, ADVERSE REACTION (their bodies are magnetized) and VACCINATION COMPLICATION (can stick a fork, paper clip, quarters, rings, lighters and its magnetized to their arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.