chrisvoncsefalvay/vaers-outcomes huggingface dataset:
outbreaks of herpes zoster; postherpetic neuralgia; stroke; cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems; cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems; cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems; cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems; cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance and for its intended purpose: the prevention of shingles (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided). On an unknown date (reported as after receiving the vaccine), the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, stroke, cardiovascular event, congestive heart failure, vision problems, hearing problems and balance problems. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient condition. In addition, the patient sustained severe and permanent personal injuries. Further, the patient had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster, balance disorder, hypoacusis, visual impairment, cardiac failure congestive, cardiovascular disorder, cerebrovascular accident and post herpetic neuralgia was not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster, balance disorder, hypoacusis, visual impairment, cardiac failure congestive, cardiovascular disorder, cerebrovascular accident and post herpetic neuralgia were considered as disabling events by the reporter.  Upon internal review, cerebrovascular accident and cardiac failure congestive were considered medically significant events.
severe headache; Dizziness; weakness; fever; chills; muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6202), dose 2 via an unspecified route of administration, administered in arm left on 02Mar2021 18:45 as 2nd dose, single for covid-19 immunisation. Medical history included covid-19, hypothyroidism, hypertension and rheumatoid arthritis. Concomitant medications included levothyroxine sodium (SYNTHROID), acetylsalicylic acid (ASPRIN) and lisinopril (LISINOPRIL). Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: EL9267), via an unspecified route of administration in left arm on 09Feb2021 at 06:45 PM for covid-19 immunisation. On 03Mar2021 06:00 am, patient experience dizziness, weakness, fever, chills, muscle aches and severe headache. Patient was not pregnant. She did not receive any other vaccine in four weeks. The patient did not received treatment for to the events. she had COVID prior vaccination and did not tested for covid post vaccination. The patient did not had any known allergies. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vertebral artery dissection and cerebellar infarcts. Nausea, vertigo. Hospitalized x 2 days  (6/28-6/30/21). Started on elliquis.  To follow up with Neurology
make me sick; muscle and body ache; muscle and body ache; some nausea; headache; overdose (4 doses in one shot); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-713740 (Moderna).  A 71-year-old female patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Lot Number: Unknown, Route of administration: Unknown), administration date: 06Feb2021, when the patient was 69-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE , Lot Number: Unknown, Route of administration: Unknown), administration date: 27Feb2021, when the patient was 69-year-old, for COVID-19 Immunization. The following information was reported: OVERDOSE (non-serious) with onset 08Oct2021, outcome "unknown", described as "overdose (4 doses in one shot)"; HEADACHE (non-serious) with onset 09Oct2021, outcome "unknown", described as "headache "; ILLNESS (non-serious) with onset 09Oct2021, outcome "unknown", described as "make me sick"; MYALGIA (non-serious), PAIN (non-serious) all with onset 09Oct2021, outcome "unknown" and all described as "muscle and body ache"; NAUSEA (non-serious) with onset 09Oct2021, outcome "unknown", described as "some nausea".  Additional Information: Reporter stated that All vaccines made her sick, muscle and body aches, some nausea, headache the next day after the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202300099348 same patient/ same reporter/ different dose/ different events; US-PFIZER INC-202300099349 same patient/ same reporter/ different dose/ different events;
Four days after receiving his first dose of the Covid vaccine, my 5-year-old son woke up with left hip pain.  He would not walk or bear weight for about two days, causing him to miss two days of school.   We gave him ibuprofen and he rested and recovered fully by day 4.  My husband is an orthopaedic surgeon and believes his symptoms were most consistent with transient synovitis.
NAUSEA,VOMITING, DIARRHEA,FEVER,CHILLS,EXTREME WEAKNESS
24 hours after receiving he dose, i experienced sever headaches, nausea,  dizziness, and sever pain in lower body. Tis lasted just under 30 minutes then all symptoms ended.
not moving neck-stiff;fever 104;tx alternated APAP w/Ibuprofen;
Nausea, followed by violent vomiting every 5-10 minutes, rapid breathing, rapid heart rate, labored breathing, general horrible feeling.  Took him to ER at 1:30, recieved fluid and anti nausea medication.  He is still in bed and feeling awful at this reporting.
This case was reported by a consumer via call center representative and described the occurrence of erythema in a 80-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included nebivolol hydrochloride (Bystolic), omeprazole (Prilosec), levothyroxine sodium (Synthroid) and lisinopril. On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th May 2018, less than a day after receiving SHINGRIX, the patient experienced erythema and induration. On 14th May 2018, the patient experienced influenza like illness, tiredness, fever, weakness and upset stomach. The patient was treated with antihistamine. On an unknown date, the outcome of the erythema, influenza like illness, tiredness, fever, weakness, upset stomach and induration were recovered/resolved. The reporter considered the erythema, influenza like illness, tiredness, fever, weakness, upset stomach and induration to be related to SHINGRIX. Additional details were provided as follows: On Friday the patient received SHINGRIX. And that day her arm started turning red and was hard to the touch. The patient's arm became red from shoulder to wrist and was hard as a rock. On 14th May 2018 Monday, 3 days after vaccination the patient developed a fever, which was 99.9 on Tuesday. For the rest of the week the patient felt very sick like she had the flu. She was weak, tired and had an upset stomach and fever. By Saturday, on 19th May 2018, the patient finally felt better. The patient saw her doctor during that week because she felt so sick and she was recommended to take an antihistamine, and the redness and hardness in her arm did improve after that.
Normal pregnancy, due 2/4/22,  7 lbs 8 ounces  Baby was born with a large  brain tumor, a high grade glioma  Baby has hypospadius and an abdominal wall hernia
Patient received the Moderna vaccine on 1/4.  Her arm was sore the next day and she was also tired. She has a localized reaction (red/swollen).  The redness/swelling/lump appeared 1/12.  The arm is hot to the touch.  She's had no fever or shortness of breath. The redness continues to spread (whole shoulder).
Seizure began at 11:30pm. He had been sleeping comfortably prior to that. He was seizing with jerking movements of both arms and legs. They also noted that his extremities were twitching. They also reported that during seizure activity, he seemed to be gasping for breath and called it "sharp inhalation" which lasted for about 5 minutes. Following the seizure, he was slightly groggy for about 10 minutes but had no other post ictal symptoms.  He did not have any precipitating factors except his parents note he had received his 6 mo vaccines earlier that day.    Patient has a past medical history of seizures 1 week following 4 month shots. Patient had multiple episodes of seizure like activity and was hospitalized and intubated at hospital. MRI, CT scan and EEG were reassuring. As was blood work. Hospital Course: Patient was seen in the ED and given tylenol suppository and IVF. Loaded with 20mg/kg of Keppra in the ED and then transferred to the floor for further workup. Then started on Keppra 10mg/kg BID. The patient had no further events during the entire inpatient course. Neurology was consulted and Dr informed the patient of the high likelihood of patient's presentation being an adverse reaction to DPT vaccine and that it was less likely primary epilepsy. A decision was made with parents' input to continue the baby on Keppra BID until outpatient appointment with Dr.
Information has been received from a physician concerning a 21 year old single female who was vaccinated on 21-Jan-2008 with the first dose of GARDASIL (Lot # 65855/1061U). The patient had an abnormal PAP test since receiving the vaccination and needed a colposcopy. The patient did not have positive PAP test prior to receiving the vaccination. Unknown medical attention was sought in the office. Patient outcome was unknown. No product quality was involved. Additional information has been requested.  Follow-up information was received indicating that the patient received GARDASIL the same day as abnormal PAP. Follow-up information was received from a physician indicating that she does not have any additional information at this time and in re-reviewing the chart, the doctor wishes to withdrawal the report. This report is related to reports WAES # 0802USA04152, 0803USA01372, 0803USA01381 with the same source. No further information is available.
Patient was tested positive for COVID infection in February; We have a patient who received 1st dose of Moderna back in January ( patient has not receive a second dose and it cross passed 36 days); This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Patient was tested positive for COVID infection in February) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (We have a patient who received 1st dose of Moderna back in January ( patient has not receive a second dose and it cross passed 36 days)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (We have a patient who received 1st dose of Moderna back in January ( patient has not receive a second dose and it cross passed 36 days)). On 12-Feb-2021, the patient experienced COVID-19 (Patient was tested positive for COVID infection in February). On 29-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (We have a patient who received 1st dose of Moderna back in January ( patient has not receive a second dose and it cross passed 36 days)) had resolved. At the time of the report, COVID-19 (Patient was tested positive for COVID infection in February) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, SARS-CoV-2 test: positive (Positive) Tested positive with COVID Infection on 12-Feb-2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was a health care professional and was reporting on behalf of a patient who received first dose of Moderna COVID-19 Vaccine and after patient's first dose, the patient was tested positive with COVID Infection on 12-Feb-2021.   Reportedly, the patient received antibody infusion at around 16-Feb-2021 or 17-Feb-2021. According to the reporter, the patient's doctor suggested to wait for 90 days from the date of antibody infusion to receive a vaccine and also suggested to get Janssen vaccine.   No Concomitant product use was reported.  Treatment information provided included antibody infusion.
tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced COVID-19 (tested positive). At the time of the report, COVID-19 (tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, SARS-CoV-2 test: unknown (Positive) tested positive for COVID-19..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Case number PHEH2015US003518, is an initial spontaneous report from a consumer (patient) on 17 Feb 2015. This report refers to a female patient of unknown age. Medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: unknown) on 10 Oct 2014. On 11 Oct 2014, she developed an allergic reaction at the injection site, full body pain, hives and headache. Outcome of the event, seriousness and causality assessment was not reported. No further information was available.
Near syncopy with Bradycardia & hypotension shortly after Menveo administration lasting close to 1hr.- normalized in about 1 hr. with conservative management.
Pt described the feeling as a lump in her throat when swallowing. "feels like something's there". Pt denied any SOB, tightness in her chest, difficulty breathing, swelling of her tongue or throat.  0929 Pt denied any contraindications to benadryl or Pepcid. Pt gave verbal consent to administer medication. Benadryl and Pepcid administered per COVID vaccine standing order for adverse reactions. 02 98-99% Pulse 86 Pt was monitored for an additional 30 minutes after medication. She gradually felt like the lump in her throat was getting better. She again denied any difficulty with breathing.
Above vaccine given @ 730AM on 9/1/21 and vaccine expired 8/31/21. Reported to Moderna awaiting further instruction.
Patient reports a red rash on her hand with 3 to 4 white welts as well. It has been 18 days since first dose but patient wanted to reported in case related. Instructed patient to contact her PCP to determine causation and for recommendation about receiving 2nd dose.
I got the COVID-19 mRNA, LNP-S, PF (Pfizer-BioNTech) PURPLE CAP on 4/8/21 and about 35 minutes later walking to my car I broke out in hives that lasted over a week.  The 2nd dose on 4/29/22 I stayed longer about 40 minutes later I experienced the some of same symptoms as when I have had an an anaphylactic reaction to nut: lip tingling, swelling of throat, airway, and mouth, also nausea.  I am self reporting because I am not sure did upon attempting the booster they told me to see my regular dr who didn't think I should take it but set-up a phone appointment with the allergy dr who said she did  think it would be ok, needless to say I am now scared.  I fear the booster reaction will be worse as I was told in prior years each allergic reaction will get worse
I don't know if I fainted or passed out found myself lying on the floor; woke up sick to my stomach; fever; I felt really cold; i felt very cold; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (I don't know if I fainted or passed out found myself lying on the floor), NASOPHARYNGITIS (I felt really cold), CHILLS (i felt very cold), NAUSEA (woke up sick to my stomach) and PYREXIA (fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    The patient's past medical history included COVID-19 on 04-Dec-2020. Concomitant products included SIMVASTATIN, LISINOPRIL and METFORMIN for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 18-Feb-2021, the patient experienced NASOPHARYNGITIS (I felt really cold) and CHILLS (i felt very cold). On 19-Feb-2021, the patient experienced PRESYNCOPE (I don't know if I fainted or passed out found myself lying on the floor), NAUSEA (woke up sick to my stomach) and PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Symptomatic treatment, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (I don't know if I fainted or passed out found myself lying on the floor), NASOPHARYNGITIS (I felt really cold), CHILLS (i felt very cold), NAUSEA (woke up sick to my stomach) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.   This case was linked to MOD-2021-187096 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non-Significant follow up appended to AER. Concomitant medication was updated.
Pt has swelling on the left arm where the vaccine was administered. Pt is experiencing numbness in her hand through her fingers. PT is experiencing a break out on her tongue and having a difficult time swallowing food.
Side effect; 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 VACCINATION COMPLICATION (Side effect) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided by the reporter. No treatment information provided .
ADMINISTRATION OF EXPIRED VACCINE; VACCINE DOSE PREPARED IN A SYRINGE AND ADMINISTERED AFTER AROUND 24 HOURS; This spontaneous report received from a pharmacist concerned a 76 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) for prophylactic vaccination. The patient received a booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809, and  expiry: 07-MAR-2022) dose was not reported,1  in total, administered on 13-NOV-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 13-NOV-2021, the patient was administered expired vaccine. It was reported that, the pharmacy prepared the vaccine for patient in a syringe on 12-NOV-2021. Patient wanted to talk to doctor before administration. Pharmacy prepared a new dose and when delivered it was discovered that, a Nurse gave the previously drawn up dose. The dose was in the syringe around 24 hours. Patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and vaccine dose prepared in a syringe and administered after around 24 hours was not reported. This report was non-serious.
bad cough; Initial information was received on 18-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involves adult and unknown gender patient who experienced bad cough (cough) and is still sick after receiving INFLUENZA VACCINE.  Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious bad cough (cough) and was sick (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event cough.  There will be no information available on the batch number for this case.