chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness; nausea; intense sweating; This is a spontaneous report from a contactable consumer (patient).  A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm left on 23Feb2021 at 10:00 am (Batch/Lot Number: EN6203) (age at vaccination 68-year-old) as dose 1, single for covid-19 immunisation. The patient had no known allergies. The patient medical history included asthma and lymphoma from an unknown date and unknown if ongoing. There were no concomitant medications reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Two hours after injection, the patient experienced with dizziness and nausea, followed by intense sweating on 23Feb2021 at 12:00 pm. The patient did not received any treatment for the events. The event ended about a half hour after beginning and were recovered on 23Feb2021.  Follow-up attempts completed. No further information expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. 02-MAR-2013, the patient was vaccinated with MMR II. Lot number, dose, route and frequency were not provided. The vaccine was exposed to 56F for 10 days, an excursion that was found to be unsupported by in-house stability data. No adverse event was reported. Additional information has been requested.
20OCT93 clinic visit mom reported that pt was hospitalized 3 hrs p/receiving vax 11AUG93; t101 ax & pt was reported to have episode of shaking;
Breakthrough COVID-19 case with symptom onset 7/22/2021:  Fever >100.4,  Runny nose/Congestion,  Sore throat,  Cough (new onset or worsening of chronic cough),  Shortness of breath or difficulty breathing,  Chest pain,  Fatigue or tiredness,  Headache,  Diarrhea (>/=3 loose/looser stools in 24 hr period). Hospitalized from 7/25/2021-7/28/2021
sore shoulder; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shoulder soreness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 18-MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced shoulder soreness (Verbatim: sore shoulder). The outcome of the shoulder soreness was not reported.   It was unknown if the reporter considered the shoulder soreness to be related to Shingles vaccine.     It was unknown if the company considered the shoulder soreness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-Mar-2023 The case was received from the patient via interactive digital media. The patient got shingles shot and 4 days prior to the reporting date, the patient had no problem, just a little sore on the shoulder. The follow-up could not be possible as no contact details were available.
Severe muscle aches, pain, swollen lymph nodes, extreme fatigue, blood shot left eye- 2 blood vessels bled in eye
First 12hrs no major symptoms, just light fatigue and a minor headache. About 16hrs post vaccination, started experiencing body aches, chills, and a fever of 101.3. Very intense headache that still hasn't gone away about 34hrs in. Severe arm pain/soreness in vaccinated arm starting about 4hrs post shot.
pt recv vax 6MAR97 & exp malaise;pt devel a small, flat, red rash on the forearm of lt arm & some on the rt arm on 8MAR97;pt did not c/o any discomfort or itching from the rash;sx resolved;
Around 6:00am on 3/29/22 I went to grab a gallon of milk with my right arm and I got a sudden sharp pain in my arm, chills and hot sweets. Next thing I knew I was laying on the grown. I don't know how long I had passed out for. I had no witness since everyone was asleep still and didn't hear me fall. When I got up after passing out I felt light headed and had a few chills still. My head hurt due to the fall.
Information has been received from a physician concerning a 17 year old female with penicillin allergy who on 16-JAN-2008 was vaccinated with the first dose of GARDASIL.  The physician reported that the patient's last menstrual period was on 02-MAR-2008.  On 28-MAY-2008, the patient experienced a miscarriage.  On 23-Jun-2008 she would receive the second dose of GARDASIL.  At the time of the report, the patient had recovered.  The patient sought medical attention at the physician's office.  Upon internal review, miscarriage was considered to be an other important medical event.  Additional information has been requested.
approximately 3 hours after injection subject developed rapid irregular heart rate consistent with recurrence of her atrial fibrillation which she had not had for at least one year prior.   Also noted chest pain and weakness.  Took an extra dose of atenolol with some improvement.  Symptoms completely resolved overnight without any recurrence since.
pt recv vax 8OCT98 & 145PM next morning broke out w/bumps, had some roughness noc before just from neck up;no resp distress;nausea;
First started with intestinal discomfort. Then after about 5 minutes, turned into diarrhea. After about 30 minutes of more discomfort and diarrhea, nausea set in. Then 15 minutes after that, vomiting occurred twice in a row. Then more discomfort and a small bit more diarrhea. After that, only a bit of internal discomfort remained. I turned on a hot bath and lied flat in it. This seemed to help. Occasional internal discomfort continues, but the diarrhea and vomiting have subsided for now (2 hours after initial onset of symptoms).
68-year-old female c/o large local reaction to left upper arm after receipt of PREVNAR 13. Exam revealed large erythematous patch 18 x 16 cm to left upper arm with central induration 7x9 cm, tender to touch. The affected area is approx. one half of her upper arm, and does not extend to either her elbow or shoulder and is not circumferential. There are no papules, pustules, vesicles or erosions. See AHLTA Note attached for details of assessment and treatment by DHA-IHB provider.
This spontaneous report was received from a certified medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L038018/expiration date- 13-SEP-2017 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature excursion was 35 F and 52.5 F for unspecified time. There was no previous temperature excursion and call was not because of the data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information is not expected as reporter dose not wants to get contacted.
Seizures; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizures) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizures) (seriousness criteria death and medically significant). The reported cause of death was Seizures. It is unknown if an autopsy was performed.   Concomitant medication was not provided.  Reporters dad and cousin died from vaccine. Reporters dad ended with strokes after Pfizer shot, and cousin died from seizures from moderna. Don't even. Reporters dad died days before fathers day last year. Treatment medication information was not provided by the reporter.  Company comment: This is a spontaneous case concerning unspecified age and gender, with no medical history reported, who experienced the fatal unexpected serious (medically significant) AESI event of seizure, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. The reported cause of death was Seizures. It is unknown if an autopsy was performed. Date of death is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning unspecified age and gender, with no medical history reported, who experienced the fatal unexpected serious (medically significant) AESI event of seizure, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. The reported cause of death was Seizures. It is unknown if an autopsy was performed. Date of death is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Seizures
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Nausea-Medium, Additional Details: pt state symptoms started about 4 hrs after vaccination. it started with swelling. and 6 hrs after pt reported having a loss of body strenght, body aches and nausea. after 48 hrs pt stated that majority of the symptoms have subsided, but on day 3 still gas some swelling (feels hot and is red) and the arm is still sore.
Myalgia, Arthralgia & Fever Narrative: Previously COVID positive. Symptoms following injection similar to symptoms while positive.
heart palpitations, stomach cramps, chest pains, severe headache, abdominal pains, pain when taking deep breath.
After receiving one dose of varicella virus vaccine live the pt experienced breakthrough chickenpox with 12 lesions on her arms and legs. Subsequently the pt recovered. No further information is available.
Started to have chills & achy ness around six. By 7:30 very bad body aches- painful joint aches especially in thumbs/hands, headache. Absolutely freezing and skin was cold to touch but no fever at any point. Went to bed and this continued until about 6:00 AM. At 2:00 am  was starving- so had cookies and milk.  By 7:00 AM on 2/8/21 felt better except for a bad headache which lasted until  6:00 PM. Then all symptoms  were gone.  Never had a fever. Hands still achy, it seems to flair up arthritis.
Severe case of hives. I needed urgent care on Tuesday 2/8/22 and went back to see my family doctor on 2/10/22 because the hives where externally and internally leaving me with a constant pain in my trachea and esophagus. As today I need to follow up with a dermatologist and gastroenterologist due the constant skin rash/itching and the gastrointestinal pain.
This is in follow-up to report(s) previously submitted on 9/17/2007. Information has been received from a 76 year old female consumer who on 29-JAN-2007 was vaccinated with Gardasil.  The patient reported that she had asked her physician if there was a vaccine for shingles.  The physician stated that one was recommended for her age and the patient was subsequently vaccinated with Gardasil.  On 11-JUL-2007, while on a cruise, the patient experienced "terrible pain" in her back.  On 13-JUL-2007, the patient broke out in a rash.  On 14-JUL-2007, the patient went to the hospital and was told she had shingles.  The patient informed the physician that she received a vaccine "not to get shingles".  The patient reported that the event "ruined 4 days of her 8 day cruise".  The patient subsequently had four visits to her physician and medication to treat the shingles.  At the time of this report, the patient had not recovered.  No further information is available. It has been determined that WAES # 0708USA03786 is a duplicate of WAES # 0708USA02052, therefore WAES # 0708USA03786 is being deleted from our files and the reports consolidated into WAES # 0708USA02052.
Rash at injection site with extreme itching, body aches, and extreme tiredness. This is the second day. Treating with Aveeno lotion on the site for the itching.
Systemic rash, maculopapular, on trunk, arms, neck, scalp, thighs and calves lasting 5 to 6 days. Also, pruritic. Tx-Benadryl.
Limo node under my right arm is swollen to the size of a tennis ball.  Same arm I was vaccinated on.
09/15/2003: Booster Td and Hep A #1 given left thigh.  Have headache, decreased appetite in week following injections.  09/21/2003-hives noted on left thigh and 09/22-few hives trunks, right leg.
Initial report was received from a health care professional on 18 and 23 February 2011. A 13 month-old male patient who had no illness at the time of vaccination and pre-existing conditions were reported as none had received on 10 February 2011, a second dose intramuscular right thigh injection of DAPTACEL, lot number C3514AA. On 14 February 2011, the patient started to develop hives at the injection site and by 16 February 2011 the hives had spread to his arms, legs, body and back. The patient was evaluated by a physician. Treatments and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information was received from a health care professional on 28 March 2011 who reported that the event diagnosis was erythema multiforme. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. On 16 February 2011 the patient was evaluated by his physician for a rash that started five days after receiving a DAPTACEL vaccine. According to the physician the patient was doing well but developed the rash around the administration site of the vaccine. The rash worsened and spread to the whole body. Physical exam revealed the patient had hives over his entire body. He had "target lesions, pink mac-pap (illegible) lesions on legs and an increased concentration at vaccination site". The patient also had swollen eyes but "not shut". Treatment included BENADRYL 3 - 4 cc by mouth every six hours as needed. The patient was given a prescription for steroids however it was reported the Mother was hesitant to give them to the patient. The patient has a history of saggital synostosis and had an unspecified surgery. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Pt started complaining to family of progressive fatigue, n/v, and tremor that started within days to 1 week after 2nd dose of Moderna. Saw PCP several times for progressive symptoms over the next 2-3 months. Presented to ICU after found down for up to 24 hours. Serum ammonia levels were found to be 436 on presentation. Despite CRRT/HD, ammonia scavengers, low protein diet, pt never woke from coma and expired after being placed on comfort care. Later found to have partial OTC deficiency with no prior episodes of hyperammonemia. Also, no known family hx of any urea cycle disorders.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 05-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
Fever 102.9, red bumpy looking rash (picture sent) over the entire body, dizziness, chills, night sweats all through the night. Call made to nurse at 5:42 pm. Treatment- Tylenol extended release arthritic 650mg X2, Advil 200 mg x4, Benadryl 25mg x1 in pm and one am 9/3/2021  am still had rash and fever of 102.5, recommended more fever reducer medication and see physician
covid-19-antibody; right subclavicular lymph nodes swelling; This is a spontaneous report from a contactable pharmacist (Patient himself).  A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Batch/Lot Number: EL1283 Expiration date: Unknown) via an intramuscular route of administration, administered in deltoid right on 12Jan2021 15:00 (at the age of 34-year-old) as dose 2, single for covid-19 immunization. Patient is non-smoker. Patient medical history was not reported. Concomitant medications included bupropion taken for an unspecified indication, start and stop date were not reported and ibuprofen taken for an unspecified indication from 23Dec2020 to an unspecified stop date. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number- EJ1685) via intramuscular route of administration, on right deltoid on 23Dec2021 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization and experienced diarrhea 24 hours of diarrhea from 01Jan2021, was diagnosis with covid-19 through nasopharyngeal NAAT. The patient underwent lab tests and procedures which included culture resulted as positive on organism was covid-19 culture source was Nasopharyngeal NAAT, sars-cov-2 antibody test resulted as negative on 22Feb2021. The patient experienced right subclavicular lymph nodes swelling on 13Jan2021 and covid-19-antibody (negative) on 22Feb2021. Patient had not attended Emergency Room and physician Office for the events reported. it was reported that it should also be noted that patient COVID-19 antibodies were negative after a blood donation on 22Feb2021. Patient was not hospitalized and patient was not admitted to an Intensive Care Unit. Patient had not developed clinical sign at rest indicative of severe system illness. Patient not required supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation for the events reported. patient not had any Multiorgan failure. Event had not required the initiation of new medication or other treatment or procedure. Patient was not taking any medication routinely prior to the event and not been treated with immunomodulating or immunosuppressing or receive any other vaccines around the time of COVID-19 vaccination. Outcome of events was unknown. No follow-up attempts are possible. No further information is expected
Arm pain,  exhaustion,  bad headache,  swollen lymph nodes near collarbone on left side - very sore to touch.
This spontaneous report as received from an other health professional refers to a patient of unknown age. On 2017 the patient was vaccinated with a dose of incorrect product storage GARDASIL 9 lot # M036059 for prophylaxis. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Sender's Comments: US-009507513-1707USA006643.
This vaccine requires reconstitution of the powder and liquid in order to be appropriately administered. Only the Liquid portion of the vaccine was provided to the patient. The solid portion was not given.
Headache, Myalgia, Arthralgia, Blurred, glassy eyes, injection site pain and severe fatigue Narrative:
I contracted COVID-19 on 19 03/13/22 which began with symptoms of vomiting, followed the next day by sore throat, brain fog, fatigued but unable to sleep due to discomfort and pain, I was unable to swallow/eat/drink because of this. I also had a headache, fatigue, body aches, and was finally able to sleep through the night on 3/18/22. My symptoms began to resolve on 3/21/22 but did not fully resolve until 3/28/22. I have lingering vertigo, and a strong aversion to meat which is new. I am seeking additional care for my vertigo.
According to ER notes: Complaint on admission - chills med report - severe rigors, fever, high fever (37.0 C).
Information has been received from an office manager referring to a 27 year old patient of unknown gender. Information regarding concurrent conditions and medical history was not provided. On 02-MAR-2015 the patient was 26 year old and was vaccinated with the first dose of GARDASIL intramuscularly (dose, lot # and application site were not reported). On 06-APR-2015, the patient was 27 years old and was vaccinated with the second dose of GARDASIL, intramuscularly (dose, lot # and application site were not reported (inappropriate schedule of drug administration). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Severe Lethargy, GIT issues: stomach upset, pain on left upper body: chest to back, severe rash on arms. Patient went to ER.
testing positive for Covid; testing positive for Covid; vaccine brand other=Moderna/Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received bnt162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL8982), in left arm, on 24Feb2021 at 13:30 as dose 2, single (Lot number: EN6203), in left arm and on 05Oct2021 as dose 3 (booster), single (Lot number: FF2857) at the age of 73 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18May2022 as dose 4 (booster) single (Lot number: 038A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Pen" (unspecified if ongoing); "Known allergies: ace inhibitors, arb blockers" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing); "gout" (unspecified if ongoing); "degenerative arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18May2022, outcome "unknown", described as "vaccine brand other=Moderna/Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "testing positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: 7 days after testing positive for Covid and starting Paxlovid within 12 hour of onset of fever to 101.5, myalgias, extreme weakness and feeling better. Paxlovid start date 06Oct2023 to stop date: 11Oct2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300351260 same patient, different drug/ event;
Warm feeling through out body. Left arm and left side of face went numb for 3hrs. difficulty breathing lasting 3hrs. severe pain in joints lasting 3 days.