chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 09Apr2021 as dose 2, single (Lot number: EW0153), in left arm, on 15Aug2021 as dose 3 (booster), single (Lot number: FA7485), in left arm and on 31Jan2022 as dose 4 (booster), single (Lot number: 33036BD) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Common Variable Immune Deficiency (CVID)" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "migraines" (unspecified if ongoing); "trigeminal neuralgia" (unspecified if ongoing); "B-12 deficiency" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure (well-controlled with medication). The patient took concomitant medications. Past drug history included: Fioricet, reaction(s): "Known allergies: Fioricet"; Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: antigen tests (her mom has ALS so patient didn't want to take chance of her getting it) for 6 days and had negative results and no symptoms; Positive, notes: daily antigen test it came back positive; Positive, notes: at-home "PCR-like" test and it was also positive; Positive; Negative, notes: Patient completed the entire regimen and tested negative and had no symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: On 26Jul2022 (the day symptoms started), started a 5-day Rx of Paxlovid, taking the first dose in and evening. Completed the entire regimen and tested negative and had no symptoms. After symptoms resolved, continued to use antigen tests (her mom has ALS so patient didn't want to take chance of her getting it) for 6 days and had negative results and no symptoms. On 06Aug2022, she woke up with an asthma attack, a cough and scratchy throat, and when she did the daily antigen test it came back positive. To be sure, she used the more sensitive, at-home "PCR-like" test and it was also positive. So, despite 5-day Paxlovid treatment, she tested positive again 6 days later and have worse symptoms than she originally had. Other medication in 2weeks was unknown.
Presented with subjective fevers, chest pain, and progressive DOE for 3 days before presenting to ED on 11/30/21. EKG and troponin positive, likely perimyocarditis. Treated with NSAIDs and colchicine. Improved with treatment.
Patient stated starting the night of the vaccine he became very lethargic, and achy. States that he had chills but is not sure if he had a fever. He could not sleep due to the pain so he took to "bufferin." The next day  he still had a lot of pain and lethargy. Around 4 PM he was able to get out of the house and started feeling better. He came by the pharmacy around 7 PM and looked well and said he is feeling better.
Right arm pain x 10 days, unable to lift arm overhead. Trouble moving his arm when swimming. Unable to put his shirt on. Slight decrease in strength of right had squeeze vs. left. X-ray done, normal, labs drawn - normal. Referral to Neurology. Treat w/rest, ice, ibuprofen Q 6 hours.
Positive Covid test done; This is a spontaneous report from a contactable consumer. A 65 year old female patient received first dose bnt162b2 via an unspecified route of administration on 04Mar2021 (Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included ongoing she take something for allergy, antihistamine. The patient concomitant medication included she take something for allergy, antihistamine. On 04Mar2021 she had the first dose of the Covid vaccine. On 16Mar2021, she had a positive Covid test done and she does have the second dose scheduled on 25Mar2021 and they are wondering if she needs to get the second dose. The outcome of the event was unknown.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (received 1st dose about 2 months ago, refer case US2019GSK057627). On 24th March 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fever and chills. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever and chills were unknown. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was experiencing low grade temperature and chills. She stated that she took some TYLENOL and at the time of reporting she was feeling a bit better.
Right arm has considerable swelling, it is red and warm to the touch. Sleepiness, stomach pain and nausea. Muscle pain included
Patient got the moderna vaccination and went to get up in the middle of the night & could not get up. Patient states she couldn't move her legs which lasted for about 30 minutes then she was able to move it got better but continued to have problems walking until a week later patient ran a fever for 1 week
Fever, swollen lymph nodes. No TX. Reported better now, lymph nodes decreased in size.
Severe are soreness that interferes with sleep 2 consecutive night.  Intermittent chills, throughout night and periodically the next day.  A headache in the morning that lasted until late afternoon.  Some intestinal distress that felt like diarrhea but did not result in diarrhea.  Loss of appetite.  The second day, in mid-afternoon, nausea.  Overall a general sense of Malaisé that interfered with normal activities.
Stomach Pain, Nausea, Reactivated previous shingles event neuralgia
Diagnosed with metastatic lymphoma after first vaccine; This is a spontaneous report from a contactable consumer (daughter). A 60-years-old male patient (father) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had injection site pain in his shoulder with redness, he was tired, he had a headache, and muscle pain in his shoulder. He also was not feeling well, had swollen lymph nodes and his eye and part of his face was swollen. He went to the hospital and was admitted, and he was diagnosed with metastatic lymphoma. The patient died on 14Jul2021.  It was not reported if an autopsy was performed.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Diagnosed with metastatic lymphoma after first vaccine
Pt received vaccine on 5/16/18 and was feeling fine. Next morning pt woke up feeling weak, had low BP and high heart rate. Pt was hospitalized for 2 days. Diagnosed w/pneumonia and sepsis w/mild leukocytosis, (R) lung infiltrate.
My husband was admitted for a hypertensive crisis a day later Bell?s palsy he developed and the hospital advised that this might be due to the vaccine
Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced swelling. The patient received a dose on an unspecified date. The reporter states that "they have seen a couple of patients in the office and on the phone who experienced swelling after receiving the vaccine". It is unknown if relevant testing was done, if there was any treatment or any diagnosis for these patients. As of 25-Jun-2010, the outcome of the event was unknown at the time of report. No additional information was available at the time of this report.
nurse told her mother that a "dear friend" also received the COVID-19 vaccine and "has the same blood pressure issues and cannot get it under control; This is a spontaneous report from a contactable consumer (patients daughter). A female patient of unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had the same blood pressure issues and cannot get it under control. Caller reported that patients dear friend also received the COVID-19 vaccine and had the same issue. The outcome of the event was unknown. Caller's husband reported that HCPs have seen this happened to other patient post-vaccination with the COVID-19 vaccine.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Constant menstrual cycle for approx. 5 months, resulting in severe anemia.
This case was reported by a physician and described the occurrence of arm pain at injection site in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject had previously received the flu shot(s). On an unspecified date in September to October 2010, the subject received unspecified dose of FLULAVAL (unknown, left arm). On an unspecified date in September to October 2010, at an unspecified time after vaccination with FLULAVAL, the subject experienced prolonged arm pain at injection site (compared to previous years the vaccine has been available). Medical attention was required at a doctor's office. At the time of reporting the event was resolved. The physician considered the event was probably related to vaccination with FLULAVAL. The physician wanted to obtain information on "other's experiences". She is seeing a greater number of site reaction arm pain from this year's FLULAVAL vaccine (2010). She is seeing the event greater in women than men. The arm pain is lasting as long as one month. This group of patients (unspecified number) has received Flu vaccine in the past. No other similar characteristics were noted; no medical history or concomitant medication similarities. The injections were administered by two physicians in her office and usually in the left arm. No further information was reported.
p/vax pt states tight feeling @ site immed p/vax but did not notice redness, edema & tenderness @ site until Am 9/19/99;advised to seek PMD today ASAP; pt w/warm, red, raised area 71mm x 42mm;
no pain afrer shot. woke up to pain and large, hot,  red swollen bump at injection site
Chills, Migraine,  body aches, fever of 101.2 to 102.2, arm soreness, redness and knot at injection site
Moderna vaccine (NDC--8077-0273-99, lot # 048C21A) was received on 7/16/2021 and placed under refrigerated temperature.  3 vials were transferred to Walmart store 2136 where 20 doses were administered beyond use date.
PATIENT IS ONLY 64 AND GOT THE FLUZONE HD WHICH IS FOR OVER 65
Local area of erythema at injection site within minutes of injection. Hives increased in severity on torso and extremities within minutes. Audible wheezing, circumoral cyanosis; anaphylaxis. HR increased 112, O2 saturation of 86%. Transported to hospital via ambulance.  Nurse follow up on 07/19/04 states: "Macular rash."
Sever agitation with anger.  Uncharacteristic of me and came on suddenly in the evening after receiving first dose of Pfizer Covid Vaccine in the morning.  Severe "brain fog" on second day. Currently two days after receiving vaccine and agitation is still an issue coupled with mood swings and changes in thinking.  Brain fog seems to have subsided. Other side effects have been moderate and expected: mild head ache, significant fatigue, a little achy, slight bit of nausea.  Physical side effects are all normal and not severe and are expected.  Mental, emotional, and thought pattern changes are of concern.
A non-serious spontaneous report of insomnia, talking in sleep and very angry has been received from a registered nurse/health professional concerning a four to 39-month-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On an unknown date in 2009, the patient received H1N1, Intranasal for an unspecified indication. After vaccination, the patient had trouble sleeping and talking in her sleep. Patient had very fitful sleep and kept walking - very angry. Insomnia began the night after receiving H1N1 and persisted for one week. The patient was recovered from event of insomnia and the outcome of the events talking in sleep and very angry was unknown.
1) Fever within first 24 hours with nasal congestion (suspect viral URI as mother had similar symptoms); COVID PCR negative 2) 9 x 9.5 cm area of erythema left outer arm (vaccination site) -- subtle findings started 9/2/21, measured 9 x 9.5 cm with erythema (nontender, not warm to touch, not indurated)  on 9/3/21.  Suspect inflammation; safety Rx for antibiotic to treat skin infection given in case redness worsens over the weekend. No itching or constitutional symptoms.
I have been feeling dizzy since I got my booster shot, She's been feeling dizzy (ongoing); neck pain; it is still a little tender; arm pain, soreness in arm; shoulder pain; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I have been feeling dizzy since I got my booster shot, She's been feeling dizzy (ongoing)), NECK PAIN (neck pain), TENDERNESS (it is still a little tender), PAIN IN EXTREMITY (arm pain, soreness in arm) and ARTHRALGIA (shoulder pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 038A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Patient history is not reported. Concomitant products included FOLIC ACID for Blood pressure high, GABAPENTIN, TIZANIDINE and IBUPROFEN for an unknown indication.On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (I have been feeling dizzy since I got my booster shot, She's been feeling dizzy (ongoing)), NECK PAIN (neck pain), TENDERNESS (it is still a little tender), PAIN IN EXTREMITY (arm pain, soreness in arm), ARTHRALGIA (shoulder pain), CHILLS (chills) and HEADACHE (headache). At the time of the report, DIZZINESS (I have been feeling dizzy since I got my booster shot, She's been feeling dizzy (ongoing)), NECK PAIN (neck pain), TENDERNESS (it is still a little tender), PAIN IN EXTREMITY (arm pain, soreness in arm), ARTHRALGIA (shoulder pain), CHILLS (chills) and HEADACHE (headache) outcome was unknown.    No concomitant medication was reported.No treatment medication was reported.This case was linked to MOD-2021-385903 (Patient Link).Most recent FOLLOW-UP information incorporated above includes:On 12-Nov-2021: Follow-up received contains: events added and reporter information added.
No additional AEs or PQC reported.; Caller reports vaccine administered after temperature excursion.; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medication was not provided.  On 04-JUN-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U034712 with expiration date: 30-JUL-2023, 0.5 milliliter, strength unknown) intramuscularly for prophylaxis after temperature excursion (product storage error). No additional adverse events (AEs) or product quality complaints (PQC) reported.  Administered dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) experienced the temperature excursion below 34.2 Fahrenheit degrees (F) for 12 hours. No previous temperature excursions reported.
I experienced pain at the shot site for three days, joint pain for about 18 hours, fever (100.0 degrees f) for 24 hours, weakness36 hours, and fatigue for about 36 hours.
Information has been received on 28-OCT-2016 from a pharmacist referring to a patient of unknown age and gender. The pharmacist reported that on unknown date the patient inadvertently received a dose of ZOSTAVAX (dose, route, and lot number not reported) instead of VARIVAX. No adverse effects had been reported. No further information was reported. Additional information has been requested.
I?m not 100 percent  and I do have anxiety. But about 5 minutes after I received my 2nd dose I got a flush feeling in my chest and then all of a sudden my heart started racing and I felt like I was going to pass out. A nurse came over and felt my pulse. After a couple of minutes my heart rate slowed down. Like I said I do have anxiety attacks but I haven?t had one for a while now. Just wanted to report what happened to me because it was a scary feeling and maybe it was a coincidence. Haven?t had it happen again.
Aches and pains (second dose); Second dose produced more severe side effects; he and his wife both received booster shots; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches and pains (second dose)), VACCINATION COMPLICATION (Second dose produced more severe side effects) and OFF LABEL USE (he and his wife both received booster shots) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A, 037K20 and 0881021A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Aches and pains (second dose)), VACCINATION COMPLICATION (Second dose produced more severe side effects) and OFF LABEL USE (he and his wife both received booster shots). At the time of the report, PAIN (Aches and pains (second dose)) and VACCINATION COMPLICATION (Second dose produced more severe side effects) outcome was unknown and OFF LABEL USE (he and his wife both received booster shots) had resolved.       No treatment medications were reported by reporter.  No concomitant medications were reported by reporter.  The patient experienced a few aches and pains with each of the first two doses but was fine so far after the booster dose. The second dose produced more severe side effects for the patient. It was unsure if the patient was currently on any concomitant medications. His wife experienced a few aches and pains with each of the first two doses but is fine so far after the booster dose. The caller mentioned that her second dose produced more severe side effects. It is unsure if the wife is currently on any concomitant medications at this time.  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.   This case was linked to MOD-2021-286836 (Patient Link).; 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.
Swelling, redness, hot to touch. Patient mother called 3/21/06 pm said patient had lump on arm with low grade fever. She was giving him TYLENOL and hot packs 3/22/06 patient came into office left deltoid down to elbow and around to back red, swollen, hard. Patient to take BENADRYL and TYLENOL. Watch if any other signs bring patient to office.
Red, swollen, hard, warm, size of a softball on both arms. Started after getting injections.
Upon getting the HPV vaccination, he syncopized with some tonic-clonic movements. The reaction was very soon after the vaccination was given. He does remember the entire episode. It lasted approximately 20 seconds per his mother's reports. He laid down for approximately 15 to 20 minutes afterwards. He felt fine at that time. He then sat down for another 10 to 15 minutes and then he was discharged to home with instructions for followup if any symptoms recur or begin. Menactra was not given to him. He had a similar reaction to Menactra in the past, but it was not as severe. He has had influenza in the past year with no reaction. He has no history of other reactions to vaccinations. He does have a likely allergy to penicillin from his infancy. This was likely HPV-related syncope. I advised them against getting future vaccinations given the response to these last two vaccinations. Flu vaccination will be reasonable to continue given his past tolerance of this, but will need to have adequate coverage and would not recommend him getting this any where, but a physician's office. I did inform them that I would be happy to complete any documentation if others feel that vaccination would be required
"within 24 hours after the vaccine, my heart started racing and my blood pressure went up"
This case was reported by a nurse and described the occurrence of accidental overdose in a 11-year-old male patient who received HAVRIX (batch number 4G7P2., expiry date 3rd October 2015). On an unknown date, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. Additional information received: A 11 years old child was given an adult dose of HAVRIX by accident.