chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 2/9 I experienced a transitory hypertensive crisis. I went to the ER. It began to subside while I was waiting for admission. I had a blood pressure of 221/30. It lasted about an hour and a half.
Within the same the sore arm pain for 2 days. Afib - my heart went erratic and never had it this bad. 2Nov2021 - In the middle on the night, my smart watch told me that my heartbeat was erratic. Slight pressure in the middle of the breast. Went to ER, everything was fine in the tests in ER.
muscle contracted; Shoulder muscle hurting; Back, legs and both arms hurt, pain all over; This is a spontaneous report from a contactable consumer, the patient. A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the right arm on 06Feb2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6200) via unspecified route of administration in the right arm on 27Feb2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other medications the patient received within 2 weeks of vaccination. On 25Mar2021 at 01:00, the patient experienced muscles at the left shoulder were contracted and formed a mass and were still hurting. The muscles in the front of both legs were contracted and hurt. The patients back hurt and both arms with pain all over. The patient had not tested positive for COVID-19 since having the vaccine and had nasal swab test (COVID-19 test) on 20Mar2021, resulted negative. The adverse event resulted in emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcomes of events muscle contractions, shoulder pain, and general body pain were not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Chills, fever up to 103.5, light head. Took 2 doses of Tylenol during a span of 12 hours and all side effects stopped by around 5:00pm on 01/28/2021
Atrial fibrillation with rapid rate, improved with addition of Cardizem and metoprolol. ED Visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Pfizer-BioNTech COVID-19 Vaccine EUA. muscle pain, joint pain, diarrhea, cough, runny nose, headache, fatigue from 11pm on 8/17/21 until 08/22/21. I still have joint pain but was able to return to work on 08/23/21 while taking Ibuprofen for the pain.
1st outbreak of full body hives occurred early the morning on April 11th. Hives on neck, chest, back, head and scalp. Hives burned and were extremely itchy and uncomfortable, unable to sleep. Urgent Care provider prescribed prednisone 20 mg tablet, cimetidine 200 mg tablet and cetirizine 10 mg tablet and hives went away.   2nd outbreak of full body hives occurred early morning on April 13th.  2nd outbreak worse than the 1st outbreak with hives on face, neck, head/scalp, chest, torso, back, groin, arms and legs. Again, hives burned and were extremely itchy and uncomfortable, unable to sleep. Saw Urgent care provider and dermatologist on April 13th and dermatologist prescribed topical steroid creams, OTC Allegra 2x a day and Hydroxyzine HCL 25mg to take before bedtime. Significant improvement of hives the next morning. As of April 15th I am continuing the prescribed treatment and hives have greatly improved but as still have light markings where the hives were.
2 hours and 25 minutes after the injection my tinnitus turned back on after a stoppage of just over one year. As noted earlier, the first attack lasted from November 2017 (after accidental aspirin overdose) to December 2019. I immediately reproduce this to the agency and tried to report via the Pfizer reporting system, but it kept crashing, so I gave up. Only today read about VAERS. This should be better advertised. Btw, below there should be a box for "possible permanent damage". I'm not checking the "permanent damage" box because that is unknown, but it may unfortunately turn out to be the case.
I had chills in the middle of the night temp was 101.4 the blood pressure was 87/72 heart rate 142 and temp was 101.4. Had cramps real bad body was hurting really bad and coughing a lot. Couldn't walk and was dizzy. Couldn't hold myself up at all. I felt good on Sat morning and then I started feeling bad Sat night and didn't start to feel better until Sunday evening.
Swollen lymph node in left  upper inner arm.  Site is swollen, red, warm, painful with approx. 1cm lump.  Pain and swelling started Saturday AM 1/2/21, redness started that Saturday night.
injection site is red - about 1.5 inches; injection site is itchy; there is a bump at the injection site; A spontaneous report was received from a consumer concerning a 79 years old female patient who developed injection site is red - about 1.5 inches/ injection site erythema, injection site is itchy/ injection site pruritus, there is a bump at the injection site/ vaccination site mass.  The patient's medical history included hypertension, cholesterol, diabetes, and bursitis. Products known to have been used by the patient, within two weeks prior to the event, included Candesartan, Pravastatin, Gabapentin, Metformin, Omeprazole, HCTZ, Trazodone, Acetylsalicylic acid, Docusate Sodium, Coenzyme qQ0 [ubidecarenone], Colecalciferol, Magnesium, Krill oil, Apoaequorin, Milk thistle [Silybum Marianum], Ubidecarenone.   The patient received their unknown dose of two planned doses of mRNA-1273 (Batch number: 026L20A) on 13 Jan 2021 intramuscularly at left arm for prophylaxis of COVID-19 infection.    On 13 Jan 2021 the patient reported the injection site is red, itchy and there is a bump at the site. reported the injection site is red, itchy and there is a bump at the site. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) injection site is red - about 1.5 inches, injection site is itchy, there is a bump at the injection site was not reported.; 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.
feeling off; achy; Cold; sore throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling off), PAIN (achy), NASOPHARYNGITIS (Cold), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (Headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced MALAISE (feeling off), PAIN (achy), NASOPHARYNGITIS (Cold), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (Headache). At the time of the report, MALAISE (feeling off), PAIN (achy), NASOPHARYNGITIS (Cold), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
hot flashes; spots on hand and feet; feels like cant process thoughts; Shortness of breath; dizziness; swelling in feet jaw and left hand; swelling in feet jaw and left hand; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes), PIGMENTATION DISORDER (spots on hand and feet), THOUGHT BLOCKING (feels like cant process thoughts), DYSPNOEA (Shortness of breath) and DIZZINESS (dizziness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003E21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HOT FLUSH (hot flashes), PIGMENTATION DISORDER (spots on hand and feet), THOUGHT BLOCKING (feels like cant process thoughts), DYSPNOEA (Shortness of breath), DIZZINESS (dizziness), SWELLING FACE (swelling in feet jaw and left hand) and PERIPHERAL SWELLING (swelling in feet jaw and left hand). The patient was treated with ALBUTEROL [SALBUTAMOL] for Breathing difficult, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever and Swelling, at an unspecified dose and frequency. At the time of the report, HOT FLUSH (hot flashes), PIGMENTATION DISORDER (spots on hand and feet), THOUGHT BLOCKING (feels like cant process thoughts), DYSPNOEA (Shortness of breath), DIZZINESS (dizziness), SWELLING FACE (swelling in feet jaw and left hand) and PERIPHERAL SWELLING (swelling in feet jaw and left hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Medical History information was reported.   This case was linked to MOD-2021-285527 (Patient Link).   Reporter did not allow further contact
Janssen COVID-19 Vaccine EUA.  Severe headache 24 hours, chills and shaking 6 hours, fever and sweating 4 hours after chills.  Took Tylenol for headache.  Laid in bed under covers with space heater going for chills.  Laid in bed for fever and sweating.
No signs or symptoms reported; Excursions occured; This spontaneous report was received from an administrator referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-APR-2021, the patient was vaccinated with an improperly stored dose of yeast)(GARDASIL 9) prefilled syringe, dose and frequency reported as 1 time dose with lot # T026168 (expiration date: 04-DEC-2022) or 1691180 (expiration date: 15-NOV-2022) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of  49 and 48 degrees Fahrenheit on 09-APR-2021 and on 23-APR-2021 respectively  for 1 hours/ 15minutes. It was not recorded by a data logger and not previous temperature excursion was reported. No signs or symptoms reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report as received from a physician, as part of a marketing research program, refers to 11 to 18 year old male patients. There were no concurrent condition and medical history. On an unknown dates, the patients were vaccinated with GARDASIL (lot number, dose and route were not reported). There was no concomitant therapy. The physician reported regarding patients who between 2006 to 2012, fainted when they received vaccination with GARDASIL. The physician reported that the incidence of fainting occurred 1 in 100 boys. The pediatrician would then have the patients leg elevated, recover and watch the patient for 15-20 minutes before letting them go. This event did not prevent the administration of second and third doses. The outcome of event was reported to be recovering/resolving. The physician stated that now her practice reminds patients to eat before vaccine and had them sit in office for 15. The physician did not see this adverse event with GARDASIL 9. The physician considered fainting to be non-serious and related to GARDASIL. This case is one of the two reports from same reporter. Additional information is not expected since the physician does not wish to be further contacted.
105 degree fever the next day chills body aches fever low grade fever nausea (including vomiting)
Patient went out of town and got very sick 2 days later.She was seen at a clinic there and given antibiotics.She called the pharmacy to report the event .She said the arm was huge and red and very uncomfortable.We checked back on 3/27 and she was better just slightly red however still feels not herself.
Client received Pfizer covid vaccine, and during her observed wait time, she became hot and felt a flush through her body. She also reported tingling in her tongue and throat. She reported itching of her chest, cheeks, and ears. Client was brought back to emergency area, and was assess by nurses. Client did have a prior history of allergy to Iodine and shellfish- but never anaphylaxis. 10:20am, pulse 68, bp 142/83, 98% O2. 10:25am, bp 140/85, still complaining of throat swelling and itching, pulse ox stil 98%. Once client was in a private area, she reported that the flushing and feeling of being hot, had gotten much better. Per Client , her tongue and throat, were not getting worse. Our Medical Director was contacted, and the decision was made to give Benadryl IM.  10:39 pulse 70, O2 95%, . 10:41 am 1ml (50 mg) Benadryl given IM in the right deltoid (lot # 080014, exp. 8/2022). Within a few minutes patient reported that signs and symptoms were better but had not completely gone away. 10:44, respirations 14/minute, O2 94%, patient sat up at this time to help clear some phlem. 10:46 client states tongue feels better. 10:53 am 96% O2, pulse 93.  Nurses continued to monitor client, and asked if she felt any worsening of her symptoms to warrant more medication. Client stated she felt a little better and would like to go home. 11:15 am, spoke to Docter again, per his instruction, client was allowed to go home with her sister. Instructed to take more Benadryl in 4 hours if symptoms return. Client was told if anything gets worse than her original symptoms, regarding her airway, tongue, lips, swallowing, she should call 911.
diarrhea; chest pain; nightmares; Difficulty sleeping; body pain; body ache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CHEST PAIN (chest pain), NIGHTMARE (nightmares), INSOMNIA (Difficulty sleeping) and PAIN (body pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement (cardiac stents), Pacemaker insertion (cardiac) (pacemaker) and Defibrillator/pacemaker insertion. Concurrent medical conditions included Diabetes.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced DIARRHOEA (diarrhea), CHEST PAIN (chest pain), NIGHTMARE (nightmares), INSOMNIA (Difficulty sleeping), PAIN (body pain), MYALGIA (body ache) and NAUSEA (nausea). The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERINE) ongoing since an unknown date for Chest pain, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (diarrhea), CHEST PAIN (chest pain), NIGHTMARE (nightmares), INSOMNIA (Difficulty sleeping), PAIN (body pain), MYALGIA (body ache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment was reported.  Patient has 8 cardiac stents and a pacemaker.  Patient reported allergic to about a dozen prescription drugs.
First dose, not initially reported, only achey muscles. Second dose, given on the 5th, side effects include:  full-body-muscle-shaking-chills, fever of 38.67°C, achey muscles, & exhaustion
High fever, passing out, shingles  1 day after on 04-11-2021 high fever treated with ibuprofen and tylenol,  shingles and passing out started on 04-13-2021
Reported to ED 6 hours after receiving HPV9, MGC, INfluenza vaccine with midly pruritic but diffusely popular rash. Vital signs WNL Resp 14, Pulse 78, Temp 97.7 orally SPO2 99%. Treated with benedryl 12.5 mg. Sent home with Mother to continue benedryl. Was seen in ED two other time for continued rash. Followed up by Providers x 3 with no improvement of rash. Seen finally by Dr on 9 Nov 2016. Refered to Dermatology.
Patient became light headed/woozy after the vaccine. Stated this has happened to her before. She was seated and monitored by RPh and EMS. Was feeling fine and left pharmacy on accord.
The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of PROQUAD with lot number N000336 and expiration date on 03-JUL-2018 (strength, dose, route of administration or anatomical location were not provided) for prophylaxis; which was reconstituted with a properly store sterile diluent (manufacturer unknown). The storage temperatures were 47 to 77 degrees Fahrenheit (°F) (47 °F) for a time frame of 21 minutes and 6 to 14 degrees Fahrenheit (°F) (9°F) for 42 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. As of 25-AUG-2017, all telephone attempts to obtain follow-up information have been unsuccessful. Sender's Comments: US-009507513-1708USA013008: US-009507513-1708USA013009: US-009507513-1708USA013010: US-009507513-1707USA005187: US-009507513-1708USA013012: US-009507513-1708USA013013: US-009507513-1708USA013006: US-009507513-1708USA013005: US-009507513-1708USA013007.
About 25 minutes after receiving the shot, I suddenly felt weak and dizzy. My vision started to go dark. I broke out into a cold sweat all over my body and could barely see anything or move my body and I felt very nauseous. I was nearly unconscious and barely able to talk. This lasted for about 20 minutes and then slowly started to recede after that. I felt able to stand after about 40 minutes, and was eventually able to walk out of the store and be driven home.   I am very very healthy and have no major medical conditions.
- Red bump size of palm.  Itches from wrist to base of neck on right side.  9x6cm area of wheal and induration.
had both Shingles shots, shingles/ suspected vaccination failure; shingles; rash on his right chest; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and COVID-19 VACCINE for covid-19 prophylaxis.   Previously administered products included Shingles vaccine (several years ago the patient took the one shot).   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's husband. The age at vaccination was not reported. The patient got both Shingles shots and after taking the two Covid shots, he had a rash on his right chest.  The reporter thought it looked like shingles.  The doctor confirmed it.  The shingles were not very bad.  The reporter believed it was caused by Covid shots. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Administered 0.25 mL of Spikevax, 12 years and older vaccine, to patient under 11 years old. After review by site medical director and informing patient/parents, determined no additional dose or additional action needed.
10/252006 began to feel bad achy all over, no fever but had headache and nauseated.  10/262006 headache worse with stiff neck. At 5 pm both eyes and lip became swollen.  "feels like she had huge lips"  Letft dark blue circle uder her left eye on 10/27/2006.  Denies difficulty breathing but states she could not get a deep breath.  On 10/27/2006 states sill fells achy but not nauseated and headache is 1/2  of what it was yesterday.  Facial swelling going down.  Feels like she can breath normally today.  Advised to watch for difficulty breathing, fever, stiff neck and headache this weekend.  If occurs should go to the physician immediately
Stored Moderna vaccine in their refrigerator and administered vaccine on 19-Feb-2022 past the BUD date 01-Nov-2021; The patient administered vaccine on 19-Feb-2022 past the BUD date of 01-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered vaccine on 19-Feb-2022 past the BUD date of 01-Nov-2021) and PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered vaccine on 19-Feb-2022 past the BUD date 01-Nov-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered vaccine on 19-Feb-2022 past the BUD date of 01-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered vaccine on 19-Feb-2022 past the BUD date 01-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered vaccine on 19-Feb-2022 past the BUD date of 01-Nov-2021) and PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered vaccine on 19-Feb-2022 past the BUD date 01-Nov-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The BUD date was reported as 01-Nov-2021 and CDC expiration was reported as 19-Mar-2022. No treatment medications were reported.
Patient developed motor tic; jaw clenching; hand movement (involuntary) for approx. a one week period post vaccines.