chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered the vaccine and ask to sit and wait 15 minutes for observation.  within 10 minutes of sitting she stated that she wasn't feeling well and was having trouble breathing and swallowing. The pharmacist was notified and an epipen was administered.
became pale, limp for approx 20 mins; no cyanosis or apnea; evaluated @ er, looked well; t100.4;
With both vaccines around 2 days later got two cold sores with each; This is a spontaneous report from a contactable nurse, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Mar2021 at 15:00 (at the age of 24-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 15:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included Attention Deficit Hyperactivity Disorder (ADHD) and migraines. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and spironolactone (MANUFACTURER UNKNOWN), both taken for an unspecified indication from an unknown date and unknown if ongoing. On 11Mar2021 at 13:00 and 08Apr2021, two days after the administration of both the doses, the patient got two cold sores with each. She did not have a break out in over two years and had been very careful and kept her schedule/diet/health the same. The one difference both times was with the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with valacyclovir (MANUFACTURER UNKNOWN) medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cold sores was recovering at the time of report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Sedation, Myalgia, Fever,  chills and fatigue. pain and swelling at injection site. Narrative:
Fever; Headache; severe chills; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and CHILLS (severe chills) in a 64-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and CHILLS (severe chills). At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and CHILLS (severe chills) outcome was unknown.        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.   Concomitant medications were not reported.
The next day on Thursday at about 4 or 5 in the evening I had started to have headaches, a high fever, and dizziness. I still had a fever on Friday morning so I didn't go into work.
Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX (Oka/Merck). The patient may have had a case of shingles. The physician didn't know if the patient had had the vaccine or not. Further information has been requested.
22DEC93 pt had vax in the AM that evening while eating pt noticed pain behind rt ear; pt states that approx 7 days later began to have facial drooping; seen by MD dx by MD as having Bell's Palsy;
Hi, I have a history of gout in my right foot, with my last flare hitting in May.  On August 7, 2022, two days after my fourth Covid vaccine (ie, second booster) which was administered on August 5, I suffered a flare up of gout in my lower right foot. I am NOT asserting that the two are related.  Just wanted to let you know. I've had a few of these gout "flares" before.  I'd classify this one as "moderate".  It hurts and I'm limping, but I don't need to use a hard show or crutches (yet -- this is now 3 days after the vaccine). To treat it, I'm resting and elevating and taking 500mg Naproxen twice per day.  It's still there, but not debilitating.
"I wanted to let you know that I experienced chest pain/palpitations/tachycardia post mRNA (Moderna) booster vaccine.   Booster received 11/10, and my symptoms started 11/20, while i was home for holiday. I experienced very short/stabbing pain localized to apex of my heart, while at rest (sitting/driving). Several short episodes of this, concurrent with tachycardia (>100 bpm at rest) and noticeable palpitations. This started Saturday night, Sunday AM went to Urgent Care and received an EKG. I was asymptomatic at the time, EKG normal. No labs drawn at UC. Sharp chest pain mostly resolved within 24 hours of onset, but the tachycardia/palpitations continued for about 5 days. These have now mostly resolved, though my heart rate is not fully back to baseline (resting HR in the 80s, normal for me is low 60s). I'm not sure if there is any further action needed, but I wanted to let you know!" Patient reports
Syncope - onset less than 1 minute - Patient was lightheaded/dizzy, cold sweat, felt clammy, slow pulse rate  Pharmacist instructed patient to remain seated. Pharmacist monitored symptoms and checked pulse. Patient gradually recovered over 5 minute period. Patient asked EMS to evaluate her. EMS evaluated her and cleared her to leave when symptoms resolved.
Had a metal implant in his right leg and his foot  turned in; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Had a metal implant in his right leg and his foot  turned in) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Had a metal implant in his right leg and his foot  turned in). At the time of the report, LIMB DISCOMFORT (Had a metal implant in his right leg and his foot  turned in) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.  The reporter stated that her husband had undergone a surgery in his right leg but was not sure whether it was performed before or after the vaccination. The reporter was also not sure whether he was administered with both doses of vaccine or not.
No additional adverse event; patient received the first dose of GARDASIL 9 on 12/6/2019, and the second dose of GARDASIL 9 on 6/18/2020; 44-year-old patient received the first dose of GARDASIL 9; This spontaneous report as received from a pharmacist refers to a 44-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 06-DEC-2019, the patient was vaccinated with the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 18-JUN-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1602284, expiration date 26-SEP-2021 (dose and route of administration were not reported) for prophylaxis. There was no adverse event reported. 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: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
6:45 Pt fainted face forward down while walking to 15 minute waiting area.  Diaphoretic, pale, incoherent x1-2 minutes.  Vomited x1 6:59PM Alert, pink. No sign of swelling or redness on face from falling.   7:15PM Released w/o assistance.
Lightheadedness; Chills; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills and lightheadedness.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient stated that they wanted to report some potential side effects of the vaccine that included some chills and lightheadedness. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events chills and lightheadedness were unknown.; Reporter's Comments: This case concerns a patient, who experienced events of chills and lightheadedness. The events occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
3 cc administered (drug error). 6 dose injection. Arm painful, red @ injection site.
MIXED MANUFACTURER DOSES.  RECEIVED FIRST DOSE MODERNA AT STORE.  RECEIVED SECOND DOSE PFIZER AT VACCINE CLINIC.
Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left side of face, joint pain, headache and neck pain. Lasted about 3 hours, shaking stopped but had chills that lasted all night. The next day, no appetite but when she ate something, she vomited. Worse things were shakes, headache and neck pain and vision. . Had vision problems. Eyes were swollen and jittery and hard to focus. The swelling went away but still unable to focus. Everything has gone except vision issue.
Only nine days after my second Moderna shot, I broke my ankle. I then had to wear an immobilizing boot for 5-6 weeks. Despite taking one baby aspirin a day during the immobilization period, I developed a blood clot in my paroneal calf vein 5 weeks into the immobilization. I am wondering if the proximity of my immobilization to my Moderna vaccination put me at an increased risk of developing a blood clot.
Patient had a cough started on 12/10/17 and 2 weeks later she was admitted to ER with irregular heartbeat.
Case number PHEH2015US000753, is an initial spontaneous report from a nurse received on 07 Jan 2015. This report refers to a 16-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was administered incorrectly with MenA powder component of MENVEO (batch number: A14069) reconstituted with sterile diluent instead of Men-CYW-135, intramuscularly on 29 Dec 2014. No adverse event was reported following the maladministration.
Initial information received on 31/Aug/2006 from a company representative. This information was reported in the context of a litigation case and the initial information was reported by a health care professional. A 31 year old male patient received an initial dose of Imovax Rabies lot number W1419-3 on 16/Mar/2004, as part of post-exposure prophylaxis following a bat bite on the patient's left middle finger. It was not reported whether the bat was tested for rabies. On 14/Apr/2004, the patient reported that he had been experiencing "shakes" and the patient was administered the subsequent dose. It was not reported whether the patient recovered from the event. This patient experienced a subsequent adverse event of "jaw chattering" following the administration of the second dose of Imovax Rabies, which is reported in case 2006-02337.
This male took the first dose of Vivotif before going to bed.  Several hours later he woke with a fever.  Outcome is unknown, further information is expected.  More information has been requested.
Vasovagal episode in the observation area folling vaccination. Spontaneous resoulution when placed in the supine position. Paramedics onsite. No treatment required.
mild cough but no chest pain, shortness of breath, abdominal pain, urinary symptoms, emesis, headache
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a Pfizer sponsored program  via a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. She received her first COVID-19 vaccine at Pharmacy on 28Dec2020. She was supposed to get her second vaccine after 21 days on 18Jan2021. She ended up testing positive for Covid-19 on 13Jan2021, so she missed that second appointment on 18Jan2021 because she had to quarantine since she tested positive. They are coming back again on Monday, 25Jan2021, which would be 28 days. She mentioned she has already recovered from the virus, and wants to know if she could now receive the 2nd dose of the vaccine even if it is already 28 days after her 1st dose. She wants to know can she get the second vaccine on Monday or does she need to wait 3 months re-do the whole thing? Events outcome was unknown.  Information about lot/batch number has been requested.
Stiff neck across the top of the shoulders to the base of the skull.  Very red (2 inches long and 1/2 inch wide at injection site). Then on 10/17/13 got a really bad runny nose and a cold.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 21-year-old female patient who received BEXSERO (batch number 16D301, expiry date February 2019). On 29th November 2017, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, 1 day 12 hrs after receiving BEXSERO, the patient experienced injection site erythema, injection site pain and heart racing. On an unknown date, the outcome of the injection site erythema, injection site pain and heart racing were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and heart racing to be related to BEXSERO. Additional information was provided as follows: The healthcare professional reported that the patient developed redness and soreness at injection site along with heart racing about 36 hours after receiving BEXSERO. No further information reported regarding the event.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 16-JUL-2015, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sore left arm , fever , chills, nausea, vomiting, headache, loss of appetite , cough, left chest pressure , fatigue and difficulty to sleep
Rheumatoid arthritis flare-ups; Fatigue; Off-balance/equilibrium is off; This is a spontaneous report from a  Program received from a contactable healthcare professional and consumer. A 49-year-old male patient received bnt162b2 (BNT162B2), dose 2 at vaccination age of 49-year-old via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation; and tofacitinib citrate (XELJANZ XR; strength: 11 mg), oral from Dec2020 (Batch/Lot number was not reported) and ongoing, at 11 mg, once daily for rheumatoid arthritis. Medical history included rheumatoid arthritis. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID-19 VACCINE) at vaccination age of 49-year-old on an unspecified date for Covid-19 immunization. The patient's concomitant medication was not reported. The patient reported that after he completed the second dose of covid 19 vaccine weeks ago on 31Mar2021, he experienced fatigue and rheumatoid arthritis flare-ups (swelling and joint pain) with no missed doses while receiving the vaccine on an unspecified date in 2021. MD was aware & prescribed him with prednisone 5 mg. The patient also reported his feeling off-balance from laying down too much because of "equilibrium is off" (2021) which was unknown if MD was aware. He mentioned that his left knee has "no cartilage & bone in bone," and swollen improved when using cbd oil (cannabinoid oil). The patient has a scheduled appointment with a rheumatologist next month. The patient was encouraged to call MD. The action taken in response to the events for tofacitinib citrate was unknown. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on a temporal association , a causal relationship between the reported events and suspect drug is assessed as possible.  The underlying medical conditions could have contributed.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Jynneos was administered beyond expiration date; Jynneos vaccines went beyond the 8 weeks in the refrigerator; Jynneos was administered beyond expiration date; Case reference number US-BN-2022-004198 is a spontaneous case report initially received on 12-Oct-2022 from other health care professional via Communication (reference number: USBAV22-1694) and concerns one patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 26-Sep-2022, Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) was administered 8 weeks beyond the expiration date and the eight weeks for refrigerating (explicitly coded as 'expired vaccine used', 'product storage error' and 'product administration error').   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 12-Oct-2022 included local case ID.  The case is linked with US-BN-2022-004197 and US-BN-2022-004198.; Reporter's Comments: A patient of unknown demographics was vaccinated with Jynneos (at an unknown dose, via unknown route or site of administration), after Jynneos had been kept in a refrigerator for 8 weeks, past the expiration date (which is considered product storage error, expired vaccine used and product administration error). No associated adverse events were reported with the reported medication error. Product storage error, expired vaccine used and product administration error are considered listed per company conventions. The patient's medical history and concomitant medications were unknown. Product storage error, expired vaccine used and product administration error are considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with Jynneos (at an unknown dose, via unknown route or site of administration), after Jynneos had been kept in a refrigerator for 8 weeks, past the expiration date (which is considered product storage error, expired vaccine used and product administration error). No associated adverse events were reported with the reported medication error. Product storage error, expired vaccine used and product administration error are considered listed per company conventions. The patient's medical history and concomitant medications were unknown. Product storage error, expired vaccine used and product administration error are considered not related to Jynneos, but to human error. The case is non-serious.
Patient was inadvertently administered pfizer vaccine dose that was less than 30 minutes beyond use time. No known treatment or adverse effects. Unable to reach patient.
After my second shot (5/13/21), I had one menstrual period shortly thereafter (I don't recall the exact dates), and have not have one since. Ordinarily my periods are fairly regular, with the exception of once after receiving multiple vaccinations (hepatitis A & B, tdap, rabies) in spring of 2019, after which I had a period that lasted more than 2 weeks.
Patient developed sudden onset fever, feeling of pressure on the chest, worse with inspiration, worse when laying down, better when standing up. The patient was given hyocyamine, famotidine, and tylenol and the fever and pain resolved. Three days later it has not recurred.
Pt reported feeling dizzy after receiving IM injection and has (+) LOC less than 30 seconds, unsure if hit head, head atraumatic without abrasions, lacerations, bleeding. Pt was assisted to a recumbent position with BLEs elevated. VS as follows: BP 122/70, HR 78, sats 97% on RA. Pt was given water and snack bar and recovered within 15 mins. She ambulated out of clinic in NAD and was driven home by roommate.