chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in joints; This is a spontaneous report from a contactable consumer, the patient. This is the first of two reports. A 76-year-old male patient received the first dose of BNT162b2 (Pfizer BioNTech Covid-19 mrna vaccine; Lot number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 13:00 (at the age of vaccination 76-year-old) as a dose 1, single for COVID-19 immunisation. Medical history included Crohn's disease, acid reflux, sluggish artery, and heart disease-stent. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had taken other medications (unspecified) within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took atorvastatin on an unknown date for unknown indication and experienced drug allergy. Since the vaccination, the patient had not been tested for COVID-19. On 27Feb2021 at 11:00, the patient experienced pain in joints that were normal. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of pain in joints which included treatment with meloxicam (MOBIC). The clinical outcome of the event pain in joints was unknown at the time of this report.  No follow-up attempts are needed. No further information was expected.
Information has been received from a health professional concerning a 22 year old female patient who on approximately 01-NOV-2006 was vaccinated with a first IM dose of GARDASIL vaccine (yeast). On approximately 01-NOV-2006 the patient experienced seizure. The reporter had no further information. It was noted that patient was 2 weeks late for her second dose of GARDASIL vaccine (yeast) and had not yet received it. Upon internal review, seizure is considered an other important medical event. Additional information has been requested.
pt vax'd w/3rd dose of hepatitis B and developed headache, nausea, diarrhea, fatigue, malaise & emesis.
5 days p/vax pt was in the sun & threw up x3 then noted hives on chest & abd;MD suggest DPH;next AM was not better went to ER because hives were worse & was on fire;itching;
Moderna covid 19 vaccine given to a 17 year old female; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna covid 19 vaccine given to a 17 year old female) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna covid 19 vaccine given to a 17 year old female). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna covid 19 vaccine given to a 17 year old female) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-132172 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132172:
This spontaneous report as received from a 54 year old female patient with penicillin allergy and no pertinent medical history and no drug reactions or allergies refers to herself. On 07-DEC-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # H011331, exp date 20-SEP-2013) in the upper left arm for shingles vaccination immediately within hours the injection site became swollen from dime to quarter size, red with bumps and circular rash. Within the next two weeks she had a breakout on stomach and cheeks. The patient contacted her physician and was told she had a mild case of Shingles. She has continued to experience nerve tingling, shortness of breath and breakouts in different areas of her body. The patient also got warm and tingling sensations. The patient was now getting back spas and having discomfort when walking. The patient's mother also reported that her daughter was administered ZOSTAVAX and had experienced a rash on her face and back and was experiencing a tingly feeling. No lab diagnostics studies were performed. Topical cream, methocarbamol, ibuprofen (manufacturer and dose not specified) was given for the patient. At the time of the report, the outcome of the events was reported as not recovered. Additional information has been requested.
LIGHTHEADED; FELT STRANGE; BRAIN FOG; SORE ARM/ARM FEELS PUNCHED; FELT UNWELL; TIREDNESS; LOCAL REACTION / REDNESS; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid19 infection, and concurrent conditions included high blood pressure, and white coat syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported the company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On NOV-2020, Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive. On APR-2021, Laboratory data included: Blood pressure (NR: not provided) Elevated. On 10-APR-2021, the subject experienced lightheaded. On 10-APR-2021, the subject felt strange. On 10-APR-2021, the subject experienced brain fog. On 10-APR-2021, the subject experienced sore arm/arm feels punched. On 10-APR-2021, the subject felt unwell. On 10-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced local reaction / redness. Laboratory data included: Blood pressure (NR: not provided) Low grade 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheaded, felt strange, brain fog, and felt unwell on 10-APR-2021, and was recovering from tiredness, sore arm/arm feels punched, and local reaction / redness. This report was non-serious.
First, I suffer from Chronic Tinnitus / Hearing Loss and occasional Vertigo.  The day following my vaccine, my tinnitus became significantly more intense and started "pulsating".  Best I can describe is the volume of the ringing pulses louder with my heartbeat.  In addition, I had two brief episodes of Vertigo within the past week whereas I normally get them no more than once or twice per year.   I'm unsure at this time whether a second shot will make it unbearable.
This spontaneous report as received from an administrator refers to an unspecified patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (which had a lot # of M024261 and an expiration date of 30-JUL-2018; however, dosage number and route of administration were not reported), for prophylaxis. The administered vaccine experienced a temperature of 35 grades Fahrenheit during 15 hours. There had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008006: US-009507513-1701USA014464: US-009507513-1701USA014465.
Within 3 hrs I started experiencing severe hip and leg pain. on left side. Excruciating pain during nighttime hours to the point you could not sleep. After 3 days it moved to knee. Went to emergency room at 3am April 4th. Discharged with no relief
At about 7:30 I started feeling extremely weak followed by coughing. Soon after my throat was tightened and it became difficult for me to breathe. My eyes have been blurry since and I?ve had a fever, cold, and my entire right side of my body hurts when I move especially from my hips down.  My eyes are extremely heavy and I feel better with them being closed
This spontaneous report as received from a nurse refers to an unspecified amount of patients of unknown demographics. Information regarding the patient's concurrent conditions, medial history and drug reactions/allergies was not provided. On unspecified dates, the patients were vaccinated with improperly stored doses and LIQUID PEDVAXHIB) which had a lot # reported as L003690 and expiration date 14-JUNE-2018 (dose, route of administration and anatomical location were not reported). There were no concomitant medications provided. The reporter stated that there was a previously temperature excursion of 9 Celsius (C) for 10 hours. On an unspecified date, the LIQUID PEDVAXHIB were exposed to 15 Celsius (C) for 120 hours. There was no data logger used to capture the excursion. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Parent states child recvd immun 5PM in rt thigh & @ 9PM rt leg swelled & was hot to touch; Pt would not walk on leg for 2 days; Parent called local MD; MD recommended packing leg in ice; Pt is walking w/out difficulty now;
On day 8 injection site become swollen, red, hard, itchy and painful.  Treated with cold packs and OTC analgesics.
Woke up not feeling good/started feeling so bad in the middle of the night; Reports a 101F fever; headache; back myalgia; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Woke up not feeling good/started feeling so bad in the middle of the night), PYREXIA (Reports a 101F fever), HEADACHE (headache) and MYALGIA (back myalgia) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053B22A, 039F21A, 044A21A and 006M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Aug-2022, the patient experienced FEELING ABNORMAL (Woke up not feeling good/started feeling so bad in the middle of the night), PYREXIA (Reports a 101F fever), HEADACHE (headache) and MYALGIA (back myalgia). At the time of the report, FEELING ABNORMAL (Woke up not feeling good/started feeling so bad in the middle of the night), PYREXIA (Reports a 101F fever), HEADACHE (headache) and MYALGIA (back myalgia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2022, Body temperature: 101 101F Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient was wondering if she got too high of a dose, she saw that they gave her 0.5ml or if patient just had a brisk response to the dose. No treatment details were reported.   This case was linked to MOD-2022-630786, MOD-2022-630782 (Patient Link).
10/17/19 evening, pt reported hives approx 6.5x4.5 inches wide, bruising at injection site, exacerbation of asthma symptoms: sneezing, coughing, itching, fever of 100.6 max, severe drainage;  pt contacted dr. and dr recommended pt receive qvar, benadryl, and hydrocortisone to treat and to contact pharmacy to fill a vaers.  pt states is feeling better and would like to report that she suspects eggs used in birds that may have been fed tree nuts.
Metal taste in mouth with 30 minutes of vaccine; low fever; body aches and pains; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0176) via an unspecified route of administration on 06May2021 at 09:30 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included metoprolol tartrate and doxazosin mesylate from unknown dates for unknown indications. The patient did not have any known allergies. The patient previously received dose 1 of BNT162B2 (lot number EW0161) on 15Apr2021 at 16:30 as a single dose in the left arm for COVID-19 immunization. On 06May2021 at 10:00 the patient experienced metal taste in mouth within 30 minutes of vaccine, low fever, and body aches and pains. The patient did not receive any treatment for the events. The outcome of metal taste, low fever, and body aches and pains was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Pt recvd Engerix-B on 23APR92; 26APR92 exp flu-like sx; rhinorrhea; sore throat; fever chills; sweats; general malaise; joint pain;
Got Booster on 11/11/21, developed SOB on 11/14/21. Went to ER on 11/14/21, work-up negative. Discharged home under stable condition with prescription for inhaler PRN
Patient received Zostavax vaccine on 1/10/16 at Pharmacy and complained that she contracted the shingles virus approximately 11 days later.
Approximately 3 weeks after the second vaccine I started having balance issues, numbness, squeezing around waist, personality changes , fatigue, insomnia, brain fog and some speech issues.
patient said she had swelling in the left arm for two weeks. patient put on the ice pack and swelling went away
Arm became red and sl. swollen approx 12 hours after injection. NO systemic effects from of am. Motrin given.
Big red swollen area that felt warm to the touch and was hard, it itches and is a little discolored.
Swelling in left arm with rash 1st dose was injected in lower part of arm heart palpitations, stuttering, shaking uncontrollably, migraine headaches, chest pains feeling off balance and terrible back pain can't sleep at night and so many doctor visits to heart doctor and family medicine doctor and endocrinology for them all to say it's long haul Covid but I didn't feel this way until after I got my vaccine. Now my family doctor has referred me to internal medicine doctor because the care I need is above her knowledge.
Information has been received from a pharmacy student with Pharm D. degree, referring to an unknown number of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot #, expiration date, dose, route and excursion details unspecified) (incorrect product storage). No adverse effects had been reported post vaccination. This is one of several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
o After about 10 minutes of receiving the vaccine, while she was in the observation unit, she suddenly developed lightheadedness, shortness of breath, and nausea without vomiting. She was assisted to the ground in a supine position and given one EpiPen injection, with subsequent improvement of her symptoms. Upon arrival to ED, she does endorse some diffuse itching over her body, but airway is asymptomatic. She denies taking Benadryl, Zyrtec, or any other antihistamines today.  o Of note, on the day of her first vaccine dose 4 weeks ago, she had gradually developed symptoms including severe fatigue, muscle aches, and headache. The following day, she also developed increased redness, hives, and similar itching to her presentation today, which she describes feeling like "bugs crawling inside." She subsequently had a virtual visit with her PCP on 1/7, who prescribed her an EpiPen and Zyrtec. She has had resolution of these symptoms and has had no other complaints since.
Pt recvd vax 6 hrs p/birth; during pt's 1st day of life, pt exp laryngeal spasm & turned blue while being fed a dextrose solution; MD felt that pt may have aspirated;
pt recv vax & t102 @ 2000 temp was 104 & pt given chewable APAP; The next morning 21JUL95 mom noticed that pt was jerking & not responding well; took pt to hosp @ 1130; sz like activity; pt had small blisters; not wanting to walk;
Patient was vaccinated on 05MAR21 @ 0420 and returned to the clinic on 13MAR21 to report a "knot" in her left arm that itched and was warm to touch.  She also reported cold chills.  She was evaluated by one of our registered nurses and was given Benadryl 25 mg po.  She is to follow-up with our onsite nurse as needed.
The pt experienced a high fever, cough, maculo-papular full body rash, starting on face and developing distally.
a 2.25 inch diameter reddened area of the injected (Right) arm; itch; reddened area was hot; achy joints; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3AK2K, expiry date 09-DEC-2024) for prophylaxis.   The patient's past medical history included covid-19. Previously administered products included Covid vaccines (received covid vaccines on an unknown date ). Concurrent medical conditions included post-traumatic stress disorder (have had post-traumatic stress disorder (PTSD)).   On 05-SEP-2023, the patient received Arexvy (right arm). In SEP-2023, an unknown time after receiving Arexvy, the patient experienced injection site erythema (Verbatim: a 2.25 inch diameter reddened area of the injected (Right) arm), injection site itching (Verbatim: itch), injection site warmth (Verbatim: reddened area was hot) and joint pain (Verbatim: achy joints).  The outcome of the injection site erythema was not resolved and the outcome of the injection site itching, injection site warmth and joint pain were resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching, injection site warmth and joint pain to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site itching, injection site warmth and joint pain to be related to Arexvy.   Additional Information: GSK receipt date: 19-Sept-2023 The patient received Arexvy and ever since the patient experienced a 2.25 inch diameter reddened area of the injected arm. The patient stated that the reddened area was hot for along time and also itched a lot. At the time of call, the reddened area was still there but had faded. The patient also experienced achy joints. The patient reported that she had never reacted to any other vaccine. The reporter did not consent to follow-up.
Heart is bouncing all over the place; Fluctuating fast heart rate; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart is bouncing all over the place) and TACHYCARDIA (Fluctuating fast heart rate) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation and Gastrointestinal disorder (Digestive Issues). Concomitant products included METOPROLOL and CLOPIDOGREL for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart is bouncing all over the place) and TACHYCARDIA (Fluctuating fast heart rate). At the time of the report, PALPITATIONS (Heart is bouncing all over the place) and TACHYCARDIA (Fluctuating fast heart rate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-041285 (Patient Link).
big red ring on her arm and it is hot, it went away and came back; big red ring on her arm and it is hot, it went away and came back; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (big red ring on her arm and it is hot, it went away and came back) and VACCINATION SITE ERYTHEMA (big red ring on her arm and it is hot, it went away and came back) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (big red ring on her arm and it is hot, it went away and came back) and VACCINATION SITE ERYTHEMA (big red ring on her arm and it is hot, it went away and came back). At the time of the report, VACCINATION SITE WARMTH (big red ring on her arm and it is hot, it went away and came back) and VACCINATION SITE ERYTHEMA (big red ring on her arm and it is hot, it went away and came back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug and treatment information was provided.
ACTHIB was inadvertently reconstituted with sterile water instead of diluent provided. No signs/symptoms of adverse reaction. There was not an adverse reation.  Error was discovered on 7/15/10.  Left blank on form since no adverse event.
Severe vertigo that lasted 4 weeks and is slowly tapering off. I still am experiencing vertigo daily.  Tachycardia that lasted 3 weeks.
Moderna COVID-19 Vaccine  Body aches, headache, mild chills, fever Treated with Tylenol and Excedrin 26 hour duration
Patient started having ascending paralysis on 11/20/2022 and eventually came to the hospital on 11/21/2022.  Absent deep tissue reflexes.  LP with high protein and MRI spine with myelitis.  Currently intubated for possible Guillain-Barré syndrome.
I received the Moderna COVID vaccine on 12/29.  12 hours after the vaccine I had numbness and tingling in my feet.  The following morning (24 hours post vaccine) I still was having numbness and tingling in my feet and my legs from knees down felt weak and jelly like. I still was able to walk fine, but it was uncomfortable, not able to work out etc.  12/31 (48 hours post) I worked for 10 hours this day and symptoms were the same, that evening I continued to have same symptoms and my knees and ankles ached intermittently. 1/1- Same symptoms as previous days. 1/2- Same symptoms and started having tingling down back of upper leg from butt to back of knee, still tingling in feet.  1/2- Went to ER waited 8 hours and left. 1/3- Went to ER and they ruled out Guillain Barre Syndrome (did complete neuro exam) and said they have not seen this particular reaction to the vaccine but due to presentation they believe it is a vaccine reaction. No treatment prescribed.