chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm sore) 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 18-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced MYALGIA (Arm sore). At the time of the report, MYALGIA (Arm sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.   Reporter did not allow further contact
Local rash about 1/2 of the patient's palm size. Raized non erythremous rash around injection site. No itching or respiratory symptoms. Rash is warm to the touch.
Delayed reaction: redness at injection site, a bump at injection site. Enlarged lymph node underneath the neck (behind clavicle bone) on the side where the vaccine injection took place
body aches; Chills; low grade fever; This is a spontaneous report from a contactable consumer. A 45-year-old female patient started to receive bnt162b2 (BNT162B2, lot number EK9231), intramuscular (left deltoid) from 06Jan2021 08:30 to 06Jan2021 08:30 at 0.3 mL, single for covid-19 vaccination. Medical history included ongoing asthma. The patient also received first dose of bnt162b2 on 16Dec2020. Concomitant medication included budesonide, formoterol fumarate (SYMBICORT) and salbutamol sulfate (ALBUTEROL); both ongoing given for asthma. It was reported that the patient received the second Pfizer covid19 vaccine dose yesterday around 8:30am. She is calling to report that she experienced body aches, chills, and a low-grade fever which all started around 8pm yesterday (06Jan2021). For the treatment, she is taking Tylenol. The outcome of the events was unknown.
vertigo, everything is spinning; vertigo, everything is spinning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for covid-19 immunization. The following information was reported: VERTIGO (non-serious), DIZZINESS (non-serious), outcome "unknown" and all described as "vertigo, everything is spinning".  Additional information: Report was not related to a study or programme. Caller stated that she had never been sick in her life, she takes no medications or nothing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed chest pains 48 hours after vaccination. Had chest pains daily for several days. 96 hours after vaccination, went to clinic. Tests showed irregular EKG, confirmed myocarditis
My husband started  exhibiting signs of dementia.  Forgetting names, word finding difficulties, personality changes. confusion which continued to progressively get worse over the next few months. He started having hallucinations at night  I brought him to Dr. to do a Neuro exam for dementia.  He sent him to a neurologist who ordered an MRI. The differential dx was Body Dementia rapid onset.  The medications (Seroquel) were not helping and severe paranoia set in.  I brought him to the ED and he was diagnosed with CJD within 3 weeks and he passed away within 6 weeks.
Woke up 3 days after the shot, feeling like I had the flu.  Felt better after getting up, and symptoms did not reappear the next day.
red-mild induration right arm 6cmx6cm. Tylenol/ Benadryl
Information has been received from a medical assistant concerning a 15 month old male with no pertinent medical history who on 19-NOV-2007 was vaccinated intramuscularly with a 0.5 ml dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (Lot #657379/0376U). There was no concomitant medication. On 20-NOV-2007, one day after vaccination, the patient developed redness, swelling and warmth at the injection site. On 21-NOV-2007, the patient was examined in the office. A diagnosis of cellulitis was made. The patient was prescribed SEPTRA. There was no laboratory or diagnostic tests performed. On 23-NOV-2007, the patient was examined and had fully recovered at that time. Additional information has been requested.
Itchy lips Doctor is called, she orders 25mg of BENADRYL orally, the patient is left under observation for 30min. Her vital signs are taken, she reports feeling better. The Doctor is notified and the patient is discharged.
She couldn't identify a green light from a red light and went through a red light; Eyes were extra blurry; Couldn't read her texts; Sore arm; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jan-2021. The most recent information was received on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of COLOUR BLINDNESS ACQUIRED (She couldn't identify a green light from a red light and went through a red light), VISION BLURRED (Eyes were extra blurry), PAIN IN EXTREMITY (Sore arm) and VISUAL IMPAIRMENT (Couldn't read her texts) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L2DA) for COVID-19 vaccination.     The patient's past medical history included Blind right eye and COVID-19 in October 2020. Concurrent medical conditions included Optic neuritis and Multiple sclerosis.   On 06-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 07-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COLOUR BLINDNESS ACQUIRED (She couldn't identify a green light from a red light and went through a red light) and VISION BLURRED (Eyes were extra blurry). 07-Jan-2021, the patient experienced VISUAL IMPAIRMENT (Couldn't read her texts). On 07-Jan-2021, COLOUR BLINDNESS ACQUIRED (She couldn't identify a green light from a red light and went through a red light), VISION BLURRED (Eyes were extra blurry), PAIN IN EXTREMITY (Sore arm) and VISUAL IMPAIRMENT (Couldn't read her texts) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test: unknown (Positive) 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.  No treatment details were provided    This case was linked to MOD-2021-208218, MOD-2021-208218 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received and contains significant information about past medical history, second dose of vaccination and adverse event.; 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.
Low grade fever (100 degrees) for 24 hours Pain at injection site for 48 hours Pain when lifting my left arm for 36 hours
I was really somewhat delirious. I went to pick up my grandchildren and I was driving all over the place.  I got horrible shivers. I went to the emergency room, and they told me I was dehydrated and sent me home. I went home. On the 9th my daughter who is an RN stated we needed to go to the emergency room. I was having shortness of breath and shivering. They got me a room; they started me on antibiotics, and they diagnosed me with sepsis and total kidney failure. They couldn't tell me what type of infection caused it. The antibiotics worked and I was out of the hospital by the 12th.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N017699, expiration date (09-JUN-2019) (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 to 14 (also reported as 6.3) degrees Fahrenheit for 3 hours and 46 minutes and between 6 to 14 degrees Fahrenheit (also reported as 11.3) for 23 hours and 58 minutes and between 15 to 46 (also reported as 22.5) degrees Fahrenheit for 7 hours and 56 minutes. Data logger was involved. There were no previous excursions reported. Product quality complaint (PQC) was not involved.
Patient received the third vaccine in the GARDASIL 9 series on January 27. On February 15 she began complaining that her "stomach didn't feel right" and she felt strange. She was weak and very tired.  On the morning of February 16, she passed out at home and was taken to the ER. On Febraury 20, she was diagnosed with POTS and has since had the diagnosis confirmed by a cardiologist and  also by a dysautonomia physician who conducted a tilt table test.  Looking back I believe she had symptoms even after the first injection as she began taking naps when she hadn't taken naps since she was 4-years-old, she complained of being tired all the time, and said she just didn't feel good often.  She seemed to be unable to concentrate and had difficulty comprehending and retaining information at school even though she has always been an A student.
Sore throat, sore arm, joint pain, low grade fever.  Saw MD and was told was having an allergic reaction. "Throat closing" given inhaled steroids, BENADRYL by PMD. 3/23/10.
Bad headache, arm/neck soreness no fever. Recommended po BENADRYL, ibuprofen and cool compresses.
Left arm is painful/ Arm is still sore today; Worse body ache than after her first dose; Slight fever; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Left arm is painful/ Arm is still sore today), MYALGIA (Worse body ache than after her first dose) and PYREXIA (Slight fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included METOPROLOL and PARACETAMOL (TYLENOL) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm is painful/ Arm is still sore today), MYALGIA (Worse body ache than after her first dose) and PYREXIA (Slight fever). At the time of the report, VACCINATION SITE PAIN (Left arm is painful/ Arm is still sore today) had not resolved and MYALGIA (Worse body ache than after her first dose) and PYREXIA (Slight fever) outcome was unknown.            Concomitant products also included high cholesterol medication (unspecified).  No treatment medications were reported.   This case was linked to MOD-2022-653217, MOD-2022-653180 (Patient Link).
12 hours after vaccine, fatigue, low grade fever and body aches for 12 hours  Positive for COVID in March 2023
Fever up to 101.2 F, chills, severe headache( left temporal, right temporal then spread to forebrain, even walking coughing makes brain hurt like tingling, loose stool, long bone pain, peri orbital edema, neck stiffness,  new onset low back, loss of appetite, loss of taste, insomnia, fatigue and dizziness. I feel like I have all repeat symptoms of covid, with worse headache and neckstiffness than actual infection. Fever last for 3 days and disappeared but headache continues and ended up in ER.  CTA negative, D dimer<200
Injection site swelled up in an area about 3 inches by 3 inches and became extremely itchy, red and warm the day after the injection. I then developed a flare-up of my psoriasis. I had a break out on my right knee about 48 hours after the injection. I also noticed small patches about a half inch circle in size on other spots like my left ankle and under my left knee where I had never had break outs before.
In the course of getting my COVID booster shot (Moderna), I have found the my menstrual cycle has significantly changed. It has been delayed with PMS symptoms- with several negative pregnancy tests. I have had no other significant medical changes or personal life changes that would result in this change. I receive the Pfizer vaccine for 1 and 2, with the Moderna Booster.
Pt received Rubella vaccine on 03/16/05. Developed lymphadenopathy and rash on 03/27/05. No other symptoms.
Rash on face one day.  Dizziness. Injection site pain, Muscle pain all over, Charlie horse from 1/12/2021 - 1/14/2021. Chills, Joint pain, Hot flashes 1/13/2021, and Nausea.
Narrative:  Pharmacy had discovered pt had received expired per beyond use preparation date of covid vaccine booster dose . Pharmacy called patient to provide clinical disclosure that the COVID dose she received was expired. Per Moderna, the dose is still effective and does not need to be repeated, but there is higher risk for infection when administering a preservative-free dose after the recommended beyond use date. Patient reports redness and irritation at the site following administration that has improved but is now itchy. Pharmacy recommended that she seek medical evaluation.
Client received 2 vaccines at the health dept. Staff member observed wavering gait. Walked back to chambers for 15 min observation period. Was observed by RN who assisted immediately. Client was lowered to the floor, eyes closed, non-verbal for a few seconds. Responsive to name. Assisted to chair, cool cloth/ice to forehead, back of neck.
Patient stated her arm was numb after shot. Stopped back after 20 minutes and said it was still numb. I did talk to her tonight and she said numbness resolved, she is fine.
This spontaneous report was received from a Medical assistant regarding unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (digital logger)(lot # L026602, expiry:19-OCT-2017; lot# L043214, expiry:30-AUG-2017, lot# M005714, expiry:03-OCT-2017. The vaccines were exposed On 10-AUG-2016 at 28.9F for 3.8 hours, on 11-AUG-2016 at 31.8F for 1.7 hours and on 26-AUG-2016 at 31.1F for 3.75 hours. There was no previous temperature excursion.No adverse effects were reported. This is 1 of 3 reports from the same reporter. Additional information has been requested.
No additional adverse effects reported; patient received improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 21-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA), lot # S009943, expiration date 26-JUL-2020 (strength, route of administration and dose were not reported) for prophylaxis. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion above 47 Fahrenheit degrees (F) / 9 Celsius degrees (C) for 1 hour and 25 minutes. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.
Projectile vomiting and sweating (both better). Productive coughing and full body aches (still current).
tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell
Caller received 1st dose of Covid vaccine 20Feb and tested positive for Covid 22Feb.; This is a spontaneous report from a Pfizer-sponsored program from contactable consumer (patient).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on 20Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Reporter states patient received 1st dose of COVID vaccine 20Feb2021 and tested positive for COVID 22Feb2021. patient wondering if she would be valuable in a clinical trial for COVID vaccine. The outcome of event was unknown.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
FELT FLUSHED; HEADACHE; A spontaneous report has been received from a consumer. The report concerns a female patient of unknown ethnic origin (age 42 years 26 weeks 2 days).    No medical history was reported.     No concomitant products were reported.    The patient received nasal Flumist (influenza vaccine (live, attenuated)), for flu prophylaxis on 17-Oct-2019.     On 18-Oct-2019, the patient experienced mild felt flushed (preferred term: Flushing) and mild headache (preferred term: Headache). By 19-Oct-2019 she felt much better.    The reporter assessed the felt flushed and headache as non-serious.
Slept all day Saturday; Fatigued and tired; Body aches; Left arm where I got the shot was sore; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept all day Saturday), FATIGUE (Fatigued and tired), MYALGIA (Body aches) and VACCINATION SITE PAIN (Left arm where I got the shot was sore) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced FATIGUE (Fatigued and tired), MYALGIA (Body aches) and VACCINATION SITE PAIN (Left arm where I got the shot was sore). On 24-Apr-2021, the patient experienced HYPERSOMNIA (Slept all day Saturday). The patient was treated with PARACETAMOL (ACETAMINOPHEN) at a dose of UNK dosage form. On 25-Apr-2021, HYPERSOMNIA (Slept all day Saturday) had resolved. On 27-Apr-2021, FATIGUE (Fatigued and tired), MYALGIA (Body aches) and VACCINATION SITE PAIN (Left arm where I got the shot was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: outcome of events updated.
feeling tired; achy; chills; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events with three doses; this is 3rd of 3 reports.  A 67-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included cardiac amyloidosis from an unknown date and unknown if ongoing, otherwise healthy and active. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation and experienced fatigue, pain and chills. Concomitant medication included tafamidis meglumine (VYNDAQEL) taken for cardiac amyloidosis, start and stop date were not reported. The patient experienced feeling tired (non-serious) in 2021, achy (non-serious) in 2021, chills (non-serious) in 2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101317667 same patient and AEs, different drug dose.;US-PFIZER INC-202101317669 same patient and AEs, different drug dose.
Patient passed out approximately about 5 minutes after receiving flu shot. She got up from a sitting position to leave and experienced vision darkness before passing out. Once patient was placed on the floor, she was awake and alert. Spoke with patient's mom 3 days later, patient is doing fine.
I had something like a sinus infection, a sore throat, coughing in chest, congestion, dizziness, and a headache. I felt tired, and I was coughing a lot. I also had a fever.
No other issues or concerns noted; Improperly stored administered VARIVAX/Temperature excursion information: (-11.83C) for 2 hours and 30 minutes; This spontaneous report was received from other reporter, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 24-MAR-2022, the patient was vaccinated with a dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U016065, expiration date: 20-MAY-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -11.83 degree Celsius for 2 hours and 30 minutes. No other issues or concerns noted (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004064: US-009507513-2204USA004065: US-009507513-2204USA004066: US-009507513-2204USA004067: US-009507513-2204USA004068: US-009507513-2204USA004069: US-009507513-2204USA004070: US-009507513-2204USA004071:
waited 15 minutes for observation, returned to car then stated to feel tightening of the throat. returned to clinic, treated with 50 mg IM Benadryl, patient laid down and was given water.
Severe bloody nose that would not stop bleeding.  911 called and came to office.  911 used medication to stop the bleeding but could not.  Went to ER and a balloon rocket was placed in nose after several hours of trying to get the bleeding under control.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 22-Sep-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L018499; expiry: 25-FEB-2017 (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
About 12 hours after getting vaccine I got out of bed  to go to the bathroom and passed out on the floor.  I don?t know how long I was out- I think only seconds.  Felt really dizzy prior to passing out