chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Localized skin reaction on neck/Approx.4x4 Inch in size extending from just above breasts to middle of neck; Feeling jittery, like she had drank too much caffiene; Marks were placed on neck to assess if redness was extending, which it did not; This spontaneous case was reported by an other health care professional and describes the occurrence of SKIN REACTION (Localized skin reaction on neck/Approx.4x4 Inch in size extending from just above breasts to middle of neck), FEELING JITTERY (Feeling jittery, like she had drank too much caffiene) and ERYTHEMA (Marks were placed on neck to assess if redness was extending, which it did not) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy, Shellfish allergy and Asthma.    On 13-Jan-2022 at 2:45 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022 at 3:05 AM, the patient experienced SKIN REACTION (Localized skin reaction on neck/Approx.4x4 Inch in size extending from just above breasts to middle of neck) and ERYTHEMA (Marks were placed on neck to assess if redness was extending, which it did not). 13-Jan-2022 at 3:05 AM, the patient experienced FEELING JITTERY (Feeling jittery, like she had drank too much caffiene). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) on 13-Jan-2022 for Localized skin reaction, at a dose of 50 mg. At the time of the report, SKIN REACTION (Localized skin reaction on neck/Approx.4x4 Inch in size extending from just above breasts to middle of neck), FEELING JITTERY (Feeling jittery, like she had drank too much caffiene) and ERYTHEMA (Marks were placed on neck to assess if redness was extending, which it did not) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient had Shingles after previous vaccination.
This spontaneous report was received from a registered nurse, concerning a 12 month-old male patient. The patient's concurrent conditions, medical history, drug reactions or allergies or concomitant medications were not reported. On 21-FEB-2017, the patient was subcutaneously vaccinated, at the same time, with a dose of PROQUAD  (0.5 ml once) lot # M041084 with expiration date of 04-APR-2018, and a dose of VARIVAX (0.5 ml once) lot # reported as M039318 with expiration date of 20-SEP-2018. No adverse symptoms were reported. No product quality complaint was involved (PQC). Additional information has been requested.
12-28 - patient complains of burning hot red, sensitive to touch. 12-29 - Rph gave TYLENOL PM when patient came to store. 1-4 Patient said site went from purple to black and blue with pain, red circle in middle.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2010, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) at a clinic (by an unspecified healthcare professional) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2013, the patient was treated at the clinic (by an unspecified healthcare professional) for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Tired, HA, nauseated, felt like I was coming down with the flu.  Resolved within 24 hours.  OTC Tylenol.
pt inadvertently recv DTP 25JUN98 devel malaise & fever;pt was taken to ER where it was noted that WBC count was elevated;ER MD dx bladder infect;
This spontaneous prospective pregnancy report as received from health profesional refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 06-MAY-2015, the patient was vaccinated with a dose of VARIVAX (Merck) lot # K006137, expiration date: 29-APR-2015, 0.5 ml, subcutaneous. No concomitant therapies were reported. The reporter stated that the patient was vaccinated when urine pregnancy test was negative. On 14-MAY-2015, the patient performd two in-home pregnancy tests that were positive (exposure during pregnancy). The last menstrual period and estimated delivery date were not known. The pregnancy outcome was pending at the time of this report. No adverse effects were reported. Additional information has been requested.
migraine; felt little winded; headache on and off; Fever of 100; soreness in arm; soft bowel movement; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100), PAIN IN EXTREMITY (soreness in arm), BOWEL MOVEMENT IRREGULARITY (soft bowel movement), HEADACHE (headache on and off) and MIGRAINE (migraine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (Fever of 100), PAIN IN EXTREMITY (soreness in arm), BOWEL MOVEMENT IRREGULARITY (soft bowel movement) and HEADACHE (headache on and off). On an unknown date, the patient experienced MIGRAINE (migraine) and MALAISE (felt little winded). On 12-Feb-2021, PYREXIA (Fever of 100) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in arm), BOWEL MOVEMENT IRREGULARITY (soft bowel movement) and HEADACHE (headache on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever, pain, chills for two days. Then an enlarged lymph node over my clavicle, pressure and pain in my neck and above clavicle, lymph node is still swollen and tender 4 post injection.
received expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses) in a 45-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 068h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 14-Mar-2022.  No concomitant medications were reported  No treatment medications were reported   This case was linked to MOD-2022-536011 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Live Follow up  received contained  Significant information reporter correct name was provided and date the vial was  initially stored in the refrigerator was reported and narrative updated.
Information has been received from a female concerning herself, with no medical history of allergies, who on 15-OCT-2008 was vaccinated with GARDASIL, 0.5ml, intramuscularly. There was no concomitant medication. Caller stated that she was pregnant at the time she received the vaccine. The last menstrual period was approximately on 01-AUG-2008 and the estimated delivery date is 08-MAY-2008. No AE related to the pregnancy reported. Caller stated that she experienced "severe pain" in her abdominal muscle and she no longer had that pain. Caller also stated that she developed a cyst on her right ovary after she got the vaccine. The patient did not indicated if the cyst has improved. The patient sought unspecified medical attention. Additional information has been requested.
Allergic reaction; Itch 3 inches long and 2 inches wide; Redness and an itch 3 inches long and 2 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE PRURITUS (Itch 3 inches long and 2 inches wide) and VACCINATION SITE ERYTHEMA (Redness and an itch 3 inches long and 2 inches wide) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE PRURITUS (Itch 3 inches long and 2 inches wide) and VACCINATION SITE ERYTHEMA (Redness and an itch 3 inches long and 2 inches wide). At the time of the report, HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE PRURITUS (Itch 3 inches long and 2 inches wide) and VACCINATION SITE ERYTHEMA (Redness and an itch 3 inches long and 2 inches wide) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided.
Fever ~ 101F, started about 18 hours after injection, lasted about 8 hours Headache, started with fever, lasted about 12 hours
Pt developed flu symptoms 10/15/2009; came in for follow up with increasing sleepiness 11/30/09 and received FLUMIST. After that time he has had an extensive work up for balance problems, abnormal movements and significant neurologic changes.
30 minutes after vaccine was given patient was very light headed and dizzie, and c/o a headache. Patient had a history of HTN, checked BP and it was 168/92, P 80, RR 14, SPO2 99%.  Rechecked BP 10 minutes later and it was 160/92. Patient continued to feel lightheaded and dizziness. Patient initially refused to let us call 911, then  spoke with her PCP office who advised she goto hospital, we called 911 and she was transported to the hospital via ambulance.
feeling like pins and needles in like when you sit on your foot and it is sleeping; Headache; tingling in her left calf and foot; vaccination site pain; soreness from left shoulder from injection site down to elbow/shoulder pain; This is a spontaneous report from a contactable consumer. A 58-year-old female patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: ER2613) via an intramuscular route of administration on 25Mar2021,14:10into left arm as DOSE 2, SINGLE for covid-19 immunization(at an age of 58 years).The patient medical history included Sciatica for which she underwent surgical procedures congestive heart failure ,allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity .Patient concomitant medication included TDAP via an intramuscular route on 10Mar2021 into left arm for the indication of whooping cough and experienced arm soreness just at injection site for approximately a day ending on 11Mar2021. It was reported that patient had a family history of congestive heart failure and diabetes. The patient took Retasis for unknown indication been taking for two or three years and also received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 24Feb2021 as DOSE 1, SINGLE for covid-19 immunization . The patient also took another vaccine within 4 weeks prior to vaccination.On 25Mar2021the patient had experienced soreness from left shoulder from injection site down to elbow(shoulder pain). On 26 mar2021 the patient had experienced tingling in her left calf and foot .On an unspecified date the patient had experienced tingling in left foot like pins and needles like when you sit on your foot and it is sleeping and experienced headache. On 24Feb2021 the patient underwent lab test and procedures which included SARS-CoV-2 test and diagnosed with positive on 26Feb2021 and stated that the only symptoms she had was a stuffy nose like she had a cold for 2 days.The patient had received treatment for the event headache, soreness from left shoulder from injection site down to elbow and treatment included with Advil.The outcome of the events soreness from left shoulder from injection site down to elbow was recovered on 28mar2021,outcome of event tingling in her left calf and foot was not recovered and outcome of event headache and tingling in left foot like pins and needles like when you sit on your foot and it is sleeping were unknown. No follow-up attempts are needed. No further information is expected.
DizzineS, sweating,weak, chilling, diarrhea, shortness of breath, death
bleeding and bruising under skin   that spread down arm    patient went to doctor doctor informed patient it will heal up in time   was a results of bleeding because of anticoagualtion therapy with warfarin and administration of vaccine
Influenza A; sore arm; Wet cough; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Influenza A), COUGH (Wet cough), PYREXIA (Fever) and VACCINATION SITE PAIN (sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Influenza.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced COUGH (Wet cough) and PYREXIA (Fever). On an unknown date, the patient experienced INFLUENZA (Influenza A) and VACCINATION SITE PAIN (sore arm). The patient was treated with OSELTAMIVIR PHOSPHATE (TAMIFLU) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA (Influenza A), COUGH (Wet cough), PYREXIA (Fever) and VACCINATION SITE PAIN (sore arm) outcome was unknown.            The doctor put her on Tamiflu and patient  wants to know if it will interfere with the shot.  Concomitant medication was not provided.     This case was linked to US-MODERNATX, INC.-MOD-2021-077806 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant follow up received. TCR attached. Patient medical history of Influenza A. 2nd dose was updated. Event sore arm for few days was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077806:Husband's case crosslinked
Numbness in right side of face particularly cheek area.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 08Apr2021 at 14:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, arthritis and hypothyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) and triamcinolone acetonide (NASACORT), from an unknown date for unknown indication and unknown if on going. The patient previously took codeine (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 08Apr2021 at 14:15, the patient experienced numbness in right side of face particularly cheek area. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported event. The clinical outcome of event, numbness in right side of face particularly cheek area was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Pt experienced hives, red, flat raised on trunk. Treated with Benadryl.
This spontaneous report as received from a consumer refers to herself, a 53 year old female patient with allergy for sulfonamide medications. The patient's medical history included rashes from unspecified products. On 13-DEC-2013 the patient was vaccinated with ZOSTAVAX injection with the "standard dose". Strength and lot number were unknown. Concomitant therapies included SINGULAIR and NASONEX. On 23-DEC-2013 the patient noticed that she had developed a rash after receiving ZOSTAVAX. On that day the rash appeared all over her torso and back. The patient stated that she may have had some spots beforehand in various places that went unnoticed until 23-DEC-2013, when the reaction had become apparent to her as a rash as well as possible reaction to the vaccine. The patient did not seek medical attention. The rash was treated with an unspecified topical cream. At the time of report the rash had not resolved. Additional information has been requested.
Swelling (hardness) and red.  Treated with  hydrocortisone.  Gone by end of week.
On May 28, 2021 had symptoms of stuffy nose and cough,  On 6/1/2021 lost sense of taste and smell. On 6/2/2021 had COVID test and was positive.
This spontaneous report as received from a female consumer of unknown age refers to herself. In January 2013, the patient was vaccinated with a single dose of ZOSTAVAX (lot #, dose and route not provided) injection. In January 2014, the patient developed a circular red ring around the injection site and a "red bump" below the site. The patient did not seek medical attention. There was not given any treatment for the events. The outcome of circular red ring around the injection site and a "red bump" below the site was unknown. Additional information is not expected.
Patient stated that she received a booster dose of 2.5ml; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Patient stated that she received a booster dose of 2.5ml) in a female 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2.5 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Patient stated that she received a booster dose of 2.5ml). At the time of the report, ACCIDENTAL OVERDOSE (Patient stated that she received a booster dose of 2.5ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment information was reported by the reporter.
This spontaneous report as received from a consumer refers to herself, a 76 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. The patient reported that back in "2000-2005" she participated in a clinical trial for what would become known as ZOSTAVAX (lot # and expiry date were not reported) for prophylaxis. She further stated that at first she received the placebo but at the end of the trial received the actual vaccine. However, starting about a week ago, the patient developed a rash. She stated that on the first night, there was some pain associated with the rash but after the first night, she only had the rash. The following information was asked of the patient, however she stated that she could not remember any of the information. Many of the fields in this report are marked, "Unknown by Reporter," because the reporter did not have specific information to provide. The outcome of the adverse events pain and rash was unknown. Causality assessment was not provided by reporter.
Chills, body aches, headache.  Tylenol, ibuprofen and Benadryl.  48 hours
Two days after the shot I was so fatigued I had to go to bed. With rest I was some better the next day. I had labored breathing at times and my heart raced for no reason over a period of a week. I had to take naps and I am still fatigued. I kept wondering what was wrong with me and I remembered I received the flu shot and looked at the pink paper they gave me. I just felt that I should report this in as much as it might be important. I have not had a reaction to a flu shot before and I have had several. I will report this to my doctor too. Rest seemed to be the key to my feeling better for a few hours at a time. I didn't take my temperature, however I think I had one the two days after the shot. You may think this is not bad enough to file a report, however, I feel you should know for data purposes.
101.5 Fever, Tenderness and Sorenes at injection site, Aches and pains, Swelling, Musce tenderness, Previous Pneumonia inoculations 5 years ago had no side effects.
The night after I was vaccinated I experienced knee and ankle pain as well as soreness at the vaccination site (left arm/shoulder).  I experienced this throughout the night and this made sleeping difficult. The next morning, I took 2 500-mg tablets of acetaminophen. This relieved my pain for several hours. At about 1 pm, I became very fatigued. I slept the whole afternoon, ate dinner, took 2 more 500-mg tablets of acetaminophen, and slept for 11 hours. The next day, I felt good and have not had any symptoms since
Child refused to bear weight after getting home from appt. where he received vaccinations. He developed (L) knee pain. He started ambulating on the leg the following day. The pain was completely resolved at f/u visit in clinic on 2/1/17.
Telephone call received from the daycare provider approximatley 1 hour after vaccines administered advising office that pt was in route to Emergency room via ambulance because pt had quit breathing 3 times since arriving at daycare.
Information has been received from a physician concerning a female who about a year ago, in approximately July 2008, was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). About a year ago, in approximately July 2008, the patient experienced flu like symptoms after each dose of GARDASIL. The patient sought medical attention by making an office visit. Additional information has been requested.
Ever since my flu shot on 1/13/11 my upper arm, where my shot was, has been very sore and hurts every time I move my arm. (section 7 -completed by patient)