chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Patient received two doses of Pfizer vaccine in Feb/Mar 21. The patient tested positive for COVID 19 on 19 Oct 21 and hospitalized with multiple symptoms to include diarrhea, shortness of breath, myalgia, COVID pneumonia and tachycardia. The patient was treated and discharged on 23 October 2021. Reported per EUA.
pain in her eyes; This case was reported by a consumer via call center representative and described the occurrence of eye pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 17th August 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In August 2021, less than a day after receiving Shingrix, the patient experienced eye pain. On an unknown date, the outcome of the eye pain was not recovered/not resolved.   It was unknown if the reporter considered the eye pain to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. The patient received 2nd dose of Shingrix vaccine and later that night experienced pain in eye. The patient was referred to follow-up with her health care professional. Batch number and expiry date was unknown. The patient did not had specific doctor at the clinic.  Note: less than a day was conservatively captured as time to onset for eye pain as per narrative until further clarification on follow up. The reporter consented to follow-up.
Patient describes localized tenderness/pain around deltoid area of arm. States she has difficulty sleeping and wonders if it is nerve pain.
got first shot and got shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles in a 81-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the first dose of shingle shot and got shingles. For tolerance with second dose, refer case US2021AMR202799, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202799:same reporter
Chills; Fever (up to 101.8ºF ); Headache; Nausea; Fatigue; Body Aches; Swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the left arm on 07Jan2021 08:00 at single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included ibuprofen (ADVIL), paracetamol (TYLENOL), calcium carbonate (TUMS), citalopram and birth control (unspecified medication). The patient previously took first dose of bnt162b2 (lot number: EJ1685, expiry date not reported), via an unspecified route of administration in the left arm on 20Dec2020 11:00 at single dose for COVID-19 immunisation. On 07Jan2021 18:30, the patient experienced chills, fever (up to 101.8ºF), headache, nausea, fatigue, body aches and swollen lymph nodes. The patient underwent lab tests and procedures which included aars-cov-2 test: negative on 08Jan2021 COVID test result=Negative. No treatment was received for the adverse events. Clinical outcome of the events recovered on an unspecified date.
17yr old received Moderna vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17yr old received Moderna vaccine.) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17yr old received Moderna vaccine.). On 26-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17yr old received Moderna vaccine.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.
Was 5 weeks pregnant at time of vaccine with strong HCG levels, approximately 2 weeks after vaccination patient suffered a miscarriage. Vaginal bleeding, cramping and passed large clots including a sac like tissue.
(L) arm 5 x 6 area pinkness with warmth and tenderness.
approx 5hr p/vax pt was running laps on athletic field prior to participating in a soccer game;pt collapsed & stopped breathing;CPR was initiated & pt transported to hosp ER;
I had the vaccine on 12/28/2020, and within the first couple days I was sitting at my computer working at home and I started to see spots and have blurred vision. I tried to keep working and it didn't work out and I went and laid down for about an hour. I was feeling better, and the auras lasted about 30 mins then they resolved. I didn't have any more auras until a couple weeks later and at the time, I was sitting on my kitchen on the floor painting some kitchen cabinets. Then the auras occurred again. They lasted about 30 mins, and there weren't any other symptoms associated with them. At the time, I didn't have any other symptoms, it was just exclusively the visual changes. Then it happened again 3 weeks later after that when I was outside, and I was standing at that time. I went to my doctor, and they didn't feel like it was associated with the Covid vaccine, but it was still very new at the time but that was their suspicion. I did go see an ophthalmologist and the exam came back normal so they were under the same impression that it might or might not be in relation to the vaccine. At the time, I wasn't having as severe sporadic headaches as I am right now. I've recovered from the auras, but not from the headaches.
Information has been received from a physician concerning a 4 week old female who on 27-FEB-2008 was inadvertently vaccinated PO with a dose of Rotateq (lot# 657519/1129U).  No adverse reactions were reported.  There was no product quality complaint.  Additional information has been requested.
Cellulitis. Treatment with CIPRO 500 mg and Naproxen 550 mg.
Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female with no pertinent medical history and no drug reactions/allergies who on 21-JAN-2009 was vaccinated with the first dose of GARDASIL (Lot# not reported).  There was no concomitant medication.  The patient was pregnant, and her LMP was 16-OCT-2008.  The patient had not experienced any known symptoms.  The patient underwent a routine prenatal workup, the result was not reported.  It was reported that the patient sought medical attention: seen at the practice.  Follow-up information has been received from the nurse practitioner who reported that on 11-JUL-2009, 38 weeks from LMP, the patient delivered a normal, healthy male baby weighing 6 pounds, 7 ounces, APGAR score 9/9.  There were no complications during labor/delivery.  An urine drug screen test was performed on 24-FEB-2009, and the result was positive for marijuana.  A maternal serum alpha fetoprotein quad screen test was performed on 26-FEB-2009, and the result was negative.  An ultrasound was performed on 18-MAR-2009, and it came back normal anatomy at 22 1/7 weeks.  On approximately 04-MAR-2009 and 27-MAR-2009, the patient experienced urinary tract infection.  On 04-MAR-2009, the patient was treated with MACROBID, oral administration, 100 mg, twice a day for 7 days.  On 27-MAR-2009, the patient was treated with BACTRIM DS TABLETS, oral administration, 1 tablet, twice a day for 7 days.  Additional information is not expected.
Complaints of nausea and vomiting and diarrhea for 24 hours following injection.
This spontaneous report was received from a medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. Information about the patients medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (administration routes, lot numbers and expiration dates were not provided). No concomitant therapies were reported. No adverse effect reported. It was unknown if the patients sought medical attention. No product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a medical assistant referring to a 8 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 13-NOV-2018 the patient received an improperly stored dose of VARIVAX (lot # N021721, expiry date: 23-AUG-2010; dose, frequency and route were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 Fahrenheit to 46 Fahrenheit for 8 hours and the data logger was involved. Sender's Comments: US-009507513-1902USA007542: US-009507513-1902USA007540: US-009507513-1902USA007543: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007545: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1902USA007536: US-009507513-1902USA007541: US-009507513-1902USA007548: US-009507513-1902USA007537: US-009507513-1902USA007544: US-009507513-1902USA007550: US-009507513-1901USA008772.
Felt like drugged; not feeling myself; palpitations; Felt like pass out; Pins and needles in arms and feet; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (palpitations), PRESYNCOPE (Felt like pass out), PARAESTHESIA (Pins and needles in arms and feet), EUPHORIC MOOD (Felt like drugged) and FEELING ABNORMAL (not feeling myself) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced PALPITATIONS (palpitations), PRESYNCOPE (Felt like pass out) and PARAESTHESIA (Pins and needles in arms and feet). On 18-Apr-2021, the patient experienced EUPHORIC MOOD (Felt like drugged) and FEELING ABNORMAL (not feeling myself). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PALPITATIONS (palpitations), PRESYNCOPE (Felt like pass out), PARAESTHESIA (Pins and needles in arms and feet), EUPHORIC MOOD (Felt like drugged) and FEELING ABNORMAL (not feeling myself) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that felt like took 10 muscle relaxers and better now but still has some symptoms. No medical history, lab data, are provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up document does not contain any new information
Local react began w/rash (welts) on lt arm next day p/vax; progressed down arm getting worse & itching; came in to hlth dept on 19NOV93 & visited ER that evening w/tightness in chest;
Muscle aches Malaise Joint pain I excepted the above 3 but I started having Bilateral Sciatica pain 10/15/22 the entire posterior side of both legs from buttocks thru feet. Skin on posterior side of legs was hypersensitive to any touch.
Low grade fever; Chills; Muscle ache; Fatigue; Foggy feeling 15 minutes after getting the vaccine; Flushed; Jaw ache; Headache; Sore neck; Right eye pain; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 23Mar2021 14:45 (at the age of 61-year-old) (Lot Number: EP6955; Expiration Date: 30Jun2021) as dose 2, single for COVID-19 immunization. Medical history included type 2 diabetes mellitus from 2018 and ongoing, blood pressure high, vitamin D low, prophylaxis,. Concomitant medication(s) included valsartan taken for hypertension from 2018 and ongoing; hydrochlorothiazide taken for hypertension from 2017 and ongoing; aspirin taken for prophylaxis from 2015 and ongoing; vitamin D nos taken for vitamin d decreased from 2016 and ongoing; calcium carbonate taken for an unspecified indication from 2019 and ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 03Mar2021 (at the age of 61-year-old) (Lot Number: EL3248) as dose 1, single for COVID-19 immunization and experienced upper abdominal swelling, mottling on abdomen and abdomen was kind of lump. The patient did not receive any other vaccines. On 23Mar2021, the patient experienced foggy feeling 15 minutes after getting the vaccine, flushed, jaw ache, headache, sore neck, right eye pain, fatigue and on 24Mar2021, low grade fever, chills, muscle ache. The outcome of headache and fatigue was recovering and the outcome of other events was recovered.  No follow-up attempts are possible. No further information is expected.
Starting 2 weeks after 2nd shot, I got diarrhea, low grade fever, distended stomach with a bulge, swollen right breast and allergies to food I never had before. So far, lobster and salmon. Lobster caused a tightening of the throat. Salmon caused tingling and swollen lips.
injection site redness; Injection site tenderness; Injection site swelling; developed an unspecified "rash" after receiving a dose of PNEUMOVAX 23; This spontaneous report was received from a medical assistant and refers to 94 years old female patient of unknown race. The patient's pertinent medical history, concurrent conditions, historical and concomitant drugs were not reported. The patient's drug allergies included erythromycin.  On 06-JUN-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) intramuscular for immunization lot number S004547 with expiration date on 12-AUG-2020 (dose, strength, frequency and route of administration were not reported).  On 07-JUN-2019, the patient experienced injection site redness, tenderness and swelling and developed an unspecified rash after receiving a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). The patient sought medical attention and treatment was given for the adverse event. No laboratories or studies were performed for the adverse events. At the moment of this report the patient had not recovered from injection site redness, tenderness, swelling and rash.  The relatedness between the events occurrence and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) administration was not reported.
Pt initially received Pfizer EL9263 2/5/21 and today 7/16/21 was given Moderna 034C21A due to vaccine availability at the event and pt status. Pt insisted and verbally gave consent in getting Moderna vaccine today despite given the option to receive same vaccine as first dose in a different clinic and different date/times. VAERS report submitted.
I am starting to miscarry.  12/01/09 ED notes for DOS 11/20/09 and OB visit records for DOS 11/30/09 DX: Vaginal bleeding  Pt presented c/o vaginal bleeding. Pt anxious about the pregnancy.  US: positive heart beats, and HCG confirmed viable fetus.
Itching at injection site; Pain at injection site; Injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Injection site swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 027A21A) for COVID-19 vaccination.     No relevant medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, ATORVASTATIN, VALACYCLOVIR [VALACICLOVIR] and LOSARTAN for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Injection site swollen) outcome was unknown.            Patient took extra strength Tylenol but the pain reoccurred after 2-3 hours. Patient also applied ice to the swollen arm.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-May-2021 contain no new information.
FEVER CHILLS ON ALL THREE DOSES OF COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER CHILLS ON ALL THREE DOSES OF COVID VACCINE) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PYREXIA (FEVER CHILLS ON ALL THREE DOSES OF COVID VACCINE). In 2021, PYREXIA (FEVER CHILLS ON ALL THREE DOSES OF COVID VACCINE) had resolved.            No concomitant medication was reported.   Treatment information was not provided. In 2021, patient received 3rd dose COVID-19 Vaccine manufactured by Moderna, because he was on Skyrizi, he was waiting for a week to pass before taking his next Skyrizi dose. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt vaccinated with DTP/OPV developed temp 101.4 went limp & pale 5 hrs after immunization.  Started 1 hr /p vax.
Upon glancing over at injection, patient reported feeling lightheaded. I went to get him a glass of water and when I got back he was sweating and appeared a little pale and looked unsteady. I got him a granola bar and said he needed to lie down. I went next door to get a nurses help and our technician called 911. He fell off the chair and was lying on his right side when I got back. The nurses took his pulse and checked his blood oxygen level and elevated his feet. EMS arrived a couple minutes later and put him on a stretcher and took patient to the hospital.
Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, these patients were vaccinated with an unspecified number of improperly stored doses of LIQUID PEDVAXHIB (lot # L006546 with expiration 27-NOV-2017: dose, frequency and route were not reported) (incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been unspecified.
It is documented that the patient received 0.3 ml of the vaccine instead of 0.2 ml. I fully believe that the correct dose was given (0.2) and that I did not pull over the correct template and lot number. Patients family was contacted and there were no adverse effects to the patient.
Patient stated that she experienced soreness the day following vaccination, and the area around the left upper arm (deltoid area) became red. Patient stated that she visited her doctor and was told that it was a result of bacteria on the skin infecting the injection site. She presented to the pharmacy with red, swollen skin in affected area, and picked up an antibiotic (doxycycline).
Information has been received from a female consumer who on 29SEP2010 received both PNEUMOVAX (dose unknown) and FLUARIX (dose unknown). It had not been identified which vaccine caused her reaction (reaction not specified) which included a hospital admission. Additional information has been requested.
Very sore and swollen and red the second day. Swelling and soreness improved, but redness stayed. By day 10 or so, it still had not improved and had become itchy. I showed it to my doctor on March 4. She thought it looked like cellulitis. She prescribed an antibiotic and told me to start taking it if the redness got any bigger. (She drew a circle around it with a marker.) It didn't seem to get bigger, so I didn't take the antibiotic. She asked me if I reported this and suggested I do so. Today is March 11 and it's no longer red and hot, but you can see faint discoloration. (Note: The reaction was similar to how I react to bug bites/mosquito bites.)
I have gone through menopause.  And started the worst period I ever had. 6 yrs no menstruation 1 week after shot. I bleed so much I thought I was hemorrhaging.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose recived in October 2018, refer case US2019GSK006344 for 1st dose). Concurrent medical conditions included eczema. In December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site rash, feeling unwell, chest pain and sensitive skin. On an unknown date, the outcome of the injection site pain, injection site rash and feeling unwell were recovered/resolved and the outcome of the chest pain and sensitive skin were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site rash, feeling unwell, chest pain and sensitive skin to be related to SHINGRIX. Additional information was reported as follows: The reporter who is a physician was reporting a case for himself. The patient received SHINGRIX on the left arm. After vaccination, the patient felt sick and the skin on the left side of his chest around the nipple was hypersensitive. The reporter stated that, it felt almost like shingles pain. The contact details of the physician was provided. The reporter consented to follow up.