chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sudden allergy to Sunlight, Polymorphous Light Eruption present on areas of skin exposed to sunlight. No prior history of sensitivity to sunlight. Appeared 24 hours after prolonged exposed to sunlight with sunscreen on. Broke out in red, itchy hives on backs on hands, forearms and back and front of thighs and legs. First appeared a week after first dose administered, went away and the  reappeared after prolonged exposure (90+ minutes) two weeks later. First event treated with steroid cream, second event treated with prednisone
Blotches; Hives on arm; Itches; Arm  sore (right); Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Blotches), URTICARIA (Hives on arm), PRURITUS (Itches), PAIN IN EXTREMITY (Arm  sore (right)) and FATIGUE (Fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOMEFLOXACIN HYDROCHLORIDE (CONTRA [LOMEFLOXACIN HYDROCHLORIDE]) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced PAIN IN EXTREMITY (Arm  sore (right)) and FATIGUE (Fatigue). On 04-May-2021, the patient experienced RASH MACULAR (Blotches), URTICARIA (Hives on arm) and PRURITUS (Itches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash macular, at an unspecified dose and frequency. On 04-May-2021, FATIGUE (Fatigue) had resolved. At the time of the report, RASH MACULAR (Blotches) had not resolved, URTICARIA (Hives on arm) and PRURITUS (Itches) outcome was unknown and PAIN IN EXTREMITY (Arm  sore (right)) had resolved.            Action taken with mRNA-1273 in response to the events was  not applicable.    This case was linked to MOD-2021-182341 (Patient Link).
Moderna COVID-19 Vaccine EUA  Patient aged 17 years, received Moderna COVID-19 Vaccine.  Moderna EAU is for patients 18 years of age and older.
Headaches for the pass three days, loss of appetite, slight fever, chills, slight muscle pain
A non-serious spontaneous report of inadvertently gave FLUMIST into one nostril was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 07-Oct-2011, the patient inadvertently received the entire content of the FLUMIST sprayer unit in one (single) nostril. The patient did not experienced any observable changes. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessment are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
had a severe headache for 2 days; lost his appetite/ loss of appetite; very tired; he slept for 2 days; he still doesn't feel real good; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) reporting for a patient (husband) via medical information team.  An 89-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Caller reports that his husband had no symptoms with the first two doses of the Pfizer Covid-19 vaccine), for COVID-19 immunization, reaction(s): "no symptoms"; Bnt162b2 (Dose 2, Caller reports that his husband had no symptoms with the first two doses of the Pfizer Covid-19 vaccine), for COVID-19 immunization, reaction(s): "no symptoms". The following information was reported: HEADACHE (non-serious) with onset Apr2022, outcome "recovered" (Apr2022), described as "had a severe headache for 2 days"; SLEEP DISORDER (non-serious) with onset Apr2022, outcome "unknown", described as "he slept for 2 days"; MALAISE (non-serious) with onset Apr2022, outcome "unknown", described as "he still doesn't feel real good"; DECREASED APPETITE (non-serious) with onset Apr2022, outcome "unknown", described as "lost his appetite/ loss of appetite"; FATIGUE (non-serious) with onset Apr2022, outcome "unknown", described as "very tired".  Additional information: NDC number and Expiry Date of COVID-19 Vaccines were Not Provided. Other Products were Not Provided. Other Conditions were Not Provided. Investigations were Not Provided. The reporter is a 88 year-old female calling about the booster dose of the Pfizer Covid-19 vaccine. She reported that she and her husband who is 89 years old received booster dose of the Pfizer Covid-19 vaccine last Friday 08Apr2022. She reported that her husband had a severe headache for 2 days and lost his appetite. She reports her husband had no symptoms or side effects with the first 2 doses of the COVID-19 vaccine. She states her husband had a severe headache for 2 days and he still doesn't feel real good. She states her husband has never had any reactions to the previous 2 doses of the COVID-19 vaccine. She states at her and her husband's age she is continuing to be told that she needs a COVID-19 booster and now she is hearing reports that she will need a 4th COVID-19 booster dose. She states if she can be sent a letter to explain why she needs a 4th COVID-19 dose she would be grateful. She states her and her husband have been really faithful with all this and she doesn't understand why this has happened. She states that she has told Pfizer about all there is to know for her husband. She states he gets severe headaches, loss of appetite and very tired. She states he slept for 2 days. The case was reported as non-serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Significant swelling in right shoulder w/pain five or six hours after vaccination. Pt took BENADRYL 25 mg.
Chills and cold legs and feet the night after getting the vaccination on Wed..  Extreme fatigue the following day, Thurs. Marked fatigue for 2 days after the vaccination, Fri. and Sat.  Sore left upper arm for 24 hours.
Mom reported that pt had recvd vax 3MAR92 & lt arm is sore w/moderate redness/swelling & some warmth; applying cold packs & APAP; advised to contact MD;
Patient received the 2nd COVID vaccine (Pfizer, Lot #: EW0187 and expiration date: 08/31/2021) around 1439 on the left arm. Patient walked up to the observation desk around 1449, during her 30 minute observation period, with complaints of "dizziness, rapid heart rate, and feeling hot." Patient was conscious, alert, and oriented x4 and claimed symptoms began 2 minutes status post vaccine administration. Patient denied any reaction after receiving the 1st dose of Pfizer vaccine and denied experiencing any chest pain, headache, nausea, vomiting, or diarrhea. EMTs had patient sit in the anti- gravity chair for further evaluation. Nurse responded to EMTs with patient. At 1455, EMT obtained baseline vital signs, while patient was sitting: blood pressure: 124/70, heart rate: 72, respiratory rate: 15. Pupils were equal, accommodating, and reactive to light. Skins were warm, dry, and normal. Chief complaint of  "dizziness, rapid heart rate, and feeling hot" was reassessed and patient stated that symptoms had subsided. Patient explained that the symptoms had a sudden onset, but lasted less than 1 minute. Patient has a history of migraines and an allergy to Penicillin. Patient stated that she had a similar reaction after receiving a dose of Benadryl, earlier this year. Patient told EMTs that she had eaten toast, tofu, and salad about an hour and a half prior to coming to the vaccination site, with limited fluid intake. EMTs gave the patient a water bottle to sip on. At 1502 a second set of vital signs were obtained by EMT, while the patient was sitting: blood pressure: 116/68, heart rate: 74, respiratory rate: 15. Pupils were equal, accommodating, and reactive to light. Patient was advised to stay an additional 30 minutes in observation for continued evaluation. Patient stated she "felt better" and all symptoms had improved. Final set of vital signs were taken at 1514 by EMT, while patient was standing: blood pressure: 114/64, heart rate: 72, respiratory rate: 12. Pupils were equal, accommodating, and reactive to light. Skins were warm, dry, and normal. Patient was negative for orthostatic pressures. At 1540, patient stated she "felt normal and that all symptoms were gone." Patient had finished the water bottle provided. Patient was then educated on expected/ adverse reactions, when to follow up with her primary care provider, and the use of V- Safe. Patient ambulated with a steady gait on her own accord out of the facility.
Shoulder & upper arm, became black & blue w/inflamation from shoulder to eblow w/pain & burning for a period of 8 days areas is still very discolored;
This case was reported by a physician via call center representative and described the occurrence of shivering in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 23rd May 2018, the patient received the 1st dose of SHINGRIX. On 24th May 2018, 1 days after receiving SHINGRIX, the patient experienced shivering, myalgia, sweating, fever and fatigue. On an unknown date, the outcome of the shivering, myalgia, sweating and fever were recovering/resolving and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the shivering, myalgia, sweating and fever to be related to SHINGRIX. The reporter considered the fatigue to be unrelated to SHINGRIX. Additional details were provided as follows: The reporting physician (who was the patient) reported that, he experienced reactions such as severe shivering, fever, severe fatigue, perspiration and myalgia and the symptoms were subsided as of on 1st June 2018. At the time of reporting the patient still felt "washed out" but did not think that was in relation to the vaccine. He had gotten lab work done in his office. Results were not back at the time of reporting. He did not go to the emergency room (ER) but during work hours his coworkers wanted to call the ambulance but he refused. The healthcare provider (HCP) was not sure to receive the 2nd dose of the SHINGRIX based on these reactions.
Approximately 10-15 mins after vaccine was administered participant came to nurse stating that her throat felt metallic, there was a red mark 2x3 noted to left deltoid. Swelling and difficulty breathing. EPIPEN administered to Lt. deltoid, 911 called, participant taken to local ER due to inability to sit up. She was given BENADRYL and discharge 2 hrs later.
beginning 14FEB97 day p/3rd vax pt dizzy, eye sight blurry, felt hot;lasted about 1 day-vertigo cont sporadically;
This spontaneous report as received from medical assistant refers to a patient of unknown demographics. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medication were not reported. On 26-MAR-2018 the patient was concomitantly vaccinated with PROQUAD (lot # N021728, expiry date: 06-FEB-2019) and VARIVAX (lot # M035142, expiry date: 03-AUG-2018) (dose and frequency were not reported) subcutaneously for prophylaxis. No adverse effects reported. No product quality complaint involved. Albumin status for PROQUAD is recombinant human albumin (rHA). This is one of several reports received from the same reporter.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever, headache, malaise and general body pain. On an unknown date, the outcome of the fever, headache, malaise and general body pain were unknown. It was unknown if the reporter considered the fever, headache, malaise and general body pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported via chat. The health care professional reported this case for herself. The patient experienced fever, body ache, headache, and malaise after receiving SHINGRIX vaccine. The HCP did not have vaccine information.
This spontaneous report as received from a medical assistant refers to a 19 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 27-JUN-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Patient returns on 2/02/10 after having Pneumococcal immunization on 2/08/10. Right upper arm down to elbow is light red with slight edema. Patient reports that R upper arm is tender. Pt called home clinic and he received a pneumococcal immunization 8/09. Pt did not remember.
Pfizer-BioNTech COVOD-19 Vacine EUA was received January 15, 2021 in the left arm muscle.  The next day an itchy rash appeared on the forearms.  The entire next week the rash continued to increase and appear on the body trunk as well as legs and arms.  We used hydrocodone 10 applied to the rash and used Benadryl 25 mg  orally.  We saw our Primary Care physician, who diagnosed the allergy to the vaccine.  He advised not taking the second dose.  After 10 days, the itchiness is subsiding as well as redness and bumps.
Fever 103-106, 7 days /p injection, coughing, rhinitis, no rash
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 30-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 01-Jan-2012. On 07-Jan-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
I still have COVID-19 symptoms. Like the cough, achy, fatigue. The symptoms are not as bad as the first day. These have been the same symptoms from the start but are improving. I started Paxlovid on tuesday and not finished with it yet.
Information has been received from a physician concerning a 4 year old male who on 28-APR-2003 was vaccinated with a 0.5 ml SC dose of Varivax. On 09-FEB-2006 the patient experienced breakthrough varicella. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Information has been received from a registered nurse concerning a 14 year old female who was vaccinated with GARDASIL vaccine (yeast) 0.5ml IM. Concomitant therapy included hormonal contraceptives (unspecified). The patient developed dizziness since vaccination. The patient had completed the series (dates of vaccination not known at this time). It was not clear at what point in the series that the dizziness began, "but it has been a while". The patient sought medical attention in office. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2008.
Diarrhea- greenish slimy, foul oder- began on Saturday.  Diarrhea has continued for 10 days.  Families pediatrician Dr. ordered stool cultures which have come back negative for Rotavirus.  Dr. is now ordering further stool cultures.  RN advised familiy to contact their Gastroenterologist.  Mother states that doctors currently have patient on oatmeal, soy formula, and apple sauce.
Got Covid vaccine and since so I have insomnia. I asked my friends who had in the same time frame, they all gave the same symptoms. The vaccine is affecting the CNS. My thinking is not clear.
NOT AN ADVERSE EVENT. ERROR MADE BY GIVING PATIENT MODERNA THAT WAS BEYOND USE DATE BY 2 DAYS. CALLED MODERNA TO FOLLOW UP AND IF PT WILL NEED TO BE RE-VACCINATED. PT ISSUE  OR CONCERN FROM THE PATIENT AT THIS TIME. MODERNA WAS KEEP IN THE APPROPRIATE TEMPERATURE
12/21/2020- 1 called with increased BP 12 hours after vaccination. Was seen by MD and went to ER. Med for BP increased and modified until stable.
Five days after receiving the guardisil shot in her left arm she awoke with a painful lump above her left clavicle.  Ten days after the lump, she saw the doctor who ran strep and mono quick tests, both were negative.  The doctor ordered E.B.titers, CBC and sed rate.  All tests results were normal. On 9-3-09 she was back in the Doctor's office with low grade fever. Doctor thought it might be sinus infection and gave her Azithromycin.  The lump did not go away during the course of treatment with antibiotics it just became less tender.  On 9-16-09 the tenderness of the lump has increased again. The size of the lump remains the same to date. We do not know if the lump formed immediately after her shot or if the level of pain on the 5th day led her to find the lump.  9/22/09 Received PCP medical records.  Visit on 8/27/09 w/neck stiffness, swelling & tenderness & left supraclavicular node x 10 days; HA & vomiting x 2 days.  Also noted pimple of left cheek that enlarged & burst spontaneously then scabbed over.  Dx w/Torticollis left side & cervical adenitis.  All labs neg.  RTC 9/3 w/cold s/s, red throat, nasal congestion & backache.  Tx w/oral antibiotics.  No further medical records available.
on 17JUL97 pt was splashed in the eye w/diluted varicella vaccine;initially pt exp burning & irritation of the eye;eye was washed thoroughly w/tap water;pt recovered from exp;
patient received the 1st dose on 21Feb2021 and the 2nd dose on 22Feb2021 at different facilities and provided 2 different cards/Doses given too close together; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received the 1st dose on 21Feb2021 and the 2nd dose on 22Feb2021 at different facilities and provided 2 different cards/Doses given too close together) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Developmental delay since 31-May-1978.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021 at 2:54 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received the 1st dose on 21Feb2021 and the 2nd dose on 22Feb2021 at different facilities and provided 2 different cards/Doses given too close together). On 22-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received the 1st dose on 21Feb2021 and the 2nd dose on 22Feb2021 at different facilities and provided 2 different cards/Doses given too close together) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Third dose of vaccination was not given to the patient.   This case was linked to MOD21-065252 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up document was received. Patient's race, ethnicity, relevant medical history, vaccine route of administration, anatomical location, event start and stop date were added. It contains significant information. On 02-Jul-2021: Follow-up document was received. Vaccine route of administration and anatomical location were updated. No severe reaction was reported to either dose of the vaccine. It contains significant information.
Case fully vaccinated with Pfizer vaccine. Last dose on 3/2/2021. Case tested positive for COVID on 9/7/21. Was admitted to hospital on 9/21/2021 and expired on 9/24/2021 while still hospitalized.
Narrative: COVID infection following COVID vaccine series 02/16, Pfizer, dose #1 03/09, Pfizer, dose #2 08/05 pt cc: fatigue, myalgias, rhinorrhea exposure: unknown 08/06 - 08/13 pt symptoms continue 08/11 COVID swab, result: detected 08/11 SARS-COV-2 LINEAGE B.1.617.2 08/11 SARS-COV-2 CLADE 21A DELTA
Nausea; chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NAUSEA (Nausea) and CHILLS (chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Dehydration, Pneumonia, Chest pain and Swelling of legs in December 2020. Concurrent medical conditions included Clot blood and Pericardial effusion since December 2020.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 10-Mar-2021, the patient experienced NAUSEA (Nausea) and CHILLS (chills). On 12-Mar-2021, NAUSEA (Nausea) and CHILLS (chills) had resolved. On 13-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.