chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness continued weeks and months after the high dose flu vaccine was received on the left hand below shoulder. Pain continues and has spread around the muscles in the area. Reported to my doctor during physical on February 14, 2018. He did not have any explanation for the muscle pain.
a recent titer test showed that it was low; This spontaneous report has been received from a pharmacist and refers to a 56-year-old male patient. The patient's medical history, current conditions, concomitant therapies, and previous drugs reactions or allergies were not reported.  On an unknown date (reported as: "when the patient was a baby"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection or measles, mumps, and rubella (MANUFACTURER UNKNOWN), administered for prophylaxis (strength, dose, vaccination scheme, lot #, expiry date, and route of administration were not provided).  On an unknown date, recent titer test showed that it was low (viral titre decreased).   The outcome of the event, and the causality assessment between the viral titre decreased  and the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection or measles, mumps, and rubella (MANUFACTURER UNKNOWN) were not provided
Fever, fatigue, brain fog, vomiting, hives, stomach upset, headache, body aches, inflammation, severe fatigue. Hives, fatigue and inflammation are now ongoing.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age. On multiple unknown dates the patients were vaccinated with improperly stored ROTATEQ, following a temperature excursion (48 hours at 0 Celsius degree) that occurred in February 2015. A digital data logger (DDL) was used to track the temperature. No previous temperature excursion occurred. No adverse effects were reported. Additional information has been requested. This is one of several reports received from the same source.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 06-MAR-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J006953, expiration date: 07-JUN-2015. that may had been improperly stored since February2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be   confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported.  This is one of several reports received from the same reporter. Additional information has been requested.
G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 5/2/2023 CONFUSION G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 5/2/2023 DELIRIUM
This spontaneous report was received from a health care professional refer to ten unspecified patients of demographics. On an unknown date in 2015 (reported as since 06-MAY-2015) the patient was vaccinated with (Oka/Merck) VARIVAX (dose, route and lot # unspecified). No concomitant medications were reported. The nurse called on 20-JUL-2015, and reported that ten unspecified patients doses of an improperly stored (Oka/Merck) VARIVAX on unspecified dates since 06-MAY-2015. No adverse effect reported. No further information was provided. The outcome of incorrect product storage was unknown. Additional information has been requested.
NO adverse symptoms at this time on day of reporting But Patient received 2 identical flu vaccines instead of one dose.
she was told it was shingles; Rash scattered over her body; This case was reported by a physician via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2022, the patient received the 2nd dose of Shingrix. In July 2022, 1 week after receiving Shingrix, the patient experienced shingles and generalized rash. On an unknown date, the outcome of the shingles and generalized rash were unknown.   It was unknown if the reporter considered the shingles and generalized rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-Aug-2022 Reporter's Comments: The physician reported that the patient had dose of Shingrix.  Over a week later she started with a rash that was scattered over her body, she told it was Shingles and a side effect of the vaccine. The follow-up could not be possible as no contact details were available.
Swelling, pain, erythema in (whole upper right) arm of injections. Symptoms started within 24hrs. At 4 days starting to improve.
patient states injection site was puffy and warm the morning after immunization, then became red later on in the day.  by about 5pm patient reported redness had extended down her left arm close to the elbow with a red line around it. patient states she felt a little lightheaded and that injection site was painful.
Red and warm left forearm, itching somewhat after second dose. Big round area where shot was given for a few days after.
Vaccine administered 09/01/09;  On 09/07/09 pt. noticed red patches on hands + thighs which felt itchy + "tight", pt seen 09/10/09.
patient got flu shot at approximately 6PM. went home and ate dinner. around 11PM she started feeling nauseous, like she had gas or indigestion so she took 2 tums. around 1AM she felt extremely ill and vomited and at 3AM she vomited the rest of the contents of her stomach and felt very ill. she took her temperature but did not have a fever. she was able to eat lunch the following day and felt better. unsure if it was result of vaccine or what she ate but her husband ate the same dinner with no issues. no injection site pain, redness, or swelling. reviewed package insert, N/V listed as side effect for 9.7 and 2.6 (n=663) respectively. pt called following day to report. called back patient at approximately 7:40PM, she was feeling better and requested no further follow up
AFib; has no appetite; all he wanted to do was sleep; felt like he was getting the flu; felt faint; lethargy; This is a spontaneous report from a contactable consumer.  A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955 or GP6955), via an unspecified route of administration on 24Apr2021 as single dose for covid-19 immunization.  Medical history included atrial fibrillation from an unknown date for 20 years. Concomitant medication included warfarin (MANUFACTURER UNKNOWN), taken for an unspecified indication, start and stop date were not reported. No prior vaccinations within 4 weeks were noted. The patient experienced AFib on an unspecified date with outcome of unknown; felt faint on 25Apr2021 with outcome of recovered on 25Apr2021 (elaborated as felt faint when his head was down by his knees, in which he had to quickly jerk himself up and go sit down), lethargy on 25Apr2021 with outcome of recovering (elaborated as lethargy/he was so lethargic, he could hardly keep his eyes open);  has no appetite on an unspecified date with outcome of not recovered; all he wanted to do was sleep (elaborated as that he laid down and his eyes were so heavy in which all he wanted to do was sleep) on an unspecified date with outcome of unknown; felt like he was getting the flu on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included body height: 180  (180 cm /5'11"), weight: 72.57 kg (160 lbs) on an unspecified date.   Details were as follows: Details were as follows: patient got his first COVID-19 vaccine shot on 24Apr2021. He said he was fine on Saturday. He said on 25Apr2021, he was so lethargic, he could hardly keep his eyes open. He said he got faint, and had to lay down. He said on Sunday, he thought the lethargy and faintness were a side effect of the COVID-19 vaccine, but the lethargy was continuing through to 29Apr2021. He said he also had no appetite, saying his appetite was waning. He said he did not feel like eating anything on 29Apr2021.  No emergency room or physician office visit was required.  He had AFIB, and that was why he had to worry about blood clots, and the reason he took Warfarin. Lethargic treatment was declined. The lethargy had improved some. He first felt faint around 10:00 an on Sunday.  Faint Treatment included cat naps during the day on Sunday, and didn't move around much. The patient noted that the faint feeling was better by Sunday night.  Reported for the last year his appetite had not been good, but he made it a habit to eat every day as a matter of his health. He said he kept asking himself what was he going to eat, and he said nothing appealed to him; he declined appetite suppressed treatment, but had taken Centrum every day for 10 years to supplement his diet, no further details provided.
Arm sore at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11May2021 at 15:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported.  On 12May2021 the patient experienced arm sore at the injection site. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if any therapeutic measures were taken as a result of the event. The clinical outcome of the event arm sore at the injection site was recovered with sequelae on 12May2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
4-6 hrs. after administration of vaccine, pt. states she had bodyaches, clammy feeling, felt light headed, denies "passing out".  Condition got worse, she was eventually taken to an urgent care on 10/19/08.  While in UC, she claims she passed out, she was then transported to an ER via 911. 10/23/08-records received with report-presented to ED 10/19/08 with C/O weakness, nausea, body ache, headache since day after flu shot. Crying.Observed in ED no fevers or chills. Depressed recently and now ready to go home.  DX: Headache resolved. Depression.
Bell's palsy symptoms, right eye pain - went to ER 4/11/15 prescriptions given for prednisone po and REFRESH LACRI-LUBE ointment - follow up with primary MD - 4/13/15 who continued prednisone.
pt recv vax;devel erythema,induration,warmth & pain at inject site on lt arm;rxn spread distally to elbow & proximal forearm accompanied by fever,chills,fatigue;"serum sickness type of rxn";almost resolved but pruritic over area involved;
Right arm red, swollen, hot to the touch. Child taken to physician who diagnosed cellulitis. Mother reported that area was 10 inches by 9 inches in size. Patient put on an antibiotic and a steroid medication.
1st Dose Moderna COVID-19 Vaccine EUA reaction started  a few days after receiving the vaccination. She got vaccine on 3/6/21 and symptoms started on 3/10/21. She reported her arm was red, swollen and felt warm; no itching or pain. These symtpoms lasted on into the next day 3/11/21. We called patient to check up on her, a few days later, and am was better - almost all symptoms were gone.  On Saturday 3/20/21 she started experiencing a second reaction with the 1st dose. Only slightly red this time, no swelling, no warmth. We checked on her Monday the 22nd, symptoms were almost gone.
One week after the shot, I developed a red, slightly swollen area around 2 inches in diameter at the injection site (left shoulder).  My shoulder itched greatly for about a day.  The redness went away in about a day and the itchiness subsided over the next 2-3 days. I continued to feel strange sensations in my shoulder and arm for several days.
55 yr old male with pmh of dm and hiv diagnosed a year ago for last 2 days. presented to er c/o multiple episodes of vomiting . pt tested positive for covid 19 pneumonia i er . he has had cough but no congestion / body aches or abd pain or diarrhea . pt received his second moderna vaccine 2 weeks ago .
Anaphylactic reaction, lips and tongue numb, face swelling, SOB, nausea, diaphoresis,double vision, weakness; all within 15 munutes..  Taken to urgent care at same site as vavcine.  Given epi-pen, IV benadryl, put on oxygen.  Predisone 50 mg qd X 2 days, oral benadryl 50 mg q 6 hrs X 48 hours.
Migraine, fever, night sweats, chills, fatigue,   Lasted 2 days.
Severe dry cough with bloody taste. Heavy wheezing. Mucus embolism. Condition manifested a week after the vaccination.  Misdiagnosed as allergy, asthma, etc.  Unsuccessfully treated with two types of H1 histamine blockers(2weeks), NSAID (2weeks) and steroids (1 week). Persisted for 10 months. Treatment with Guaifenesin for 2 months resolved the issue.
I was fine til about 2am when I was faint and light headed with flu-like symptoms, stuffy nose, body aches + terrible migraine headache. Was so sick that I was unable to find my migraine meds (prescribed by doctor). Have history of migraines but haven't had one in several month...I was dizzy and worried about thowing up and fainting. Note: usually never recieve the flu shot but not during 2020.
Patient was  put on the schedule for a flu vaccine when she was really supposed to be getting a Tdap. She had already received her flu vaccine about 2 weeks ago.  Patient has an autoimmune disorder which she was concerned about and questioned if it was ok to get 2 flu vaccines and still get her Tdap. Dr. spoke with patient and patient decided to go ahead with the Tdap vaccine during the same office visit. Assistant Nursing Supervisor has been in contact with the patient since the vaccines were given and patient states she is doing fine and has been in touch with her physician with everything being ok.
DIARRHEA THAT STARTED THE NEXT MORNING.  MOM REPORTED PATIENT HAD 12 EPISODES. SHE DID NOT TAKE HIM TO THE ER. STATED THAT THE DIARRHEA HAS STOPPED AND HE  HAS RESUMED A NORMAL DIET.
Her arm got swollen about 3 inches and red. She went to the walkin clinic next day and got diagnosed with cellulitis and got put on Keflex and Percocet.
Recieved an influenza shot 20 min later started itching with hives. Chest felt heavy.
About 5 hours after the shot on March 23, 2021 I started having chills.  I then woke up around 3am on March 24, 2021 feeling nauseous and very very tired. I then feel back asleep around 9:00 a.m. on March 24th and slept until around 4pm that day. I still felt kinda out of it, but I was much better by the morning of March 25th.  i took tylenol and drank plenty of water.
VAccination site itchiness; Rash; Vaccination site swelling; VAccination site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (VAccination site itchiness), RASH (Rash), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (VAccination site redness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (VAccination site itchiness), RASH (Rash), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (VAccination site redness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) ongoing since an unknown date at an unspecified dose and frequency and HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (VAccination site itchiness), RASH (Rash), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (VAccination site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter. Treatment included ice pack.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: No specific follow-up information recorded.
NauseaVomiting Injection Site Soreness, Nausea x3 days Narrative:  Other Relevant History:
I am a female healthcare worker who is reporting a miscarriage at approx. 6 weeks + 4 days; for data acquisition of a female who became pregnant within 6 months of receiving an mRNA vaccine with which there is limited data surrounding pregnancy and birth defects. I am otherwise healthy with 1 previous pregnancy and 1 healthy full term child born pre-pandemic in 2019.
Patient had Moderna vaccine 2/25/21. On 2/26/21 she had some head pain then facial numbness near L eye that then radiated down L side of face, had L side facial drooping which has improved. Still having a tingling sensation in entire mouth. Patient also reports lower tooth pain in L side of mouth on 2/26 that subsided approx. 2 days later. Patient says head pain was not like usual migraine pain.
4/9/2007, Neck glands on both sides - swollen and hard. resolved by 4/15/2007. 4/10/2007 - Rash started and progressed (face , shoulders, abdomen, Arms and back) resolved by 4/13/2007. * (hydrocortisone) cream for itching.
Reporting as employee health: Staff member reported that she had miscarried as of  2/16/21
First extreme pain radiating down arm. Pain continued for four days. On April 22 a serious rash began to develop. On April 25 I called pharmacy. Pharmacist told me to come in. He examined rash; said if it extended perimeters of his markings, I should see primary care doc. It did!! Contracted PC doc. He said send photo. I did. He said it looked like adverse reaction to shot. Suggested intake loratidine. Watch spread of rash.
pt reports a Ulcerative Colitis flare that began around 1/27, after pt had pfizer covid vaccine on 1/22 at Hospital.  flare has stabilized by treating with lomotil and bentyl.  pfizer covid vaccine lot EL3249, exp 5/21
Acute onset severe h/a trembling, temp 97.5, BP 154/104, p-80 transferred to urgent care ctr for cont further tx.
PT WAS ACCIDENTALLY GIVEN  PFIZER BIVALENT COVID VACCINE FOR 12YRS & UP 0.3ML  INSTEAD OF THE PFIZER BIVALENT COVID VACCINE FOR 5YR TO 11YR 0.2ML. PT WAS OBSERVED IN CLINIC. HAD NO ADVERSE REACTION.  LEFT HOME AFTER OBSERVATION
Vaccine went under temperature excursion; No adverse event; Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion).    No concomitant medications were reported. It was unknown if the patient receives any other vaccines in the 4 weeks prior to COVID-19 vaccine. Due to Lost power the in the middle of the day at 12:00 PM, had to place all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. No reported symptoms. No treatment information was provided.  This case contains information for the 10th of 26th adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:(Patient 1)
Mother of patient reported severe tiredness for at least 40 hours.  Patient returned to normal activity level after the 40 hours.
shingles in private parts; Very itchy; received the Shingrix vaccine as she was healing from a previous case of shingles on her left hip; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (The patient was healing from a previous case of shingles on her left hip.).   In June 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2022, unknown after receiving Shingrix, the patient experienced off label use. On 7th October 2022, the patient experienced shingles and pruritus. On an unknown date, the outcome of the shingles and pruritus were not recovered/not resolved and the outcome of the off label use was unknown.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comment: The reporter stated that the patient received her first Shingrix vaccine in June 2022, in the left arm.   The patient recieved Shingrix vaccine as she was healing from a previous case of shingles on her left hip.   The reporter stated couple weeks ago she experienced another out break of shingles. The reporter stated the shingles was in her private parts and very itchy. The reporter also mentioned when case of shingles was healed to get the second Shingrix vaccine by December 2022 to benefit from the 90% coverage. The reporter did not give consent to follow-up. Additional Supportive Information: The patient received the Shingrix vaccine as she was healing from a previous case of shingles on her left hip which lead to off label use. As per source document time to onset for Shingles and Pruritus were 4months was captured.