chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Aproximately 1-2 minutes after receiving the Flu Vaccine Patient stated not feeling well. Assisted promptly in lying down. BP drastically dropped,( non audible) patient looked very pale and diaphoretic. Lost conciousness for at least 10- 15 second. Administered Epinephrine 0.3 mg IM. Patient responded well. BP went up to 100/60. Patient able to communicate with his wife about incident. Left to East side medical ER walking accompagned by EMT staff. FU later , patient declined going to ER as stated by wife he is doing fine but kind of shaky. Called again this AM . According to wife patient is doing fine
11pm woke up from severe heart palpitations. 120 heart rate for 5 hours. Also chills and shakes.
Report received from a physician (who is also the patient) on 24-SEP-2010 (received via Merck WAES: 1009USA04907). A male patient received one dose of influenza vaccine (brand unknown, batch number & expiry date: unspecified, route of administration: not specified) on 20-SEP-2010. The patient's medical history and concomitant medications was not provided. On 21-SEP-2010, the evening after vaccination with the suspect drug, the patient developed a fever, chills and night time sweating. The patient was treated with TYLENOL and felt better during the day. The event lasted until the morning of 23-SEP-2010. The patient sought medical attention - the patient is a physician. The patient's outcome was recovered on 23-SEP-2010. No further information is available. The case was reported as serious due to intervention to prevent serious criteria. The reporter did not provide a causality assessment in relation to the suspect drug. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.
I had a sinus infection and broncitis and I started develop a strong headache. As the day went by the headache was not going away. The top of my nose on the bridge felt tingling and numb. Overall, the symptoms were not bad however the headaches persisted months after, and still do not go away. They move around where they are located as well, sometimes they are behind the eyes, other times they are more to the side. I have always been healthy until the vaccine, and it might have nothing to do with the vaccine but I am not sure. These headaches are an oddity to me.
A few hours after receiving the Covid 19 bivalent booster and addition to the Flu shot (which was administered into my right arm at the same pharmacy visit) I experienced pain I my right ear and lower jaw. The muscles of my jaw were sore and it was painful to chew on that side of my mouth for a few days and the ear on that side was painful for the first couple of days after the shots and remained tender and sensitive for about 4/5 days. There was no adverse effect on my hearing on that side but I could not chew or bite down on that side of my mouth without pain or sensitivity for almost a week. I am finally to the point where the ear and jaw on the right side of my face feel as though they are back to normal.
This case was reported by a nurse and described the occurrence of elevated liver enzymes in a 54-year-old male subject who was vaccinated with Havrix, for prophylaxis. Medical history included non-smoker and non-drinker. On 26 May 2005, the subject received the 1st dose of Havrix (lot AHAVB043BA). On 26 May 2005, the subject was also vaccinated with Typhim VI, (lot Y0794) and YF-Vax (lot UE498AA). On 28 December 2005, the subject received the 2nd dose of Havrix (lot AHAVB066AB). On an unspecified date in January 2006, less than one month after the 2nd dose of Havrix, the subject experienced elevated liver enzymes. The elevated liver enzymes resolved on an unspecified date after 08 February 2006 and before 24 February 2006. The nurse considered the event to be related to vaccination with Havrix. Comment: Elevated liver enzymes was assessed as medically serious.
presents in the facility with complaints worsening dyspnea.  States patient has not been feeling good for the past 5 days with onset of dyspnea on exertion about 2 days ago.  He reports that last night, he experiences chest tightness and orthopnea while lying in bed with chills and generalized weakness,
No adverse effects reported.; 15-month-old patient was administered GARDASIL 9; This spontaneous report has been received from a physician referring to a 15 months old patient of unknown gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 11-NOV-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # reported as 161498 but upon internal validation established as 1614898, expiration date: 15-NOV-2021; frequency, route and dose details were unknown) for prophylaxis (product administered to patient of inappropriate age). No adverse effects reported.
Pt developed a rash, located on trunk, thighs and waist. No hives. Complained of a sore throat, no respiratory distress instructed to take over-the-counter Benadryl. Follow-up scheduled for 7/30/01.
mild congestion, body aches, chills 100.6 fever headache  (resolved about 27 hours after vaccine. Rash; red, blotchy rash, raised in areas, on breasts and  rib cage- day 2,3 fading on day 4
Received COVID vaccination on 01/06/2021 at 8:00 at the COVID vaccinations clinic.  About 2:20pm employee states that  Left arm started aching.  Around midnight, employee states that right elbow began to ache as noticed redness and swelling approximately 2-3 inches below injection site.  States swelling and redness increased over the course of two days.  Friday, the swelling and redness began to improve.
developed a painful rash on her leg after vaccination.  Lab work was done to test for Shingles and that was negative.  She received Acyclovir.  Similar rash developed on genitals 9/4/2021..  Has been in a monogamous marriage the whole time.  No new partners.  Lab work confirmed herpes-Quest lab.  This is a recurrent permanent skin condition due to a virus.
She received her flu vaccination on 10/04/18 approx. at 1300.  She called Employee Health on 10/05/18 stating she is sick, 'I've taken Ibuprofen all night long, I hurt so bad.'  She was reminded of the s/s listed on her VIS.
tested positive on binax rapid antigent test 1/6/2022, asymptomatic
He is autistic; My youngest had a seizure after his first MMR; This spontaneous report was received from the patient's mother referring to a male patient of unknown age. The patient's concurrent conditions, concomitant medications, and medical history were not provided.  On an unknown date, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route of administration, lot# and expiration date were not provided) for prophylaxis.       On an unknown date, the patient had a seizure after his first measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). He was autistic.  The outcome of the events was unknown. The causality between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.  Upon internal review, seizure and autism were determined to be medically significant.
Red bumps started appear over my body midday of the second day (Got the shot Monday, bumps appeared Tuesday). Now Wednesday I am covered, and they are starting to burn when touched. Not too itchy.
Information has been received from a consumer concerning her 6 year old daughter who on 20-DEC-1999 was vaccinated SQ with a 0.5 mL dose of Varivax. Five years ago, in August 2001, the patient developed a case of the shingles. On 09-AUG-2006, a second outbreak of the shingles appeared in the same spot. The consumer's daughter did not have an outbreak of chicken pox. The patient's outcome was not reported. Additional information is not expected.
Had a breakthrough case of Covid-19 on 23AUG2021; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had a breakthrough case of Covid-19 on 23AUG2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 01120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced COVID-19 (Had a breakthrough case of Covid-19 on 23AUG2021) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Had a breakthrough case of Covid-19 on 23AUG2021) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.        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. Company comment:This case concerns a 70-year-old, female patient with medical history of immunocompromise, who experienced the unexpected serious adverse event of special interest of COVID-19. Drug ineffective was considered an additional event. The events occurred approximately 159 days after the second dose of Moderna COVID-19 vaccine. The medical history of immunocompromise remain a confounder for drug ineffective. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-378929 (Patient Link).; Sender's Comments: This case concerns a 70-year-old, female patient with medical history of immunocompromise, who experienced the unexpected serious adverse event of special interest of COVID-19. Drug ineffective was considered an additional event. The events occurred approximately 159 days after the second dose of Moderna COVID-19 vaccine. The medical history of immunocompromise remain a confounder for drug ineffective. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Three days after I received the Covid vaccination I began symptoms of Shingles. I ended up having Shingles on the left side of my face.
Numbness, tingling and severe muscle cramping in left upper arm, trapezious muscles and neck.
This was my booster.  After midnight that night my sides of my neck started to swell from my neck to the bottom of my ear.  The left side was much more swollen than the right side.  My left ear hurt like an earache.  I could not lie down on the left side due to pain.  I took ibuprofen and administered ice to the left side of my neck.  By morning the swelling had gone down although my ear still hurt  and I was uncomfortable while eating  as it still felt a little swollen when swallowing.   Around 2:00 p.m. on the same day my left side started to swell up again.  I felt a lot of pain and could not chew anything solid.  I took ibuprofen again and applied ice and swelling went back down.
Migraine; Vomiting; Shingles/7 to 8 days after her second shot, she had her first shingles episode.; Covid arm develop in lower arm; This case was initially received via Regulatory Agency (Reference number: US-irms-MOD21-127520 ) on 08-Apr-2021. The most recent information was received on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), HERPES ZOSTER (Shingles/7 to 8 days after her second shot, she had her first shingles episode.), VACCINATION COMPLICATION (Covid arm develop in lower arm) and VOMITING (Vomiting) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A71A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (took medication though she was not taking it at that time because she' was waiting to feel better.).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION COMPLICATION (Covid arm develop in lower arm). On 30-Mar-2021, the patient experienced HERPES ZOSTER (Shingles/7 to 8 days after her second shot, she had her first shingles episode.). On an unknown date, the patient experienced MIGRAINE (Migraine) and VOMITING (Vomiting). In April 2021, VACCINATION COMPLICATION (Covid arm develop in lower arm) had resolved. At the time of the report, MIGRAINE (Migraine) and VOMITING (Vomiting) outcome was unknown and HERPES ZOSTER (Shingles/7 to 8 days after her last shot, she had her last shingles episode.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug details not provided.  Treatment details not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Added patient details, medical history and event details.
pallor of skin, weakness, dizziness, diaphoresis, hypotension, BP 80/0 150PM, BP 120/70 155PM; had pt flat w/legs elevated;gave 02;BP 134/84;emesis x 1;
1 of 4 linked same reporter cases (other related cases: 1210USA012785, 1210USA013663 and 1210USA013665). This spontaneous report as received from a pharmacist refers to unspecified number of patients who on unknown dates were vaccinated with RECOMBIVAX HB. The patients might have been vaccinated with improperly stored of RECOMBIVAX HB but did not have any other information. No adverse effects reported at that time. The outcome of the event was unknown. Additional information is not expected.
LEFT SHOULDER PAIN; FELT TIRED; PAIN IN BOTH OF LEGS AND CALF; PAIN AT INJECTION SITE; BRUISE ON HIP; FELL OVER A BOX; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included shoulder surgery, and concurrent conditions included type ii diabetes, lupus, and cholesterol issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bruise on hip. On APR-2021, the subject experienced fell over a box. On 05-APR-2021, the subject experienced pain in both of legs and calf. On 05-APR-2021, the subject experienced pain at injection site. On 06-APR-2021, the subject experienced left shoulder pain. On 06-APR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on 06-APR-2021, and felt tired on 07-APR-2021, had not recovered from left shoulder pain, pain in both of legs and calf, and bruise on hip, and the outcome of fell over a box was not reported. This report was non-serious.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 15Sep2021 (Lot number: EW0183) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: THERMAL BURN (non-serious) with onset 15Sep2021, outcome "unknown", described as "Became like I got burnt right there"; SKIN EXFOLIATION (non-serious) with onset 15Sep2021, outcome "unknown", described as "my skin peeled/ My skin to be peeling right there besides the shot/ my whole skin came up with the Band-Aid"; BURNS SECOND DEGREE (non-serious) with onset 15Sep2021, outcome "unknown", described as "and then I got a blister right there"; BURNING SENSATION (non-serious) with onset 15Sep2021, outcome "unknown", described as "Band-Aid was lifting up with my skin and it burned"; SCAR (non-serious) with onset 15Sep2021, outcome "unknown", described as "I developed a burn mark". Therapeutic measures were not taken as a result of thermal burn, skin exfoliation, burns second degree, burning sensation, scar. Additional information: When probed if consumer had any vaccination 4 weeks prior to COVID 19 Vaccine, Consumer stated, "No." She stated, "she was calling because she was told to let you all know that she did take the vaccination shot, the first shot Pfizer and she developed (incomplete sentence). She said she did take the shot 2 days ago and she took the shot, they put a Band-Aid on and then she developed a burn mark, it became like she got burnt right there, skin peeled and then she got a blister right there. And know she was not allergic to the Band-Aid. she have worn but she was 53 years old. She have always worn Band-Aids. And there was no other reason for her skin to be peeling right there besides the shot." She stated, "2 days ago (15Sep2021). When she got the shot, later on that day she got ready to take the Band-Aid off and that's when she noticed the Band-Aid was lifting up with her skin and it burned, whole skin came up with the Band-Aid. She did not have any marks over there." There was the date when she was supposed to get the second one." Scheduled date for the second shot: Consumer stated, "06Oct2021." Follow-up attempts are completed. No further information is expected.
Extreme fatigue, pt. hurt all over, required bed rest x24 hrs; injection site warm & tender, pt did not come to clinic.
Warm injection site, fever, swollen lymph node on same side as injection near collar bone.
She has controlled hypertension, after receiving the vaccine she said that her blood pressure was high and out of control for 2 weeks. She even visited her doctor's office because she felt so horrible. She has had controlled HTN for a long time.
red rash; dizzy; 100.2 F temperature; fatigued; chills; soreness in the arm; COVID like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), COVID-19 (COVID like symptoms), RASH ERYTHEMATOUS (red rash), DIZZINESS (dizzy) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm), COVID-19 (COVID like symptoms) and CHILLS (chills). On 20-Feb-2021, the patient experienced DIZZINESS (dizzy). 20-Feb-2021, the patient experienced PYREXIA (100.2 F temperature) and FATIGUE (fatigued). On an unknown date, the patient experienced RASH ERYTHEMATOUS (red rash). On 20-Feb-2021, DIZZINESS (dizzy) and CHILLS (chills) had resolved. On 21-Feb-2021, COVID-19 (COVID like symptoms), PYREXIA (100.2 F temperature) and FATIGUE (fatigued) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in the arm) and RASH ERYTHEMATOUS (red rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: 100.2f (Inconclusive) 100.2F.         no concomitants were provided. no treatment medication were provided.   This case was linked to MOD-2021-224883 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: followup has done on 16-jun-2021 and unknown date patient administered second dose. event  were updated  that rash on her arm
Headache, NauseaVomiting, chills, fatigue Narrative:  Other Relevant History:
Episodes of apparent cyanosis began hours after vaccines given. (Lips turn blue). Presented to the ER day after vaccines. Admitted x 3 days witnessed event: not cyanosis. Just physiologic vasodilation.
Case number PHEH2015US000681, is an initial spontaneous report received from a pharmacist on 05 Jan 2015. This report refers to a 62 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 24 Oct 2014. It was reported that the patient received FLUVIRIN which reached temperature below 36 degree F for 3.5 non-consecutive days and 33.1 degree F for less than 12 hours. Reporter did not believe that the vaccine was frozen. She thought that it could be due to thermometer malfunction. But she was not sure. No adverse event was reported following this medication error.
One week afterwards. I lost all energy to function normally. I had no appetite and did not eat for 4 days. When I forced myself to eat, I could not hold any food down.
The following day after the vaccine, I woke up with a headache, and tenderness in my left armpit, back of arm and neck.  Was only able to raise my arm 1/4 way.  No relief with Aleve.  The symptoms worsened as the evening progressed.  Took Tizanide 5 mg.  Mild relief.  Awoken in the middle of the night with excruciating pain in the left arm, neck and shoulder.  Applied Ulta Tiger Balm, placed a heating pad to the areas and took Aleve.  Received some relief. Mild to moderate pain continued the rest of the day despite continuing with the same regiment.  Once a gain I awoke with increased pain, now it was radiating to my scapula, upper back and left side of chest.  I sat up in the bed and continued with the regiment.
This patient came into the health dept at 10:30 AM of immunization, no adverse reactions at the time of immunizations. The mother brought the child back to the health dept at 1:30 PM with systematic rash and welts. He was sent to the ER. Treated with Benadryl and sent home.
Presented w/ epigastric pain since yesterday and n/v. Tx for acute hypoxemic resp. failure req. intubation d/t exacerbation of CHF and secondary to Covid + infection/pneumonia.
Severe chest pains.  Had x-rays,  2 blood tests and 2 EKGs
Called pt for a follow-up and she informed me she has been sick. Pt stated that she got similar symptom when she got the shot last year. Sx - cough, chest pain/congestion and bodily aches.