chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received Tdap on 1/12/08. On 1/13/08 pt noticed left arm was swollen, red and hot to touch. Pt did not receive treatment at that time. Pt arrived in our
Right upper outer arm pain at the site where she received her Shingrix vaccine number one 10/28/20 with pain getting worse with time.  It is exacerbated by doing certain motions at the elbow level such as flexing or reaching for items with a very sharp pain that will last 30 seconds to a minute or so.  If she keeps her arm still, it does not hurt.  Patient is taking nortriptyline and tizanidine without any benefit for her. Of note, patient has not had problems with any other vaccinations such as flu shots, tetanus shots, etc.
Nose Bleed Approximately 3 hours following injection and recurring  on 4/24; 4/25; 4/26; 4/27
He had reaction to it; the reaction is bad; at first it was just a red circle and it was hot; it's been 8 days and it's turning, now it's getting infected and it's still red like bright red; He had reaction to it; the reaction is bad; at first it was just a red circle and it was hot; it's been 8 days and it's turning, now it's getting infected and it's still red like bright red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), on 20May2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MACULE (non-serious), INFECTION (non-serious) all with onset May2022, outcome "not recovered" and all described as "He had reaction to it; the reaction is bad; at first it was just a red circle and it was hot; it's been 8 days and it's turning, now it's getting infected and it's still red like bright red".  Additional information: Reporter was calling on behalf of father. Patient had the Pfizer vaccine on the 20May2022, he had reaction to it. Reporter wanted to know what to do because the reaction was bad. At first the reaction was just a red circle and it was hot but it had been 8 days and it was turning and getting infected. It was bright red and it was getting infected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I wanted to let you know  I developed a Covid arm rash after my second Moderna dose. I had fever, chills, fatigue the day after the injection and the rash started appearing that night. The rash became the size of a peach (fairly round) the next day. It is located about 3 inches below the injection site. It is gradually fading but still remains today.  My daughter is pregnant and received her first dose of Moderna. She developed a small rash but no other symptoms. It may have been slightly raised. I'm worried for her second dose.
Fever (102) chills, fatigue, loss of taste and smell, migraine, swelling and redness in shot sight, loss of appetite, swollen lymph nodes in arm of shot. They started 12 hours after getting the shot. Lasted for over 12 hours and currently the swelling and redness is still present after 48 hours from shot.
Shortly after receiving the vaccine the patient became nauseous and hot (415pm). We got a cold cloth and placed it on the back of her neck and also moved the trash bin over in case she became ill. The patient briefly passed out  and emergency was called (416pm)  the technician kept talking to her to keep her calm and her husband. When EMTs arrived (420pm) they took her vitals and when she agreed they transported her to the ER
8-13-07 - seen by MD. Varicella disease x 1 week - numerous vesicles over trunk and face; fever 102 oral. Zovirax tsp QID 200cc.
Client's #1 dose was unknown at the time of vaccination for #2 dose; client also did not disclose that dose #1 was Moderna.  Client denied any adverse event from either dose.
TD given 28SEP94 @ 1500; 3OCT94 c/o erythema, warm, edema, afebrile, discomfort; placed on Keflex 500mg qid x 10d; 17OCT94 all sx resolved;
-Severe pain and swelling in Right Arm. Patient states it started within an hour. Size of butternut squash at max size. Spoke to patient, didn't seek medical attention and states swelling has begun to resolve approx 24 hrs later.
c/o itching over all of body, tongue + lips.  Referred to Dr at Health office.
ITCHINESS; RED BUMPS ALL OVER  BODY (ON CHEST, STOMACH, BACK, AND LEFT, RIGHT ARM/UNDERARM, WHICH  VACCINE WAS ADMINISTERED); This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. Concomitant medications included terbinafine for drug used for unknown indication. On 24-JUN-2021, the subject experienced itchiness. On 24-JUN-2021, the subject experienced red bumps all over body (on chest, stomach, back, and left, right arm/underarm, which vaccine was administered). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchiness and red bumps all over body (on chest, stomach, back, and left, right arm/underarm, which vaccine was administered) was not reported. This report was non-serious.
Began with stomach pains, rash on the top and bottom of both feet. Stomach pains were intermittent then became constant. 1 year later 2/09 diagnosed with Crohn's. I feel the vaccine initiated the Crohn's.  5/8/09 Received PCP medical records of 2/28/08-4/22/2009. FINAL DX: Crohn's disease w/terminal ileum inflammation & stricture s/p laparoscopic assisted ileocecal resection/anastamosis Records reveal patient experienced good general health on 2/28/09.  RTC 4/29/08 w/increasing abdominal pain x 2-3 wks w/1 episode emesis, urinary frequency over past few days.  RTC 5/21/08 w/tinea pedis & cellulitis.  RTC 5/30/08 w/dermatitis.  RTC 6/13 w/continuation of cellulitis of foot & tinea pedis.  RTC 10/16/08 & referred to GI for 4-6 mo hx of abdominal pain & diarrhea w/normal GYN exam & no relief from pepcid.  GI consult records of 12/30/08-4/16/09 included & reveal intial dx of non specific colitis.  Hospitalized 3/11-16/2009 w/Crohn's disease. Did not respond to med treatment & re-hospitalized 4/16-4/22/09 for surgery.  No further records available.
Upon completion of administering the vaccination, when the guest was getting up she fainted as she was going to observation. Guest fell to floor, I was 5' away at another vaccination station.  Staff who vaccinated her responded directly to her. She was unconscious and eyes rolled back. She was out for about 10 seconds. Vitals were taken and guest was talking to us. I left guest with staff and two other RN's and called emergency for an ambulance from EMS. We monitored guest until EMS arrival.  EMS was given report and care was transferred to EMS. They put her on the stretcher and transported. to  Hospital. Talked with her mother Monday 11/22/2021 and she said she was checked in ER and it was determined that it was a Syncopel  Episode and she was released.
Patient admitted to being nervous prior to administration and said he did not like needles.  Patient was consulted about what to expect, side effects, and asked if he had any additional questions prior to receiving vaccination.  Patient declined and said he wanted to have the vaccine administered.  Patient sat down in the designated waiting area.  Approximately 2-5 minutes later patient blacked out and his body weight caused the chair he was sitting in to flip over, thus landing on the floor.  EMS was called.  Patient came to about 30-60 seconds later.  Patient was disoriented, sweaty, pale, and shaky.  Blood pressure was taken with a result of 143/95.  EMS arrived and evaluated the patient.  Patient admitted to having nothing to eat or drink today and being very anxious previous to getting the vaccine.  There were no signs of an allergic reaction.  Patient's blood pressure was checked about 20 minutes later and was returning towards normal.  Patient declined transport to the hospital, but mother was called to come pick him up.  Patient was advised to get something to eat soon and to rest and be observed for the next 24 hours.
Unable to hear out of left hear due to severe tinnitus; Severe Tinnitus and mild vertigo; Severe Tinnitus and mild vertigo; severe muscle aches diffusely; fever (103.1); nausea; vomiting; This is a spontaneous report from a contactable Physician (patient). A 36-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Oct2021 13:00 (Batch/Lot Number: FH8020) (at the age of 36 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 prior vaccination. There were no known allergies. There was no other vaccine in four weeks. The patient's concomitant medications were not reported. It was reported that 12 hours after vaccination (reported as on 23Oct2021 12:00 AM), there were severe muscle aches diffusely, fever (103.1), nausea, vomiting. These lasted for 3.5 days (also being reported as not recovered, pending clarification). Then 4 days after vaccination (26Oct2021), there was Severe Tinnitus and mild vertigo. Patient was unable to hear out of left ear due to severe tinnitus. The outcome of events was not recovered. Events resulted in doctor or other healthcare professional office/clinic visit. Treatment was used for the events (primary care doctor - medication).  COVID was not tested post vaccination.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Twelve Moderna vaccines were given in office today. Only 11 were drawn up this morning and the 12th dose was, most likely, a left over dose from yesterday. After incident was discovered, Moderna manufacturer was contacted per CDC recommendation. (Case #: MOD21-060693).  Patient called with: The Moderna Vaccine you received may have been outside of the 6 hour thaw recommendation. We contacted the Moderna manufacturer and CDC. At this time, there are no recommendations for revaccination. You will still receive your 2nd dose as previously scheduled. Titers will be available at no cost in 2-3 months after your second vaccine.
She was at pharmacy had her 3rd Pfizer booster 3 days ago. She denies problems with the first 2 doses She got her booster and was walking around shopping, and within 15 min she got dizzy. Her dizziness got worse in an hour later. She went home and ate dinner, then 30 min later she felt even worse with severe dizziness and sob, but no angioedema. She called EMS and her Systolic BP was 200s. She got epinephrine and benadryl IV. The EMT noted that she had a bright red rash on her chest. By the time she arrived to the hospital she was feeling better. Arrived to hospital at 1720 with VS: Temp 98.1, HR 110, Resp 18, BP 177/99, O2 98 She was observed in the ED and was feeling better with improving urticarial rash.
Patient received four shots in the same day, three in the left arm (Boostrix, Shingrix, and the Pfizer COVID vaccine), and one in the right (Prevnar 20). About 2-3 days later, a liquid filled ball about the size of a golf ball form right above his left elbow. It wasn't painful, but 2 weeks later it still wasn't getting any smaller. He hadn't done anything to treat it at the time.
Pain level at 8-9 on a scale of 1-10  at injection site. Unable to use arm for 4-5 days, significant pain for another 3 weeks.  Pain level at 2-3 continues - to this day.  4/25/2015.  Some days up to
Redness at injection site (without pain), approximately 2x3 inches. Appeared about a week after vaccination and lasted about a week. Also, slight pain in armpit (no swelling) that appeared and lasted the same amount of time.
area indurated, edematous, w/central vesicle w/mild numbness & weakness in lt forearm;
This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. The patient was administered the first dose of RECOMBIVAX HB 02-JUL-1993, the second dose on 04-NOV-1993, the third dose 10-MAY-1995. The patient was inadvertently administered fourth dose of RECOMBIVAX HB on 15-OCT-2014. No adverse effects reported. No product quality complaint (PQC) was reported for RECOMBIVAX HB. Additional information is not expected as the reporter did not wish to contact.
Swelling around eyes few hours after BEXSERO shot given in office. Took oral BENADRYL and subsided.
Post Flu injection experienced welts on head, chest, back of neck, and one on face. Pt did not have any swelling of eyes, lips nor any wheezing or difficulty breathing.
Fatigue; Headache; Muscle Pain; Joint Pain; Nausea; fever; Swelling of lymph nodes near arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), NAUSEA (Nausea), PYREXIA (fever), LYMPHADENOPATHY (Swelling of lymph nodes near arm) and CHILLS (Chills). On 23-Mar-2021, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), NAUSEA (Nausea), PYREXIA (fever), LYMPHADENOPATHY (Swelling of lymph nodes near arm) and CHILLS (Chills) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.
Diarrhea, Nausea, Fever, Swollen and Itchy Eyes.
Staff gave the Pfizer bivalent vaccine to the patient in her right upper arm, and as soon as the needle was pulled out there was a gush of blood and vaccine that came out of her arm. She was cleaned up and a six-inch red rash formed around the injection site. She was given another dose on the left upper arm intramuscular and there was no adverse reaction. The facility director called Dr., and he prescribed Benadryl 25mg x1 right then and routinely after if needed.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. On 27-FEB-2015, the patient was vaccinated with an expired dose of M-M-R II (dose 0.5 ml, subcutaneous, lot # H018948, expiration date 18-OCT-2014). No adverse effect was reported. Product quality complain (PQC) was not involved. Additional information has been requested.
Dizziness, Headache, Myalgia, c/o chills,tinnitus,stomach ache,injection site sore Narrative:
4-5 cm itchy hive rash appearing 6/5, seen in clinic 6/7/13. Had travel vaccinations 6/4/13 planned travel 6/9/13 for 7 weeks. Rash only to left deltoid where all 3 vaccines given. Afebrile, temp 97.5 F. Treatment - BENADRYL and local hydrocortisone.
HYPOTENSION 3/27/2023 ATRIAL FLUTTER, UNSPECIFIED
MMR vaccine given at 12 mon well visit along with other vaccines. Rash maculopapular erythematous all over body 10/26/22 to 10/28/22. Started resolving later rash lasted 5 to 7 days.
collapsed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "collapsed". Clinical course: Warm transfer from (Name withheld). Transfer agent had a caller on the other line calling about the Pfizer COVID-19 vaccine. Caller's father, the patient, just collapsed and patient received the Pfizer COVID-19 vaccine and caller had wanted to speak to someone higher up about this. Upon transfer caller stated caller was pissed off citizen, and caller continued to use inappropriate language, therefore call handler disconnected the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within about 2 or 3 hrs of receiving my latest Covid shot, my arm began to feel sore.  Shortly afterwards,  all my muscles and joints began to ache and I felt very cold even though it was 75 degrees inside. I developed a bad headache (I rarely get headaches) and felt exhausted. I fell asleep on my sofa and woke up 3 hrs later, exhausted and weak, with my heart racing and also feeling nauseous. I was barely able to get to my bed and just collapsed. It felt like a really bad case of the flu with heart palpitations and high heart rate and nausea. I don't recall having such a bad reaction to any of my previous Covid shots (all Moderna shots). At 22 hours after my shot, I'm finally feeling a little better.  This shot was pretty rough.
multiple episodes of inconsolable crying beginning immed p/vax & cont x 2 days;episodes lasted 2-3 hr each time;
12/21/21 called patient no answer left message to return call.  12/21/21 2:58 pm Patient returned call states she had soreness and was tired for a couple of days with first dose and was wiped out for a week after second dose. States she is not going to get the booster or another dose of any COVID vaccine. Sates she is done.
The day after the shot she had a rash over entire body it lasted 4 days, and 4 days she had her first seizure and 2 weeks was diagnosed with epilepsy.
Local reaction at the site of inj arm swollen, tender and red. Child also c/o headache. Recommend ice therapy, rest, and TYLENOL, or MOTRIN. PRN for fever or pain.
Severe headache; Muscle pain; Fatigue; Stiffness in shoulder; Severe chills/was shaking for 4 hours; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in shoulder), CHILLS (Severe chills/was shaking for 4 hours), HEADACHE (Severe headache), MYALGIA (Muscle pain) and FATIGUE (Fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included RIVAROXABAN (XARELTO) and ATORVASTATIN for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in shoulder) and CHILLS (Severe chills/was shaking for 4 hours). On 19-Feb-2021, the patient experienced HEADACHE (Severe headache), MYALGIA (Muscle pain) and FATIGUE (Fatigue). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness in shoulder), CHILLS (Severe chills/was shaking for 4 hours), HEADACHE (Severe headache), MYALGIA (Muscle pain) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided by reporter.
This spontaneous report was received from a nurse prescriber via a company representative and refers to a 20 year old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (dose, route of administration, lot # and expiration date were not reported). Then (date not specified), she received a second dose of VARIVAX (dose, route of administration, lot # and expiration date were not reported), both for prophylaxis. On an unknown date, the patient underwent a blood test (in order to proof her immunity) and showed she was not immune to the disease. The reporter planned to give to the patient another dose of VARIVAX but he/she wondered if one dose of the vaccine should be given and then repeat the blood work or just one dose of the VARIVAX should be given and then repeat the dose of the vaccine after 3 months. The outcome of antibody test negative was unknown. The causality between antibody test negative and VARIVAX was not provided. Additional information has been requested.
felt that some amount of the vaccine dripped onto her arm; A spontaneous report was received from a pharmacist concerning a 63-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and felt that some amount of the vaccine dripped onto her arm.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 25 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. Date of first dose of the vaccine was not provided.  On 25 Jan 2021, the patient was given her 2nd dose of the Moderna COVID-19 vaccine and claimed that she felt that some amount of the vaccine dripped onto her arm. Consent to follow up obtained.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, felt that some amount of the vaccine dripped onto her arm, was resolved on 25 Jan 2021.; Reporter's Comments: This case concerns a 63 year old female patient who received her second of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection and felt that some amount of the vaccine dripped onto her arm. There were no reported adverse events associated with this case of incomplete dose administered.
lt upper thigh-19.5cm x 7 1/2cm erythematous skin w/warmth red swelling;pt able to work w/full range of motion;