chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Passed out/fainted; The patient received Flucelvax Quadrivalent and Spikevax on the same day, both in left deltoid; This spontaneous case was received on 22-Dec-2021 from a pharmacist (reference number: SEQW21-06337) and concerned a 29-year-old, male patient.  The patient's concurrent condition included hypoglycaemia before injections (the patient had not eaten all day before receiving both vaccines). The was not taking any concomitant medications.   On 22-Dec-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: left deltoid) for influenza prophylaxis The batch number reported was 309621 and expiry date 30-Jun-2022.  On the same day, the patient was vaccinated with a non-company, co-suspect Spikevax (elasomeran; route of administration: intramuscular, anatomical location: left deltoid, dose and indication: not reported) (explicitly coded as 'Product administration error'). The batch number was not reported.  On the same day, shortly after receiving Flucelvax Quadrivalent and Spikevax, the patient fainted/passed out for less than a minute. Pharmacist called for an ambulance and provided a Coke for the patient to drink in the meantime. Pharmacist stated that patient felt fine after drinking the Coke and walked out with the paramedics.  On the same day, the patient recovered from the event.  The reporter did not provide a causality assessment.  The event of 'faint' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: On the same day, shortly after receiving Flucelvax Quadrivalent and Spikevax, the patient fainted for less than a minute. Causality is assessed as possibly related, although confounded by co-suspect. The patient received Flucelvax Quadrivalent and Spikevax on the same day, both in left deltoid. Product administration error is assessed as unrelated per company's conventions.; Sender's Comments: On the same day, shortly after receiving Flucelvax Quadrivalent and Spikevax, the patient fainted for less than a minute. Causality is assessed as possibly related, although confounded by co-suspect. The patient received Flucelvax Quadrivalent and Spikevax on the same day, both in left deltoid. Product administration error is assessed as unrelated per company's conventions.
Patient broke out in raised red hives the evening of the immunization.  The hives worsened the next day.  Patient's mom advised to administer Benadryl 25mg po q 4 hrs prn and apply moist, cool compresses to irritated areas as needed.
1..5 hrs after shit. Right arm red, rash, itching. Hives from shot up onto right side of neck, right side of face, into hair on right side. R side of face swollen, numb and droopy. About 5 hrs after started having severe stomach cramps, nausea, bad headache, achy, joints hurt. This lasted fir two days. For another 10 days have felt sore joints and muscles, Headache, rash, fatigued, face still slightly swollen, numb and droopy. Symptoms were less after 2days but still there.
Chest pressure  in middle of chest and around back. Blood pressure went high. Went to er
Right after patient's well baby visit on 11/30/2012 her doctor told me to be on the lookout for a delayed fever or reaction to the shot within 7-10 days. 10 days later, patient woke up with a fever at 4:00 in the morning (around 102F), we gave her Tylenol. She couldn't go back to sleep, fever got worse by 9:30AM, so I gave her another dose, which still didn't bring it down. She was lethargic all day. We took her temperature at 2:15 and it was 104.1 F. She was in our bed resting a few minutes later, when she called for us to come see her. We got in the room, she looked at us, and then started seizing. She seized for about 60 seconds. Turned blue. I called the ambulance, they came and took her to the ER. She was not responsive. She was not responsive for hours after the seizure. Doctor said normally kids are somewhat back to normal by then, and so he wanted to do a spinal tap to see if it was meningitis. It was not. About 3 hours after her seizure, she finally started to look at us, recognize us as her parents and act a little normal. She was discharged from the hospital around 8:30PM, as having a febrile seizure. I am pissed that no one told me the risks associated with combining the two shots that she got that day on Nov 30 (HIB PRP-T Conjugate & Pheumococcal Conjugate). I would have never let them give them to her. Her current treatment is to give her round the clock Motrin & Tylenol for 3 days. All the tests that they ran (chest x ray, strep, blood cultures)...everything came back negative. Doctor didn't want to admit that her high fever which resulted in a very terrifying seizure could have been the cause, but we believe it was.
Site of injection on left arm has remained swollen and "red" since the injection 11/3/21.  Patient has applied ice topically and taken acetaminophen and diphenhydramine.  Swelling is isolated to the left arm at injection site.
Hives to back and upper right thigh noted Sunday evening. Tried BENADRYL x once with no relief.
There is a small, weak, shooting pain in my chest around the area of my heart. It lasts for about half a minute to a full minute before dispersing. It rarely happens and so far, it has been about once daily. My left arm is also experiencing a weak, dull pain on the outer side of my bicep. It starts in the middle and goes down to the elbow. It sticks around for a while but it did not start until 07/09/2021.
I have left and right side lower back pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (I have left and right side lower back pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced BACK PAIN (I have left and right side lower back pain). At the time of the report, BACK PAIN (I have left and right side lower back pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment drugs were reported.
Patient with underlying MS and pregnancy.  Patient reported that Fever, body aches, chills, fatigue after administration of 2nd dose.  Presented to the Emergency Department / OB triage in labor 4  days later (1.24.21) Patient is a 34 y.o. female at 37w0d with Estimated Date of Delivery: 2/14/21 who presents today with spontaneous labor.  HOSPITAL COURSE:  Patient underwent an uncomplicated vaginal delivery and was discharged home in stable condition.  ESTIMATED DUE DATE: Estimated Date of Delivery: 2/14/21  GESTATIONAL AGE AT DELIVERY: 37w0d.  Patient weight = 2.63 KG
her sugar is raised; sweats; body hurt/ pain (in back chest, and arm); fever 101.3; dizzy; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (her sugar is raised), HYPERHIDROSIS (sweats), DIZZINESS (dizzy), NAUSEA (nausea) and MYALGIA (body hurt/ pain (in back chest, and arm)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced DIZZINESS (dizzy), NAUSEA (nausea) and PYREXIA (fever 101.3). On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (her sugar is raised), HYPERHIDROSIS (sweats) and MYALGIA (body hurt/ pain (in back chest, and arm)). At the time of the report, BLOOD GLUCOSE INCREASED (her sugar is raised) was resolving and HYPERHIDROSIS (sweats), DIZZINESS (dizzy), NAUSEA (nausea), MYALGIA (body hurt/ pain (in back chest, and arm)) and PYREXIA (fever 101.3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Body temperature: 101.3 (High) 101.3. On 08-Apr-2021, Body temperature: 99.3 (Low) 99.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Pt did not respond to Engerix-B vax series 23JAN91 HBSAB neg; 1 booster dose was administered;
Information has been received from a registered nurse referring to an unspecified patient of unknown age and gender. Patient's concurrent conditions included developmental issues. Information regarding patient's medical history and concomitant medications were not reported. On unknown dates, in 2011 (two separate unspecified dates), the patient was vaccinated with two doses of M-M-R II, (dosage schedule, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT), (dosage schedule, route, anatomical location, lot number and expiration date were not reported). In approximately 2018 (reporting as "7 years after receiving M-M-R II"), the patient was seen in the physician office were labs were performed, demonstrating elevated measles titers. No other side effects were reported. No treatment was given for the event. The patient's outcome was not recovered. No causality assessment between the event and the vaccine was provided by the nurse.
Pt developed fever on 9/20/01 after vax given. The morning after vax pt's mother reported pt's temp to be 100.4. Pt was given Motrin. Pt also had fussiness, crying, and refusal to walk. Pt was referred to private MD.
Developed chicken pox from taking a booster injection of shingles vaccine. It took a little after (one month) after taking vaccine.
Patient developed hives across chest and arms & reported to nursing at 14:00 PM. Nursing contacted MD. Benadryl 25mg orally was ordered and administered @ 14:09 PM.  No further symptoms reported or noted. Symptoms resolved in approximately 3 hours.
I have had pain in my left deltoid muscle since receiving the vaccine. On Jan 13 I saw my health provider because I also developed a rash two weeks after receiving the vaccine at the injection site. The rash resolved a few days later, however, I still have significant pain in that muscle with certain movements of the arm.
After having the second shot, 24 hours later I'm running a 101.5 fever; chills; achiness; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Apr2021 at 13:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) and bupropion hydrochloride (WELLBUTRIN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 13:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021, 24 hours later, the patient experienced fever of 101.5(unspecified units), along with chills and achiness. On 27Apr2021, the patient checked body temperature and the result was 101.5(unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 101.5 fever along with chills and achiness were not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Night sweats for 3 nights so far; cystic pain and fever for 24 hrs.
High blood pressure, dizziness, blurry vision, nose throat, asthma attack, headaches, weakness, body aches, nauseas, stomach pain. Still sick after 4 days.
This case was reported by a physician and described the occurrence of increased liver enzymes in a 4-year-old male subject who was vaccinated with Havrix for prophylaxis. Concurrent vaccination included influenza virus vaccine given on 27 January 2007. Concurrent medications included Amoxicillin trihydrate and Dimetapp-DM. On 27 January 2007 the subject received 1st dose of Havrix at 720 elisa units. At an unspecified time after vaccination with Havrix, the subject experienced increased liver enzymes and lethargy. This case was assessed as medically serious. At the time of reporting the outcome of the events were was unspecified. The physician considered the events were possibility related to vaccination with Havrix.
Hallucinations. Woke up seeing yellow bugs approximately 12 hours after vaccine. No fever, no vomiting, no headache. Persisted while wide awake, normal exam.
fever; nausea; aches; This is a spontaneous report from a contactable consumer (Patient) received from a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received the second dose of Covid-19 vaccine today (date not specified). According to her, she had a reaction fever, nausea, aches with the first Covid shot so her Doctor told her to take Ibuprofen after receiving the second dose. She doesn't have Ibuprofen at the moment, but she has Aleve and Bayer Aspirin. Patient was asking if it is okay to take these medications instead of Ibuprofen. The outcome of the events was unknown.  Information on lot/ batch number has been requested.
neck pain; Headache; pain on injection site; fatigue; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), HEADACHE (Headache), VACCINATION SITE PAIN (pain on injection site), FATIGUE (fatigue) and NAUSEA (nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced NECK PAIN (neck pain), HEADACHE (Headache), VACCINATION SITE PAIN (pain on injection site), FATIGUE (fatigue) and NAUSEA (nauseous). At the time of the report, NECK PAIN (neck pain), HEADACHE (Headache), VACCINATION SITE PAIN (pain on injection site), FATIGUE (fatigue) and NAUSEA (nauseous) outcome was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Vasovagal syncope event within moments of 2nd vaccine being administered.   Covid vaccine was administered first.  Flu vaccine was administered second. Stood up and grabbed his coat off the counter then moved back to the chair and was in the process of sitting back down.  He slumped over the left arm of the chair.  I asked if he was okay.  He was unresponsive.  I yelled for help and for someone to call 911.  (Note that 911 was called at 11:18am).  He regained consciousness before anyone else got to the room.  He asked what happened.  I explained that he fainted.  He started sweating and his hands were shaky.  He was able to respond to questions.  I suggested that he put his head between his knees.  He stayed in the chair with his head between his knees.  EMS arrived at 11:28am.  BP was 122/46, HR was 84 and O2 saturation was 99%.  He declined transport and signed off on EMS documents.  He moved from the vaccination room to the waiting area.  I offered him a bottle of water.  He drank the water and sat there until 11:59am.  I took his blood pressure before he left.  It was 121/90, and pulse was 69.
I am still weak and tired 5 days later.  I nap (highly unusual for me) and feel better for a little while but if I do anything I get weak and tired again.  I get feeling fogginess like I'm lost in a fog and can't even function.  Then I lay down and I get feeling better.  I keep thinking I'll shake it and get well but this has been going on for five days now.  Also I have never had a headache in my life, but I am getting recurring small headaches.  And I just feel weird, not right.
pt recv vax in lt arm @ 7PM & exp head pressure @ 715PM; BP 120/74, HR 84; epi given;exp flushing & funny feeling prior to epi;paramedics took pt to ambulance per stretcher;
I had body aches, fatigue, and cough. I tested positive for COVID-19. I went to a clinic the next day and they prescribed me medication. I started feeling better within two days.
Pt recv vax on 2/19/99; post vax pt exp respiratory problems, fussy, fever
Orbital edema, fatigue, muscle ache, tested positive for mono 10 days after vaccine.
Information has been received from a consumer concerning her 15 month old son who on 1/25/00 was vaccinated with MMR II (636401/1277K). The mother reported that recently her son was diagnosed with "slight PDT." The mother reported that her son did not have autism but that it was on the same spectrum. Upon internal review, developmental delay was considered to be an other important medical event (OMIC). Additional info has been requested.
No additional AE details; a RECOMBIV AX HB vaccine which expired 10/31/2021 was administered today 11/09/2021; Information has been received from a clinical manager referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.  On 09-NOV-2021, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot# S022584, expiration date: 31-OCT-2021; dose, strength, frequency and route were not provided) for prophylaxis (Expired product administered). No additional adverse event provided.
Patient recieved 1st dose of J&J and recievd 2nd dose of Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved 1st dose of J&J and recievd 2nd dose of Moderna) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (1st dose). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On 28-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved 1st dose of J&J and recievd 2nd dose of Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved 1st dose of J&J and recievd 2nd dose of Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported. No treatment information was provided by the reporter. Reporter was unable to verify if patient was immunocompromised or not.   This case was linked to MOD-2022-511288 (Patient Link).
headache; Initial information received on 28-Feb-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves male patient (of unknown demographics) who experienced headache (headache), while he received vaccine YELLOW FEVER VACCINE and while treated with DUPILUMAB [DUPIXENT].  Medical history, concomitant, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient started taking DUPIXENT (DUPILUMAB) dosage unknown (with an unknown batch number) for prophylactic vaccination. On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE produced by unknown manufacturer (lot number not reported, of unknown Expiration date) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious headache (headache) of Unknown latency following the first dose intake and of Unknown latency following the last dose intake of DUPILUMAB.The patient developed a non-serious headache of Unknown latency following the administration of YELLOW FEVER VACCINE.  Laboratory data was not provided.  Final diagnosis was headache.  It was not reported if the patient received any corrective treatment.  On an unknown date, the patient outcome is not reported for the event.  Information on the batch number is requested.
This case was reported by a healthcare professional and described the occurrence of vomiting in a 3-month-old (almost 4 month old) female subject who was vaccinated with ROTARIX. Concurrent vaccination included HIB and PEDIARIX and PREVNAR all given on 4 March 2009. There were no concurrent medications. On 4 March 2009 at 15:02 the subject received 1st dose of ROTARIX (oral). On 4 March 2009, at 15:20, just 18 minutes after vaccination with ROTARIX, the subject experienced vomiting. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was unrelated to vaccination with ROTARIX.
The patient developed a red raised blister on her left deltoid, patient reported this developed within 24 hours of vaccine. It did not itch & was warm to the touch. Patient later Followed up with MD. MD stated blister may be due to Fluid accumilation in subcutaneous tissue. On 10/25/19 patient stated blister is popped & flat. Patient will Follow up if anything else changes.
5-8-7 Pt came to immunization clinic for 3rd Rabies vaccination 5/4. Review of prior vaccination (Rabies #2) pt states that 2 days after vaccination she noticed hives on her stomach that itched. Pt stated she had been outside that day and was very hot and thinks that's where hives came from. After giving 3rd rabies vaccine, pt was instructed to wait at least 15 min to be monitored. At about 15 min mark, pt said she was itchy on arms and back. Inspection of back revealed no redness or bumps. Pt given 50mg liquid BENADRYL PO and monitored. Pt monitored for approx 30 min afterwards, and itching gradually decreased and itching ceased. Pts boss was contacted (she was going to work) and told of situation. After approx 45 min after getting vaccine, pt stated she felt fine and wanted to go to work. Pt instructed to call back tomorrow for update. Any swelling of throat or itching of tongue or lips, to ER. Called pt on 5-8-17, no answer. Pt called again 5-8-17, no answer.
Tenderness to palpation on the left deltoid and trapezius swelling, and warmth.
LARGE REACTION TO SECOND DOSE OF ENGERIX-B, A few hrs /p vax 2nd dose of Engerix developed an 8 cm induration /w erythema, & pain. This persisted for approx 36 hrs & was localized to site of inject.Seen @ MD's ofc treated /w meds, recovered
Pain and tingling down left arm immediately after flu shot. Ongoing symptoms including weakness and pain in left deltoid.