chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inflammation of hands and feet after 48 hours such that I couldnot get one shoe on; body aches from hours 12-48; sweats without fever from hours 8-48; chills at 6 hours; headache within 15 minutes; overall malaise; intestinal issues (gas, cramps, diarrhea then constipation); as if my system has been in shock; intestinal issues (gas, cramps, diarrhea then constipation); intestinal issues (gas, cramps, diarrhea then constipation); intestinal issues (gas, cramps, diarrhea then constipation); excessive sleepiness for last 10 days; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Left arm on 26Feb2021 09:00 (at the age of 60 year old) as dose 1, single for COVID-19 immunisation. Medical history included mitral valve prolapse, osteoarthritis, skin cancer from an unknown date. Patient has known allergies to penicillin and erythromycin. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication. Prior vaccination, patient was not diagnosed with COVID-19 and did not receive other vaccine in four weeks. Patient was not pregnant at the time of vaccination. On 26Feb2021, within 15 minutes, patient experienced headache, chills at 6 hours, sweats without fever from hours 8-48, body aches from hours 12-48, intestinal issues (gas, cramps, diarrhea then constipation), excessive sleepiness for last 10 days, and overall malaise, as if her system has been in shock.. After 48 hours, on 28Feb2021, patient had inflammation of hands and feet, so she removed rings and could not get one shoe on. Since the vaccination, patient had not been tested for COVID. No treatment was received in response to the events.  The outcome of the events was recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, GlaxoSmithKline. In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified. For the 79 linked subjects please see cases: A0756483A - A0756489A, A0756491A - A0756562A. The CR provided lot number AFLUA3208A to QA regarding this product complaint, while the report received stated: AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
death; This spontaneous report was received from a consumer and refers to an infant patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally (strength, lot #, and expiry date were not provided), for prophylaxis (strength, dose, lot # and expiry date were not provided).  On an unknown date, the patient died. The cause of death was not provided, and it was unknown whether an autopsy was performed.   The causal relationship between the patient's death and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2212USA001743:
After second dose chills after 24 hours, severe abdominal pain, aches, swelling  and redness to left arm, extreme fatigue
had a flu shot reaction Friday afternoon, Saturday and Sunday and felt like she gonna die; was cold and constantly under blanket; no appetite but liquid only; bumping into things; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to case 2022SA417185 (CLUSTER).  This case involves a 82 years old female patient who experienced had a flu shot reaction friday afternoon, saturday and sunday and felt like she gonna die, was cold and constantly under blanket, no appetite but liquid only and bumping into things after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, strength lot and expiry date: unknown) via unknown route in an unknown administration site for prophylaxis vaccination.  On an unknown date the patient developed a non-serious had a flu shot reaction friday afternoon, saturday and sunday and felt like she gonna die (immunisation reaction), cold and constantly under blanket (feeling cold), no appetite but liquid only (decreased appetite) and bumping into things  (clumsiness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (had a flu shot reaction Friday afternoon, Saturday and Sunday and felt like she gonna die, was cold and constantly under blanket, no appetite but liquid only, bumping into things ).  At time of reporting, the outcome was Recovered / Resolved for all events
This spontaneous report as received from an immunization coordinator refers to an unknown number of patients of unknown age and gender. The immunization coordinator mentioned VAQTA that was improperly stored might have been given to an unknown number of patients. VAQTA was exposed to temperatures of 32F (Fahrenheit) for 110 hours (temperature excursion not supported by stability data). No adverse effects reported. This is one of several reports from the same source (1402USA007570, 1404USA012060, 1404USA012062 and 1404USA012063). Additional information has been requested.
From telephone call received on 12/23/02 from a physician regarding a 32 year old female patient who came in with a splinter in her foot. Physician gave her a Td booster on 12/14/02 (lot # U0821AA, expiration date 7/8/04). After 24 hours, the patient developed pain in her left deltoid where the vaccine was administered, which extended from her shoulder to her wrist. On a pain scale of 1 to 10, she described her pain as 7. Pain alternated from throbbing to achiness and involved her left chest also. Patient stated at time she felt weird. Tylenol and Advil did not alleviate her symptoms. The symptoms peaked at 36 hours and she was seen by physician on 12/19/02. Her range of motion was good and pain was subsiding by 12/22/02. The case is closed.
Extreme muscle and bone pain, upset stomach, dizzy, fever, sensation of skin burning and sensitive to touch, headache, fatigue, and nose bleeds.
No additional AE information provided.; accidentally been given PEDVAXHIB vaccine that was diluted; accidentally been given PEDVAXHIB vaccine that was diluted; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 08-SEP-2022, the patient was vaccinated with the diluted first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 ml, lot # W002453 was confirmed to be valid, expiration date 24-JUN-2024, for prophylaxis (route of administration and anatomical site were not provided). It was reported that the person administering the product was diluting the vaccine with 0.5 ml of normal saline and then drawing up 0.5 ml, and administering it to patients (product preparation error, incorrect dose administered). No additional adverse event information was provided (no adverse event).; Sender's Comments:  US-009507513-2209USA007893: US-009507513-2209USA007866: US-009507513-2209USA008290: US-009507513-2209USA008058: US-009507513-2209USA008125: US-009507513-2209USA008275: US-009507513-2209USA008249: US-009507513-2209USA008273: US-009507513-2209USA008037: US-009507513-2209USA007891:
DIARRHEA; DIFFICULTY BREATHING; FEELING HOT; SWEATING; TIRED; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced diarrhea, difficulty breathing, feeling hot, sweating, tired, and nausea. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, difficulty breathing, feeling hot, sweating, tired, and nausea. This report was non-serious.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, the patients were vaccinated with doses of M-M-R II, injection, lot # L007216, expiration date 03-MAR-2017 (strength, dose, route and site of administration were not reported), which were exposed to the temperature of 49.1 Fahrenheit degrees for 13.5 hours. No adverse effect was reported. There were not previous temperature excursions. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
My father fell from bed upon waking and was so weak he could not get up. He remained on the floor for 3 hours until help arrived. He spent 2 nights at Hospital. He is still very weak.
Breakthrough case admission after 5 vaccines Pfizer 2/24/21 Lot# EN6202;  Pfizer 3/17/21 Lot# EN6204;  Pfizer 9/30/21 Lot#FE3592; 5/12/22  Pfizer Lot# FM9992; Moderna 9/7/22 Lot# as7140C
NEEDLE MALFUNCTION- PATIENT DID NOT GET DOSE SO HAD TO REDO3.
Pfizer-BioNtech COVID 19 Vaccine EUA: Developed throat itching, mild throat swelling, flushing, and mid upper back pain about 24 hours after the vaccine was given
can not breath; Jabbing pain in my back; Chest really hurt; Suspected vaccination failure; I got it about three weeks ago; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got it about three weeks ago). On an unknown date, the patient experienced difficulty breathing (Verbatim: can not breath), back pain (Verbatim: Jabbing pain in my back) and chest pain (Verbatim: Chest really hurt). The patient was treated with morphine. The outcome of the vaccination failure was unknown and the outcome of the shingles, difficulty breathing, back pain and chest pain were resolving.   It was unknown if the reporter considered the vaccination failure, shingles, difficulty breathing, back pain and chest pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, difficulty breathing, back pain and chest pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt date: 09-JUL-2023 This case was reported by patient via interactive digital media. The patient reported that he or she got it about three weeks ago, and he/she still have jabbing pain in his/her back, the pain is really intense, it's unbearable.  The patient states that he/she went to twice, they gave his/her morphine, and it did nothing for his/her. The patient states that his/her chest really hurt, and he/she couldn't breathe. Get the vaccine people, Even though he/she got two vaccines, it hit he/she really hard, thank goodness he/she had been slowly getting better since. Follow up was not possible, as no contact details were available. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Within 6 hours his right upper arm was red and within 24 hours his entire upper arm was very swollen from shoulder to elbow with redness one inch past elbow. Given BENADRYL and oral antibiotics. Arm better by 10/7/13.
swelling and blisters at vaccination site, fever polysporin on blisters Motrin and Tylenol for fever
patient received vaccine that morning and later that evening around 5pm called the pharmacy and said her arm had begun to swell and was red and a little warm to touch. No difficulty breathing or swelling of face or throat. Just in the arm where vaccine was given.
I started to develop a fever 2-3 days after the first vaccine. My fever continued for 9 days straight, even though i was taking antipyretic
She did have discomfort after the first vaccine.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 39-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 18:00 (Lot number: FC3180) at the age of 39 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Fibromyalgia" (ongoing), notes: She had Fibromyalgia was diagnosed 9 years ago. She has taken Tylenol arthritis because Fibromyalgia. Concomitant medication(s) included: TYLENOL taken for fibromyalgia (ongoing). The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "She did have discomfort after the first vaccine.".  Additional information: No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) were none. After second dose of vaccine on 10Sep2021, the patient had the usual arm discomfort right after. Saturday, she had pain in her arm, shoulder, and on her back by her bra strap. By that night, she had all the same pain plus some in her shoulder blade area. The pain has increased to the point of unbearable now. The pain started radiating to the other areas on Saturday 11Sep2021. The initial discomfort started right after she got the vaccine at 6pm. She pretty much immediately experienced discomfort. She did have discomfort after the first vaccine.  No follow-up attempts are possible. No further information is expected.
hives, redness, swelling at site of ppd administration withe hives extending to entire anterior surface of lower left extremity-ppd received 6/21/04-required topical hydrocortisone and oral benadryl treatment
Itchinig - Rash - Ice - Benadryl  tablets - Cream (corizone)
some pain and soreness, sick for a couple hours then it was gone by morning; some pain and soreness, sick for a couple hours then it was gone by morning; some pain and soreness, sick for a couple hours then it was gone by morning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (some pain and soreness, sick for a couple hours then it was gone by morning), ILLNESS (some pain and soreness, sick for a couple hours then it was gone by morning) and MYALGIA (some pain and soreness, sick for a couple hours then it was gone by morning) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (some pain and soreness, sick for a couple hours then it was gone by morning), ILLNESS (some pain and soreness, sick for a couple hours then it was gone by morning) and MYALGIA (some pain and soreness, sick for a couple hours then it was gone by morning). At the time of the report, PAIN (some pain and soreness, sick for a couple hours then it was gone by morning), ILLNESS (some pain and soreness, sick for a couple hours then it was gone by morning) and MYALGIA (some pain and soreness, sick for a couple hours then it was gone by morning) had resolved.      Treatment of these events were not provided.
15 minutes after Moderna COVID vaccine patient experienced dizziness, slight chest tightness, and numbness to her lower lip. She was given benadryl 25 mg. Her dizziness, chest tightness, and lip numbness resolved. She did have elevated blood pressure reading at 1200 was 130/90 1230 was 180/82 it took 2 hours of resting to get her blood pressure down to 152/82
Right arm swollen, red painful to lift. Patient developed red scaly rash and felt "out of it". Headache, nausea, body aches, coughing, sore throat. Patient took BENADRYL after speaking with RN. Urgent care advised by RN.
FELT TIRED/ Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (FELT TIRED/ Tiredness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (FELT TIRED/ Tiredness). At the time of the report, FATIGUE (FELT TIRED/ Tiredness) was resolving.            Patient's husband had cancer. Relevant concomitant medications were not reported.  On unknown date, the patient took second shot of Moderna COVID-19 Vaccine and felt arm hurt. On unknown date, the patient took booster dose of Moderna COVID-19 Vaccine and felt tired.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623797.
headache; soreness in my arm; My lymph nodes are tender; This is a spontaneous report. A contactable (age 54; Unit: Unknown) male consumer reported that:  A 54-years-old male patient received bnt162b2, (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, expiration date: not reported), via an unspecified route of administration on 23Feb2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had first dose last Tuesday and called a while ago about transmissibility. Patient reported that the patient lives with family members. The patient stated that he did not know if he had a Covid asymptomatic carrier. After a couple of weeks, we are supposed to wear a mask. Are you transmissible? The patient also stated If I was vaccinated, and I give it to someone else is it going to be a new variant. It was stated that patient never had a headache and a week later starting last night patient had headache that feels like a nail going through my head and I have soreness in my arm. My lymph nodes are tender. The outcome of events was unknown No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Diabetic; Diarrhea; This is a solicited report based on information received by Pfizer from Regulatory Authority (manufacturer control number: 21K-163-3923698-00). A contactable consumer (patient) reported for herself that a 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 and dose 2 via intramuscular in 2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation; adalimumab (HUMIRA), via subcutaneous from an unspecified date at citrate free, from an unspecified date and ongoing, at citrate free for moderate to severe adult Crohn's disease. The patient's medical history and concomitant medications were not reported. There was no known allergies. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2021, the patient experienced diarrhea. In Apr2021, the patient experienced sick with diarrhea. In May2021, the patient experienced diabetic. The patient underwent lab tests and procedures which included blood test: blood sugar was in 400s on 11May2021. The action taken in response to the events for adalimumab was dose increased. In 2021, the sick with diarrhea resolved. The outcome of diabetic was unknown.   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events diabetes mellitus and diarrhea and the suspect drug BNT162B2 cannot be 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.
Patient came back to the pharmacy on 9/5/18 to report her adverse events following vaccine administration on 8/30/18. Patient reports a fever of 102F on the first day, which she took TYLENOL and ibuprofen for. On days 2-6, she experienced redness and swelling in the left arm without any itching. She said the swelling was very noticeable and there was swelling to her left armpit as well. On day 7, the swelling resolved. Also on day 7, the injection site is itchy but the itchiness is tolerable.