chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After leaving office child broke out in generalized rash all over body itchy rash face reddened. Gave 1 1/2 tsp Benadryl at 9:45. Returned to office at 10:15. No respiratory distress BP 102/72 P-109 Pulse 0x 99% examined by Dr- 2 tsp Orapreo given. Child observed until 11:15. Remained stable. Rash faded.
After my first shot on July 19, 2021, I felt extremely tired and had a lot of brain fog. I had my antibodies tested 6 weeks later which resulted in no antibodies being detected. I received my second shot on September 20, 2021 & a few hours later, I felt a sudden heat wave come over my whole body. About 2 days later, I was achey and extremely tired & am now falling asleep rapidly like no other time before in my life & reported this to my doctor on July 22, 2021. On July 22, 2021, in the evening, I started to have pain in under my arm (perhaps in my lymphnodes) in my armpit on the same arm where I was given the shot. This morning, the pain has increased & very tender to the touch.
PATIENT CALL 11/01/2021 REPORTING GENERALIZED URTICARIA WHICH STARTS AFTER RECEIVING THE VACCINE AND AT THIS TIME WAS NOT RESOLVED; PATIENT ALSO RECEIVE INFLUENZA VACCINE BUT HE PREOVIOUSLY RECEIVED THIS VACCINE WITHOUT ANY REACTION
Severe sickness comparable to when I had chemo for breast cancer 11 years ago. vomiting, diaharea, severe ulcer pain, overall sick, very sick feeling, temp of 101.5. I had covid in September 2020 and received first covid shot on Sunday. feb 28th. No problem at all with injection site. I have been very sick and now have activated an old ulcer and am in extreme pain.
On 4/4/2021, I developed a red rash on both arms at approximately 3 pm.  As the evening progressed, the rash spread to both legs, tops of both feet and lower back area.  I took a Benedryl dose in tablet form before going to bed. As of 4/5/2021, the rash is still present.  My physician was notified.  I have taken another Benedryl tablet to help with the rash.
Received the vaccine around noon 2/18/21. Began feeling unwell the same day around 7pm. Right now it's 2/19/21 at 7:50 pm and I continue to have severe headache, all-over body aches and feel like I had a fever but don't according to thermometer. I am feeling worse as time progresses.
Spinal pain, fever, headache, dizziness, heart rate jumping up to 140?s. Extreme Coughing . Lung pain, body aches, chills,  loss of taste and smell, nasal/sinus congestion inflammation
the first shot I did I had no side effect sore arm that was it; This is a spontaneous report from a contactable consumer(Patient herself). A 36-year-old female received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration as SINGLE DOSE for covid-19 immunisation. Patient medical history includes celiac disease and concomitant medications include Claritin-D, Iron supplement, Products B-12, vitamin D. Patient had sore arm. The outcome of the event was unknown.  Follow up attempts are completed, no other information is expected.
Patient experienced a breakthrough menstrual period one day after receiving vaccine. This period was heavier than usual and lasted about 5 days. Exactly two weeks after vaccination a menstrual period began that was heavier and painful than the patient has ever experienced. This patient has never had irregular or heavy periods and has taken hormonal birth control for 4 years.
Today I'm not feeling well; Weakness; I have some headache; Little bit of chill that started yesterday afternoon; My ribs started feeling wrapped tight/compression on my ribs that got away; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Today I'm not feeling well), MUSCULOSKELETAL CHEST PAIN (My ribs started feeling wrapped tight/compression on my ribs that got away), ASTHENIA (Weakness), HEADACHE (I have some headache) and CHILLS (Little bit of chill that started yesterday afternoon) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included COLECALCIFEROL (VITAMIN D3) and FISH OIL for an unknown indication.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (My ribs started feeling wrapped tight/compression on my ribs that got away) and CHILLS (Little bit of chill that started yesterday afternoon). On 02-Oct-2021, the patient experienced MALAISE (Today I'm not feeling well), ASTHENIA (Weakness) and HEADACHE (I have some headache). The patient was treated with OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Adverse event, at a dose of 40 mg. At the time of the report, MALAISE (Today I'm not feeling well), ASTHENIA (Weakness), HEADACHE (I have some headache) and CHILLS (Little bit of chill that started yesterday afternoon) outcome was unknown and MUSCULOSKELETAL CHEST PAIN (My ribs started feeling wrapped tight/compression on my ribs that got away) had resolved.
Patient reports onset 1 day ago with redness at injection site, feverish, started the morning after injection. Today redness still at injection site, are is warm to touch, pain at site, area is "hard". Patient states she has been taking tylenol for the pain and fever. Ice to injection site
Vaccines administered into left and right thighs approximately 1:15pm. About 4 hours later, child appeared to develop severe pain in left leg with continuous crying, redness/swelling at injection site, low grade fever, and inability to bear weight through extremity for several hours. Child was given a warm bath, MOTRIN, and cold compresses, followed by TYLENOL after no relief.
Fainted; This is a spontaneous report from contactable nurse via Pfizer Sales Representative.   An 11-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, Lot # number CN8295. Exp 31Aug2022) at single dose in the right deltoid, hpv vaccine (HPV VACCINE) via an unspecified route of administration in the left deltoid, both on 17Jun2020 for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced fainted after the doses were given in the doctors' office on 17Jun2020. Patient said that he had not had breakfast that morning. The outcome of unknown.; Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
Headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient asked how long headache would last from Shingrix.
Initial information was received from a health care professional on 19 December 2007. Follow up information was received from a health care professional in the on 20 June 2008. Based upon this new information a narrative has been created for this case. A two year old-male patient with no past medical history received a fourth injection of FLUZONE (lot number U2476GA), on 04 November 2007. According to the patient's mother approximately six hours after vaccination, the patient began experiencing edema of hands and feet and hives. The day after vaccination he was seen by his physician and treated with Benadryl. The treating physician suspected "a viral illness vs. a vaccine reaction". The patients symptoms resolved within 2 days.
received expired Moderna COVID-19 vaccine for their booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine for their booster dose.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine for their booster dose.). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine for their booster dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days. No concomitant medications were reported. No treatment medications were reported.
Immed. local injection site reaction "muscle knot" with red colored skin. Skin not warmth to touch with no complaints of pain at injection site, (-) knot pain. The knot decreased in size to almost normal with no red skin color in 15 mins. Pt complained of tingling of fingers that resolved within minutes of injection.
On the same day of vaccinations the pt developed a fever of 102 to 103 degree F and an injection site reaction. The pt's mother reported that the child cried very painfully after injection was given for 1-2 hours.
mild persistent headache                                                 all symptoms are mild flushed face tired lack of appetite/ food tastes different rash
This is a spontaneous report from a contactable consumer. A 76-year-old female patient received PREVNAR 13, via an unspecified route of administration in the arm from 06Sep2018 at single dose at single dose for pneumonia immunisation. Medical history was reported as none. Concomitant medication included COUMADIN. After vaccination the patient thought her arm was going to fall off because it hurt so bad and stated that she went to the emergency room and they kept giving her pain medications, but the pain medications were not helping and did not do any tests to see if anything was wrong with her arm, they gave her morphine, DILAUDID and BENADRYL and none of it helped. They sent her home with LORTAB and it did not help either. Patient reported that the pain continued in her shoulder and neck and part of her back and chest on the right side. Patient described the pain throbs and aches at night. Patient also mentioned that she even had a hard time putting her clothes on because of the pain. Patient also reported that she was coughing every now and then. Patient then went to the doctor's office, and was told that since she was on warfarin sodium and she might have a blood clot in her arm, but didn't do any tests or anything. Outcome of the events was unknown.
RED SWOLLEN AREA OF 3 IN. X 2 IN. PATIENT HAS TAKEN BENADRYL AND WAS ADVISED TO APPLY A COLD COMPRESS TO AREA FOR 15 MIN. PT WILL MONITOR FOR BREATHING ISSUES.
Double vision, tingling in fingers, severe neck and head pain pain on side of face and top of head,  Touching hair hurt, touching ear hurt.  dizzy, fell out of bed.
Diarrhea since 4-29-13 date of admin. Vomited
Repeated pneumonia, multiple bronchitis, and mono-nucleosis, gastro-intestinal distress, fevers, chills, hospitalization. Life long: yearly pneumonias resistant to inoculation, annual and bi-annual bronchitis, symptoms of COPD and chronic breathing problems not associated with asthma.  Chronic fatique.  Cardio-Vascular degeneration, high blood pressure, and events and tendancy toward vascular dissection.
Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number, dose and route were not provided) which was exposed to 1C for 14.2 days. No adverse effects were reported. Additional information has been requested.
Sine 06/12/2021, my body has been covered in swollen, red, itchy hives. My left arm swelled for several days and was bruised, itchy, and very painful. The reaction on my arm subsided after a week, but the full body hives, sore throat, headache, joint pain, chest pain, and exhaustion have continued daily since. I have had swollen lymph nodes and a spot appeared on my mammogram that I had to have rechecked.
slight / minimal tenderness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Feb2021 11:50 (Lot number: EL9263) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Feb2021, outcome "unknown", described as "slight / minimal tenderness at injection site".  Additional Information: Verbatim and Event Description: The caller and the husband got a 4 weeks schedule for 2nd dose. The Patient reported neither her husband or she had any side effects from either of their vaccination, except slight tenderness at site of injection.  Follow-up (29Mar2021): Patient age at time of vaccination was reported as 70 years. Prior Vaccination within 4 weeks: None. Concomitant drugs was reported as None. Patient Medical History was reported as None. Relevant Test was None. Event Onset date was next day. Seriousness criteria: Not Serious.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was received from a health care professional on 26 August 2009. A 48-year-old female patient, with a history of asthma and allergies to cats and smoke, received a right deltoid intramuscular injection of ADACEL (lot number C3250AA) on 20 August 2009. Approximately 12 hours post-vaccination, she experienced an asthma attack. She was seen by a physician, and the event was still ongoing at the time of the report. Concomitant medications included PROVENTIL, TUSSINEX, XOPENEX, AND SYMBICORT.
two doses "years apart", two years since dose two; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.    Additional Information: GSK Receipt Date: 2-Sep-2022 Reporter's Comment: The patient who was over 65 at the moment of this report received two doses of Shingrix years apart and that it had been two years since dose two. The reporter consented to follow up. Additional Supportive Information: The patient received two doses of Shingrix years apart and that it´s been two years since dose two, which led to drug dose administration interval too long.
fever of 100.6; chills; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches), PYREXIA (fever of 100.6) and CHILLS (chills) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced MYALGIA (muscle aches). On 16-Mar-2021, the patient experienced PYREXIA (fever of 100.6) and CHILLS (chills). On 15-Mar-2021, MYALGIA (muscle aches) had resolved. At the time of the report, PYREXIA (fever of 100.6) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 100.6 (High) 100.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.   Treatment information was not provided.   Reporter did not allow further contact
Mother of child called today to report child has had a fever since she got her vaccines on June 11. She reports the fever has gone down today, however, now she has a rash on her left shoulder where she got her shot.
Patient passed away on 7/28. Previous to this, he was COVID positive on  7/21 which he believes he got from his wife. Patient did have symptoms.
This spontaneous report as received from a Licensed Practical Nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unspecified dates, the patients were vaccinated with a dose of improperly stored PEDVAXHIB with lot number M025194 and expiration date of 22-MAR-2019 (strength, route of administration and dose were unknown), which was stored at 35 Fahrenheit degrees for 1 hour and 47.5 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.
On 02/17/2021, patient received the second dose of COVID-19 Moderna vaccine in the left arm. Approximately 3 days post-administration, patient developed pain, swelling and erythema of the shoulder extending to the posterior/proximal anterior sections of the arm. Patient was unable to move arm due to swelling and presented to the Medical Center Emergency Department on 02/22/2021. A CT of the extremities revealed cellulitis, myositis, and possible fasciitis without abscesses. Subsequent MRI found myositis and cellulitis without evidence of osteomyelitis. Patient began to develop erthematous blotches and an Infectious disease consult was placed. Patient was started on broad-spectrum antibiotics (Ceftriaxone, vancomycin, and clindamycin). After cultures were obtained, patient was de-escalated to ceftriaxone. Two sets of blood cultures taken prior to antibiotics and a left arm swab showed no growth (finalized). On 02/26/2021 patient underwent incision and debridement of left arm with findings of edematous soft tissue without abscess or necrosis. On 02/28/2021 all antibiotics were discontinued per Infectious Disease provider due to lack of concern for infection.
Post vax the patient develeoped a macular rash at the injection site, on her upper chest and the top of bilateral arms and shoulders. The patient was treated with Benadryl.
Patient states she was shopping in the am and woke up in the ambulance.  She was told she had a seizure and fell and hit her head.  She was admitted site from 4/10/21 to 4/13/21.
Received the flu shot on 10/7/16. On 10/21/16-Became symptomatic for Bell's Palsy. (She was prescribed Prednisone and Acyclovir).
Hospitalization: 12/26/2022 - 1/3/2023 (8 days) Presentation to the ED: AMS.  COVID + date: 12/26/2022  Treatment: steroids.  Discharge to: home.  Pfizer ER8733 3/29/2021 Pfizer EW0161 4/19/2021 Pfizer 33026BD 11/19/2021 Pfizer FM9992 5/1/2022 Pfizer Bivalent GJ2524 9/14/2022
body aches; nausea; diarrhea; Initial information received on 03-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via a specialty pharmacy.  This case involves "an approximately" a 58 year old female patient who experienced body aches, nausea and diarrhea while receiving vaccine INFLUENZA VACCINE and while treated with DUPILUMAB [DUPIXENT] via dupilumab single dose pre filled pen and COVID-19 VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In September 2021, the patient started taking DUPIXENT (DUPILUMAB) injection 300 mg QOW (every other week) subcutaneously (strength: 300 mg/ 2ml, batch number and expiration date: unknown) for Severe persistent asthma via dupilumab single dose pre filled pen. In October 2021, the patient started taking COVID-19 VACCINE (strength, formulation, dose, frequency, route, batch number and expiration date: unknown) for Prophylactic vaccination. In October 2021, the patient received a  dose of suspect INFLUENZA VACCINE (strength, formulation, dose, frequency, route, batch number and expiration date: unknown) for prophylactic vaccination.  In 2021 the patient developed a non-serious event "body aches" (pain) (unknown latency) following the first dose intake of DUPILUMAB and (unknown latency) following the first dose intake of COVID-19 VACCINE. In 2021 the patient developed a non-serious event "nausea" (unknown latency) following the first dose intake of DUPILUMAB and (unknown latency) following the first dose intake of COVID-19 VACCINE. In 2021 the patient developed a non-serious event "diarrhea" (diarrhoea) (unknown latency) following the first dose intake of DUPILUMAB and (unknown latency) following the first dose intake of COVID-19 VACCINE.  It was reported, "patient reports got covid booster and flu shot last week. Developed body aches, nausea, diarrhea. no fever she says, not sure is she should hold off on her dupixent dose. advised pt (patient) to speak with her physician to see if md (medical doctor) wane her to hold off until her symptoms improved . no additional information provided."  DUPILUMAB (DUPIXENT) was continued. Action taken with  INFLUENZA VACCINE (INFLUENZA VACCINE) and COVID-19 VACCINE (COVID-19 VACCINE) was unknown.  It was not reported if the patient received a corrective treatment for the events (body aches, nausea, diarrhea).  At time of reporting, the outcome was Unknown for the event body aches, was Unknown for the event nausea and was Unknown for the event diarrhea.
This spontaneous report as received from a female patient of unknown age refers to herself. The patient had no pertinent medical history. On 17-APR-2018, the patient was vaccinated with a first dose of GARDASIL 9 for prophylaxis (lot #, expiration date, dose, route and site of administration were not reported). There were no concomitant medications. On 17-APR-2018, the patient felt a little faint and lightheaded but not enough to pull over while driving home. She was also having some stomach discomfort but was not sure if it wasn't from something she ate. The patient did not seek medical attention and no treatment was given for the adverse events. The outcome of events was reported as not recovered/not resolved. Causality assessment was not provided.