chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had some big time nausea with that second shot on the second day; general malaise; some fever; . This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, Manufacturer unknown), for COVID-19 immunization, reaction(s): "nausea". The following information was reported: NAUSEA (non-serious), outcome "recovered", described as "I had some big time nausea with that second shot on the second day"; MALAISE (non-serious), outcome "unknown", described as "general malaise"; PYREXIA (non-serious), outcome "unknown", described as "some fever".  Additional information: Caller has questions regarding allergic reaction. Caller has received the Pfizer Covid-19 booster dose and experienced pain in his shoulder blade and on his neck. Caller asked if there are similar reports of "referred pain". Caller added that he has loose bowel which is "not totally diarrhea but it's close." Caller mentioned that he got from the previous two vaccine experiences but actually he didn't have it with the first one. Caller said, "he got it on the second day of the second dose, but it was gone by the next morning then he had some of the general, some, he had some big time with that second shot on the second day." Caller stated that there's a certain amount of that which was just expected. Caller mentioned he doesn't have a major diarrhea. He was just mainly checking on the neck and shoulder blade issue if "referred pain was possible from that per se." Caller added that, He got mobility. He can swing his arm like throwing a baseball but it does hurt because he got the shot in his arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sick; flu like symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick) and influenza-like symptoms (Verbatim: flu like symptoms). The outcome of the sickness and influenza-like symptoms were resolved.   It was unknown if the reporter considered the sickness and influenza-like symptoms to be related to Shingles vaccine.     It was unknown if the company considered the sickness and influenza-like symptoms to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-JUN-2023 This case was reported by a patient via interactive digital media. The reporter reported that he had the vaccine and stated that it was not too bad at all. The reporter's wife got the vaccination shot and was sick for 2 to 3 days with flu like symptoms. The follow-up could not be possible as no contact details were available.
I did not have an adverse reaction to the vaccine. I got sick with an upper respiratory infection on 12/25/2022. I also had double ear infection too. I had three virtual medical office visits and I saw my prior doctor. I was given antibiotics for the respiratory infection and ear infection. As of today, I still have some congestion.
Based on additional information received on 23-Jul-2015, this case became medically confirmed. Initial unsolicited report received from a non-healthcare professional on 04 June 2015. A 54-year month-old female patient, had received a first dose of ADACEL (batch number U5095AA, expiry date, dose were not reported) intramuscularly in left deltoid on 01 June 2015 (15:00 hours). Patient had also received a dose of POLIO VACCINE (batch number U001-1, expiry date, dose, dose number were not reported) intramuscularly in left deltoid on 12 May 2015. Illness at the time of vaccination was reported as urinary tract infection (UTI). Pre-existing physician diagnosed allergies birth defects, medical conditions were reported as hypertension (HTN), neuropathy feet and there was no known drug allergy (NKDA). Concomitant medications were lisinopril, gabapentin, NASONEX, CLARITIN, mvi, BIOTIN, vitamin D, calcium. On 01 June 2015 (18:30 hours), i.e. 3.5 hours post vaccination, patient developed low grade temperature (temperature 98 degree celsius) and experienced headache after unspecified time on the same day. Patient had tiredness and muscle aches on 02 June 2015. Other laboratory investigations were reported as none and corrective treatment was not reported. At the time of this report, patient was recovered from the event of low grade temperature on 03 June 2015 and was not recovered from tiredness, muscle aches and headache. Documents held by sender: none. Follow up information received from a nurse on 23-Jul-2015. On 01 June 2015, the patient developed headache. On 02-Jun-2015, he had tiredness and muscle aches. On 05 June 2015, the patient recovered from the above mentioned events. Documents held by sender: none.
Patient received Johnson and Johnson Vaccine around 4/1/21. Patient presented to the emergency department today with chest discomfort and shortness of breath. CT scan results: segmental pulmonary emboli within the superior segment of the left lower lobe and lateral basilar segment of the right lower lobe. Patient does have a history of PE 10/2020 with obvious insult of immobility post gastrectomy and was treated successfully. Patient was not on anticoagulants prior to arrival today.
C/O tiredness 1/13 (one day after vaccines), walked to classroom teacher during class and had syncopal/loss of consciousness for 3 seconds. No known seizure activity, no prior history of syncope, no fevers. Went to school nurse, seemed fine after. Had normal breakfast that morning, event not associated with exertion.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 24Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa antibiotics" (unspecified if ongoing), notes: known allergies: Sulfa antibiotics. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
potential interaction between the COVID-19 virus and the virus affecting his cancer; small pain in [his] arm; This is a spontaneous report from a contactable consumer reported for himself. A 83 years old male patient received the Second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry date was Unknown) via unspecified route of administration on 12Feb2021 for COVID-19 immunisation. Patient historical vaccine included received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry date was Unknown) via unspecified route of administration on unspecified date as 1st dose single for COVID-19 immunisation. Patient medical history included has rare cancer called classic Kaposi sarcoma. Patient concomitant medication was not reported which was associated with a virus. Patient explained that this virus lived dormant in his body but last year, his immunes system became weak, and the virus activated. Patient added that it manifested as a lesion on his skin and his current prognosis is of 5 years. Patient stated he needs to start chemotherapy, yet after researching he found opposing recommendations as to when he should start his treatment following the COVID-19 vaccination. Patient added he also found a recent publication from a scientist in (publication name) stipulating a potential interaction between the COVID-19 virus and the virus affecting his cancer. Patient said based on this article the cancer virus may be activated by the COVID-19 virus; and wants to make Pfizer aware of it. Patient asked for general recommendation on how long to wait before starting chemotherapy. Patient mentioned speaking with HCP, including physicians and his wife but would like to get our perspective. He also reported having small pain in his arm after the second dose of vaccination and he took Tylenol, and it was fine now. The outcome was unknown for potential interaction between the COVID-19 virus and the virus affecting his cancer and recovered for pain in his arm.  Failed to offer warm transfer to DSU. E-transmitting AE.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
I experienced a fair amount of injection site pain, more in the right arm where I received the flu shot.  I began to feel a bit achy around bedtime and that proceeded fairly quickly to an onset of severe chills, aching, and shaking, which lasted for a number of hours while I tried to sleep through it.  I had limited chills when I awoke, felt achy, for most of the day, and the arm pain continued to bother me throughout the day.
Patient reported 12/10/2013 that since his flu shot on 11/1/13 his arm has been tender to touch at the injection site. There are no signs of swelling or inflammation, nor are there any lumps or abnormalities that can be felt under the skin.
This case was reported but a nurse and described the occurrence of jaundice in a 10 year old female patient who received hepatitis A vaccine inactivated. The patient's medical history was notable for diabetes mellitus (type not reported). On 7/1/04 the patient received a dose of Havrix (dose number not specified). At an unspecified time following the administration of Havrix, on an unspecified date in July 2004, the patient experienced jaundice, elevated liver enzymes and diarrhea. The patient was seen at a physician's office. A test for antibodies to hepatitis A, performed on 7/23/04, was inconclusive. The outcome of the events is unknown. Jaundice and elevated liver enzymes were assessed as medically serious (OMIC). Follow up 02/14/05: A request for recovery statust has been made. 60 day follow-up report (October 1,2004 to October 21, 2004).
pt recv 31OCT96 by that evening noticed redness & swelling & arm felt heavy;states 2NOV96 & measured 3 1/2 inches diameter;saw MD 13NOV96; had 1 3/4cm red & sl swollen area that was soft & non tender;
Shortness of breath, rapid heart beat, dizziness, extreme chills, coughing (deep bronchial), lightheadedness.
40 yo female receiving first dose Pfizer vaccine ? nurse provided education. Client expressed feelings of anxiety, ?I am so nervous, that?s why I bought my husband with me,? as she held her hands tightly together.  In addition, a young pt. (between ages 5-11) received her vaccine, and yelled, which increased client?s anxiety level; she put her forehead in her hands, closed eyes tightly and stated, ?oh no, that just makes me more nervous.?  Nurse (I) acknowledged her feelings, educated anxiety-induced reaction, then instructed client to take slow, deep breaths, which client demonstrated properly.   1:52 pm client received Pfizer 0.3 ml (first dose) and immediately reported feeling ?lightheaded, I know I worked my self-up and that girl did not make it better.? Instructed slow deep breathing, and possible 30-minute wait; client then requested nurse take blood pressure. 1:53 pm manual blood pressure 140/92 right arm ?that?s high for me, I usually run low.? Reinforced anxiety-induced reaction, then stood-by as client got up and walked to waiting section (accompanied by her husband); informed client would check blood pressure again in 15 minutes re: monitoring time.  2:00 pm reported decrease feelings of lightheadedness ?better.? 2:08 pm blood pressure decreased to 120/80 right arm, denies feelings of lightheadedness ?I know it was my nerves.? 2:10 pm client stated, ?I feel much better now.? 2:15 pm no further complaints; client left with husband
Vaccine was given on 7/15/03. On 7/28/03 pt came in with a cellulitis of the leg (left) at the injection site. Was put on Duricef and told to come back if the reaction went beyond the Dr's markings. Came back 7/29/03. Reaction was larger and pt was given 1 gram of Rocephin IM. Was told to come back in AM, if reaction was bigger. Leg was much better, told to continue Duricef.
INCORRECT PRODUCT STORAGE; ADMINISTRATION OF VACCINE FROM PUNCTURED VIAL LEFT OVERNIGHT (OVER 6 HOURS); This spontaneous report received from a pharmacist concerned a 61 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: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 25-OCT-2021 11:14 for prophylactic vaccination. No concomitant medications were reported.  On 25-OCT-2021, the patient experienced administration of vaccine from punctured vial left overnight (over 6 hours). On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from punctured vial left overnight (over 6 hours) and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20211049878.
Upon leaving observation, pt stated her lips felt "tingly".  No edema present to site.  Pt, recieved (2) Benadryl 25mg from this nurse to take w/ her.  Pt was currently @ work, and did not want to take meds @ present time.  Left observation @ 11.02.
Extreme chronic fatigue, brain fog, lack of concentration and focus, taking naps during the day (unusual) sleeping more than 12 hours during the night. Symptoms have lasted over a month!!
Information has been received from a certified medical assistant concerning a patient of unknown age and gender, who on 14-AUG-2012 was administered with an expired dose of VARIVAX (Merck) subcutaneously (dose not reported) (lot # 668650/1040Z, Exp: 11-AUG-2012). No adverse effects reported. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (EXTREMELY FATIGUED) and IMMUNISATION REACTION (SICK AFTER SECOND DOSE OF COVID 19 VACCINE ) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In April 2021, the patient experienced IMMUNISATION REACTION (SICK AFTER SECOND DOSE OF COVID 19 VACCINE). In August 2021, the patient experienced FATIGUE (EXTREMELY FATIGUED). In 2021, IMMUNISATION REACTION (SICK AFTER SECOND DOSE OF COVID 19 VACCINE) had resolved. At the time of the report, FATIGUE (EXTREMELY FATIGUED) had not resolved. No concomitant products were reported. In April 2021, the patient experienced sick after second dose of Covid 19 vaccine. In August 2021, the patient experienced extremely fatigued. In 2021, the sick after second dose of Covid 19 vaccine resolved. Moderna covid-19 vaccine (covid-19 vaccine mrna (mrna 1273)) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. In Mar 2021, patient received first dose covid-19 vaccine manufactured by Moderna. On 02-Apr-2021, patient received second dose covid-19 vaccine manufactured by Moderna. The patient was treated with vitamin B.  Causality for Humira (adalimumab). The reporter's causality for the event(s) of extremely fatigued with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of sick after second dose of Covid 19 vaccine was not provided. No treatment information was reported by the reporter. 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.
Chest pain on multiple circumstances or occurrences during exercising (hiking). Shortness of breath.
12 hours after injection arm pain chills fatigue headache nausea 24 hours after vaccine lip swelling 48 hours more lip swelling and face swelling
Vomiting, trembling, chest pain on the left-side, shortness of breath, dizziness and vomiting lasted for several hours.
Client reports light headed, faint, nausea, queasy, Injection site feels hot and sore. pulse 82, Temp 95.5 Symptoms began about 1 PM today. Client in driving and seems disoriented. Encouraged to pull over and get to nearest ER.
pt recvd MR vax on 4FEB92 & several days p/vax devel generalized joint pain & swelling; @ time of report pt had persistent occasional aches & swelling of ankles & fingers but was able to work;
Heavy feeling, throbbing feeling from elbow down. Tingling in left arm. Is totally relieved by laying it down flat. But when getting up it goes to throbbing/heavy feeling pain again.
I started having headaches that were pretty intense and constant. It progressed between doses to having a headache everyday. I had swelling and joint pain, I went to the doctor for the ongoing headaches except for some OTC treatment. I got some blurriness and numbness in my left shoulder. My biggest concern was the constant headaches.  I also saw my rheumatologist. He increased my acthar between shots to see if it would calm things.
1MAR91 fever 102; Hosp on 4MAR temp 106.5, broke out in rash all over body on 4MAR91;
patients that had lymphatic issues were having aggravated lymphatic issues after receiving the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHATIC DISORDER (patients that had lymphatic issues were having aggravated lymphatic issues after receiving the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lymphatic disorder.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced LYMPHATIC DISORDER (patients that had lymphatic issues were having aggravated lymphatic issues after receiving the Moderna vaccine). At the time of the report, LYMPHATIC DISORDER (patients that had lymphatic issues were having aggravated lymphatic issues after receiving the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The doctor (specialist) recommending the patients with lymphatic issues, not to get the Moderna vaccine.
vision loss Narrative:  Developed loss of vision in left eye on 1/7/2021. Visited Retina specialist, has to receive injections to her left eye for the next 4-6 months due to a branch retinal occlusion with swelling and vision loss.
mom called 10AUG93 local react 3 in diameter site; also spoke to MD nurse-both advised ice pake redness heat; 11SEP93 redness now both sides of arms from elbow to neck down chest; 12SEP93 pain @ inject site;
Allergic reaction to the vaccine; Hives on the posterior aspect of both arm and the posterior left leg; This spontaneous case was reported by a physician and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction to the vaccine) and URTICARIA (Hives on the posterior aspect of both arm and the posterior left leg) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included BENZTROPINE [BENZATROPINE], HALOPERIDOL, METHADONE, MIRTAZAPINE and POLYETHYLENE for an unknown indication.    On 06-Feb-2021 at 11:35 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021 at 1:27 PM, the patient experienced ALLERGY TO VACCINE (Allergic reaction to the vaccine) (seriousness criterion intervention required) and URTICARIA (Hives on the posterior aspect of both arm and the posterior left leg) (seriousness criterion intervention required). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intramuscular) on 06-Feb-2021 for Adverse event, at a dose of 25 mg once a day; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intramuscular) on 06-Feb-2021 for Adverse event, at a dose of 50 mg once a day and PREDNISONE (oral) on 06-Feb-2021 for Adverse event, at a dose of 60 mg once a day. At the time of the report, ALLERGY TO VACCINE (Allergic reaction to the vaccine) and URTICARIA (Hives on the posterior aspect of both arm and the posterior left leg) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Vital signs measurement: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included 25mg bendaryl IM, 60mg prednisone PO. The patient was not having any breathing difficulty, lungs were clear and vitals were normal. After treatment, the patient was monitored for 30 minutes more and found that itching stopped. The patient went to UC approximately four hours later stating that her symptoms reoccurred.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient fainted and fell to the floor while leaving the office, very pale, diaphoretic, smelling salts used, somewhat disoriented and vomited.  Wheeled back to exam room BP taken, vomited again and became more oriented after 10 minutes.  at 15 minutes after the event patient felt better and left without complaints accompanied by her sister.
Client stated he felt "weird" after HPV vaccine and proceeded to faint while sitting on exam table. Client recovered within a few seconds and stated he felt nausea and vomited a scant amount. Provided client with cool rag, water to drink as well as a snack. After a few minutes he stated that he no longer felt weird and was feeling back to normal.
9/25 Thursday: no swelling. 9/26 Friday after 2 PM: small knot. Later parent placed ice on LD, arm swelled more and became red. Saw urgent care physician.