chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm hurt; Couldn't lifted up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt) and LIMB DISCOMFORT (Couldn't lifted up) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt) and LIMB DISCOMFORT (Couldn't lifted up). At the time of the report, PAIN IN EXTREMITY (Arm hurt) and LIMB DISCOMFORT (Couldn't lifted up) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2021, SARS-CoV-2 antibody test: positive (Positive) Reactive positive for Anti-SARS-COV-2 IgG antibodies. On 19-Jun-2021, SARS-CoV-2 test: negative (Negative) DDF SARS-COV-2 AB IgG was 8.52 reactive and under normal range it's an arrow going to -1.41 and under units index and sore dry blood spots.. On 09-Sep-2021, SARS-CoV-2 antibody test: positive (Positive) Reactive positive for Anti-SARS-COV-2 IgG antibodies. On 09-Sep-2021, SARS-CoV-2 test: DDF SARSCOV-2 AB IgG was 2.93 reactive and under normal range again it's an arrow going to -1.41 and under units it's index and sore dry blood spots..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.    This case was linked to MOD-2021-335697 (Patient Link).
The injection site, 8 days  after the shot is a red/warm/hard oval lump about 3" long and 2" wide.
Information has been received from a health professional concerning a 73 year old female with high blood pressure, 2 diverticulosis, atrial fibrillation, degenerative disk disease and osteoporosis, an allergic reaction to tetracycline, AUGMENTIN, CIPRO and a reaction to monosodium glutamate (MSD), who on 07-JUN-2007 at 11:30 was vaccinated with Zostavax (Oka/Merck).  On 10-JUN-2007 the patient experienced itching and red hot wheals with red streaks.  No labs were done.  Subsequently, the patient recovered from itching and red hot wheals with red streaks.  No further information is expected.
During the 15 minute post-vaccine observation period, patient complained of feeling lightheaded, Vitals obtained, BP 230/106, sats 98%, HR 53. Placed in reclining position, comfort measures administered, BP remained elevated up to 233/116 so transported to ED via our medical center transport team. Hypertensive urgency resolved within 9 hours, and patient was discharged home in stable condition with BP 156/72.
! day after the second dose patient developed sore throat, mouth sores, body aches and swollen joints. She initially had a fever that resolved.
After receiving the vaccine the patient became clammy and fainted. Patient faints every time she gets a vaccine. We let the patient lay down to regain consciousness and she did after about 30 seconds. After patient sat for a few minutes she was feeling well again
Day after the second dose of vaccine, patient developed extensive swelling, with symptoms resembling angioedema. The swelling continued to randomly appear days after vaccination as well. Patient was prescribed steroids and diphenhydramine to control allergic reaction, however symptoms appear to be worsening  over time. Significant swelling of the lips, neck, face continue to appear, which resemble angioedema type of reaction.
Bad case of hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Bad case of hives) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson COVID 19 vaccine (Primary dose). Past adverse reactions to the above products included No adverse event with Johnson and Johnson COVID 19 vaccine.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Bad case of hives). The patient was treated with PREDNISONE for Hives, at a dose of 4 doses; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Bad case of hives) outcome was unknown.            No Concomitant medications were reported.  Two days after receiving the booster dose, patient started having a bad case of hives. The hives got worse each day. Patient had been taking antihistamines and steroid. Patient's father stated that he does not have his son's vaccination information.
Bruising at injection site; slightly larger than a quarter with swelling, slightly larger than the bruise and tenderness.
On 1/25/00, was vaccinated with the first dose of varicella virus vaccine live and on 2/7/00, the pt developed a "chickenpox rash that consisted of 30 lesions on her back, legs, stomach and chest. The pt also developed redness and swelling at the injection site." Lab evaluation revealed a negative varicella titer after 1 dose of the vaccine. The pt sought unspecified medical attention. Additional information has been requested.
Circular redness around injection site, continued to grow large for 7 days.  Patient returned to clinic for observation.  Reddened area now 6X9 CM.  Not hot to touch.  Patient says it itches.  Pt instructed to apply cortizone cream to site and follow up on Monday 11/10/14.  Call PT today, she states redness around injection site is almost gone.  Much relief with cortizone cream.
Chills Fever of 101 degrees Tiredness Slight head "wooziness"
Still feverish; Dizzy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not provided), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date as 1st dose, single for COVID-19 immunization. The patient had experienced still feverish and dizzy on an unspecified date. It was reported that patient got vaccinated with second dose on tuesday and was still dizzy, still feverish and wondered was that normal. The outcome of the events was reported as unknown.  Information regarding the lot/batch number has been requested.
Severe swollen lymph node in left arm pit with severe pain- size of a plum Severe headache  - 2days Extreme tiredness - 2days Chills  - 2 days Night sweats x 2 days
heart was racing; tingling feeling; passed out; dizzy; queasy; I am diabetic; sick; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot number: EN9581, Expiry Date: 31May2021) on 17Feb2021 and 13 days later patient started feeling sick and wholly got sick. Patient went for the second vaccine and passed out as she got the vaccine right there in the hospital (10Mar2021), so they gave her the vaccine and then patient sick for the next three weeks 3 and half weeks. The first-time patient passed out they took her to the emergency room for whole afternoon on 10Mar2021 because patient was so dizzy and queasy and she guessed they did like 'A1C' on her. They made sure that took blood for her they made sure patient was diabetic. They wanted to make sure there was nothing wrong with patient and then they sent patient home at same afternoon and patient went home and another whole week she was so dizzy and nauseous and now she was tingling feeling. All kind of weird things happened to patient and her heart was racing. Patient took herself back to the hospital after a week. Patient had to stay in the hospital for two days. And then they did MRI on her and a CAT scan and then they sent patient to neurologist and then patient to do another MRI. Patient been for past six weeks was being turmoil. Outcome of the events was unknown.
High fever, chills, body aches, extreme fatigue, fullness/tightness in chest, severe red eyes.
Dizziness, Headache, Myalgia, Arthralgia, Fever,  fever 103.5 weak myalgias arthralgias week five days Narrative:  Other Relevant History:
Numbness right upper arm lateral aspect and base of right thumb since 7:15 am today
Narrative: Patient received Moderna COVID vaccine at outside facility on May 20, and began experiencing symptoms on May 21. Patient call pharmacy call center on May 24th with chief complaint of chills, body aches, headaches, cough with large amounts of green phelgm stating the texture of the phelgm was different, & nausea. Follow up phone conversation with PCP on June 1, patient continued to complain of productive cough - CXR performed and revealed interstitial lung markings - in tandem with symptoms, patient was diagnosed with URI (bronchitis/sinusitis) and prescribed doxycycline
Pt exp pain at inject site min after vax. Pain persisted for 2 days. Reporter notes: Inj given w/1.5 in. needle. Reporter stated other pts exp same rxn but was unable to track these pts.
p/vax pt devel an inj site rxn characterized by redness & swelling;
Information has been received from a medical assistant concerning a 3 year old female who on 24-NOV-2008 was mistakenly vaccinated IM with PNEUMOVAX 0.5ml (LOT# not reported) instead of her fourth dose of PREVNAR. No adverse effect was reported. This was not due to product confusion. It was not reported whether the patient sought medical attention. Follow-up information was received from the physician's Office manager. The patient had received the vaccine (lot# 662663/0980X) by human error on24-NOV-2008. The patient was fine and she would be coming back to the physician's office in 2 months for PREVNAR at the next well visit. No further information is available.
PATIENT WAS GIVEN VACCINE INTENDED FOR CHILDREN ABOVE 3 YEARS OF AGE. FAMILY HAS BEEN NOTIFIED OF MISHAP. NO ILLNESS OR REACTIONS CAUSED BY VACCINE.
A serious spontaneous report of vocal cord paralysis with symptoms of hoarseness of voice and sore throat has been received from a physician concerning 47-year-old female patient subsequent to Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. Neither relevant medical history nor concomitant medications were reported. On 27-Oct-2009, the patient received Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal for an unknown indication. On the same day, immediately after vaccination, the patient had vocal cord paralysis with symptom of hoarseness of voice and sore throat. The outcome of vocal paralysis with symptom of hoarseness of voice was not resolved and outcome of sore throat was resolved.
No additional adverse events reported; A dose of PROQUAD was administered instead of MMR II, that was concomitantly given with a dose of VARIVAX to a 1 year old child by mistake today; A dose of PROQUAD was administered instead of MMR II, that was concomitantly given with a dose of VARIVAX to a 1 year old child by mistake today; This spontaneous report was received from a registered nurse referring to a 1-year-old patient. The patient's current condition, pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 15-FEB-2022, nurse stated a dose of vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U029179 and expiration date upon internal validation was 08-MAR-2023), 0.5ml was administered instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II), that was concomitantly given with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # U024765 and expiration date upon internal validation was 10-AUG-2023), , 0.5 ml to a 1 year old child by mistake on same day for prophylaxis (wrong product administered and Accidental overdose). No other information given. No additional adverse events reported.
Pt received her 3rd and final dose of HPV vaccine on 6/3/08.  Per mother patient was found dead, in bed on 6/22/08, in her dorm room at an out-of-state college.  According to the autopsy the patient had been dead for about 48 hours.  According to mother autopsy was negative except for splenic inflammation. 8/22/08 Autopsy report also states Final Diagnoses: Cardiac arrest, cause undetermined w/recent history of PAC w/otherwise normal EKG; normal echocardiogram 2/08; no evidence of myocarditis; acute pulmonary edema; slight splenomegaly; cardiac blood neg for ethanol; urine (+) for ethanol=16 mg/dl; liver (+) for acetaldehyde (incidental finding). 3/5/09-records received for DOS 8/22/07-seen for routine visit and first annual pap test..PE normal.  First HPV vaccine administered. 2/4/09-records received for DOS 11/20/07-C/O chronic PAC and irregular heart beat.
mom noted fine rash Monday noc around 11PM; by Tuesday AM pt had light head to toe splotches; mom called MD wed AM & was told to take pt to MD; MD saw pt Wed PM & confirmed allergic urticarial rash w/o fever or other sx; given DPH & APAP;
Heavy, unprecedented period flows for periods following vaccine, primarily in first two periods after vaccine. Serious, unprecedented abdominal pain and cramping during first few days of menstruation periods following vaccine dose 1, has continued 4 cycles past the vaccine and is still continuing and has not subsided.
8/13/04 Right shoulder pain, nausea, fever; used Aleve. 8/14/04 Seen in ER, right shoulder pain, no ecchymosis, no swelling, given sling and Vicodin PO. 8/16/04 Seen at family practice; tissue inflammation. Referred to specialist if needed.
Muscle aches, joint pain, headache, and low-grade fever.  Also, lethargy. These symptoms lasted 24 to 30 hours.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th September 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patient received 1st dose of Shingrix and experienced sore arm. The patient had done blood work for a rheumatology consult and would visit an orthopedic surgeon. The reporter called back and updated the correct date for the 1st dose as 10th September 2020. For the tolerance of 2nd dose of Shingrix, refer case US2021AMR002842. The case is linked with the case number US2021002013, reported by the same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021002013:Same reporter US-GLAXOSMITHKLINE-US2021AMR002842:
No additional Adverse Event information provided; Expired "Hepatitis A" vaccine was accidentally administered; This spontaneous report was received from an executive referring to an unknown age and gender patient.  The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient has been accidentally vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) (manufacturer unknown) (reported as a "Hepatitis A") (strength, dose, frequency, lot number, expiration date, route of administration, and anatomical injection site were not provided) (expired vaccine used).   No additional adverse event (AE) information was provided.  This case is non-valid due to the lack of patient identifiers.  Follow up information has been received on 13-JUN-2022, from a medical assistant. The case has now become valid as the patient was specified as 35-year-old, who was allergic to erythromycin. The patient has no past medical history and has no concomitant medications listed.  On 06-MAY-2022, expired hepatitis A vaccine inactivated (VAQTA) was administered in the left deltoid of the patient, by a trained medical assistant, at a private doctor's office and was purchased with private funds. The vaccine is not available for return.
No adverse effects reported; expired vaccine administered; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that on 13-MAY-2019, the patient was inadvertently administered a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (Lot: N014485; expiry date: 10-MAY-2019) (dose and route were not reported) that was expired (expired product administered). No adverse effects reported.
Patient was given Pfizer vaccine on first dose and inadvertently give Moderna on 2nd dose. No adverse event occurred.
After my first COVID shot on 3/30 I started with ear pain and itchiness. Went to immediate care center and was diagnosed with acute otitis externa of left ear. After my second COVID shot on 4/20 I got the same symptoms in the right ear.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  On 18-Oct-2021, the vial was placed in the refrigerator. The vial did not undergo any temperature excursion and the patient had no adverse event.  The reporter also said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  No treatment information was provided.   This case was linked to MOD-2022-491837 (Patient Link).
This spontaneous report as received from a certified medical assistant refers to a 1 year old patient of an unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) unknown route and strength (lot # K015970 with expiration date 23-SEP-2016 or lot # K021847 with expiration date 03-NOV-2016 or lot # L001335 with expiration date of 13-JAN-2017) which were exposed to temperatures outside of the recommended range. There was no adverse events reported. The reporter could not break out which specific lot number of vaccine was administered to the patient. This is one of the several reports received from the same reporter. Additional information has been requested.
Shingles - rash on right side of abdomen.  A week of 800MG acyclovir, 5/day.
Information has been received from a registered nurse concerning a 16 month old male who on 06/19/2004 was vaccinated with a dose of varicella virus vaccine live.  On 10/23/2004 the patient developed a vesicular rash of about 50 lesions over his entire body.  Unspecified medical treatment was sought and no other symptoms were noted.  At the time of this report the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Palpitations lightheaded nauseous Developed  high blood pressure  Elevated heart rate  Blood Tests Dextrose
This medically confirmed spontaneous report concerns a 52 year old female patient. The reporter is the patient who is also a pharmacist. Medical history included a drug reaction to doxycycline (rash). Concomitant medications included multivitamins daily. The patient has had influenza vaccine once last year which was not AFLURIA. On 02-Oct-2012, the patient received AFLURIA (batch no. unspecified) via intramuscular route in the left arm. About one week to 10 days post vaccination, the patient developed sensory issues. She had numbness, tingling of the buttocks, genitals, that moved down one side of her leg. It was almost like a hypersensitivity reaction. The patient stated that subsided somewhat, but now has mostly tingling, numbness, coldness in her legs and feet. Even when lying down in bed the tingling occurs where her body is in contact with the bed. The patient states she thinks this is an immune mediated response to AFLURIA. The event outcome was not recovered.
6-4-2021 15:30. Subjective: This 17 y/o male pt presented to the vaccine administration site and was administered his first dose of the Pfizer Covid-19 vaccine. Prior to receiving the vaccine the patient had made a comment in regards to not liking needles. Following vaccine administration the pt stated that he began to feel dizzy and ?then things went dark.? The patient was seated vertically in a chair and had fallen forward onto the ground. Patient care was immediately administered and the patient was moved supine with his lower extremities elevated. The patient regained consciousness immediately and asked if he had ?fainted?? The patient then stated that he was very warm and had not eaten or drank very much today. The patient attempted to then sit up rapidly from a supine position causing him to have a second vasovagal syncopal episode. The patient was placed in a supine position following this and cold packs were administered as well as vitals were taken. The patient remained A&O X4 with a GCS of 15 for the remainder of patient contact. EMS was called and the patient was then transported with consent of his legal guardian to the nearest E.D. Objective: Pt was noted to have two consecutive vasovagal syncopal episodes following his first dose of the Pfizer Covid-19 vaccine. The patient stated he had not eaten or drank very much today. Assessment, PE,VS: The patient was noted to have a small abrasion to the right side of his face secondary to his glasses striking him after he had fallen. The patient's BP was noted to be 100/60 mmhg with a pulse of 64. The patient was A&O X4 with a GCS of 15 following his two separate syncopal episodes. HEENT: All findings normal, pt?s pupils PERRLA at 4mm. Cardiac: Normal Pulmonary: Normal, however verbal respiratory rate control was advised to the pt. Abdomen: Normal, cold compress applied. Extremities: Normal, Cold compress applied. Plan: Pt was continuously monitored and transferred to EMS care for transport to the nearest
EXCRUSIATING BODY ACHES AND NECK PAIN, FEVER OF 103.2. NAUSEA AND VOMITING. ALSO HEADACHE ON 3/7/21.
Pt recvd 1st dose of Engerix-B & 8 hrs post vax exp chills, fever, body aches, & mouth cold sores (herpes simplex on lips); pt took APAP; events resolved w/in 3 days;
Administered vaccine that was drawn the day before and thus expired. no adverse effects seen at this time.