chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slightly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Slightly sore arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Slightly sore arm). At the time of the report, PAIN IN EXTREMITY (Slightly sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided    Reporter did not allow further contact
Enlarged right atrium. Pulse rate from 120 to 125 Lasted  three weeks
This case was reported by a consumer and described the occurrence of local reaction in a male subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included allergies and asthma. Concurrent medications included SINGULAIR, ADVAIR and NASONEX. On 24 September 2009 at mid-afternoon, the subject received 1st dose of FLUARIX (right arm), and experienced intramuscular formulation administered by other route. On 25 September 2009, 24 hours after vaccination with FLUARIX, the subject experienced a local reaction. The consumer reported that the subject, her husband, was given a GSK flu vaccine intradermally, but was uncertain if it was FLUARIX or FLULAVAL at his physician's office. The consumer stated that the physician's office only reported that it was a GSK vaccine. The consumer reported that she was informed by the physician's office that the vaccine was administered intradermally due to there being a vaccine shortage. The subject experienced a big local reaction 24 hours after receiving the vaccine. The consumer reported that the physician's office stated that this was normal. At the time of reporting the local reaction were improved. At the time of reporting the events were improved.
Information has been received from a physician through the pregnancy registry concerning a pregnant (LMP 9/3/02) 25 year old Asian female with no concurrent medical conditions and no previous pregnancies, who on 9/21/02 was vaccinated with a dose of varicella virus vaccine live for immigration purposes. Concomitant vaccination included a dose of MMR II. Other concomitant therapy included prenatal vitamins. On 10/29/02 the pt had a spontaneous abortion. The pt did not develop a local reaction at the vaccination site. The pt did not develop chicken pox or shingles symptoms post vaccination. The reporter noted that there were no complications during pregnancy or labor/delivery. These were no diagnostic tests during pregnancy. There were no infections or illnesses during pregnancy. Additional info is not expected.
Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in an elderly female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Administration of the Moderna COVID-19 vaccine past the published expiry to 19 patients. The vaccine were thawed on the day of administration and administration was spread out throughout  the end of March to the beginning of April.  Number of doses/vials: 19 doses. Date the vial was initially stored in the refrigerator: 01Apr2022/thawed on the day of use. Date(s) of administration of vaccine: 19 patients were administered on 29Mar2022, 30Mar2022, 31Mar2022, 01Apr2022 and 04Apr2022.. The vial did not undergo any temperature excursions.
Swelling from injection site right deltoid to wrist red raised rash below injection site. Treatment with Benadryl and Prelone.
Soreness at injection site-took ibuprofen for pain relief, applied arnicare natural cream neither gave relief from the soreness. Dizziness and nausea 1-2 days after the vaccine was administered--pt took dramamine but had no relief. Headache that comes and goes 1 day after the vaccine.
I had an 11 year old male here in clinic for routine immunizations. He was given TD, MCV4 and HPV #1 at 9:20am and within 1-2 minutes while still in my office he became nauseated and his facial color went pale.  I had two other nurses assist with getting him to lie down and elevate his feet; he was able to talk to us about how he was feeling. Vitals taken at 9:22am B\P 110/80 Pulse: 75. We then had his sit up after a few minutes  and took his B/P 115/75 and his color started to return to normal and he was no longer nauseated. We then had his stand to retake his B/P 108/60 Pulse 68. He was alert and talking and able to walk out with his mom.
day 2 after shot arm was sore. patient had chills, pressure in the head, achy body and no taste.
pain starting in legs, spreading through body. rec'd vaccine in May, believes she has Guillan-Barre. states she normally walks w/out a cane and has some episodes of urinary incontinence.  54 years old with past history of asthma came in for with lower extremity weakness and pain after she was given the Johnson & Johnson COVID-19 vaccine on May 7, 2021.  Patient thinks this is related to the vaccine, she thought it was progressive pain and worsening of weakness which has become unsteady.  Admitted to the hospital to rule out Gilliam Barré and other progressive post viral infection myelopathies.  We will also worried about multiple sclerosis.  She did have a spinal tap which is completely normal with no evidence of encephalitis, meningitis or evidence of Gilliam Barre, she did also have MRI of the brain, cervical, thoracic and lumbar spines which is also completely negative.  Seen by neurology and think this is likely fibromyalgia because of the weakness and pain together not clinically fitting with any post viral infection neuropathy.  Patient was put on Cymbalta but this will take at least about 1-2 weeks to get the effect of improvement.  She was seen by PT and OT and has some improvement to her weakness and was able to walk with assistance and recommend that she'll go home with home health to continue therapy and she'll follow-up with neurology.  She may also benefit from Tizanidine if Cymbalta is not making a lot of difference.?
got sick; pain after second dose; develop a fever of 102 F; Aches after second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (got sick), PAIN (pain after second dose), PYREXIA (develop a fever of 102 F) and MYALGIA (Aches after second dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunodeficiency NOS (moderately immunodeficient).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (got sick), PAIN (pain after second dose), PYREXIA (develop a fever of 102 F) and MYALGIA (Aches after second dose). In 2021, ILLNESS (got sick), PAIN (pain after second dose) and MYALGIA (Aches after second dose) had resolved. At the time of the report, PYREXIA (develop a fever of 102 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 102 f (High) fever of 102 F.         No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-321147 (Patient Link).
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 83 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 14-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 14-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/07/21Lot#EL3248  2nd dose  01/27/21,lot#EL9262 Diagnosed covid positive:08/05/21 Symptom onset:08/02/21 Exposure: Symptoms:Cough, loss of smell, scratchy throat,runny nose, loss of smell.
I developed severe abdominal pain.  CT scan of the abdomen was negative, but my LFTs were markedly abnormal (ALT 622, AST 315).  I underwent numerous tests for autoimmune hepatitis and viral etiologies of hepatitis, all of which were negative.
Extreme dizziness and difficulty concentrating, and fatigue for 2 days progressively getting worse
Pt was administered a Hep B booster using a pediatric dose 10mcg/0.5ml Engerix-B on 7/9/2007 instead of an adult dose. No adverse event noted.
All symptoms were reported at the time as separate incidents that continued over the course of a week and ended with an ER visit. Symptoms were not known to be related to vaccines at the time.  Symptoms: Severe Back/ Pain in right side, severe pain then migrated to the chest, chest tender to the touch, rapid heart rate/best, severe pain in chest feeling as if heart was going to explode, chest pain then migrated to left arm and wrist, swollen and inflamed left arm and hand, unable to lift of bend hand and fingers, fluid retention and ankle swelling. This happened between the day following my second dose and the middle of the next week.
Very sick; temperature of 100 degrees; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick) and PYREXIA (temperature of 100 degrees) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PREGABALIN (LYRICA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and PREGABALIN (LYRICA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Very sick) and PYREXIA (temperature of 100 degrees). At the time of the report, ILLNESS (Very sick) and PYREXIA (temperature of 100 degrees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 degree.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.   Patient was never been that sick with a vaccinations. It took her five days to get over this and ran a temperature of 100 degrees.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Localized Petechiae around injection site 3 days after receiving vaccine.  Redness, swelling, warmth, & itching on Day 7 1/24/2021 in the evening around 7:50pm PST. Took Benadryl 25mg 1 tablet.  Less itching & swelling, but mild redness spreading but still localized on Day 8. Ice pack applied x 20min. Still monitoring. Overall symptoms are mild.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 30-DEC-2015, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
A week post vaccine #1 noticed a large red, circular lesion on right are at injection site. Felt somewhat firm compared to the other arm. Redness has not subsided at this time. Initially following the injection on the same day had minimal reaction - very sore arm but no other immediate reactions.
toxic synovitis rt hip;WBC of synovial aspirate >100K neutrophils;bilat knee effusions & pain;
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 01-APR-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J011828 and expiry date: 26-DEC-2014, reported as 16-DEC-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Vaccines were given in the morning of 11/29/2018. Pt was lethargic and was refusing to eat. On 11/29/2018 pt passed away in his crib, sleeping around 10:45am.
In November I had a drippy nose, I developed a cough, coughing up phlegm, started having headaches off and on. I called my doctor after I took a home COVID-19 test that came back negative. I got a new prescription on an inhaler, advised me to use extra strength Mucinex. It took eight weeks for me to start feeling better. Then two weeks later I started having the same symptoms again. Neither time did it move to my lower lungs or turn into a secondary infection.
Day 1  Evening: Arm/injection site tender Day 1 Overnight: chills, headache, feverish feeling (did not take temperature) Day 2: Exhausted; Headache - felt like top of head would explode; chills; waves of nausea; slept most of day & evening wrapped in multiple blankets, heavy sweats, sweater & socks! Day 2 Overnight: chills - but not as bad; headache continued in spite of Tylenol Day 3: Still tired/exhausted; managed a shower, then napped; Headache different & moved to different parts of my head; by 6:00 pm started feeling a little more normal; nausea feeling gone Day 3 Overnight: slept pretty good, not so cold Day 4:  Feeling almost normal; ran out of energy - took a nap late afternoon Day 5:  Feeling normal EXCEPT Arm continues to be red, swollen and a hard lump
Myalgia; Chills; This case was reported by a pharmacist via sales rep and described the occurrence of myalgia in a 92-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia and chills. On an unknown date, the outcome of the myalgia and chills were recovered/resolved.   It was unknown if the reporter considered the myalgia and chills to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR144039   Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's Comment: The reporter mentioned that, she gave the Shingrix to a patient and he mentioned that, he had myalgia and chills.  The reporter stated that the side effects that the patient experienced were less severe after the 2nd dose of Shingrix. The reporter did not agree to follow up from GlaxoSmithKline. Additional Supportive Information: This case has been linked with the case US2022AMR144039, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR144039:Same reporter
This case was reported by a physician and described the occurrence of injection site pain in a 75-year-old male patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose 0.5ml, received on 6th July 2018, intramuscularly, for tolerance refer case US2018157103). On 21st September 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and general body pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and general body pain were unknown. It was unknown if the reporter considered the injection site pain and general body pain to be related to Shingrix. Additional details were provided as follows: This case was reported by patient for himself. The patient experienced events without malaise or headache.
It has been between 102 and 103; Fever is going up; Chills; Headache; Achy; Nausea; This is a spontaneous report received from a contactable consumer(patient). A 46-years-old female patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration, administered in Arm Right on an unspecified date at 11.45 (Lot Number: EW0153) as single dose for covid-19 immunisation. Medical history included High blood pressure. Concomitant medications included lisinopril; metoprolol. Patient got the second shot at 11.45 and then woke up in the morning with chills, headache, achy, nausea and a fever, it has been between 102 and 103. Patient just rest and take some medicine, how high does my fever have to be before going in. Fever is going up but patient just took the medicine Tylenol. Events outcome were not recovered.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "AFib". Clinical course: No prior histories of heart problems. These spike proteins are firing throughout the human body. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme muscle soreness, tingles, numbness and overall pain at the injection site, past my elbow.  Hurts to raise my arm for every day living and practice piano.
After receiving vaccines pt. was fine. He assisted the MA with blood draw/shots given to his sister by holding her legs. Then he sat down & got dizzy. MA helped him onto the table to lie down. She got me & checked his O2=90, HR=60, as I walked into the room, pt. was pale and responsive. S1 S2; BBs CTA ACP. He said that nothing hurts. His vitals immediately bounced back to normal O2=100%, HR=81. He remained supine x 15 min, was observed total of 20 min. Per mom, pt. didn't eat anything prior receiving shots. He ate a cookie after he was ready to sit up and respond feeling much better.
My upper lip swelled up and was numb and tingling for about 3 days on days 10-12. I have photos if needed.
There have been no adverse health related events due to the vaccine being given. I needed to file VAERS because  the vaccine was given to a 4 year, 11 month old pt. The pt will not be 5 years old until January 8th, 2022
swelling of both hands; redness of both hands; itchy rash on testacles; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (swelling of both hands), ERYTHEMA (redness of both hands) and GENITAL RASH (itchy rash on testacles) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling of both hands), ERYTHEMA (redness of both hands) and GENITAL RASH (itchy rash on testacles). At the time of the report, PERIPHERAL SWELLING (swelling of both hands), ERYTHEMA (redness of both hands) and GENITAL RASH (itchy rash on testacles) outcome was unknown.        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.   No concomitant medications were provided.  No treatment information provided
Very short-term syncope, probably caused more by anxiety/stress from receiving a vaccine as patient was nervous when actually receiving a shot. Patient reported nausea and appeared to be hyperventilating right after incident occurred so mother took him to the restroom together with member of pharmacy staff. Patient returned after a few minutes reporting he was feeling much better. Was able to walk and converse freely. Kept patient for 30 minutes observation period.