chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatigue; itching at the injection site; aggressive itchiness under the armpit of the vaccinated arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FATIGUE (fatigue), INJECTION SITE PRURITUS (itching at the injection site) and PRURITUS (aggressive itchiness under the armpit of the vaccinated arm) 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 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (fatigue), INJECTION SITE PRURITUS (itching at the injection site) and PRURITUS (aggressive itchiness under the armpit of the vaccinated arm). On 15-Feb-2021, INJECTION SITE PRURITUS (itching at the injection site) and PRURITUS (aggressive itchiness under the armpit of the vaccinated arm) had resolved. At the time of the report, FATIGUE (fatigue) 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 relevant concomitant medications were reported.  Treatment details included Lidocaine cream, Ice and Zyrtec.
pain, inflammation, loss of strength started occurring in various joints singularly, intermittently, lasting several weeks.  Became more frequent & stronger after covid booster shot on 11/6/21.  Ortho treating knee arthritis had referred to rheumatology.  Rheumatology APN ran blood tests on 11/10/21 and eliminated dx for RA, gout, lyme disease.  Discussed that covid vaccine might be cause of high inflammation responses because of timing of vaccine administrations & outbreaks.  Working diagnosis at this point is pseudo-gout being treated with daily prednisone 20 mg.
Within 10 minutes after the injection my left shoulder began to itch was super red and hot.  I notified them and per policy I was transported  to the ER and was given IM 50mg benegryl, 40mg oral predinosone and I was monitored for another 1.5hr.  1/2 after the benedryl I still had the redness and flush in the neck and chin area the chest area redness had cleared up.  I was released with a prescription of benedryl for 4 days to take every 8hrs for the symptoms.  I continued with the benedryl for the next day and the symptoms subsided a little so I stopped taking the benedryl and I continued to take the prednisone.
This spontaneous report was received from a physician, via a company representative, referring to four female patients of unknown age. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (manufacturer unknown) for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients died. It was unknown if an autopsy was performed.  The causality assessment was not provided.; Sender's Comments:  US-009507513-1905USA004181: US-009507513-1905USA004180: US-009507513-1905USA004179: US-009507513-1905USA004178: US-009507513-1905USA004182: US-009507513-1904USA013391:
This is a spontaneous report received from a noncontactable reporter (other HCP). A 58-year-old female patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# FD7218), at the age of 58, on Jan 12, 2022, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (manufacturer unknown), for COVID-19 immunisation. The patient had pyrexia/fever and nausea, onset Jan 2022, with outcome of unknown. No follow-up attempts possible. No further information expected.
Muscle soreness left neck; Visible and painful lymph nodes 1- just above clavicle 2- below clavicle; At injection site raised, red, warm and itchy; At injection site raised, red, warm and itchy; At injection site raised, red, warm and itchy; This is a spontaneous report from a contactable Other HCP(Patient). A 47-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number EL9267), via an unspecified route of administration on 13Feb2021 at 08:30(at the age of 47-years-old) administered in Arm Left as a single dose for COVID-19 immunisation. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number EL9262), via an unspecified route of administration on 23jan2021 at 08:15 administered in Arm Left as a single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included amlodipine; atenolol (all taken for an unspecified indication, start and stop date were not reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.The patient previously took diovan and experienced allergy. On 14Feb2021 at 17:00 PM, the patient experienced at injection site raised, red, warm and itchy. Has increased to 2.5 inches in diameter. Visible and painful lymph nodes, 1 just above clavicle, 2 below clavicle. Close to shoulder joint. Muscle soreness left neck. No treatment was given for the events. The outcome of the events was not recovered.   Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Soft spot bulging out/ brain inflammation. Fever. Tired wouldn't wake up. Has milestone delays. Couldn't bear weight on his legs for months, he was doing it before vaccines.
sore left arm; Fatigue; Caller partner received his second Moderna COVID-19 vaccine booster shot on 8FEB2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), FATIGUE (Fatigue) and ACCIDENTAL UNDERDOSE (Caller partner received his second Moderna COVID-19 vaccine booster shot on 8FEB2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Patient was not immunocompromised.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), FATIGUE (Fatigue) and ACCIDENTAL UNDERDOSE (Caller partner received his second Moderna COVID-19 vaccine booster shot on 8FEB2021). At the time of the report, PAIN IN EXTREMITY (sore left arm), FATIGUE (Fatigue) and ACCIDENTAL UNDERDOSE (Caller partner received his second Moderna COVID-19 vaccine booster shot on 8FEB2021) outcome was unknown.            No treatment medications were reported by the reporter.   This case was linked to MOD-2022-570966, MOD-2022-570996, MOD-2022-571007, MOD-2022-571008 (Patient Link).
09/21/21 - started having chest pain and shortness of breath  10/25/21 - woke in middle of night with one leg completely dead/numb as if my circulation was being cut off 10/30/21 - after work I decided to mow the lawn to get up the rest of the leaves in my yard before the snow came and while mowing I started to be extremely short of breath and my wrists were killing me. Never had this pain in my wrists ever in my life! I decided to take a break and call my father to tell him about it. I pushed through and finished the lawn by only using one hand at a time.  10/31/21 - I woke with both hands and forearms swollen and extremely painful. I couldn't even close my palms to open my door. I later took a nap and my left arm went completely dead/numb. I decided I better get to the ER thinking I was having a heart attack.  I was diagnosed at the ER with carpal tunnel syndrome. I have never had any signs or symptoms of carpal tunnel EVER! This was the start of my terrifying experience and many many specialists and Dr. appointments.  11/1/21 - Carpal Tunnel Specialist - Dr. - confirmed carpal tunnel  by tapping on my wrists and they flung back and extremely painful. I was given the option to schedule surgery or get steroid injections. I opted for steroid injections, as I had to get back to work!  11/08/21 -  I started to get neuropathy and numbness in my legs. Confused by the "carpal tunnel diagnosis" I reached out to the Dr. office and asked about the numbness. They said "that isn't from carpal tunnel" confused as was I, I was then referred to a spine specialist.  11/18/21 - MRI on neck and back to check for damage/pinched nerves.
This spontaneous report as received from a female patient (also reported as office manager) of unknown age referring to herself. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, a drop of GARDASIL 9 (lot # N013698; expiry date: 19-DEC-2019) got onto her hand while she was reporting a product quality complaint (PQC) for a broken pre-filled syringe of GARDASIL 9 (occupational exposure to product, accidental exposure to product, product quality issue and exposure via skin contact). No known adverse effects were reported. A PQC was filed for the broken pre-filled syringe.
Patient had a rash develop around injection site about 2 to 3 inches. It is red and inflamed.
Fever, chills, nausea, body aches (like flu), lasting 3 days. Swelling and soreness at injection site, lasted until next injection/2 weeks.
c/o dizziness, throat feels funny. Denies SOB, Chest pain, headache. Patient performed her fingerstick 143 BP: 164/86, 134/90 ( RECHECK); Sp02: 100 RA; HR 86  Seen and cleared by EMS
PT HAD A SWOLLEN ARM FROM THE TOP OF HIS RIGHT SHOULDER DOWN TO ABOUT AN INCH ABOVE HIS ELBOW. IT WAS WRAPPED AROUND THE OUTER ASPECT OF HIS ARM. HERE WAS REDNESS AND SWELLING, ITCHING AND BURNING.
On 9/23, backs of thighs hurt & felt weak.  Pain moved to ankles-felt like they were sprained. Pain about the same for several days, but involved calves also.  On 9/30, ankles started to swell. Called doctor & made appt.  After weekend of resting, still had pain & swelling.  On Tuesday, thighs were hypersensitive & weak.  Wednesday, legs were weak & painful & ankles stayed swollen.  Dr put me on prednisone and symptoms got better.
On 12/13/22, 12 Pfizer Bivalent boosters were administered at two shelters.  The two loose unpunctured vials had expiration dates of 12/09/22.  The vaccine had expired 4 days earlier, expirations are on the boxes and not vials so nurse was unaware.  Call to office, told to complete VAERS and call manufacturer. If not viable: follow CDC guidelines which is to notify client and re-vaccinate in 8 weeks.  Pfizer requested data logger temps and calibration certificate as well as event details. Per Pfizer, we are within the 75 days of stability assessment.
Fibromyalgia flare; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Fibromyalgia flare) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia flare). At the time of the report, FIBROMYALGIA (Fibromyalgia flare) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information was provided.   Reporter did not allow further contact
Ear ache; Sharp pain in my head; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear ache) and HEADACHE (Sharp pain in my head) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (Ear ache) and HEADACHE (Sharp pain in my head). At the time of the report, EAR PAIN (Ear ache) and HEADACHE (Sharp pain in my head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were not provided.
Headache, dry-mouth and Chills, Left arm injection site very painful including my neck and shoulder. This caused me to sleep on my back which is recovering from a accident. Sore lower  back now. for the last 12 hours, I have been taking ibuprofen. Headache seems to be getting better as of 9:AM 2/1. Back and arms still sore.
Sore arm; loss of appetite; nausea; headache; fatigue; This is a spontaneous report from a contactable other health care professional (Other HCP, patient herself). A female patient of unspecified age (reported as 31 also reported as 61) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EH9899) on 16Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient experienced side effects reported as sore arm, loss of appetite, nausea, headache, fatigue. All side effects occurred two days after first dose of vaccine (18Dec2020). The outcome of the events was unknown.
Information has been received from a registered pharmacist concerning a 78 yr old male who was hospitalized for a knee replacement who on 14Jul05 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649978/0709P). On approx 14Jul05, the pt developed a localized skin reaction, fever and cellulitis. The pt was treated with IV antibiotics for the cellulitis. Subsequently, the pt recovered. The pharmacist did not believe that the adverse events prolonged the pt's hospitalization and she did not feel this was an other important medical event (OMIC). A product quality complaint was not involved. No further information was available.
Patient noticed a rash on his arm at injection site. Rash was 4" in diameter, flat, not hard or itchy, and warm to the touch.  Patient will schedule an appointment with a primary care provider.
According to health department, patient was hospitalized after receiving 2nd dose back in February. Patient was admitted to medical facility for altered mental status and fever.
Arm pain at site if injection 12-24 hours after injection, then improved. Axillary tenderness and pain 24-48 hours after injection, not yet improved causing difficulty with physical responsibilities at work.
Developed intussusception on 12-3-08. Barium enema reduced it.  1/6/09 Reviewed hospital medical records of 12/3-12/4/08 FINAL DX: Intussusception Records reveal patient experienced colicky abdominal pain, sleep disturbance, decreased appetite, lethargy & bloody stools.  Admitted for overnight observation & d/c to home in AM.
Doctor call the store on Tuesday April 13, she indicates patient arrived to her clinic on Sunday April 11 late night, the patient have a 3"-4" laceration in his left arm, in the same place vaccine was administered on March 31.  She prescribed to him Benadryl 50mg in night and Allegra in the morning. She argue that laceration was made by vaccine COVID 19 Pfizer BioNtech administration. Pharmacist contacted the patient, he said "On Sunday April 11 I was painting my fathers in law house, I was making a lot of strength in that side of my arm and later night I see that reaction or laceration in my arm.". "I felt right but when Im taking a bath I see that laceration, so I decided to go to my prescriber". He said by phone. Today he said do not have nothing in my arm.
Tingling to the jaw, Later got muscular aches & pains, insomnia, restlessness, sensitivity to sounds. Next day she got swellings under the arms. 12/07/01 her s/s have eased but sill has heaviness in her legs.
I have 2 sons ages 15 and 12 that are on a modified vaccine schedule to accommodate severe allergies. They were to receive Tdap doses and instead received 2 consecutive doses (2 weeks apart) or D-Tap vaccine instead.
Fever; Chills; Aches; This is a spontaneous report from a contactable Consumer, the patient. A 64 years old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA Vaccine; Lot numb: EN6208) via unspecified route of administration on left arm on 16Mar2021 at 11:00(at the age of 64 years old) as a single dose for COVID 19 immunisation. Medical history included Bronchiectasis. Concomitant drugs included and taken before two weeks of vaccinations which includes ADVAIR (Fluticasone Propionate/ Salmeterol), PRILOSEC (Omeprazole), XYZAL (Levocetrizine), Azithromycin, Losartan for unknown indication. Allergies to medications, food, or other products was reported for the drug Sulfa. Prior to vaccination, the patient had not been tested positive for COVID 19. On 17Mar2021 at 15:00 the experienced the events fever, chills and aches. Since the vaccination, the patient had not been tested positive for COVID-19. The clinical outcome of the events fever, chills and aches was recovered on unknown date. No follow up attempts are possible. No further information is expected.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported   This case was linked to MOD21-152032, MOD-2021-351062 (Patient Link).
Pruritus at injection site (received vaccine @ 10 am).  Developed  @ 5pm 11/18/08.  Swelling, induration.- Swelling 6 cm x 3 cm noted.
Erythema, Edema, Pain- Benadryl, Zantac, Prednisone.
Many of my IBS; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (Many of my IBS) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-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 IRRITABLE BOWEL SYNDROME (Many of my IBS). At the time of the report, IRRITABLE BOWEL SYNDROME (Many of my IBS) outcome was unknown.            Concomitant information was not reported Treatment information was not  reported.
Administered 4:05pm. Reacted at 4:20pm with anaphylaxis - Left eye swelling, shallow breathing, no airway edema, +tongue swelling. Given Epinephrine 0.15mg IM, Benadryl 1mg/kg po, Orapred 2mg/kg. Called and sent to ER for further observation.
sterile water was used instead of the solution in the packaging; sterile water was used instead of the solution in the packaging; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter was a nurse practitioner at clinic. The age at vaccination was not reported. The reporter stated that someone in her clinic administered Rotarix with the wrong diluent. She advised sterile water was used instead of the solution in the packaging, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter wanted details on how to proceed after vaccination and if they need to be re-vaccinated. No information available on the patient or who administered the vaccine. Prescriber of vaccination was not known. The reporter did not consent to follow up.
Information has been received from a Registered pharmacist (R.Ph.) concerning a currently 71 year old female patient. The patient's pertinent medical history was not reported; however, her concurrent conditions included rheumatoid arthritis. There were no drug allergies/drug reactions. On unknown date in 2011, the patient was vaccinated with an unspecified dose of ZOSTAVAX, via subcutaneous route, (strength, dose, anatomical location, lot number and expiration date were not reported). Secondary suspect therapy included ENBREL. Concomitant medications included MOBIC, folic acid (manufacturer unknown), PRILOSEC and methotrexate (manufacturer unknown). It was reported that the patient received ZOSTAVAX while on therapy with ENBREL and as a result, the patient experienced multiple outbreaks of shingles "on and off for the past 5 years", approximately since 2011; at the time of the report, reported as currently, she had an outbreak of shingles. The patient sought medical attention by visiting the physician, and received treatment that included VALTREX. At the time of reporting, the patient had not recovered from the adverse event. No product quality complaint was involved. The relatedness between the outbreak of shingles and therapy with ZOSTAVAX was not reported. The reporter considered the outbreak of shingles as a significant disability/incapacity event. Additional information has been requested.
4JUN91 pt devel arm inflammed & edamatous in area immun given, t99.9 orally; 5JUN91 knot size of half dollar, visible & painful to touch; Pain upon moving arm, especially elbow, burning sensation;
This patient came in to clinic with PCP.  Asketd for COVID booster at age 17, was given vaccine that was approved for 18 and older. This occurred May 10,2022,  was discovered October 2022. Patient was notified, now 18, he asked him mom also be advised. Both deny any adverse outcome. Clinic advised VAERS report be completed.