chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination adverse reaction; Fell; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell) and IMMUNISATION REACTION (Vaccination adverse reaction) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis.    The patient's past medical history included Ex-alcohol user (DRINKS WHISKEY, BOURBON AND RHUM EVERYDAY FOR AT LEAST TWO GLASSES) from 1973 to 1983. Concurrent medical conditions included Type II diabetes mellitus, Nodule, Allergy to animal dander (CAT HAIR ALLERGY MANIFESTATED BY HIVES), Tobacco user (A PACK OF CIGARETTE A DAY) since 1973, Anxiety, Blood cholesterol abnormal, Rheumatoid arthritis, Liver disorder and Panic attacks. Concomitant products included AMITRIPTYLINE for Anxiety, ALPRAZOLAM (XANAX) for Anxiety and Panic attacks, EZETIMIBE and ROSUVASTATIN for Blood cholesterol abnormal, FOLIC ACID for Liver disorder, METHOTREXATE for Rheumatoid arthritis, INSULIN DETEMIR (LEVEMIR), INSULIN ASPART, EMPAGLIFLOZIN (JARDIANCE) and GLIMEPIRIDE for Type II diabetes mellitus.   In 2019, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced FALL (Fell). On 01-Feb-2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). In 2021, IMMUNISATION REACTION (Vaccination adverse reaction) had resolved. At the time of the report, FALL (Fell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Ultrasound Doppler: Poor blood circulation in legs. On 16-Dec-2021, Bone scan: Result not reported.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event(s) of covid vaccination reaction after first dose and Fell with RINVOQ(UPADACITINIB) was no reasonable possibility.  Treatment medications were not reported.  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.   This case was linked to MOD-2021-624168 (Patient Link).   Reporter did not allow further contact
First dose side effect of moderate 6/10 injection site pain; This is a spontaneous report from a contactable physician. A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 17Dec2020 11:00 at single dose for an COVID-19 immunization. The patient medical history included attention deficit hyperactivity disorder (ADHD), allergic rhinitis (no serious/life threatening allergies). Known allergies: isoniazid (rash). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. First dose side effect of moderate 6/10 injection site pain, responded well to naproxen. Did not seek medical care. Prior to vaccination, the patient was not diagnosed with COVID19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was recovering.  Information on the Lot/Batch Number has been requested.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers to 63rd out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment. Amended narrative accordingly.
This spontaneous report as received from a female consumer of unknown age (who is a Nurse Practitioner) reporting on herself via company representative. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, Lot # and route not reported). No concomitant Medications reported. The patient stated she had developed a case of shingles after she had received ZOSTAVAX (onset date: approximately in April or May 2012). It "cleared up in a couple days," but she still had post herpetic neuralgia (PHN) in her right hand. The patient was treated with spinal corticosteroids (unspecified) "steroids" and anti-virals. The patient sought Medical attention. The relatedness between the events and ZOSTAVAX was unknown. Additional information has been requested.
Achy bones and muscles; Really tired; Achy bones and muscles; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Achy bones and muscles), FATIGUE (Really tired), MYALGIA (Achy bones and muscles) and HEADACHE (Headache) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BONE PAIN (Achy bones and muscles), FATIGUE (Really tired), MYALGIA (Achy bones and muscles) and HEADACHE (Headache). At the time of the report, BONE PAIN (Achy bones and muscles), FATIGUE (Really tired), MYALGIA (Achy bones and muscles) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-037105 (Patient Link).
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with GARDASIL 9 (lot# reported as L004014 with expiration date 04-MAR-2017; dose, dose number and route were not reported), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Fever, malaise, pain and heat at infection site. Tool Tylenol to reduce all effects.
Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) 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. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 09-Nov-2021. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter address updated.
Developed hypersensitivity vasculitis as diagnosed by Dr. Red spots on the legs and sometimes on the arms & back. Pain, swelling, bumps. At times could not walk due to the pain. Missed several days of school (10-20 days) and some work. Condition would take several days to resolve. Symptoms seemed to be triggered by periods of standing.  Symptoms started on/about Feb 10, 2022. Had several flareups over the course of 2022 and several periods of missing school and work. Issue finally ended about Sept 2022.  Dr prescribed Prednisone 20mg and Omeprazole 20mg in May 2022 which seemed to help. Had to do a couple treatments of the Prednisone. 2-3 visits with primary care physician, 3-4 visits with specialist Dr, plus the several trips for urine sample and bloodwork.
5:20 PM: Stomach pain, doubled over in pain, nausea, mumbling, pain at injection site, body aching, tiredness, lethargy. 7:15 PM: vomiting. 8:30 PM: excessive vomiting- 5 to 6 times in last hour. 100.4 temperature, edgy, flinching when touch body, sore all over. 10:45 PM fever of 101. 11 PM vomiting. 11:10 PM diarrhea. 1/5/17 12:15 AM vomiting, fever of 100.7. 7:45 AM fever of 100.9, same symptoms as above: nausea, stomach pain, tired, body aches. 8:20 AM complaining of numbness in body, pain all over body, everything hurts, headache, pain in abdomen between navel and waistline. 10:15 AM fever of 100.8. 1:05 PM fever of 99.7. 1:30 visit to pediatrician, told to watch my son and note any changes, doctor is reporting to VAERS.
Information has been received from a RN concerning a 44 month old white female with an amoxicillin allergy who on 03/05/2001 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 636368/1341K), SC.  There was no illness at the time of vaccination.  On 11/18/03 in the AM the pt presented with "red bumps, fluid filled, crusty lesions and itchiness on face, thighs, back and stomach."  Subsequently, the pt recovered.  The reporter considered "red bumps, fluid filled, crusty lesions and itchiness on face, thighs, back and stomach" to be other important medical events (OMIC).  Additional information has been requested. The follow up received on 12/16/03 states the pt was treated with Atarax and fully recovered. Follow-up info from the reporter stated that "red bumps, fluid filled, crusty lesions and itchiness on face, thighs, back and stomach" are not considered to be other important medical events. Additional inof has been requested. This rreport no longer meets the criteria for expedited submission to the FDA.
Shingles vac. given 5/26/11. Left flank rash started 6/3/11 (approx). Left flank pain started 6/10/11.
36 hours following vaccine patient c/o injection site left deltoid, being reddened, tender & swollen approx. 2.5-3 inch circle around site. Encouraged to ice, take Benadryl &/or antihistamine.
Severe malaise, muscle spasms, H/a, dark urine, swelling from deltoid to elbow and (R) axilla x 7 days.
The backs of my knees hurt really bad when I try to straighten my legs out; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (The backs of my knees hurt really bad when I try to straighten my legs out) 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 ARTHRALGIA (The backs of my knees hurt really bad when I try to straighten my legs out). At the time of the report, ARTHRALGIA (The backs of my knees hurt really bad when I try to straighten my legs out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
The patient felt lightheaded 8 minutes after the vaccine so he put the seat back ( he was waiting in his car for 15 minutes after the shot) His friend that was waiting with him stated that it appeared that he passed out and his body got tense like a seizure. It only lasted a minute then he sat up and said he felt fine. He called his doctor and stated that he will follow up with him
COVID-19; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), PYREXIA (fever) and CHILLS (chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included OMEPRAZOLE, SIMVASTATIN, AMLODIPINE, DOXEPIN, HYDROCHLOROTHIAZIDE, FISH OIL, CALCIUM CITRATE (CITRACAL [CALCIUM CITRATE]), VITAMIN D3, GUAIFENESIN (MUCINEX) and MACROGOL 3350 (MIRALAX) for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 14-Jan-2021, CHILLS (chills) had resolved. On 16-Jan-2021, PYREXIA (fever) had resolved. At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, COVID-19: (Positive) Positive.     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 included antibody infusion ER.
Patient reported full body rash and discoloration of the skin resembling erythema. Of  note, he also complained of itchiness from rash disturbing sleep.
No reaction was serious enough to receive medical care. On day 9 and 10 after receiving my first dose of moderna I had a very itchy large warm red raised rash at the injection site. I tried using Benadryl cream which didn?t help and switched to Cortisone cream which did help with the itch. After 2 days the rash got less red and itchy and mostly disappeared. Right after the injection I had a small red blotch that went away after 5 days and was not itchy. Then this big itchy rash appeared days later.
Patient received her vaccine without incident. She then stood by and watched while her father received his vaccine. After his vaccine was completed (a few minutes after she received her vaccine) and without any warning, she fainted to the floor. She was unconscious for a few seconds before awaking very disoriented. Once she realized what had happened, she began panicking and hyperventilating a little. She reported being dizzy and nauseous. She sat down for approximately 10 minutes after the incident and calmed down a little before she left under her own power with her father.
Quarter sized bumpy red rash over injection site and 2 inch wide red streak going down arm toward elbow. Urgent care physician put her on Keflex in case it was cellulitis but thought it was just an injection site rxn.
injection site reaction of warmth; injection site reaction of raised lump; Initial information received on 26-Aug-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a female patient who experienced injection site reaction of warmth (vaccination site warmth) and injection site reaction of raised lump (vaccination site mass), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On 24-Aug-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot: UJ432AB) via an intramuscular route in the deltoid (not specified) as prophylactic vaccination.   On 24-Aug-2020, the patient developed non-serious injection site reaction of warmth (vaccination site warmth) and injection site reaction of raised lump (vaccination site mass) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown at the time of reporting for both the events.  There will be no information available on batch number for this case.
Fainted, Could not get up for 30 minutes; Tunnel vision; Clammy Skin; Headache; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0164), dose 1 via an unspecified route of administration, administered in Arm Left on 22Aug2021 at 16:00 (at the age of 12-year-old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Medical history was none. The patient had no COVID prior vaccination. Known allergies was reported as unknown. There were no concomitant medications. The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. The patient had not been COVID tested post vaccination. On 22Aug2021 at 04:15 AM, the patient experienced fainted, tunnel vision, clammy skin, headache and could not get up for 30 minutes. No treatment was received to treat the events. The patient outcome of the events was Unknown at the time of this report.  Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Piercing headaches along forehead when bending over ,lying down and turning head ,&  coughing . CAT scans and MRI with contrast show nothing. Experience every day since April.  Have had a handful of headaches in my lifetime.. It's not a typical headache or migraine. Doesn't effect eyes, temples.  Just along hairline in  forehead.  Visited ENT twice, all clear, Neurologists  said all clear. Did two rounds of steroids...didn't help at all.
I have not had chicken pox in my lifetime or have I had cold sores, not even as a child. Since the vaccine (final one in July 2018) I have had four severe cold sores on my lips. The first adverse effect was about one week after the last vaccine I had a cold sore develop along with tiny blisters on my upper lip; extreme pain in the rightsize of my face (shooting pain). The symptoms are tingling, itching, burning and pain of the affected area. Also, blister like bumps. After the blisters dried, my lip cracked and bled. Two weeks healing time for each one.
Seen at ER evening Tdap administered. C/o arm feeling paralyzed. Several physicians consulted - no one has seen this reaction from Tdap.
not feeling all that great today; arm hurt a lot; chills; feeling feverish; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Nov-2021 and was forwarded to Moderna on 03-Nov-2021.    This spontaneous case was reported by a patient and describes the occurrence of MALAISE (not feeling all that great today), VACCINATION SITE PAIN (arm hurt a lot), CHILLS (chills) and PYREXIA (feeling feverish) in a 76-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling all that great today), VACCINATION SITE PAIN (arm hurt a lot), CHILLS (chills) and PYREXIA (feeling feverish). At the time of the report, MALAISE (not feeling all that great today), VACCINATION SITE PAIN (arm hurt a lot), CHILLS (chills) and PYREXIA (feeling feverish) outcome was unknown.            Patient got the previous two doses without any problems.  No concomitant medication reported. No treatment medication reported.
Third morning after vaccine, two red bumps next to each other on abdomen were noticed. No itch, no pain. Four days later (today), bumps are still there and also now, redness surrounding bumps about an inch in diameter.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of improperly stored RECOMBIVAX HB (dose and route were not reported) lot # L016427, expiration date 13-APR-2017, lot # L004754, expiration date 10-NOV-2016 and lot # J012515, expiration date 14-APR-2016. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient believed to get a Prevnar 20 but got a Prevnar 13 instead
Body aches roughly 20 hours after the injection, Extremely red and inflamed injection site. Pain and inflammation at the injection site lasted until 2/14/23.
This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. Pertinent medical history was unknown. On 28-JAN-2015 the patient was vaccinated with PNEUMOVAX23 (lot # J013344, route of administration, dose and anatomical location was unknown) which was expired on 22-JAN-2015 (Expired product administered). Concomitant medications were unspecified by reporter. No known adverse effects. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Per patient, Received immunization on 04/07/2021 and was sore and "colored" after injection. Within two weeks, noticed area started "sinking in" and was painful. It took a month before it was better, felt bruised. Noticed scar.
Patient developed a 1x1cm nodule associated with 5x7cm erythematous area, left tricep. Patient was given ice, Tylenol and prescribed Keflex.  On a follow up visit doctor noted that nodule dissipated and cellulitis resolved.
Injection site redness, edema, and discomfort.  Recommended Benadryl, OTC pain relievers, and warm compresses as treatment.
Swelling of arm and had knot on arm red rash, soreness itching, nausea. Diarrhea, headache went to ER and was given BENADRYL and also Cortisone by Dr.
Around 05/01/2021, I started to have blood pressure issues. I saw the doctor because I got really dizzy. My blood pressure started going really low and it  started fluctuating between high reading and low readings. He referred me to a cardiologist and then a nephrologist. No outcome, still working on it. They increased my blood pressure medication, but they still don't have the issue under control.
Patient was seen 12 days after the vaccine was given because her parents noted a red spot on her right thigh which began a few days before.  The spot was noted to be erythematous, nontender, not warm, blanching and oval with a punctate center.  No streaking was noted.  No fever was noted.  The patient was happy and playful.
Pain, redness, heat, soreness in left arm at injection site started about 36 hours after the injection. Reddish lesion spans surface of deltoid muscle and is warm to the touch. The pain and soreness subsided about 72 hours after the injection but arm is currently still red in appearance and warm to the touch.
Currently pregnant, EDD 10/25/21.  Patient reports sharp shooting pain in left arm.  Exacerbated by movement, but is present without movement.  Was initially at injection site, but has migrated toward the front of the shoulder.  Pain is localized to upper arm, not radiating downward.  Area is warm with mild swelling.  Difficult to move arm in first 48 hours affecting ability to perform ADL's.