chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SMALLPOX LESIONS ON BACK. PATIENT WAS TREATED AS AN OUTPATIENT01/27/03 WITH AMOXICILLIAN PO 250 MG #30, DECONAMINE SR #20 AND TYLENOL 325MG.  PATIENT DID NOT RESPONDE TO TREATMENT. ON /2/21/03 PATIENT WAS TX'D AGAIN WITH CEPHALEXIN PO 500 MG #40 AND HYDROXYZINE HCL PO 25 MG #20. PT WAS ADMITTED TO NHCP ON 2/22/03 AND WAS TREATED WITH NAFACILLIN 2 GM IM AND WAS REFERRED TO DERMATOLOGY.
Raised swollen red lump on left arm with localized itching and heat at site. Patient reported via electronic message system. Patient was contacted by triage nurse and scheduled with provider in clinic. Patient cancelled appt with provider.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of GARDASIL (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
varicella vaccine-associated primary varicella infection; A 4-year-old female with ataxia-telangiectasia was vaccinated;    This literature marketed report was received from  the authors of the published article as stated above, concerning a 4-year old female child. The patient's concurrent conditions included ataxia-telangiectasia. The pertinent drug reactions/allergies and concomitant medications were not provided.    On an unspecified date, the female child with ataxia-telangiectasia presented for question of vaccination. Family was  concerned to travel with patient's immunocompromised state in the setting of the measles outbreak. The immune system evaluation showed adequate T cell function testing, and it was thought that she should be able to tolerate live vaccines (Product use issue).    She proceeded with the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and varicella virus vaccine live (Oka/Merck) (manufacturer unknown) or Zoster Vaccine Live (manufacturer unknown) for prophylaxis (doses, route, lot #, expiration date, and anatomical location were not provided).   Subsequently, 12 days later, the patient developed a runny nose and 104 F fever. She broke out in papules that returned positive on varicella zoster PCR. She only required supportive care, with no use of antivirals or hospitalizations. Testing showed the strain she had was the same as the varicella vaccine, confirming a varicella vaccine-associated primary varicella infection.    The authors considered that patient's lymphocyte function testing was adequate, and it was thought her T cells should appropriately be able to respond to the vaccine, but unfortunately this was not the case. It may not be enough to determine if a patient can appropriately respond to vaccines as the patient was self-limited and may have prevented a future more significant varicella infection.    The authors considered the event varicella zoster virus infection to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown) or Zoster Vaccine Live (manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience.
itching at the site of injection; redness at the site of injection/circular 7cm top to bottom and 7cm right to left; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the site of injection) and VACCINATION SITE ERYTHEMA (redness at the site of injection/circular 7cm top to bottom and 7cm right to left) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma and Overactive bladder. Concomitant products included TIMOLOL for Glaucoma, TOLTERODINE L-TARTRATE (DETROL LA) for Overactive bladder, MULTIVITAMIN IRON for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the site of injection) and VACCINATION SITE ERYTHEMA (redness at the site of injection/circular 7cm top to bottom and 7cm right to left). At the time of the report, VACCINATION SITE PRURITUS (itching at the site of injection) and VACCINATION SITE ERYTHEMA (redness at the site of injection/circular 7cm top to bottom and 7cm right to left) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment for the event.
Muscle spasms; This case was reported by a pharmacist via call center representative and described the occurrence of muscle spasm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle spasm. On an unknown date, the outcome of the muscle spasm was unknown.   It was unknown if the reporter considered the muscle spasm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced muscle spasm. The healthcare professional was not at work and could not provide patient demographics, lot number, or expiration dates. The healthcare professional did not provide any additional information. The reporter stated that the patient is a physician and would be contacting GSK with additional details. This case has been linked with case US2019GSK095730 (1st dose case), reported by the same reporter.
Left shoulder was sore for a day; fever,chills; aches; coughing; headache; Congestion; 6 following weeks of weakness; hurting lungs; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient of (unknown demographics) who was experienced left shoulder was sore for a day (arthralgia), fever chills (pyrexia), aches (pain), coughing (cough), headache, congestion (respiratory tract congestion), 6 following weeks of weakness (asthenia), hurting lungs (pulmonary pain), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious left shoulder was sore for a day (arthralgia), fever chills (pyrexia), aches (pain), coughing (cough), headache, congestion (respiratory tract congestion), 6 following weeks of weakness (asthenia), hurting lungs (pulmonary pain), (unknown latency) following the administration of INFLUENZA VACCINE.  There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, outcome of the events was unknown.  There will be no information available on batch number for this case.
MILD INFLAMTION AT INJECTION SITE  ASSOCIATED WITH NASAL CONGESTION, 24 HRS POST VACCINATION.  PT ADVISED TO TAKE AN ANTIHYSTAMINE IF SYMPTOMS DO NOT RESOLVE.
Extreme pain at injection site, joint pain, muscle weakness, migraine, chest tightness and pain that radiates down my left arm and back up into my jaw, numbness in my left arm and fingers, upper back pain, shortness of breath, fatigue, fainting spells, and tachycardia.  Diagnosed with inappropriate sinus tachycardia and pericarditis.  Given colchicine and propranolol
Patient reported a lot of pain in left arm and couldn't even sleep on it. The next morning he thought he was blacking out. Left message on patient's answering machine to see how he was doing.
it's a bit warm; rash; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (it's a bit warm) and RASH (rash) 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) UNK dosage form. On an unknown date, the patient experienced SKIN WARM (it's a bit warm) and RASH (rash). At the time of the report, SKIN WARM (it's a bit warm) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment medications were provided by the reporter.
I received my vaccine on 04/23/2022. On 05/23/2022 I started having runny, stuffed nose, fatigue, diarrhea and I felt as if I had a cold. On 05/25/2022 I was tested positive for Covid. Spoke to doc and had a telehealth on 05/26/2022. I was prescribed Paxlovid. After taking the Paxlovid the symptoms went away.
after first dose of moderna 2/13/21 back started to get itchy , and after second dose 3/13/21 she started getting more itchy and then had her grandson look and saw the rash all over her back. tried using Aquaphor which helped a little with the itch - went to dermatology 4/14/21 and had biopsy taken.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-DEC-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a 82 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was subcutaneously(SQ) vaccinated with ZOSTAVAX (Lot# reported as 0172AE, Exp date: 18-APR-2013, single dose, dose/frequency unspecified) on 06-SEP-2012. There was no concomitant medications therapy. The pharmacist reported that the patient developed a widespread, itchy rash on her hands, legs, abdomen, and under her breast 3 hours after administration of ZOSTAVAX on 06-SEP-2012. The patient had sought medical attention via coming to pharmacy. No lab diagnostics studies performed. The patient was recommended to take BENADRYL and contact her physician if symptoms persist. The outcome was reported as not recovered/not resolved. Additional information is not expected.
SkinRash, Rash Itchy, golf ball size area red with raised bumps
Patient was pregnant and received the flumist live virus.  The patient explained to the nurse that she was pregnant and should not be receiving the mist.  The nurse stated that the rules have changed and conferred with two other nurses who agreed and administered the vaccine to her.
15 minutes after vaccine, patient stood up to walk to bathroom, fainted and fell to floor.  He did not lose consciousness but he was lightheaded and could not stand. Nurses said it was Vasovagal syncope. He laid down and rested and was fine.
This spontaneous report as received from a registered nurse refers to a 11 months old patient. The patient was vaccinated with the first dose of VARIVAX (lot number not provided) 17 day prior to his first birthday on 12-JUL-1999. No other co-suspects were reported. No concomitant medications were reported. The second dose was administered on 23-APR-2003. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
4 days after vaccine patient has had intermittent chest tightness and palpitations.  Last few minutes, happen daily
Client in 2 days after vaccine administration, right arm, site of Dtap (Daptacel), red, swollen, from shoulder to antecubital, mother states arm was more swollen day after vaccination but today is more red than swollen, itching also.
October 7, 2022, Patient got very dizzy, could not walk, confused, blank stare and could barely talk.  Fire Dept. responded and transported patient to Hospital.  CT Scan completed and discovered a blood clot near the brain.  Transported by helicopter to different Hospital.  A Thrombectomy was completed and partial blood clot was removed.  Blood clots were then discovered in the right leg, right arm, both lungs and another in the brain, not counting what was already removed.  No explanation as to why the blood clots formed. Patient later passed away on October 20, 2022.
HIVES, HANDS AND FEET WERE NUMB, BLOOD SUGAR DROP, RESPIRATORY RESTRICTION, MOUTH AND TONGUE SWELLING.
Dirrhea onset day 2, for several days. Took immodium, some relief, but dirrhea continued whenever off immodium. Continued for 1 month non-stop. * No symptoms after 1st dose just second 5/9/19-6/20/19 symptoms persisted.
chills; weakness; fatigue; body aches; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3248), via an unspecified route of administration, administered in left arm on 26Jan2021 at 14:30 as single dose for COVID-19 immunisation. The medical history included that the patient previously took penicillin and experienced allergy. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL1284), via an unspecified route of administration, administered in left arm on 04Jan2021 at 14:30 as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other concomitant medication within 2 weeks of vaccination. On 27Jan2021 the patient experienced chills, weakness, fatigue, body aches. The patient did not receive treatment for events. The outcome of event was recovering.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Initially developed a few itchy hives on my right outer calf on 5/13. It became widespread from my knee to my ankle by 5/16. On 5/17 smaller itchy bumps had spread to my stomach and chest and I was evaluated by PCP, who directed me to take Zyrtec and apply Eucerin. By 5/19 smaller itchy bumps had spread to my arms, and my right ankle and foot had started swelling. PCP prescribed a course of antibiotics as a precaution.  By 5/21 rash had spread to my back and continued in all other locations. On 5/21 dermatologist prescribed oral steroids (prednisone) and topical triamcinolone.   Swelling in leg subsided after a few days. Itching was reduced but still present through to June 1.
15 months old infant recieved Adacel instead of pentacel/no ae; 15 months old infant recieved Adacel/no ae; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 months old male patient who experienced 15 months old infant recieved  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) for Immunisation; and POLIO VACCINE INACT (IPV) for Immunisation.  On an unknown date, the patient received a 4th dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6273AA via unknown route in the right thigh. On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.   It was unknown if any adverse event occurred.
Breaking out in sweats; Couldn't get out of bed; all I did was sleep; whole body had aches all over her joint; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Breaking out in sweats), MOVEMENT DISORDER (Couldn't get out of bed), PAIN (whole body had aches all over her joint), CHILLS (Chills) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE 1A PHARMA), LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN 81).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN (whole body had aches all over her joint), CHILLS (Chills) and HEADACHE (Headache). On 06-Jan-2021, the patient experienced MOVEMENT DISORDER (Couldn't get out of bed) and SOMNOLENCE (all I did was sleep). On 07-Jan-2021, the patient experienced HYPERHIDROSIS (Breaking out in sweats). At the time of the report, HYPERHIDROSIS (Breaking out in sweats), MOVEMENT DISORDER (Couldn't get out of bed), PAIN (whole body had aches all over her joint), CHILLS (Chills), HEADACHE (Headache) and SOMNOLENCE (all I did was sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Ibuprofen.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Allopecia; 2 sites; first site initally about the size of a large quater; located at bottom right posterior of scalp 2nd site a small punchout at crown of scalp approximate the size of an oversized nickel Both sites continued to lose hair for a couple of months after first visit to dermatologist (who administered injections to treat hair loss).  Actual onset of hair loss unknown but estimate approximately 3-4 weeks before first visit to doctor. The visit to doctor is the date entered into this form on prior pages.  Hair is slowly growing back now.  Have had injections approximately monthly
p/vax localized lt deltoid; erythema/swelling; apply ice/heat; prophylactic antibiotics (r/o cellulitis process)
Environmental heat intolerance, excessive perspiration.  I am now unable to be out in any type of heat without having symptoms of heat exhaustion, even after a short time.  Now whenever I work out (5 days a week) I sweat excessively and soak my clothing and a hand towel.  This has never happened to me before and is not getting any better as time passes.  This is very distressing to me and embarrassing.
Patient was supposed to have received Adacel and was inadvertently given Daptacel instead intramuscularly in the deltoid/ No AE; Initial information was received on 12-Mar-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 10 years and 11 months old male patient who was supposed to have received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] (lot number not reported) and was inadvertently given DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead via intramuscular route in the deltoid NOS (unknown if left or right deltoid)  (wrong product administered).  The patient's past vaccination(s) included DAPTACEL with Had four previous doses. Medical history, past medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to wrong vaccine administered.  It was unknown whether the patient had any adverse reactions.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
My 1st and 2nd dose was Pfizer. I started getting symptoms of postnasal drip which was mild. Then the next day, I was tired and achy. 2 days later the cough started and a severe runny nose. I took an at home COVID-19 test that was positive. The cough got worse and worse while lots of mucus. I took DAYQUIL and was worried about getting my children sick. I also had chills and intense jaw pain that developed. I was out of work for 2 weeks. I was in communication from my doctor and received a prescription for PAXLOVID but once I read the side effects, it is not recommended for breast feeding so I did not take it. The fatigue and cough lasted longer than 2 weeks. My other symptoms lasted the first week. I still have a residual cough.
Hypersensitivity reaction at injection site with redness, inflammation, pain. Itching with DPT #5, IPV #4. Pt is treated with Atarax, antihistamine and topical hydrocortisone cream.
Raised, firm, swollen, red, hot area surrounding injection site, approximately 3" in diameter by 3/14/2019; gradually subsided but with peeling of overlying skin (such as with a mild sunburn) over the next week
sore arm and shoulder for several week, tried OTC nsaids etc..MD referred pt to Orthopedic MD and he believes pt has bursitis related to vaccine administration.  Gave steriod injection and referred to physical therapy
PATIENT DESCRIBED INITIALLY HAD COLD FEET, THEN PROGRESSIVELY WORSENED INCLUDING HER SKIN FEELING IT WAS BURNING, EXTREMELY NAUSEOUS, PALPITATIONS AND SORE THROUGHOUT BODY. SHE REPORTED SHE HAD A TEMPERATURE OF 100.4F. COULD NOT MOVE FOR HOURS AND SLOWLY THE SYMPTOMS LESSENED, BUT STILL REMAINS SORE.