chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A little red marks that turned into water blisters; as itchy little red marks scattered over arm and legs; The blisters will leak out and will turn into a black scar.; as itchy little red marks scattered over arm and legs; The blisters will leak out and will turn into a black scar.; blister is burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: BLISTER (non-serious), outcome "unknown", described as "A little red marks that turned into water blisters"; PRURITUS (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "as itchy little red marks scattered over arm and legs"; SCAR (non-serious), BLISTER RUPTURE (non-serious), outcome "unknown" and all described as "The blisters will leak out and will turn into a black scar."; BURNING SENSATION (non-serious), outcome "unknown", described as "blister is burning".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
From telephone contact with reporting nurse it was stated that a 2 month old female patient received an IPOL, a Tripedia, a Prevnar and a Comvax vaccination on 5/18/01. Sometime after the vaccination the patient became very fussy, irritable and developed a fever of >104.5 degrees F which lasted about 7 hours. From additional correspondence received on 9/4/01 additional patient, vaccine and responsible physician information was provided. This case is closed.
received a dose / that was not shaken vigorously to obtain a homogeneous, turbid, white suspension; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a 68-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number Z59N7, expiry date 8th October 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe (batch number Z59n7, expiry date 8th October 2022) for prophylaxis.   On 21st June 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 21st June 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate reconstitution technique. On an unknown date, the outcome of the inappropriate reconstitution technique was 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: This case was reported by a pharmacist. Age at vaccination was not reported. Pharmacist reported  female patient received a dose of Boostrix that was not shaken vigorously to obtain a homogeneous, turbid, white suspension, which led to inappropriate reconstitution technique. Consented to follow up.
redness and swelling of left bicep; redness and swelling of left bicep; fatigue; itching; pain at left arm "neuropathy"; pain at left arm "neuropathy"; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (pain at left arm "neuropathy") in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced NEUROPATHY PERIPHERAL (pain at left arm "neuropathy") (seriousness criterion medically significant) and PAIN IN EXTREMITY (pain at left arm "neuropathy"). On 13-Jun-2021, the patient experienced PRURITUS (itching). On 14-Jun-2021, the patient experienced FATIGUE (fatigue). On 15-Jun-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness and swelling of left bicep) and VACCINATION SITE SWELLING (redness and swelling of left bicep). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) at an unspecified dose and frequency and ETHANOL (ALCOHOL SWABS [ETHANOL]) at an unspecified dose and frequency. On 20-May-2021, NEUROPATHY PERIPHERAL (pain at left arm "neuropathy") and PAIN IN EXTREMITY (pain at left arm "neuropathy") had resolved. On 15-Jun-2021, FATIGUE (fatigue) had resolved. At the time of the report, PRURITUS (itching), VACCINATION SITE ERYTHEMA (redness and swelling of left bicep) and VACCINATION SITE SWELLING (redness and swelling of left bicep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  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. Further information has been requested.; 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. Further information has been requested.
SEVERE vomiting for 10 hrs, SEVERE shivers, SEVERE muscle ache/headache
I was Vaccinated on Friday March 26, on Sunday night March 28 I had a sudden episode of uncontrollable shortness of breath while sitting having and not strenuous activity. Immediately went to emergency room. First blood pressure on examination was 180/100, also experienced tachycardia with heart rate fluctuating between 100-120s while sitting on stretcher SPO2 remained normal at all times between 98-100%. All exams performed (Labs, Ekg, CTA, UA) showed normal results per MD. Symptoms began to subside on their own and was give small dose of Ativan to continue to help symptoms subside and was discharged with a diagnosis of "anxiety". Today is March 31st nearing April 1st and I have had intermittent shortness of breath at times just sitting down and other times when performing light activity tachycardia and shortness of breath. I do not agree with the diagnosis of "anxiety" as today I had an episode of shortness of breath and tachycardia after conversation and laughing with my spouse without anything on my mind completely distracted the symptoms began. I am a healthy 25 year old woman with no serious past medical history the only change that occurred before my sudden symptoms was receiving the vaccine just 2 days prior and I truly believe this was the cause.
Felt wave of dizziness shortly after vaccine administered.  Dizziness passed, so left facility. right after vaccine administered.  After approximately five minutes felt tingling on left side of face around cheek and lips.  After another 2 or 3 minutes mouth felt cottony and tasted funny.  Arrived home 1 minute later and took 25mg Benadryl.  Numbness and tingling still present, but not worsening.  Took another 25mg Benadryl at 1845.  Numbness still present when went to sleep approximately 2100.  Some numbness along left side of mandible still this morning (0845 11/16/21).
This spontaneous case reported by a consumer, describes the occurrence of musculoskeletal chest pain (pain in the ribs) and costochondritis (inflammation in the ribs) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 044A21A and 015M20A) for COVID-19 immunization. No medical history reported. On Feb 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 12, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient had musculoskeletal chest pain (pain in the ribs) and costochondritis (inflammation in the ribs). At the time of the report, musculoskeletal chest pain (pain in the ribs) and costochondritis (inflammation in the ribs) outcome: unknown. Diagnostic results: On an unknown date, computerised tomogram: normal (could not find anything wrong). The pain did not start right away after the doses of vaccine. No concomitant medications or treatment information provided.
patient suffered syncope. fainted multiple times within a 15 minute period after regaining consciousness. blood pressure and heart rate also dropped to 79/44 pulse 49. Blood pressure slowly increased over 30 minute period. An unconscious episode resembled a seizure. called Emergency patient was taken to ER for follow up. Returned next day to report BP had stabilized.
Patient started hyperventilating after receiving vaccination. BP 124/84; HR 65; O2 sat 98-99%.  Pt has history of anxiety attacks and was stable for discharge after 20 minutes
Vomiting after every set of shots . So far received HepB, DTAP, Hib, IPV, Prevnar, MMR and Varivax.
Around age 1, a hard, itchy nodule developed in left thigh at immunizations injection site; it is intensely itchy, can become red and swollen when itched or when she has a cold. The hair surrounding the spot is darker than the rest of her leg hair. Vaccination Granuloma induced by aluminum containing vaccines.
The patient was nervous about receiving the vaccine, but he was fine after it was administered and sighed with relief. Then he went to our waiting area and about two minutes later he slumped forward into his girlfriend. I ran out there and helped him out of the chair and onto his back on the ground and he immediately felt better.
102 fever (1-2 days), purple nails (1day), freezing feeling (3 days), chills (3days), heart palpitations (3 days), aches (3 days), skin soreness (3 days), fatigue (1week).
Abrupt onset, about 11 hours after the vaccine, of rigors and fever to 100.4, and myalgias.
Chills; Enlarged lymph nodes; Body aches in her back and shoulders; Body aches in her back and shoulders; fever of 99.6/low grade; Sore arm; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the right arm on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included urinary tract infection (UTI) from 06Jan2021 and ongoing. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), in the left upper arm with no issues. At first, she just had a sore arm on 08Jan2021. Then this morning, on 13Jan2021, she was having chills, enlarged lymph nodes, body aches in her back and shoulders, and a fever of 99.6. It is low grade but does not take much. She has been checking her temperature every 4 hours and it is not any different. She was taking paracetamol (TYLENOL) for a few days to ward anything off. Today (13Jan2021), she laid off the paracetamol to see if she really did have a fever. She did not want to mask it. So, she is taking paracetamol for that off and on. She talked to one person who said the symptoms should last 1-2 days. Then another person said they could last up to a week. She hopes that it is related to the vaccine. She will be mad if she gets COVID after doing all of this. Outcome of the sore arm was recovered on 09Jan2021 and of the remaining events was not recovered.
SUSPECTED COVID-19 INFECTION; LETHARGY; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 45 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included: body mass index (32 BMI) and iodine allergy, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. Patient was on other medication or products within 2 weeks of starting covid-19 treatment. The patient received covid-19 vaccine (dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported and has been requested. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine (Dose number in series 1). The patient received non-company suspect vaccine Moderna/Spikevax (dose number in series 2) (form of admin, route of admin and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with non-company suspect vaccine Moderna/Spikevax (Dose number in series 2). The patient received non-company suspect vaccine Pfizer (tozinameran) (dose number in series 3) (form of admin, route of admin and batch number were not reported, expiry: unknown) dose was not reported, administered at left arm on 24-JUL-2022 16:00 for covid-19 prophylaxis. Concomitant medications included lisdexamfetamine mesilate.  The patient took non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 11-AUG-2022 and last dose on 16-AUG-2022 for treatment of covid 19. On 22-AUG-2022 at 15:00, six days after taking paxlovid the patient experienced cough, runny nose, shortness of breath with difficulty breathing fever (suspected covid-19 infection) and lethargy (dose number in series 3). Currently the patient was on day 16 since the first symptom and feels like she was getting worse. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran and tozinameran was not applicable and with paxlovid was drug discontinued. The patient had not recovered from suspected covid-19 infection and lethargy. This report was non-serious.
Patient was given a dose of COVID-19 Pfizer Gray Cap Vaccine after the 12 hour use by time. The vaccine had been left out from the day prior, the staff member thought it was a new vial and used it to give a dose of the vaccine to a patient.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 lot # M041394 with expiration date 23-MAY-2018 (dose and route of administration not reported). The vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 30 minutes. Digital data logger was used to record the excursion. The vaccine already underwent previous excursion of 32 to 35 degrees Fahrenheit for 185 hours and 45 minutes. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA010520: US-009507513-1704USA005828.
EVENINING OF 1ST DOSE - LEFT ARM AND SHOULDER WAS EXTREMELY SORE. MIDNIGHT - NECK STARTED HURTING AND FELT A FLASH HEADACHE. SOON AFTER, BACK STARTING HURTING, (LOWER RIGHT & LEFT FLANKS OF BACK), NECK AND LEGS FELT WEAK. 9AM NEXT DAY, HEADACHE RETURNED.
Slight pain at injection site at moment of injection, but then no pain after for the remainder of the day. Felt slight body aches at bedtime (11PM). Slept poorly all night due to body pains. Woke to muscle aches and slight join pains, which worsened throughout the day. Low grade temperature appeared at noon the day after the shot, and stayed into the night. Headache began around 5PM and got worse. Tylenol helped at 7PM. Slept from 7:30PM to 7:30AM. Felt back to normal by morning.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, body aches, fever, HA, joint pain, nausea, chills, fatigue Narrative:
Pt received PNEUMOVAX 23 at physical 8-17-11. On 8/18, pt called stating she had been vomiting, had hives, itching and diarrhea since the night before. Pt took BENADRYL. Pt seen in office 8/18. Had coarse bronchial breath sounds. Site tender, warm, erythematous raised 5 cm area. (L) arm slightly enlarged. Rx cetirizine in am. BENADRYL at night. Prednisone taper.
Breakthrough COVID infection in fully vaccinated patient. Positive date 10/07/2021.
Shingles; Sore arm /Sever heel pain; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and MYALGIA (Sore arm /Sever heel pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced HERPES ZOSTER (Shingles) and MYALGIA (Sore arm /Sever heel pain). The patient was treated with ACYCLOVIR [ACICLOVIR] for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) and MYALGIA (Sore arm /Sever heel pain) outcome was unknown.            No concomitant medications were reported   This case was linked to MOD-2021-273317 (Patient Link).
11 x 5 cm erythema over (R) ant thigh - warm no tenderness. 11 x cm erythema plaque one, (L) ant thigh and mild tenderness and warmth. Tx - ice packs to affeted area; BENADRYL PRN.
Positive covid test 7/7/2021. Pt did report of a negative covid test done outside of clinic after this positive.
getting a double dose of Poliovirus Vaccine described as the consumer receiving the prescribed Kinrix and a dose of IPOL, which was not prescribed with no reported adverse event; Initial information received on 20-Apr-2022 regarding an unsolicited valid non-serious case received from healthcare professional.  This case involves a 4-year-old female patient who was getting a double dose of poliovirus vaccine described as the consumer receiving the prescribed kinrix and a dose of ipol, which was not prescribed with no reported adverse event while receiving vaccine ipv (vero) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (Kinrix) for prophylactic vaccination.  On 20-Apr-2022, the patient received 0.5 ml, once dose of suspect IPV (VERO) (lot T1D481M, expiry date: 22-Jul-2025) via intramuscular route in the left thigh (left leg) as prophylactic vaccination.  On 20-Apr-2022 the patient developed a non-serious event "getting a double dose of poliovirus vaccine described as the consumer receiving the prescribed kinrix and a dose of ipol, which was not prescribed with no reported adverse event (extra dose administered)" same day following the administration of IPV (VERO).  It was reported "Caller stated a patient was given Dtap and Ipol. Caller wanted to know what should they tell the patient. A Clinic calling to report a medication error of getting a double dose of Poliovirus Vaccine described as the consumer receiving the prescribed Kinrix and a dose of IPOL, which was not prescribed. The caller reported that the Kinrix contains DTap and IPV."  Action taken with poliomyelitis vaccine (inactivated) (Ipol) was not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown for the event getting a double dose of poliovirus vaccine described as the consumer receiving the prescribed kinrix and a dose of ipol, which was not prescribed with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Dizziness, Myalgia, Arthralgia, shaking Narrative:  onset of s/s day after shot  Other Relevant History:
Modern a COVID-19 vaccine EUA.  One week after receiving the vaccine, the injection site began itching, was hot to the touch, and a lump under the skin could be felt. A dime size red area was at the injection site. The next day, the injection site was still hot, still has a lump, and the redness is now quarter sized. Prior to this, the arm was a little sore for the first one or two days, with no other symptoms.
hours after the jab i got sicker than crap. Nauseated, headache and joints started hurting. Got worse over night . lasted two days. nauseated went away so did the headache. but not the joint soreness. The second jab was in the left arm was sore injection site swelled up and was red and swollen around injection site. was warm to the touch and the red area was the size of a baseball.
Information has been received from a registered nurse concerning a 12 month old male who on 13-FEB-2007 was vaccinated SC with a 0.5 ml dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (rHA) (lot# 656038/0204U) in the left thigh. On 25-FEB-2008 2 days before the physician's office visit, the patient developed a rash. On 27-FEB-2008 the patient presented to the office with a rash all over his body. The patient was not recovered at the time of this report. There was no product quality complaint. Additional information has been requested. Follow-up information from the reporting registered nurse concerning a 12 month old male who on 13-Feb-2008 was vaccinated SC with his first dose of VARIVAX (Merck) (lot# 1122U) in the right thigh. There was no illness at the time of vaccination. Concomitant vaccinations administered on that same day included the first IM dose of Hepatitis A (lot# 6554432/0613F) in the left thigh, the first SC dose of MMR II (lot # 65603B/0204U) in the left thigh and fourth IM dose of HIB Conj vaccine (ACTHIB) (lot# UF295A1) in the right thigh. On 25-FEB-2008 the atient experienced rash all over body. On 26-Feb-2008 the patient experienced varicella characterized by vesicle eruption on right anterior thigh and had a few maculopapular rash on his abdomen area. It was also noted that the wrong vaccine MMRII (lot # 656038/0204U) was reported for the adverse event and should have been for VARIVAX (Merck) (lot # 1122U). On 01-MAR-2008 the patient recovered from VARICELLA and Macolopapular rash. Additional information has been requested.
The patient passed out cold immediately after getting the injection. He fell forward out of the chair and landed prone on his face. He came conscious quickly after we rolled him on his side. The paramedics treated him for a laceration on his nose and forehead and he left the store on his own.