chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via a company representative refers to a 22 year old male patient. On unknown dates the patient was vaccinated with 2 separate doses of VARIVAX (Merck) (strength, dose, injection site and lot # not reported). On an unknown date the patient was found to have lower than normal titers after the 2 doses of VARIVAX (Merck). The outcome of event was unknown. The causal relationship was not reported. This is one of several reports received from the same source. Additional information has been requested.
Fever, chills, nausea, vomiting, diarrhea, lt arm pain, lt axillary lymph node swelling, lt breast pain, lt neck pain, headache, lt ear pain. Lt sided cervical nerve inflammation radiating into lt side of face and head/neck/ear
staph epidermidis abscesses seen 12SEP I&D @ clinic 13SEP in hosp x 3 days;rx w/ATB;
Attendee received First dose Pfizer vaccine at 3:43 pm in the left arm. Lot# FJ8762. Did well, 3:48 pm Attendee conveyed he has anxiety, also conveyed included feeling like he was "going pass out. Darkness in front of eyes". Attendee assisted to the cot to lie down, legs elevated. Preexisting Conditions: Nothing prior to event; Slender build.  Reported after event has history of Needle Anxiety and not eaten or drinking lunch, eaten cereal for breakfast, had not drank much. 3:55pm While lying down, Attendee stated he felt better. He was never diaphoretic and stopped appearing pale; continued drinking and snacks provided. 4:30pm - Care Practitioner educated on home discharge/adverse reaction instructions and departed.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-SEP-2015, the patient was vaccinated with ZOSTAVAX at 0.65 ml, subcutaneous (lot # L016284 with expiry date of 07-AUG02016) in the left deltoid and then it was discovered that on 03-OCT-2014, the patient had been already administered a dose of ZOSTAVAX (lot # K007989 and expiry date of 03-SEP-2015). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Seizure; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. The patient experienced seizure on 10Apr2021. The patient had no other vaccine in four weeks. The patient was tested for COVID post vaccination. The patient underwent lab tests and procedures which included nasal swab: negative. Therapeutic measures (medication and follow-up treatment) were taken as a result of seizure. The outcome of the event was not recovered. The event was reported as serious-hospitalized, disability, life-threatening.
Office Visit  10/19/2021 Internal Medicine Acute bronchitis, unspecified organism +1 more  Dx   Progress Notes   Date of Service: 10/19/21 Diagnosis Plan 1. Acute bronchitis, unspecified organism  azithromycin (ZITHROMAX) 250 mg tablet 2. Suspected COVID-19 virus infection  COVID-19 PCR   COVID-19 PCR     Plan   Patient Instructions I am sorry that the body aches cough, weakness, and low-grade fever have been a problem over the past several days.  On examination today, I hear a fair amount of mucus in both lungs, so I would like to treat this like acute bronchitis.  Please start the course of a azithromycin.  Watch for diarrhea with this antibiotic. Patient is a 57 y.o. male who presents for ZONE PATIENT COLD, CONGESTION, MYALGIA.   3-4 days ago body aches.  Productive cough.  No appetite.  Litle weak, dizzy.   No loss of taste or smell.   Phone call to the office yesterday morning described arm soreness. 10/8/2021 he received the first Pfizer COVID-19 dose in his left deltoid. In the call, he described pain at the vaccination site and joints in the left arm.
Vesicle-like rash @ injection site (L arm) with redness and a single lesion that had been scratched and is now open.
Red rash face, chest, arms, 15 min after vaccine.  no temp, no resp distress no tx needed. Rash disappeared after several hrs.
Creatinine jumped.; BUN and Creatinine jumped; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 03Mar2021, for Covid-19 immunization. The following information was reported: BLOOD CREATININE INCREASED (non-serious), outcome "unknown", described as "Creatinine jumped."; BLOOD UREA INCREASED (non-serious), outcome "unknown", described as "BUN and Creatinine jumped". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient experienced adverse reaction after taking both shots of the vaccine. Something has changed in his Lab Work after he can no longer get radiation for cancer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt pain pain in right hip down his legs like sciatic nerve), MYALGIA (felt pain pain in right hip down his legs like sciatic nerve, bodyaches), PYREXIA (pyrexia), HEADACHE (headache) and FATIGUE (fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027b21a04) for COVID-19 vaccination. No medical history was provided by the reporter. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PYREXIA (pyrexia). On 09-Apr-2021, the patient experienced HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced PAIN (felt pain pain in right hip down his legs like sciatic nerve) and MYALGIA (felt pain pain in right hip down his legs like sciatic nerve, bodyaches). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (felt pain pain in right hip down his legs like sciatic nerve), MYALGIA (felt pain pain in right hip down his legs like sciatic nerve, bodyaches), PYREXIA (pyrexia), HEADACHE (headache) and FATIGUE (fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 99.5. On an unknown date, Multiple sclerosis: Inconclusive. On an unknown date, Rheumatoid arthritis: Inconclusive. On an unknown date, X-ray: narrowing in right hip 2mm left hip 4mm. No concomitant medication included. Treatment medications included steroids for inflammation were provided. This case was linked to MOD-2021-085735. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: significant follow up received, patient demographics updated, AE progress/outcome, Lab work, Dose 1 and dose 2 information updated.
Information has been received from a pharmacist concerning a female patient who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck) (lot # 658861/1822U). Subsequently, the patient developed an erythematous injection site rash. It was unspecified if medical attention was sought. The patient recovered on an unspecified date. There was no product quality complaint involved. Follow-up information from the pharmacist indicated she did not have the names of the patients involved in the event. Additional information requested. This is one of several reports from the same source.
Hands and feet were numb and  had discoloration  Approx 7.5 hrs after vaccine was administered. Major chills and body shakes.  I have a picture of my hand. Other symptoms were as expected ( fever, headache) and went away after 48 hrs.
I lost vision and became dizzy and lightheaded five minutes after shot. I returned to the clinic and sat down. My blood pressure was under 90/60 once I regained stability.
Patient experienced syncope approx. 5 minutes after receiving dose. Hypotensive with approx. BP of 80/40. Was transported to hospital by emergency first responders
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 07-DEC-2015 at time- 03:34, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.8 and 1.6 (units unspecified) for 53 minutes respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Onset swell, itchy, induration within 24' after SQ varicella vaccine. Examination revels 3cm induration, 5cm and tender, minimum erythema - (R) arm
Taken to ER 11OCT91 generalized urticaria, chills, shaky, eyes rolled back, didn't respond, t105.6; stayed in ER for 18hrs; said was immun rxn; blood tests, throat cult neg;
VACCINE ADMINISTERED WAS OUTSIDE OF APPROVED STORAGE AND HANDLING INSTRUCTIONS..PFIZER MANUFACTURER RECOMMENDED REVACCINATION, BECAUSE IT DOES NOT HAVE DATA TO SUPPORT VACCINE STABILITY.
At 2:34pm the patient had tingling to fingers on both hands. Vitals were taken. Observed for another 30 min and was sent home. Notes were that right side did resolve no notes about left side.
since march 2nd, his arm is still killing him'.; This spontaneous report was received from the patient's wife via Pfizer referring to her husband, an 83 years old male patient. The patient was in excellent condition prior to diagnosed of 2 tumors left kidney. And reported cancer in adrenal gland and spleen, vena cava vein. The patient was also taking pembrolizumab (KEYTRUDA).  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23 valent) (PNEUMOVAX23) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis. Since 02-MAR-2020, the patient had a very bad reaction to pneumococcal vaccine, polyvalent (23 valent) (PNEUMOVAX23), the patient's arm was still killing him (pain in extremity). The outcome of pain in extremity was unknown.     The causality between pain in extremity and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was related.
Pt recv'd varicella vaccine 6/26/12, mother presented to clinic the following day, 6/27/11 to report concern about adverse reaction to vaccine. Left arm shows 5.5 cm induration with an open sore central to induration. Clear discharge noted and cellulitis. No fever, no pain. Some itching. Cleaned wound & placed antibiotic ointment and covered infection precautions given. Pt to return if needed.
Also received the senior flu shot, same arm, same time.   Adverse event was that I became infected with COVID 13 days after receiving the Omicron variant booster. I tested positive two days later (on day 15). This was  the fifth in my series. All prior vaccines were Moderna.  Note that my wife started displaying symptoms 8 days past my inoculation and tested positive 10 days past. She had four boosters, but not the omicron variant.
This spontaneous report as received from a other health professional refers to a 57 year old patient (in source document referred as patient 1) of unknown gender with no reported medical history. On 03-APR-2013 the patient was vaccinated PNEUMOVAX23 (route and dose unknown), lot number H04196 with expiration date 19-MAR-2014 . No other suspect therapy or concomitant medication was reported. On 05-APR-2013, 3 days after onset of therapy the patient experienced cellulitis at the injection site following administration and was prescribed KEFLEX for treatment. The outcome of cellulitis at the injection site was reported as recovering/resolving. The reporters relatedness of cellulitis at the injection site to PNEUMOVAX23 is unknown. This case is linked with MARRS number 1304USA007298 (same reporter link). Additional information is not expected.
2 vaccines place one on each arm on 6-6-17. Mom called office concerned that left arm was swollen and red to touch - was advised by office to mark area and apply BENADRYL cream on 6-7-17 - if no better call back for appt. Appt. on 6-8-17 (8 cm length, 12 cm width).
Developed reported temp of 102 degrees F within 24 hrs after H1N1 vaccine.
I had no reaction at all to the shots, no swelling, no bruising, no sleepiness and I cant even see where the injection was made.  I had the second dose on 02/18/2021(lot number EL9267), and I had a third shot on 08/16/2021 (lot number FC3182), I had no reaction whatsoever to any of the three shots.
Headache, Fever, CoughWheeze, NASAL DRIP, MUSCLE FATIGUE, EXHAUSTION Narrative:
after vaccine series, recurrent shingles/ suspected vaccination failure; recurrent shingles, lower back; recently was diagnosed with chickenpox/chickenpox after getting the Shingrix vaccine; Genital lesions; Painful; Constipation; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, chickenpox, genital lesion, pain and constipation. The patient was treated with linaclotide (Linzess) and acyclovir. On an unknown date, the outcome of the vaccination failure, chickenpox and pain were unknown and the outcome of the shingles was recovering/resolving and the outcome of the genital lesion and constipation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, chickenpox, genital lesion, pain and constipation to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that after receiving the Shingrix vaccine series, she developed genital lesions, recurrent shingles outbreaks on lower back, that was painful, and began having constipation. The patient was prescribed acyclovir for the genital lesions and lower back. Linzess was also prescribed to patient by healthcare professional for constipation.  The patient also disclosed that she recently was diagnosed with chickenpox by her healthcare professional. The patient's healthcare professional referred patient to dermatologist and the patient had not yet seen dermatologist but planned to. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
got COVID after the 1st shot; got COVID after the 1st shot; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the third of three reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient got COVID after the 1st shot. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021503608 same reporter/vaccine, similar events, different patient.; PFIZER INC-2021503619 same reporter/vaccine, similar events, different patient.
On 10/03/2022, I developed a fever, sore throat with minimal congestion and severe fatigue. My employees described that I was incoherent to the point that they couldn't follow my sentences. That all lasted for around a week. My fever got up to 102.5. I went to the doctor who prescribed a steroid, an antibiotic, a cough syrup with codeine. I took multiple at home COVID-19 tests but were all negative. I had a cough from October until early February that did not go away. They eventually prescribed me prednisone when symptoms would not go away. My other symptoms went away by mid-October. However, in January, I had to be seen at the emergency room. I had developed pneumonia. I was having chest pain and irregular heartbeat. I'm just now to the point where I feel fully recovered. My resting heartbeat has gone up around 8 beats per minute and has not gone back down.
5 death happen; This is a spontaneous report from a non-contactable consumer. This consumer reporting same event under the same suspect product for 5 patients. This is 3rd of 5 reports. A patient of an unknown age and gender received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient died after Pfizer vaccine. It was further reported that couple of deaths occurred after Pfizer vaccine, some of them immediately, some in few hours. The reporter stated that in one village with 2000 population, 5 death happen and some after the 2nd vaccine and one of them immediately after vaccine, The vaccine was kept in ice box for like 5 hours, other village it just about 3, another village or 2.  The reporter stated if the vaccine was carried by just ice for like 5 hour, may be this was the problem.  Outcome of the event was fatal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100944572 same reporter/drug/event, different patient; Reported Cause(s) of Death: 5 death happen
Patient states she experienced severe nerve pain within hours after receiving the Moderna booster and lasted for several days, Patient stated that nothing would control the pain. Patient denies any other possible contributing factors.
felt a little tired; however the rash as described after the first Moderna Monovalent vaccine continued; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FATIGUE (felt a little tired) and RASH (however the rash as described after the first Moderna Monovalent vaccine continued) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 59267-0304-02) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No medical history was reported by the reporter.  Concomitant products included ACYCLOVIR [ACICLOVIR], FINASTERIDE, VALSARTAN, ROSUVASTATIN and TADALAFIL for an unknown indication.   On 19-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (felt a little tired) and RASH (however the rash as described after the first Moderna Monovalent vaccine continued). The patient was treated with PREDNISONE for Rash, at an unspecified dose and frequency; LORATADINE at an unspecified dose and frequency; DIPHENHYDRAMINE at an unspecified dose and frequency; HYDROCORTISONE at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE at an unspecified dose and frequency. At the time of the report, FATIGUE (felt a little tired) outcome was unknown and RASH (however the rash as described after the first Moderna Monovalent vaccine continued) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient's wife reported no chronic medical conditions. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.   This case was linked to MOD-2023-720364 (Patient Link).
diarrhea; nausea; vomiting; swollen glands; body aches everywhere like she hasn't had in her entire life; headache; fever of 99 degrees; She stated she has been in bed all day; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DIARRHEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting) and LYMPHADENOPATHY (swollen glands) in a 71-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.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 29-Apr-2021, the patient experienced DIARRHEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting), LYMPHADENOPATHY (swollen glands), MYALGIA (body aches everywhere like she hasn't had in her entire life), HEADACHE (headache), PYREXIA (fever of 99 degrees) and SOMNOLENCE (She stated she has been in bed all day). At the time of the report, PAIN IN EXTREMITY (sore arm), DIARRHEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting), LYMPHADENOPATHY (swollen glands), MYALGIA (body aches everywhere like she hasn't had in her entire life), HEADACHE (headache), PYREXIA (fever of 99 degrees) and SOMNOLENCE (She stated she has been in bed all day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
the hair loss started right away, a big and very different amount of hair.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Jun2021 (Lot number: EW0186) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number=EW0186, lot unknown=False, administration date=01Jun2021, dose number=1), administration date: 01Jun2021, when the patient was 33 years old, for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 16Jul2021, outcome "not recovered", described as "the hair loss started right away, a big and very different amount of hair.".  Additional information included: The patient did not receive other vaccine in four weeks. The patient was not Covid tested post vaccination. The patient had no known allergies or other medical history.   No follow-up attempts are possible. No further information is expected.