chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; seven blisters; stress; This is a spontaneous report from a contactable consumer. A 103-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in Jan2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had her first dose in January, second dose was scheduled on 19Feb2021. The patient did experience "mild' case of shingles following first dose and maintains seven blisters. The reporter asked if the patient is to receive second dose. It was further reported that "HCP indicated stress related" (pending clarification). The outcome of events was unknown.  Information on the lot/batch number has been requested.
Left upper arm given vaccinations a day later returned with s/s of cellulitis, no other s/s of allergy reaction; treat cellulitis +helping
Arm and shoulder area are hurting; Worse in the mornings; can't raise his arm; This spontaneous case was reported by a physician assistant and describes the occurrence of PAIN IN EXTREMITY (Arm and shoulder area are hurting), PAIN IN EXTREMITY (Worse in the mornings) and INJECTED LIMB MOBILITY DECREASED (can't raise his arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 immunization.     no medical history reported.     On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm and shoulder area are hurting), PAIN IN EXTREMITY (Worse in the mornings) and INJECTED LIMB MOBILITY DECREASED (can't raise his arm). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm and shoulder area are hurting), PAIN IN EXTREMITY (Worse in the mornings) and INJECTED LIMB MOBILITY DECREASED (can't raise his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications used by the patient were not provided.   Reporter did not allow further contact
Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
arm was sore for about 3-4 days; Rash got larger, redder, itchier; warm to the touch; itchy; rash; speckled red spots that were raised; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (speckled red spots that were raised), PAIN IN EXTREMITY (arm was sore for about 3-4 days), VACCINATION SITE REACTION (Rash got larger, redder, itchier), VACCINATION SITE WARMTH (warm to the touch) and PRURITUS (itchy) 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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced RASH MACULAR (speckled red spots that were raised), PRURITUS (itchy) and RASH (rash). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore for about 3-4 days), VACCINATION SITE REACTION (Rash got larger, redder, itchier) and VACCINATION SITE WARMTH (warm to the touch). The patient was treated with HYDROCORTISONE for Itchy, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (speckled red spots that were raised), PAIN IN EXTREMITY (arm was sore for about 3-4 days), VACCINATION SITE REACTION (Rash got larger, redder, itchier), VACCINATION SITE WARMTH (warm to the touch), PRURITUS (itchy) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information also included anti-itch ointment.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up was received on 26 APR 2021 included reporter details was updated.
spent 5 hrs in the ER due to arm having problems; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on Dec2020 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient spent 5 hrs in the ER due to arm having problems on an unspecified date with outcome of not recovered. The patient was hospitalized for event. The patient worked in Healthcare and got first shot the end of Dec2020 and the second on 19Jan2021. The patient contacted employee health at the and reported what they believe is side effects from the vaccines that happen not right after having the vaccine. Patient spent 5 hrs in the ER due to arm having problems a couple weeks after the 2nd injection and as of today 07Mar2021 still ongoing.  Information on the lot/batch number has been requested.
Patient arrived to observation room around 11am following vaccination with Moderna dose #1, no distress noted, sitting in back of room. Around 11:05am, patient was seen by observation RNs as putting head down into hands and started to wave for assistance. Per patient, she felt hot, light-headed and  faint. Patient's lower extremities were elevated on adjacent chair and 10LPM 02 administered via bag mask. Vital signs measured: p64, R22, BP120/76, 02:99%. Patient stated she felt mild "scratchiness" in her throat, which dissipated in less than 5 minutes. No presence or reports of angioedema, wheezing, shortness of breath, hypotension, rash/redness.  Benadryl was drawn up and prepared in case of need for administration, Epipen also nearby. After about 20 minutes of sitting with legs elevated and O2 flowing, client reports feeling better, no longer feeling "scratchy" throat. Patient states she was anxious to receive vaccine and thinks symptoms are due to anxiety. Patient's husband present and assisted patient to car around 11:30am. No further intervention needed.
developed diffuse blistering and burning rash to face along with fatigue 4 hours after receiving. 2/6/2021 had an episode of dizziness and vertigo
Patient came in to the pharmacy 4 days after the flu shot has been administered and said she had know in her throat 3 hours after the administration and pain in the abdomen/stomach area and she went to the ER where she was given Benadryl shot and she was OK afterwards.
redness spot on the site of injection. kind of an oval around injection site about 3 to four inches  big
After vaccination, patient presented with dizziness and labored breathing within 2 minutes of receiving the vaccine. He reported that he felt warm, out of sorts, heart racing, shakiness, and chest pain.
PT mother states that the next day her son started with fever 24 hours after the vaccine. He had a fever for the next 8 days. At times his fever got up to 103F. His other symptoms were that his lymph nodes in his neck got very swollen and painful to touch and was very tired. He also threw up 3 times on various days. He also had a very mild sore throat before his vaccine. His pediatrician thinks it was the vaccine with in combination with his virus, was tested for strep, mono and covid, and all was negative, also lab work was performed and all was negative. He slowly started to feel better after his fever went down.
Shortly after receiving Zostavax vaccine, suffered a stroke, hearing loss, and shingles.; Shortly after receiving Zostavax vaccine, suffered a stroke, hearing loss, and shingles.; Shortly after receiving Zostavax vaccine, suffered a stroke, hearing loss, and shingles.; Information has been received from a lawyer and the patient (pt) regarding a case in litigation involving a male patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     In or around 2012, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, frequency, lot/batch # and expiration date were not reported).     On an unknown date, reported as "shortly after receiving zoster vaccine live (ZOSTAVAX)", the pt suffered a stroke (cerebrovascular accident), hearing loss (deafness), and shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt symptoms had resulted in physical limitations not present prior to using it. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition.  As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.    The reporter considered the events to be related to zoster Vaccine Live (ZOSTAVAX).  The reporter considered the events to be disabling. Upon internal review, stroke, hearing loss were determined to be medically significant events.
received only the liquid part of Shingrix; received only the liquid part of Shingrix; This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was a medical assistant. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The reporter informed that the patient accidentally received only the liquid part of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consent to follow up. No further information available. This case had been linked with US2021AMR095814 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021095331:same reporter
Given a 2nd booster in less than 4 months since the 1st booster received. No known symptoms at this time.
died from heart attack; This is a spontaneous report from a contactable consumer via a Pfizer Sponsored reported for a male patient (Husband). A male patient of an unspecified age received first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient died from heart attack exactly 1 week later after vaccine on an unspecified date. Never had any heart issues or anything. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died from heart attack
Pain in every joint; Loss of bladder function; Blood platelet count went to 636,000; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Lot number: EN5318) at the age of 82 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, At 11:00, Batch/lot number: EL3246, Anatomical location: Left arm), administration date: 2021, for COVID-19 Immunisation. The following information was reported: PLATELET COUNT INCREASED (caused and prolonged hospitalization, disability, life threatening) with onset 25Dec2021 at 01:00, outcome "recovered with sequelae", described as "Blood platelet count went to 636,000"; BLADDER DYSFUNCTION (caused and prolonged hospitalization, disability, life threatening) with onset 25Dec2021 at 01:00, outcome "recovered with sequelae", described as "Loss of bladder function"; ARTHRALGIA (caused and prolonged hospitalization, disability, life threatening) with onset 25Dec2021 at 01:00, outcome "recovered with sequelae", described as "Pain in every joint". The patient was hospitalized and prolonged hospitalization for arthralgia, bladder dysfunction, platelet count increased (hospitalization duration: 52 day(s)). The events "pain in every joint", "loss of bladder function" and "blood platelet count went to 636,000" required emergency room visit. The patient underwent the following laboratory tests and procedures: Platelet count: went to 636,000, notes: high. Therapeutic measures were taken as a result of arthralgia, bladder dysfunction, platelet count increased. Clinical course: Patient had pain in every joint which felt like when cutting with razor or knife and loss of bladder function. He was hospitalized for 2 months. He had two surgeries on bladder spine nerves. He recovered with lasting effects. He received many treatments. Patient did not received other vaccine in four weeks, not received other medications in two weeks.
My lymph nodes were swollen and the side of my throat and hurt from my ear down to my whole neck. I waited to get it looked at until I was going to a routine visit with my doctor. When I went, she did a Thyroid Antibody Testing and levels were very high. My PCP raised my dosage of thyroid medicine levothyroxine. I'm doing better since my medication was increased and I've been avoiding foods that trigger my immune system.
After the 1st injection, she had the worst period of her life, extreme bleeding and painful. After the 2nd injection she was still bleeding and her period stopped. She began to have horrible diarrhea.
Client had swelling in his right ankle to his knee the following day. Did not feel well after the vaccinations. He thought his pneumonia had not resolved. Went to Area Health Center by ambulance on December 8, 2021 after collapsing. He was vomitting and unresponsive. His breathing had been getting progressively worse until this incident. He had no appetite prior. He was taken by ground ambulance to Hospital and then flown to other hospital for 6-7 days. He was diagnosed with blood clots in his right leg that traveled to his lungs. He was told his blood was as thick as motor oil. He had a thrombectomy and was diagnosed with an enlarged heart and 2 cerebellar strokes. He was discharged to home after 6-7 days because the hospital was so full with covid patients. He was told he was to sick to go home but to well to be in the hospital. He was discharged with pneumonia and had a fungal infection. He did receive PT at home. On January 23rd he was found nonresponsive by his wife again. She called 911 and he was transported to Hospital again and life flighted. He was in the ICU intubated and with chest tubes for 20 days. He was septic. He had a tracheotomy placed and was life flighted to an Hospital for 21 more days. His lungs were still filling with fluids. After 21 days he was transferred to a hospital for 3-4 days due to his lungs still being full of fluid. He was extubated then transferred to hospital still having pneumonia. He was there for a month getting extensive rehab learning to walk and perform ADL's. He is home now, recovering. He is still on oxygen continuously and taking diuretics daily.
Patient became flushed, hot, severe headache, face was numb. Blood pressure was elevated 183/94, heart rate 119 bpm.  Moved patient to cooler area of clinic. Blood pressure 5 minutes later, was 170/83,  heart rate 105 bpm, headache was not as severe. Patient remained in clinic for 30 min. Blood pressure was 125/73. Patient felt well enough to leave.
Duplicate Dose of Prevnar20 (had already received it back on 05/23/2023).  Patient reports no obvious ADRs from the inadvertent, 2nd dosage of Prevnar20.
Adverse event: Redness and rash appeared at the injection site 1 hour after injection. New red spots gradually appeared at back, front, on the left palm (both front and back) and in between left fingers. Patient did not take any medication and slept over night. The following morning (07/6/2023), more red spots appeared to the right palms and in between right fingers. Patient denied anaphylaxis symptoms during the time being.  Treatment: Patient was advised to take benadryl 25 mg and waiting for MD evaluation. Benadryl 25mg with unknown dosing and quantity was started around 1 PM 07/06/2023 per patient.  Outcome: Awaiting MD evaluation. Patient denied anaphylaxis symptoms at the time of report
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 12-JUN-2017, the patient was vaccinated with a dose of PROQUAD lot number reported as: M000336, expiration date on 03-JUL-2018 (strength, dose number and route were not provided) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). It was reported that the dose of PROQUAD was improperly stored at 43° Fahrenheit degrees for 11 days. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported.  No adverse effect was reported. Additional information has been requested.
Erythema, warmth, 10 cm x 10 cm area 10-15-2010; has gotten bigger size 10-14-10.
12 spots on body x 3days-some crusty exposed to chicken pox in daycare;afeb;
Syncope right after injection given. Of note, he has a history of fainting episodes with injections. BP 131/83, pulse 79. Laid on floor with legs elevated. Given water, juice, and crackers. Resolved.
Vaccinated at 11:00 a.m. Started adverse reactions at 3:00 a.m. Fever of 103 degrees, nausea, diarrhea. Overall tiredness.
Moderna COVID-19 Vaccine EUA dose given 38 days after the BUD for refrigeration
Occupational exposure to product via eye; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OCCUPATIONAL EXPOSURE TO PRODUCT (Occupational exposure to product via eye) 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 OCCUPATIONAL EXPOSURE TO PRODUCT (Occupational exposure to product via eye). At the time of the report, OCCUPATIONAL EXPOSURE TO PRODUCT (Occupational exposure to product via eye) outcome was unknown. Not Provided     No relevant concomitant medications was reported. Treatment information was not provided. Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the non serious event of occupational exposure to product via eye. The event occupational exposure to product via eye occurred while the patient was vaccinating. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the non serious event of occupational exposure to product via eye. The event occupational exposure to product via eye occurred while the patient was vaccinating. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
The patient received a jansen dose and had a seizer after the shot. The ambulance was called however the patient was able to go home and not to the hospital.
Patient went to ER 10 hours after getting a vaccination because she had a fever of 107F.
11 days p/vax pt t101.5-102, achy, exhausted & h/a;next day fine rash on abd & chest sl itchy;17MAR97 abd & chest rash gone & devel rash raised erythematous papules on all fingers;rash extended to elbow, knee & heel of feet;erythema mult
Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 22Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 23Oct2021, outcome "unknown", described as "Fever". The patient woke up with fever this morning after taking second Pfizer shot for COVID.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Pain immediately at injection site. Worsened over the day, evening of 11/2/2020. Woke up 11/3/2020 in the morning with redness at injection site and bruise where needle entered skin. Remained painful. Redness and pain worsened 11/3/2020 and began to streak to her axillae. She notified the office on 11/4/2020 and was brought in for an exam.  Bruising noted at injection site.  Erythema noted lower than injection site with streaking towards axillae. Hot to touch and painful
This spontaneous report as received from a pharmacist refers to a 58 years old female patient with no medical history or drug reactions or allergies. On 20-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H019997, expiration date 02-FEB-2014), subcutaneous in the left arm. Concomitant therapies included MOTRIN, ULTRAM, TOPAMAX, and NORCO. On 21-AUG-2013, the pharmacist was reported that the patient developed 5 inch by 3 inch area consisting of hives and rash on the injection site on her left arm where ZOSTAVAX was given. The patient did not perform lab diagnostics studies, but she sought medical attention, the pharmacist saw the patient. The patient was given treatment for applying ice on her arm. She also used BENADRYL cream and pills. The outcome of events was reported as not recovered.  Additional information has been requested.
Patient feeling nausea and dry heaves in beginning, then dizzy and diaphoretic. Mat brought in and patient assisted to floor and blood pressure taken 100/70 pulse 62. After 5 minutes Client states "I am feeling better" Blood pressure 100/70. Client up to sitting postion and not diaphoretic anymore. Client up in chair drinking and eating granola bar and juice. Client to sit for 10 minutes before leaving.