chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning an approximately 10 month old patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck). On approximately 04-DEC-2007, the patient developed 75 to 100 lesions. At the time of the report, the patients' outcome was unknown. This is one of several reports received from the same source. No further information is available.
right  arm at site was red hot inflamed swollen painful the swelling progressed into the next ay after 24 hours Dr. office was notified a prescription for a Medrol Dose Pack was sent to Pharmacy the pain in the right arm persisted while the swelling resolved
Vaccinated 1/16/2021. Noticed small red, hot patch below arm on evening of 1/17/2021. Marked area with pen. Upon awakening on 1/18/2021 noticed red, hot area had spread into 2 other small areas below original area. Went to ED in hospital and talked to the doctor on call
This spontaneous report as received from a pharmacist concerning a patient of unknown age who was vaccinated with, 0.6 ml dose of PNEUMOVAX23 on 11-JAN-2013 (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Rash on both Ankles; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number AS479, expiry date 25th September 2021) for prophylaxis.   On 9th September 2019, the patient received the 2nd dose of Shingrix. On 9th September 2019, less than a day after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist asked any information on this type of reaction after 2nd dose Shingrix. The healthcare professional (HCP) stated that patient experienced rash on both ankles within 5 hours after 2nd dose administration. The HCP stated that no fever, chills or pain.  The reporter did not consent to follow-up.
The evening of the shot and through the night the patient experienced pain and itching in the upper third of her arm. Red dots developed. MD ordered antibiotic SMZ/TMP DS 1 BID x 10 days.
Narrative:  90yo M with h/o cardiac disease including afib, prostate cancer, hypothyroidism,macular degeneration, hearing impairment, OA passed away while inpatient at hospital. no additional information was given. Pt had received covid vaccines on 1/14/21 & 2/11/21. Vaccinations appear unrelated to pt's death.
11MAR father p/c clinic c/o pt having a stiff neck that started approx noon & was getting worse since coming home from school; sent to ER father stated the only tx pt recvd was pain med & monitoring for 6 hrs;
About 6-8 hours after receiving Comvax #3 and Varivax #1, child experienced febrile seizure with fevers persisting for 4 days then resolution with no other Sx. Treated with Motrin and Tylenol for fever.
A week after I was given the second dose of Shingrix, I developed a full blown and sever case of shingles.
a patient was billed for fluad and administered was Fluzone Quadrivalent/ No AE; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacistf.  This case involves a patient with unknown demographics who was billed for INFLUENZA VACCINE INACT SAG 3V [FLUAD] [batch number, expiry date and other dosing details are not applicable] and administered  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination (wrong product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to wrong vaccine administered. (Latency: at same time of vaccination)  At the time of report, patient had no 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 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.  There will be no information available on the batch number for this case.
Severe arthritis flare that lasted 2 weeks, before subsiding.  Resulted in difficulty walking.
Fatigue, headache, Muscle/Joint Pain, Chills, Feeling unwell,  dizziness
Product temperature excursion issue; No adverse event; Patient received vaccine after temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue ) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  In March 2023, 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. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue ) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue ).    No concomitant medications were reported.  It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Lost power the next day in the middle of the day at 12:00 PM. Had placed all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. On 2-Mar-2023-28-Mar-2023 vaccines were administered to 26 patients. No reported symptoms.  No treatment medications were reported.  This case contains information for the 15th of 26th adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Master case
Patient was administer 0.3 mL of undiluted Pfizer Vaccine. Pt offered MD exam to include EKG and troponin levels with follow up. Pt has no complains.
Pulmonary embolism; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 21-Mar-2021 to 24-Mar-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information included was blood thinner.  Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
Received second dose of vaccine at about 9:20 a.m. on Saturday,  with no immediate adverse reactions. Around 8:30 p.m. on Saturday I began to have severe stomach cramps and bloating, with my stomach sensitive to touch and it was difficult to catch my breath. Symptoms lasted for about an hour before I started vomiting. After vomiting 3 times and taking benadryl I had stomach cramps lasting about an hour, then all symptoms subsided.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 01-FEB-2016 or 02-FEB-2016, the patient was vaccinated with a dose of PEDVAXHIB (lot # K026533 exp date 07-AUG-2017) (dose and route not reported) or a dose of GARDASIL (lot # K011562 exp date 08-APR-2017) (dose and route not reported) that were exposed to a minimum temperature of 328 degrees F and maximum of 84.3 degrees F for 8 hours. The current temperature was 48 degrees F in a time frame of 8 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
lump on their left shoulder/the lump was still there until that day,they called it a lump that does not go away.; After the 3rd shot (1st booster dose), they had a whole Covid arm; COVID arm which turned to a red rash and lasted for over a month; This spontaneous case was reported by a patient and describes the occurrence of SKIN MASS (lump on their left shoulder/the lump was still there until that day,they called it a lump that does not go away.), VACCINATION SITE REACTION (After the 3rd shot (1st booster dose), they had a whole Covid arm) and RASH ERYTHEMATOUS (COVID arm which turned to a red rash and lasted for over a month) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (on the left arm) on 21-Nov-2021. Past adverse reactions to the above products included No adverse event with Flu vaccine.   On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VACCINATION SITE REACTION (After the 3rd shot (1st booster dose), they had a whole Covid arm) and RASH ERYTHEMATOUS (COVID arm which turned to a red rash and lasted for over a month). On 21-Dec-2021, the patient experienced SKIN MASS (lump on their left shoulder/the lump was still there until that day,they called it a lump that does not go away.). At the time of the report, SKIN MASS (lump on their left shoulder/the lump was still there until that day,they called it a lump that does not go away.) had not resolved and VACCINATION SITE REACTION (After the 3rd shot (1st booster dose), they had a whole Covid arm) and RASH ERYTHEMATOUS (COVID arm which turned to a red rash and lasted for over a month) had resolved.            No concomitant information was reported. It was reported that on 21-Dec-2021 patient was in hospital for a special infusion and lump was not on the deltoid area, not exactly on the injection site but above it. MRI was done because they thought it was a tumor and theywere told that it could be a fatty lipoma.  The patient's healthcare providers advised not to get the next booster dose since patient had the rash twice and it got much worse the second time around. It was reported that patient had to apply steroid on red rash because it would not go away on its own.   This case was linked to MOD-2022-649343 (Patient Link).   Reporter did not allow further contact
Difficulty breathing - anaphylactic shock. Epinephrine administered with oxygen and respiratory therapy, but patient ultimately sedated, intubated and placed on respirator for about 10 hours.
acute cerebrovascular accident; transient ischemic attack; Painful lesions on his right thigh; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications. In or around 27-SEP-2017, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), Plaintiff suffered left-sided weakness, slurred speech along with altered mental status. Plaintiff was admitted to the hospital where he was diagnosed with acute cerebrovascular accident. On an unspecified date, plaintiff was admitted to the hospital a second time with symptoms of being unable to walk,recurrent nausea and vomiting and was diagnosed with a transient ischemic attack. Plaintiff also experienced painful lesions on his right thigh. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), Plaintiffs symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of Zostavax, the pt sustained severe and permanent personal injuries. 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. As a direct and proximate result of Defendants' conduct, pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   The outcome of the events was not recovered.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events to be disabling as the pt suffered  serious, progressive, permanent, and incurable injuries.  Upon internal review, acute cerebrovascular accident and transient ischemic attack were determined to be medically significant.
Significant swelling of upper left arm from injection site to above elbow, redness, mild pain/ discomfort Self treated with acetaminophen, compress
facial paralysis; post herpetic neuralgia; vision problems; neurological problems; Information has been received from a lawyer regarding a case in litigation and refers to a currently approximately 66-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 15-JUL-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route not specified) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently (date unknown), the patient was treated by providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX): post herpetic neuralgia, facial paralysis, vision problems, and neurological problems. The outcome of the events was unknown. The causality between the events and zoster vaccine live (ZOSTAVAX) was considered to be related.  Upon internal review, facial paralysis was determined to be medically significant.
Stiff neck the very next day, still have. Right elbow joint soreness.  Fatigue, feel weakness in legs.
This spontaneous case, initially received on 12-Oct-2018, reported by other non-healthcare professional, concerns a 44-year-old, adult female patient. The patient's current condition included metal sensitivities. On an unspecified date in Oct-2017 (reported as late Oct-2017), the patient was administered Influenza vaccine (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). Within 24 hours of vaccination, the patient experienced red welts (reported as about 3x1) at the site of injection for 1-3 weeks. On an unspecified date after vaccination, the patient also experienced fever and aching all over, for a couple of weeks, as a reaction to the vaccine. According to the patient's primary care physician (PCP), the reactions were either due to the mercury or the sorbitol contained in the vaccine and the reporter thought that it was due to the preservatives in the multi dose vial (MDV). At the time of this report, the patient had recovered from injection site redness and welts. The outcome of the events fever and generalised aching was not reported. This case was cross-linked to the case 201804492 due to the same reporter. Follow-up received from other non-health professional on 02-Nov-2018: The patient's age (44 years) and current condition 'metal sensitivity' was added. Vaccination date "Oct-2017" was added. The events 'injection site erythema' and 'injection site urticaria' was added. Narrative and case comment was amended accordingly.
3 inch swelling of vaccine site and a bruise. A rash started the next day. It appeared to be hives down my arm front and back of my left arm where I received the shot. I used baking soda paste on them. It took 5 days for them to go away.
New eruptions of my lupus facial rash appeared  over the course of the first seven days after the injection along with 2 weeks of multiple areas of joint pain and extreme fatigue.
Symptoms: tingling on right side of body--face, arm and hand, foot First event on 3/22/2021 starting at about 4:15 pm, lasted about 15 minutes Second event on 3/23/2021 starting at about 10:15 am, lasted over an hour.  Went to ER during this event; had additional tingling on site in the ER.
About 5-6 minutes after getting the shot my vision went spotty, I felt weak and eventually fainted ending up laying on the floor of the building in a puddle of (cold) sweat.  My arm remained very sore for about 5 days (until the following Monday).  The night after the shot I was awaken after just 2 or so hours of sleep feeling cold and shaky, also alternating cold sweats and weakness.  I wasn't able to sleep from 2am onwards, but also too weak to get out of bed until 10am so I called out of work for Thursday morning as a sick half day.  Severe headache and moderate dizziness remained with me for the first 48 hours after the shot into Friday night.
07/04/22  presents Triage with "contractions" "39w6d" PMHx "Anemia"
This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via Pfizer-sponsored program Support. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date (batch or lot number was not reported) as dose 1, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sinus drainage, sore throat. It was reported that she scheduled for second shot this morning was not able to take it because she has some sinus drainage and sore throat but still confirming if she can take it. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.
Injection site pain; Injection site discomfort; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE DISCOMFORT (Injection site discomfort) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 021B21A and 040A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: TDAP (vaccination site-left arm) on 04-Jun-2021 and Flu shot (vaccination site-left arm) on 04-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu shot and TDAP. Concurrent medical conditions included Blood pressure high (5 years), Migraine (5 years), Latex allergy (latex), Drug allergy (Sertraline) and Allergy to NSAIDs (Meloxicam). Concomitant products included PROPRANOLOL for Blood pressure high, TOPIRAMATE (TOPAMAX) for Migraine.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2022, the patient experienced VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE DISCOMFORT (Injection site discomfort). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of twice daily for 4 days now. At the time of the report, VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE DISCOMFORT (Injection site discomfort) outcome was unknown.      Patient was taking concomitant medication(Propranolol,Topamax) for 5 years now.  Patient have not contacted her doctor but she applied warm compress and healing pad to ease the pain and discomfort.  Patient mentioned that aside from the Moderna vaccine there were other vaccines that she received last year that included Pneumonia vaccine and Zoster vaccine received on 28Dec2021.
Had the shot at 8:30 a.m. At 12:00 pm felt out of breath and heart rate of 170 after climbing 1 flight of stairs. Sitting quietly for 30 min brought HR down to 100-110 but no lower. HR did not return to normal until 4:00 pm. Noted increase in heart palpitations in the evening of the day of the shot. These palpitations have occurred frequently while in a resting state every day since (now on day 6).
reddened area on right arm with a darker center surrounded by an erythematous area around it.  It measures 4cm by 4cm.  warm to touch.  No fever.  Temp 97.9.  Patient states arm started hurting the day after the shot was administered.  Site is itchy and painful to touch.  Rates pain 5 out of 10.  Patient states only allergy is to Penicillin.
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting chills Narrative:  s/s as above, onset within 12 hours of injection