chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx 25 mintues after the vaccine (at 10:55AM), pt c/o itching/burning in the back of right thigh. Checked area, erythema and warmth noted of a 4inch diameter area on posterior right thigh. Also noted urticaria on right dorsal forearm and right inner forearm, each approx 2 inch diameter. Also urticaria noted at base of left thumb at crease of wrist, approx 1 inch diameter. patient c/o itching at all sites. Denies any respiratory sxs, no odd sensation in mouth/throat/tongue/lips. See ROS and PE for further details. Gave pt 25mg oral benadryl capsule with water. She had mild sensation of sleepiness afterward. Within 30 minutes the urticaria on the right forearm was resolved. The left base of thum/wrist area was with mild erythema, The posterior left thigh area was much paler and pt states all areas no longer were itching. VSS, BP was decreaed to WNL.  Additional post-vaccine screening: patient states she feels fine and was ready to go home. She lives at home with her 20 yo son who was going to be home all day today. She plans to go home and relex. Gave pt three more samples of 25mg benadryl and instructed to take at least one more dose today at bedtime, but to take every 6 hours as needed. Also reviewed s/s to take her epipen, and when she should go to ER or call 911. Also instructed pt that she should not receive the second dose of moderna vaccine. Will contact pt tomorrow to check on her. Advised her to notify her PCP of the reaction. Advised she may wish to consult her allergist in future if another covid vaccine may be appropriate. Patient verbalizes understanding and agreement with plan of care. patient d/c home after a full 75 minutes of observation. Will complete the VAERS form
Rash on face, back and chest for 3 days. Some to legs. Pt had cough and drainage. No one else had reaction.
itchy throat; tingly lips; hives; rash over entire body; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2020 (Lot number: el1284) at the age of 41 years as dose 1, single for covid-19 immunisation. There was unknown if the patient receives any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROAT IRRITATION (medically significant) with onset 29Dec2020, outcome "recovered", described as "itchy throat"; PARAESTHESIA ORAL (medically significant) with onset 29Dec2020, outcome "recovered", described as "tingly lips"; URTICARIA (medically significant) with onset 29Dec2020, outcome "recovered", described as "hives"; RASH (medically significant) with onset 29Dec2020, outcome "recovered", described as "rash over entire body". Therapeutic measures were taken as a result of throat irritation, paraesthesia oral, urticaria, rash. The treatment included Benadryl.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 (BNT162B2) to the events of throat irritation, paraesthesia oral, urticaria, rash cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt started having extreme fatigue, nausea and body aches day after MENACTRA #2 vaccine. 2 days after seemed "unfocused" and left eye wandered inward. Sent to ER.
About 5 hours (340) after receiving immunizations mom states child became very pale and was making "grunting noises." Mom states child seemed bothered when she moved his legs. Mom did not check temp but stated child "felt a little warm". Mom states after about 20 min child "seemed more himself". During that time mom put child in a cooler environment. She gave water & TYLENOL at 420pm.
8 hours after the patient received his Moderna vaccine, he developed blisters bilaterally to lower extremities. He was diagnosed with vasculitis. He has had recurrent infections and poor wound healing since.
Elevated temperature, chills, fatigue, muscle/joint pain, headache, sore arm. 17 weeks pregnant- estimated due date 7/03/2021.
This case was reported by a consumer and described the occurrence of injection site pain in a 63-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (as a 15 years old in 1970). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and muscle pain. On an unknown date, the outcome of the injection site pain and muscle pain were recovered/resolved. It was unknown if the reporter considered the injection site pain and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and experienced strong pain at injection site and muscle aches for a week or so. At the time of reporting the patient was in fair condition for his age, side effects were almost all gone and said that he hopes this works because the side effects were worse than he remember with shingles as a 15 year old brought on by bad jelly fish sting and he survived and he also said that this information hopefully works on the SHINGRIX research. This case has been linked with case US2018GSK158157, (same patient for 2nd dose) reported by the same reporter.
12/27/21 presents to ED for "shortness of breath". PMHx of "seizures, OSA on CPAP, ADHD, DVT, TBI secondary to MVA, nerve damage with loss of sensation to the right leg, and bipolar disorder"
On 3/20/09, approximately 24 hours after injection, left arm red, hard, swollen, hot and c/o itching.  Over the next 3 days, redness, swelling and itching decreased.  Tylenol and Benadryl given after problem began in 3/20/09.
pt c/o light headed, dizzy. Pt has anxiety. Pt had panic attack prior to vaccine. Low fever 99.6, vital normal, after additional monitoring by ems pt was released no transport needed.
This spontaneous report as received from a other healthcare worker refers to a patient of unknown age. Medical history and current conditions were not reported. On 19-AUG-2014, the patient was vaccinated with (Oka/Merck) VARIVAX lot # J014407, expiry: 13-NOV-2014, 0.5 milliliter, subcutaneous one for unknown indication. Concomitant medications were not reported. On 19-AUG-2014, it was reported that 5 doses of (Oka/Merck) VARIVAX were improperly stored and administered to unspecified patients. No adverse events were reported. Product quality complaint was not reported. Additional information has been requested.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/05/21pfizer,Lot#EL3246 2nd dose: 01/26/21Pfizer,Lot# EL9262 Diagnosed covid positive:07/27/2021 Symptom onset:07/27/21 Exposure:unknown Symptoms:fever, fatigue, runny nose
Information has been received from a physician via company representative concerning a elderly female (age not provided) who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot# not provided).  Subsequently the patient developed reaction (not further specified).  The patient's outcome was not reported.  There was no product quality complaint involved.  Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unknown number of patients (age and gender were unknown). On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (lot# H010445, exp. date 23-MAY-2014) (dose and route not reported). It was reported the lot of VARIVAX (Merck) underwent multiple temperature excursions that was recently discovered after a review of freezer temperature data over the past two years. This lot of VARIVAX (Merck) exposed to -2.5 degrees C for a period of 650.5 hours. The excursion date range from 30-AUG-2012 to 19-JUN-2013. All the stock except two vials of the lot number were administered to an unknown number of patients. Last dose administered on 19-JUN-2013. This VARIVAX (Merck) lot number was not supported. The reporter stated that she believed that some of the VARIVAX (Merck) should have had stability information to support some of the excursions. No adverse events were reported. This is one of several reports from same source. Additional information has been requested.
Information has been received from a published article, title as stated above. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #5 of 32, a 35 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 35 year old female on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. On an unspecified date after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced influenza-like symptoms, symptoms of arthritis and arthralgia. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327, WAES # 1004USA02328, WAES # 1004USA02329, WAES # 1004USA02331 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Received doe #1- left deltoid on 1/8/2021-within  10 minutes of receiving the vaccine had a "wave of warmth" come over my body and my heart rate suddenly increased to the 140's. Began to feel fullness in my throat and extremely tremulous.  Nurse monitored my BP- elevated 140/101 with no hx of HTN. HR remained elevated for ~ 10 minutes than began to normalize. BP slowly began to decrease to more normal range. Tremors continued along with tingling sensation to extremities.  Monitored by nurse for ~ 1 hour. Symptoms improved. Drove home. Extremely fatigued. Took dose of Benadryl. Fitful sleep with sporadic  episodes of tachycardia on day #1. Following day 1/9- extreme fatigue, arm soreness,  "spacey" feeling, weakness and nausea. Took additional doses of Benadryl. Slept 12 hours. Awoke on the following day ( 1/10), with persistent fatigue and nausea.   Had insomnia that night and was restless, Awoke on 1/11 again with nausea, fatigue, arm soreness resolved but itchiness  injection site.
19jan90 pt vax 2nd hepta B. 2hrs later pt devel nausea, tiredness, and h/a. sx remitted spontaneously.
During a chart audit it was discovered that this patient received the incorrect immunization.  He was not injured there was no adverse reaction, the patient/mom has been notified and has been scheduled to return to our office for immunizations.
Received a dose from a punctured vial after the 12 hour; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose from a punctured vial after the 12 hour) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose from a punctured vial after the 12 hour). On 09-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Received a dose from a punctured vial after the 12 hour) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  No treatment medication reported by reporter.    This case was linked to MOD-2021-208074, MOD-2021-258552, MOD-2021-258572, MOD-2021-258599, MOD-2021-258615, MOD-2021-258632, MOD-2021-258644, MOD-2021-258660, MOD-2021-258672, MOD-2021-258682, MOD-2021-258689, MOD-2021-258691, MOD-2021-258693, MOD-2021-258697, MOD-2021-258699, MOD-2021-258700, MOD-2021-258702, MOD-2021-258703, MOD-2021-258704, MOD-2021-258706, MOD-2021-207548, MOD-2021-258660 (Patient Link).
pregnant and received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received vaccine) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received vaccine). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not reported. Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this  female of unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Worst migraine I have ever had. Aimovig usually prevents them from becoming severe, as well as taking 1 sumatriptan at onset of migraine. It took 6 hours, 2 sumatriptan pills, sudafed, ibuprofen, and heat to get the migraine down to its usual pain level. Light was much more painful than usual as well. Usual migraine pain for me is a 6 on the pain scale. This migraine was a 9.
Oral rashes; Feeling of cut in the mouth; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 25Mar2021 at 12:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no known allergies. Concomitant medications included bisoprolol fumarate (CONCOR) taken for hypertension. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 13:00, the patient experienced oral rashes and had feeling of cut in the mouth. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events oral rashes and feeling of cut in the mouth were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Very sore joints and muscles beginning three days after injection.  Was worse at night.   Made much worse by even moderate exercise.  Muscles felt extremely fatigued.  Also developed significant neuropathy in feet, ankles, and calves.  After three weeks the continuously sore joints and muscles went away but there is still fatigue after exercise well beyond normal.  Also, the significant neuropathy remains.
Reaction/Event: cellulitis on her arm where she received the injection; Case Narrative: Initial unsolicited report received from a pharmacist on 7 March 2016. This case involves a 15-year-old (age reported as 16 years) female patient who was vaccinated with an intramuscular dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone QIV) (batch number UI493AB, expiration date 30 June 2016) in right deltoid and a subcutaneous dose of Pneumovax (batch number I022262) in right deltoid on 13 November 2015. Patient medical history included juvenile arthritis, Raynaulds Phenomenon. Patient did not have illness at the time of vaccination. Concomitant medications were not reported. On 16 November 2015, three days following the vaccination, the patient was diagnosed with cellulitis on her arm where she received the injection. Lab data and corrective treatments were not reported. On an unspecified date, the patient recovered from the event. List of documents held by sender: none.
Information has been received regarding a case in litigation from a lawyer, an approximately 57 year old female patient, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2013, the female patient was administered the ZOSTAVAX by a healthcare provider at a hospital (lot number, dosage and route of administration not provided). On an unknown date in 2014, the patient was treated by a physician at a hospital for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
REDNESS, SWELLING AND ITCHING AT THE VACCINE SITE.  INSTRUCTED TO TAKE OTC BENADRYL.
Hypotension, dehydration, fever, emesis - abdominal pain on 11-23-09 late PM.  Immunization 11-23-09 in AM.  Pt. hospitalized on 11-25-09.  Seen in ER first. 12/8/2009 MR and ED records for 11/25-11/26/2009, patient with c/o's fever, abdominal pain, vomiting, lightheadedness, one incident of "passing out"
Local allergic reaction after first dose - erythema and itching After second dose hives on upper body, itching, shortness of breath, difficulty breathing - the symptoms were relieved with Benadryl Allergic reaction after second shot was much more significant compared to the first shot I informed my PCP dr. about these reactions.
This is a spontaneous report from a contactable consumer (patient). A 60-year-old female reported she received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine,  solution for injection, batch/lot# not reported), at the age of 60, via an unspecified route of administration, on Monday, Jul 5, 2021, single dose, for COVID-19 immunisation. Medical history included arthritis. The patient's concomitant medications not reported. Historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation and didn't have any symptoms. On an unspecified date, patient experienced a swollen/bloated feeling, had a sore arm, felt achy and had discomfort. Reportedly, her diet has been the same. She has been exercising the same and nothing is different in her lifestyle. She wants to know how long the side effects last and if this has been reported. The outcome of the events: unknown. Information about batch/lot number requested.
Shingles outbreak about a week after 1st dose. Ringing in ear started same day as 2nd dose, still ringing a week later.
fever of 101.2, which started approximately 24 hours after vaccine associated with pain and redness to injection site. He also reported body aches.
The day after vaccine during the night I started coughing and feeling congested. Low grade fever and bas cough. Goopy eyes similar to pink eye and congestion and coughing. I did not go to work. I went to a clinic and they tested for Covid-19 the test was negative. Used compresses on the eyes and medication  for cold like symptoms. The symptoms lasted an entire week. The cough hung around for three weeks  after vaccine.
tested positive for covid infection after receiving the 1st dose of Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for covid infection after receiving the 1st dose of Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced COVID-19 (tested positive for covid infection after receiving the 1st dose of Moderna vaccine). At the time of the report, COVID-19 (tested positive for covid infection after receiving the 1st dose of Moderna vaccine) 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.   No Medical History information was reported. No concomitant information was reported. Treatment information was not reported.
WORST HEADACHE, FELT LIKE SHE WAS BEING HIT REPEATEDLY WITH A HAMMER; MUSCLE SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced worst headache, felt like she was being hit repeatedly with a hammer. On 16-MAY-2021, the subject experienced muscle soreness. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from worst headache, felt like she was being hit repeatedly with a hammer, and muscle soreness. This report was non-serious.