chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was healthy prior to administration of Menactra. Received vaccination on 7/6 and presented on 7/25 with urticaria. Urticaria lasted approx. 1 week and was treated with claritin during the day and benadryl at night.
Information has been received from the mother of a 32 month old male with no pertinent medical history or drug reactions/allergies, who, in March 2005, was vaccinated with Varivax. Additional vaccines (not specified) were given). On 02-SEP-2006, the boy experienced chicken pox. The patient developed 10 lesions. There was no fever or any other symptoms. No laboratory testing was performed. The patient had not recovered. Additional information is not expected.
Low fever 99.4.    Joint aches.   Chills.    Red raised swelling at injection site.
Information has been received concerning a pt who was vaccinated with varicella vaccine on 10/26/95. In June of 2000, the pt was diagnosed by his mother with mild breakthrough varicella. the pt sought unspecified medical attention. It was reported that the pt had a normal incubation period and recovered shortly afterwards.
Patient / 40 years old  / Shingrix / with a prescription from his gastroenterologist; Patient who is 40 years old received the first dose of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 40-year-old male patient who received Herpes zoster (Shingrix) (batch number AP545, expiry date 25th January 2023) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix. In April 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced drug prescribing error. On an unknown date, the outcome of the inappropriate age at vaccine administration and drug prescribing error were unknown.  Additional case details were reported as follows: The patient received the first dose of Shingrix in April 2021, which led to inappropriate age at vaccine administration. The patient went to the facility with a prescription from his gastroenterologist, which led to drug prescribing error. The reporter consented to follow up.
had the shingles shot still have them but not as bad/suspected Vaccination failure; still have them but not as bad; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (at the age of 10 years old, also in 20s of age for about 3 times a year).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got Shingles after vaccination. The patient reported that shingles after vaccination was not bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Eye swelling - woke up this morning with eyes swollen shut, face puffy, improving after giving Benadryl and using cool compresses. No other symptoms.
2 hours after injection got extremely tired and had rashes similar to that of a scalding water burn on the tops my feet.  They are circular in shape and the skin between my toes hurt. The rash covers the majority of the tops of my feet. They are itchy. I have almost slept since 8pm last night and it is now 3:15 the following afternoon. My husband had difficulty waking me up. I have been extremely foggy and jumbleing my words each time I wake up and when I try to text I dont realize I'm typing words that do not make sense.  I also have the normal symptoms like headache and sore arm. Tops of my hands seem puffy and red.  Extreme thirst and hunger.
Pt woke up 3/26/21 with drooping of face on one side. Got evaluated by doctor following day with Bell's Palsy.
Eczema flare up worse after 2nd shot; condition aggravated; Sore arm/Arm sore to the touch/Arm sore when she rubs it; Still experiencing pain in left arm; Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema flare up worse after 2nd shot), CONDITION AGGRAVATED (condition aggravated), MYALGIA (Sore arm/Arm sore to the touch/Arm sore when she rubs it), VACCINATION SITE PAIN (Still experiencing pain in left arm) and PYREXIA (Fever) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Eczema.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced MYALGIA (Sore arm/Arm sore to the touch/Arm sore when she rubs it), VACCINATION SITE PAIN (Still experiencing pain in left arm), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). On an unknown date, the patient experienced ECZEMA (Eczema flare up worse after 2nd shot) and CONDITION AGGRAVATED (condition aggravated). At the time of the report, ECZEMA (Eczema flare up worse after 2nd shot), CONDITION AGGRAVATED (condition aggravated), MYALGIA (Sore arm/Arm sore to the touch/Arm sore when she rubs it), VACCINATION SITE PAIN (Still experiencing pain in left arm), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.            No Concomitant medication was taken by the patient. No Treatment medication was taken by the patient. The patient's arm was sore when she rubbed and touched it .It was painful when she worked out.   This case was linked to MOD-2021-257906 (Patient Link).
Redness, warm to touch, hardness on Left deltoid radiating towards underarm. Patient put ice on and off on 10/14/10.
Diarrhea, upset stomach, very fatigued, chills Narrative: Afebrile, upset stomach & diarrhea. Staying out of work while side effects resolve.
Patient developed painful, itchy rash with blisters.  Rash was in patches over most of her body. Rash developed approximately 24 hours after receiving flu vaccine.  She received the vaccine on 12/13/06.  She went to the doctor Saturday, 12/15 & was kept over night in the hospital.  She was much better Sunday morning, 12/16 & was discharged with prescription for Medrol Dosepak, Benadryl, & Vicodin.  Her husband says the doctor said reaction was probably from the flu shot. She said she had received flu shots in the past.  1/18/07 Received medical records from hospital which reveal patient admitted 12/16-12/17/06 following rapid progression of extensive rash 48-72 hours after flu fax.  Rash was exceedingly painful & pruitic. Also had fever, chills & malaise & night prior to admit had nausea & vomiting. Treated w/IV steroids & Benadryl.  Rash almost completely resolved within 24 hours.  D/C home on steroids, pain med & Benadryl.  Allergy referral was recommended. FINAL DX: Erythema multiforme, presumed secondary to flu vax; & asthma.
1 yr child recvd DTP/OPV/MMR 4Dec89. On 13Dec89 developed fever 105 and convulsion. 2 days before fever began, child wanted to sleep & not active, child ill for 10 days.
Dose spit out by the patient; Dose spit out by the patient; This non-serious case was reported by a physician via sales rep and described the occurrence of regurgitation of medication in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On 31-MAR-2023, the patient received Rotarix lyophilized formulation (oral). On 31-MAR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: Dose spit out by the patient) and accidental underdose (Verbatim: Dose spit out by the patient). The outcome of the regurgitation of medication and accidental underdose were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:31-MAR-2023 The sales representative submitted for possible dose of Rotarix that was spit out by the patient, which led to accidental underdose.  No additional adverse event details were available. The reporter consented to follow up.
Day 2 - fever to 100.1, fatigue, aches, headache  Day 3 - 5, no fever, fatigue, aches, headache, nausea (less each day) Day 6 - normal
I felt like I had the flu, it started in my throat, I had coughing that moved into my chest. I went to Clinic where I was tested for COVID-19 that came negative. I was prescribed Tessalon Perles to help with my cough, advised to get rest, drink plenty of fluids. I started feeling better the next day, the cough was finally completely gone within a week.
09:30 slight injection site pain   14:00 vertigo   14:10  diarrhea  14:35  diarrhea 19:30 took Tamsulosin 0.4 mg  Atorvastin K 40mg Metoprolol Succ ER 25mg  Nicotinamide 500mg  Krill Oil 500mg  Biotin 10Kmcg  21:00 rapid heart beat  followed by nasal congestion and coughing making breathing difficult  23:00 symptoms continued but got more severe and resembled a bad head cold but no fever; body temperature taken orally was 96.7F   started use of Afrin Nasal Spray both nostrils to control congestion and post-nasal drip which was causing cough; took one (1) oral tablet of Coricidin HBP Max and continued use of Afrin; symptoms began to subside; 02:00 02/16/2021 fell asleep sitting up; 10:00 woke with no symptoms but continued to have a sore R arm at injection site; no need for additional Tx or medications; no  physician consultation
Left thigh swelling and red. 9/20/13 at 11:45 plan of treatment Augmentin 400 mg-57 mg/5ml take 1tsp twice daily; Prednisolone 15 mg/5ml take 1 1/2 tsp daily.
Stored in freezer and not administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product storage error in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted product storage error (Verbatim: Stored in freezer and not administered).  The outcome of the intercepted product storage error was unknown.   Additional Information: GSK receipt date: 07-MAR-2023  The reporter was pharmacy manager.  The reporter reported Shingrix was accidentally stored in freezer and vaccine was not administered to patient. The reporter did not consent to follow-up.
1 hr -- urticaria abd wall,  redness  eyes , dry mouth --  rx prednisone, benadryl-- full recovery  in 24 hrs
A few hours after the administration of the vaccine the individual noted adverse effects. He states that his life is not the same, experiencing chest pain and pressure, shortness of breath, potential arrhythmias, vomiting, night sweats and fatigue. The symptoms have been ongoing and haven't resolved.
This is a spontaneous report from a non contactable nurse. A child (age and sex unknown) was administered a dose of PREVNAR on an unknown date. The route and site of administration were unknown. Relevant medical history was not provided. Concomitant medications were not provided. On an unknown date after vaccination, the patient developed an egg allergy. Diagnostic tests and treatments were not reported. The event was non-serious. The outcome of egg allergy was unknown.
Irritability with long periods of crying and inconsolability. Fever 101.8 rectal. Vomiting x 1. decreased oral intake.
High Blood Pressure (180mmHg) 5 days  after first shot,Blood Pressure went out of control, 5 days  after first shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High Blood Pressure (180mmHg) 5 days after first shot, Blood Pressure went out of control, 5 days  after first shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.  Concurrent medical conditions included Borderline hypertension (Never had to take medications to control blood pressure.) On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced HYPERTENSION (High Blood Pressure (180mmHg) 5 days after first shot, Blood Pressure went out of control, 5 days  after first shot). The patient was treated with LISINOPRIL ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPERTENSION (High Blood Pressure (180mmHg) 5 days  after first shot, Blood Pressure went out of control, 5 days after first shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 180 (High) 180mmHg. On an unknown date, Electrocardiogram: result not reported ER staff did not tell him anything about his EKG, so he assumes that it was normal. On an unknown date, Heart rate: 100 100 BPM. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient never had COVID disease. No concomitant product use was provided.  The patient visited the emergency room and they did EKG and started him on blood pressure medications. The second shot was taken on 23-Apr-2021.  On 17-May-2022, his Blood Pressure was under control while he uses medications. He states that after vaccination, his blood pressure never went back to normal or borderline, without medications.
Received 3 doses of Pfizer with last dose on 8/30/21 admitted to hospital for COVID symptoms. Unknown specifics to vaccine (date and lot numbers of other doses-pt retrieved else where)
Fatigue; light-headed; nausea; physical weakness; headache; body ache; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 07May2021 07:15 (Batch/Lot Number: EW0185) as a single dose for covid-19 immunization. Medical history included allergy to peanuts and shellfish allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient has not been tested for COVID-19. After the administration of first dose, the patient experienced fatigue lasting from 2 days after dose through receiving 2nd dose, light-headed, nausea, physical weakness, headache and body ache. Following questions of what were caused can't be answered. The patient received full-time care while bedridden first day and a half from his partner and continue to receive care daily as he was not able to accomplish much on his own at this point. He does not know if this was a permanent condition caused by the vaccine nor does he know what the extent of any permanent damage was. This was the worst his body has ever felt. The outcome of the events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Pt presented in office on 9/30/15 with left arm red and swollen. Dx cellulitis. Pt put on oral ABx.
Type II Diabetes Mellitus,  Obesity,  GERD, CKD III, Benign Hypertension, Diabetic gastroparesis       Patient presented to ED x11 days after receiving COVID booster and Seasonal Flu shot, with petechiae on bilateral lower extremities and found to have platelet count of 1. At same time patient has had a upper respiratory infection for the past 3 weeks. Patient was given one platelet transfusion and started on high dose steroids, for Immune Thrombocytopenic Purpura. Thrombocytopenia was not attributed to COVID or Flu vaccine, due to no strong association with Pfizer vaccine, however to completely rule out Vaccine Induced Immune Thrombotic Thrombocytopenia, ddimer and anti-pf4 antibodies were obtained and all were negative. Patient continued to improve on high dose steroids, where her most recent platelet count has been 40. Thrombocytopenia was induced by upper respiratory infection leading to ITP. Report submitted due to close nature of receiving vaccines to onset of illness.
right arm sore; interval between 2 doses> 42 days; Weak feeling next day; mild headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (right arm sore), INTENTIONAL PRODUCT USE ISSUE (interval between 2 doses> 42 days), ASTHENIA (Weak feeling next day) and HEADACHE (mild headache) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (right arm sore), INTENTIONAL PRODUCT USE ISSUE (interval between 2 doses> 42 days), ASTHENIA (Weak feeling next day) and HEADACHE (mild headache). At the time of the report, PAIN IN EXTREMITY (right arm sore), INTENTIONAL PRODUCT USE ISSUE (interval between 2 doses> 42 days), ASTHENIA (Weak feeling next day) and HEADACHE (mild headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
redness, warmth, and itchiness to injection site and surrounding area 1 week after the shot
Headache and severe body aches. Felt as though entire body was extremely bruised and fragile. Couldn't even move arms or legs without pain. Symptoms subsided after 36 hours from start of pain.
Red maculopapular rash on 13 days after MMR given. No fever. No URI sx.
Moderna vaccine (NDC--80777-0273-99, lot # 048C21A) was received at Walmart store 5731 on 7/16/2021 and placed under refrigerated temperature.  3 vials were transferred to STORE where 20 doses were administered beyond use date.
Balance was greatly impaired; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199) via unspecified route of administration in left arm on 15Mar2021 at 14:30 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. The patient medical history included diabetic. The patients concomitant medications included glimepiride (MANUFRACTURER UNKNOWN), pioglitazone (MANUFRACTURER UNKNOWN) and crestor (MANUFRACTURER UNKNOWN) all for unknown indications and since unknown dates. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 17Mar2021 (two days after vaccine) at 03:30, the patient woke up to go the bathroom and balance was greatly impaired. The patient had to hold onto the wall to get in the room and it was going on for a week now. The patient had no symptoms of anything before the vaccine, so she was wondering if this is a side effect and have others been affected this way. The patient was concerned about contacting her doctor regarding what was happening and how long will it be continuing and was also concerned to get the second round of the vaccine scheduled on 5Apr2021. No treatment was received for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event balance was greatly impaired was not recovered at the time of this report.   No follow-up attempts are needed. No further information expected.
On May 18, 2021 participant woke up with shortness of breathe and was very dizzy. Went to her doctor on may 20th  did a D dimer and it came back elevated. I also seen a pulmonologists and hematologist.
Drug-induced lupus erythematosus; Blisters; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4443322-00.  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunization; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUPUS-LIKE SYNDROME (medically significant), outcome "recovered", described as "Drug-induced lupus erythematosus"; BLISTER (non-serious), outcome "unknown", described as "Blisters". The action taken for adalimumab was unknown. Clinical course was reported as, The patient had Humira caused medically induced lupus episode and also caused huge blisters on her chest also. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter considered "drug-induced lupus erythematosus" and "blisters" related to BNT162b2. Causality for adalimumab (HUMIRA): The reporter's causality for the event(s) of Humira caused medically induced lupus episode and blisters on chest with Humira (Adalimumab) was a reasonable possibility (also reported as Probable).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug-induced lupus erythematosus" and "blisters". 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
Approximately 15 minutes post vaccine, patient complained about large local reaction at shot site.  Redness noted and lungs clear no other symptoms.  Ice pack applied.  Then some chest pain felt to be due to anxiety exam- normal. Observed and given a soda since had not had lunch.  Then at 40 minutes developed itching on back with a large welt and a welt on right hip.  50 mg of Benadryl given and patient observed.  Allowed to go home at 1 hour 10 minutes past start of reaction.  Told to continue Benadryl for 24 hours and a medrol dose pack given.