chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a healthy 5-year-old female with no pertinent medical history who on 03-JUN-2003 was vaccinated with a subcutaneous dose of 0.5 milliliters of varicella virus vaccine live (Oka/Merck) (Lot# 642640/0308M). There was no concomitant medication. On 07-SEP-2007 the patient developed shingles. On 10-SEP-2007, the patient was seen at the doctor's office with about 15 lesions on the right leg. No laboratory or diagnostic tests were performed. The outcome was reported as not recovered. No product quality complaint was involved. Follow-up information received on 26-Sep-2007 states that "the patient developed post herpetic neuralgia in the last few days". No additional information was provided. Additional information has been requested.
Patient presented with hypersensitivity after administration of COVID vaccine (COVID arm).  Her first dose was treated as a cellulitis with antibiotics (10 day course of Keflex). Patient went to urgent care before seeing me in the office and again was treated as a cellulitis with Keflex. Second vaccine reaction was a lot worse than the first. She was also given Norco and tylenol for pain at  the urgent care to help with pain. At my visit she was prescribed Prednisone for 7 days and famotidine and zyrtec. She was also given a shot of solumedrol. A couple days later was told to increase her Prednisone dose.
Pt developed rash, pain at site of injection; area is hot to touch, throbbing.
Rash all over her belly below her navel, on her back on both sides of her spine, and right above her buttocks,rash itches like crazy; Chills; Fever; Achiness; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on an unspecified date, as DOSE 2, SINGLE for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for covid-19 immunization and experienced discoloration on her breast and immediately felt the vaccine in arm. On an unspecified date, after her second dose, the patient experienced rash all over her belly below her navel, on her back on both sides of her spine, and right above her buttocks, rash itches like crazy. Caller stated that she hasn't changed anything such as laundry detergent. The patient stated she went to a dermatologist. The patient was given samples of cream to try on it. The patient stated that she also had chills, fever, and achiness on an unspecified date. The patient would like to know, if there has been a lot of reports of something like this going on. The outcome of the event Itchy rash was unknown, Chills, Fever and Ache was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA295187, same reporter. This case involves a 63 years old female patient who received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number, expiry date and dose not reported via unknown route in unknown administration site. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that 63-year-old Female who was injected with the FLUZONE HIGH-DOSE. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
I was 6 1/2 weeks pregnant and my estimate due date was 8/28/2021.  I had some spotting be the shot.
This was my second shot of the series.  No problems with the first one.  This shot on 12/27 made the arm extremely sore.  Blood detected on bandaid when removed that afternoon.  Arm extremely sore on Saturday morning.  Heat, red, swollen.  Started taking 1000mg  Accetaminophen.  Tried cool packs and heat packs.  Heat seems a little better.  No real relief.  Sunday 12/29 the arm is swollen, red area has increased in size, and is hot and it itches.  Monday, 12/30 went Pharmacy to advise them of the adverse reaction.  It looks more like extravasation than a local reaction.  Has been 72 hours  Lower part of the area looks like a bruise is forming. Still hot, swollen, itches, and hurts.  Can't scratch hard enough to control the itch because of the soreness
Vasovagal episode.   After receiving dose patient complained of feeling lightheaded, nauseous and was visibly sweating.  Vitals were taken 10:10 106/60 97% HR: 52. At 1015 vitals were 118/10, 98% and HR 65.  Patient was given wet towels around his neck and on his forehead. brought cot to patient and patient placed in trendelenburg position. pt given water and stated he was no longer lightheaded or nauseous but continued to have HA. Pt at that time was being evaluated by both doctors.   Patient then walked to monitor area where was continuously checked on until 1100 when his vitals were rechecked (118/80, 68HR). Pt stated he felt better and was released and recommended not to drive. Pt says his brother would drive him home. -  RN
Heart Attack; Somebody stab me in the back; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Diabetic (Some members of his family are Diabetic, but he is not.) since an unknown date. Concomitant products included PANTOPRAZOLE, METOPROLOL SUCCINATE (TOPROL), ATORVASTATIN CALCIUM (LIPITROL [ATORVASTATIN CALCIUM]) and TICAGRELOR (BRILINTA) for an unknown indication.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart Attack) (seriousness criteria hospitalization and medically significant) and BACK PAIN (Somebody stab me in the back). The patient was hospitalized from 14-May-2021 to 16-May-2021 due to MYOCARDIAL INFARCTION. The patient was treated with Surgery (Operation on 14-May-2021) for Myocardial infarction. On 14-May-2021, MYOCARDIAL INFARCTION (Heart Attack) and BACK PAIN (Somebody stab me in the back) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: an enzyme was high (abnormal) An Enzyme was high normal value is around 0.01 and he had it on 2.         Concomitant medications included one additional unspecified medication.  Based on the current available information and temporal association between the use of the product and the start date of the events, 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 events, a causal relationship cannot be excluded.
Medication error. LVN gave vaccine to 17 year old female patient. Pt didn't have any reaction to vaccine during 15 minute observation
Possible diagnosis of shingles, 30 or so blisters on  genital Labia area.,red  raised blisters.  Tested for sexually transmitted diseases and negative results. Very painful and lasted about 10 days
Could not get out of bed; Muscle weakness; Fever; Sore arm; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness), PYREXIA (Fever), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue) in an 80-year-old male 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 was provided by the reporter.  Concomitant products included LISINOPRIL, APIXABAN (ELIQUIS), AMLODIPINE and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness), PYREXIA (Fever), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue). On 10-Jun-2021, the patient experienced LETHARGY (Could not get out of bed). On 10-Jun-2021, PYREXIA (Fever), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. At the time of the report, MUSCULAR WEAKNESS (Muscle weakness) and LETHARGY (Could not get out of bed) outcome was unknown.            Case crosslinked with Patient's wife's case - MOD21-109695  Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided.
Within 1 hr - slightly swelled/itchy nose => resolved within few hrs Within 3 hrs - the sensation of swollen lips (not visible), Zyrtec 10 mg BID started => almost resolved in 72 hrs.
pt recvd vax 20JUL93 AM that PM 8PM itching, swelling, redness; sl diarrhea aching elbow down forearm; site lt deltoid warm; DPH to site-ice;
Events: Pain, Swelling, Fever, Redness of the skin, clouding of consciousness. Treatment: Went to emergency room was treated and prescribed antibiotic and BENADRYL. Discussed with provider over the phone. Outcome: After taking BENADRYL, symptoms immediately started to disappear.
Developmental regression evident within 5 to 6 months, loss of gross and small motor suspected at 8 weeks, loss of speech and social connection, loss of appetite, diarrhea and cyclic vomiting, severe sensory issues, purposeless and hyperactive behavior. Pt had 1st MMR/MSD/1161W/LL on 11/1/94 as well as a 2nd OPV/Lederle/PO on the same date. The 60 day follow-up states language loss/disorder; neurological issure-sensory, motor; social/emotional delays; developmental delays; learning disabilities; attention/hyperactive issues. Follow up information received on 09/18/2002 states " Cognitive delays/ learning difficulties, sensory issues, speech/language-communication disorder, auditory processing problems, fine & gross motor delays, social & emotional difficulties". The annual follow-up states "cognitive delays/learning disabilities, sensory issues, speech/language-communication disorder, auditory processing problems, fine and gross motor delays, social and emotional difficulties."
Soreness in shoulder at injection site; Fever; Chills; Inability to sleep the first night; Lingering headache (3days); Backache (upper and lower); Sore neck; Nose bleed; Nose congestion; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient experienced soreness in shoulder at injection site, fever, chills, inability to sleep the first night, lingering headache, backache, sore neck, nosebleed and nose congestion. The outcome for all the events was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Child received flu vaccine on 9/22/17 AM and that same evening at 10pm the child's mother called saying he developed hives diffusely on his body. He was itchy and was given one dose of benadryl with relief. No other signs or symptoms developed.
I had severe joint pain the same day with tiredness that lasted over 24hrs. The following day I am having severe muscle pain, the joint pain decreased but the muscle pain seems to be targeting areas; I had severe joint pain the same day with tiredness that lasted over 24hrs. The following day I am having severe muscle pain, the joint pain decreased but the muscle pain seems to be targeting areas; I had severe joint pain the same day with tiredness that lasted over 24hrs. The following day I am having severe muscle pain, the joint pain decreased but the muscle pain seems to be targeting areas; I had severe joint pain the same day with tiredness that lasted over 24hrs. The following day I am having severe muscle pain, the joint pain decreased but the muscle pain seems to be targeting areas; This is a spontaneous report from a contactable other health care professional(patient). A 38-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported), via an unspecified route of administration, administered in Left Arm on 21Aug2021 09:15 (at the age of 38 years old) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization . The patient had not received any other vaccine within 4 weeks. Patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. Medical history included HBP (high blood pressure) hypertension, pain. The patient have had previous history of pain over the years. Concomitant medication in 2 weeks included nifedipine, vitamin d, MULTIVITAMIN (ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate) and elderberry taken for an unspecified indication, start and stop date were not reported. No known allergies was reported. On 21Aug2021 11:00,The patient experienced severe joint pain the same day with tiredness that lasted over 24hrs the following day having severe muscle pain, the joint pain decreased but the muscle pain seems to be targeting areas where the patient had previous history of pain over the years and it was tightening my muscles. The patient had not taken any pain medication to help with the symptoms. The patient did not received any treatment for the events. The outcome of the event arthralgia was recovering, fatigue was recovered on 22Aug2021 and the other events myalgia, muscle tightness were unknown.  Follow up attempts are completed. No further information was expected.
Around 9:30/10p, about 32 hours after receiving the vaccination, my whole body except for my face, hands and below my knees broke out in hives.
Spiked a very high fever with bad chills, heart racing, muscle cramps, and migraine. Very fatigued and loss of appetite
Tested positive for COVID-19  on 29Aug21.; Tested positive for COVID-19 on 29Aug2021; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 23-year-old non-pregnant female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0170), via an unspecified route of administration on 09Apr2021 (23-year-old at the time of vaccination) as dose 1, single and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0158), via an unspecified route of administration on 30Apr2021 (23-year-old at the time of vaccination) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had not received any vaccine within four weeks. The patient was tested positive for covid post vaccination. On 29Aug2021, the patient was tested positive for COVID-19 and Loss of sense of taste/smell. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Nasal Swab, positive on 29Aug2021. The outcome of the events were recovering.
Arm was just sore the following day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was just sore the following day) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was just sore the following day). At the time of the report, PAIN IN EXTREMITY (Arm was just sore the following day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 27 Feb 2021, the patient received second dose of mRNA-1273 (Lot number: 012A21A) via unknown route in the right dominant arm for prophylaxis of COVID-19 infection.  No concomitant medications were reported. Treatment details was not provided.   This case was linked to MOD-2021-059392 (Patient Link).
Local redness and warmth at injection site, about 2-3 inches in radius around the site. Occurred approx. 5 days after injection.
Shortly after 1st covid vax pt reported fullness at top of head and chest. No SOB. No itching, SOB.   OP clear Lungs clear RRR   Sx resolved shortly after. Pt advised discussing the incident and 2nd vaccination with PCP.
Moderate pain/warmth at injection site; mild fatigue with 1st dose lasting until 03/07/2021. Fever 103.5; chills; body aches; severe fatigue with 2nd dose lasting until 04/04/2021. Fever 100.1; body aches; moderate fatigue until 10/30/2021 with 3rd dose.
No adverse reaction to vaccine. Patient made appointment to get the vaccine because his school asked for him to get one. After receiving the vaccine the patient stated that the school called him saying that he doesn't need the vaccine and that he completed the series back in 2001
Under arm swelling, which mostly reduced in 3 week, but did not go away completely. Cysts in the armpit and on the side of the left breast. I never had this problem before.
Felt horrible; very weak; fever; headache; moaned from achiness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt horrible), ASTHENIA (very weak), PYREXIA (fever), HEADACHE (headache) and PAIN (moaned from achiness) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 077M70A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM, PRAMIPEXOLE and TRAZODONE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt horrible), ASTHENIA (very weak), PYREXIA (fever), HEADACHE (headache) and PAIN (moaned from achiness). At the time of the report, MALAISE (Felt horrible), ASTHENIA (very weak), PYREXIA (fever), HEADACHE (headache) and PAIN (moaned from achiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-055528 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-055528:Second Dose
I missed my period. I am not pregnant and have never ever missed a period since taking birth since I was 11 years old.
This spontaneous report was received from an office manager referring to a 12 month old patient of unknown gender. The patients' medical history and concurrent conditions were not reported. On 30-MAR-2018, the patient was vaccinated with an improperly stored M-M-R II lot # N001532, expiration date 13-JAN-2019 (anatomical location and administration route were not reported) for prophylaxis. Concomitant medications included properly stored sterile diluent. No adverse effects were reported. The vaccine was stored at 47 degree Fahrenheit to 77 degree F (61.7 degree F) for 2 hours 30 minutes and 32 degree F to 35 degree F (33F) for 6 hours 51 minutes. The previous temperature excursion was reported as 47 degree F to 77 degree F (52F) for 1 hour 30 minutes. The call was due to digital data logger. This is one of several reports received from same reporter. Sender's Comments: US-009507513-1803USA010116: US-009507513-1808USA007354: US-009507513-1808USA007353: US-009507513-1808USA007351: US-009507513-1808USA007352.
Case number PHEH2014US006400 is an initial spontaneous report received from a pharmacist on 28 Mar 2014. This report refers to an 11 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M13017 and expiry date: 30 Sep 2014), at dose of 0.5 ml intramuscularly on 26 Mar 2014. The MENVEO reached 32 to 34 F for  up to 25 hours (at different time increments) within 8 day period and was subsequently administered to patient. Reporter does not believe that the vaccine was frozen. No adverse event reported following this administration error.
muscle aches; over did not feel well; joint aches; headache; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 09Sep2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient reports that he received his first dose of the Pfizer Biontech covid 19 vaccine around 10:15-10:30 yesterday. Last night (on 09Sep2021)  he experienced muscle aches, joint aches, headache and over did not feel well. Patient seeking information about how long these side effects typically last. The outcome of the events was unknown.  Follow-up activities closed. Batch/lot number not available for vaccine/BNT162B2.