chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Did not feel as good today; Chilly; Took the temperature and it was only 100; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not feel as good today), CHILLS (Chilly), PYREXIA (Took the temperature and it was only 100) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 028L20A and 011120A) for COVID-19 vaccination.     The patient's past medical history included Eye operation (Eye surgery) since July 2021.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced VACCINATION COMPLICATION (Did not feel as good today), CHILLS (Chilly), PYREXIA (Took the temperature and it was only 100) and HEADACHE (Headache). At the time of the report, VACCINATION COMPLICATION (Did not feel as good today), CHILLS (Chilly), PYREXIA (Took the temperature and it was only 100) and HEADACHE (Headache) had not resolved.            The patient has taken pills (blood thinner).  Treatment medications was not reported.  company comment : This case concerns a  76-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Malaise and the expected non-serious events of Chills, Pyrexia, and Headache . The events occurred on the day of the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the earlier doses were disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-381162 (Patient Link).; Sender's Comments: This case concerns a  76-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Malaise and the expected non-serious events of Chills, Pyrexia, and Headache . The events occurred on the day of the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the earlier doses were disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient received shingrix vaccine in her left arm first, she said her arm was already starting to feel sore as I was prepping for the flu shot to be injected into her right arm. Soon after getting the fluzone HD, patient tells me that she's dizzy and would like to stay seated. I noticed she was turning pale, so I gave her an extra chair to elevate her legs. I had my technician call 911 in the meantime. Patient was feeling hot and started to sweat, I gave her some water when she told me she "was coming back." she started to feel better but I noticed her fingers in the right hand were turning reddish-blue. That's when EMS came and took her blood pressure, her BP was 80/46 so they took her to the hospital immediately. Patient hadn't had anything to eat ever since she woke up in the morning
Initial and follow-up information has been received from a nurse and a consumer concerning her 10 year old daughter who is a student with an amoxicillin allergy and well controlled but moderate asthma, who on 04-Aug-2008, was vaccinated with the second dose of VARIVAX (Merck) (lot no. 660495/0431X) SC, into the left arm at approximately 15:30 pm. Concomitant therapy included Montelukast Sodium (MSD), ADVAIR, ZYRTEC and ASTELIN. On 05-Aug-2008, one day after receiving the second dose of VARIVAX (Oka/Merck) the patient reported area of redness and tenderness at the injection site in left arm and pain in in the same arm. The physician suggested BENADRYL. The patient was seen in an emergency room because the swelling had increased. The emergency room prescribed MOTRIN. The nurse reported that days after, the patient recovered from the symptoms. There were no lab tests preformed. No further information is available.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Patient concurrent conditions and medical history were not reported. On 25-MAR-2014 the patient was vaccinated with PNEUMOVAX lot # J014401 (Expiry: 26-NOV-2014) by intramuscular route (dose and frequency was not reported). On an unknown date in March 2014 patient experienced severe redness and swelling at the injection site where the PNEUMOVAX was injected. Patient had difficulty in lifting the arm that had received PNEUMOVAX injection. The patient visited physician (reporter also mentioned 3 patients received PNEUMOVAX from same lot# and an unspecified patient among 3 visited an unspecified emergency room). Reporter was not sure whether patient received treatment with either decadron (manufacturer unknown) or SOLU-MEDROL. The outcome of the event was reported as recovering. The reporter did not provide the causality between event and the suspect drug. Lot check was requested by reporter. Additional information has been requested. This is one of several reports from same reporter.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 21-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
she is little dizzy; This is a spontaneous report from a contactable consumer (parent). This consumer reported for a 13-year-old female patient (reporter's daughter). A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0185; expiration date not provided), via an unspecified route of administration on 15May2021 17:00 as single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient experienced 'she is little dizzy' on 15Ma2021. Patient's clinical course is as follows: It was reported that the patient was 13-years-old and got Pfizer shot this afternoon about 5 o'clock. Now patient stated 'she is little dizzy'. Reporter stated 'And I don't know is it related to that or not I just wanted to ask'. Reported also mentioned that 'Yes. In certain places you get that at 13'. When concern was paraphrased the reporter stated 'Yes'. When information about department was given, reporter stated, "Are they are there now?". Reporter was informed about Pfizer drug safety role and asked for permission to probe further questions, reporter stated, "Honestly I would like to go to site cause it's 12 o'clock midnight here, it's little late". When probed for lot and expiration, reporter stated, "It's not on the card. Oh 1st dose Pfizer, EW0185". Outcome of the event was unknown.
This case was reported by a pharmacist and described the occurrence of hepatitis B surface antigen positive in a 2-month-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  Concurrent medical conditions included premature infant.  On 28 July 2008 and 27 August 2008, the infant subject received the 1st dose and 2nd  dose of ENGERIX B (.5 ml, unknown).  On 28 August 2008, 31 days after receiving the 1st dose of ENGERIX B, and one day after receiving the 2nd dose of ENGERIX B, the subject was tested for hepatitis on a routine panel and was found to be hepatitis be surface antigen positive.  The subject was a premature infant, who had been hospitalized in the neonatal intensive care unit since birth on 28 June 2008, for a period of two months.  The subject received the 1st dose of ENGERIX B at 1-month-old, and the 2nd dose of ENGERIX B at 2 months-old.  This was considered to be an inappropriate schedule of vaccine administered.  The reporting pharmacist stated that subject was preparing to be discharged form the hospital when the 2nd dose of ENGERIX B was "inadvertently" administered.  At the time of reporting, the hepatitis B surface antigen positive was unresolved.  The inappropriate schedule of vaccine administration was reported to be resolved.  The pharmacist considered the events were probably related to vaccination with ENGERIX B.  Follow-up information received 17 November 2008 was unclear, but seemed to indicate the following.  The neonate did not received an inadvertent 2nd dose of ENGERIX B on 27 August 2008,  but a dose of PEDIARIX which he has intended to get.  The nurse administering the PEDIARIX experienced an inadvertent needle stick which prompted the hepatitis panel to be run on the baby.  At that time, the baby's hepatitis B surface antigen was found to be positive.  It was reported that the event resolved.  Please see case number A762868A for details regarding the needle stick.
Initial report received on 07 July 2009 from a health care professional in the country. A 10 year old female patient received ADACEL (lot number C3004) in the left deltoid and VARIVAX (manufacturer Merck, lot number 0655Y) on 07 July 2009. Two to three minutes post vaccination, the patient's head began to hurt. The patient fell back on the table and her eyes began to dilate. She began staring for about 10 seconds. The patient was monitored. No other reactions were noted besides crying at the time of the report. The patient's recovery status was unknown. The patient has a history of Rolandic epilepsy. The patient has been seizure free for 4 years and has been off medication for 1 year. Follow-up information was received 23 July 2009 from a health care professional in the country. ADACEL had been administered intramuscularly in the left deltoid. According to the reporter, they believed the patient lost consciousness for several seconds as the patient was unresponsive. The physician returned to the examination room to evaluate the patient; no treatments were prescribed and no laboratory testing had been performed. The event had been partially witnessed by the medical staff and according to the reporter, the patient recovered several seconds later. Due to this new information received, it was determined this case meets seriousness criteria and has been upgraded to serious. List of Documents held by Sender: none.
Around weekend of the 1st of September she developed some redness and swelling at injection site. Whole upper arm swollen could barely move arm. She also reported a hard lump on her lower abdomen.
bilateral pulmonary embolism due to clots coming from a large DVT in my right thigh, above the knee; bilateral pulmonary embolism due to clots coming from a large DVT in my right thigh, above the knee; bilateral pulmonary embolism due to clots coming from a large DVT in my right thigh, above the knee; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 20Aug2021 at 09:30 as dose 2, single (Lot number: Fa7484) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Lot number: Fc3183, Administration time: 09:00 AM, Anatomical location: Left arm), administration date: 21Jul2021, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization, medically significant, life threatening), DEEP VEIN THROMBOSIS (hospitalization, medically significant, life threatening), THROMBOSIS (hospitalization, medically significant, life threatening) all with onset 31Dec2021 at 12:00, outcome "recovered" and all described as "bilateral pulmonary embolism due to clots coming from a large DVT in my right thigh, above the knee". The patient was hospitalized for pulmonary embolism, deep vein thrombosis, thrombosis (hospitalization duration: 3 day(s)). The event "bilateral pulmonary embolism due to clots coming from a large dvt in my right thigh, above the knee" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pulmonary embolism, deep vein thrombosis, thrombosis.  Clinical course: Facility type of vaccine was pharmacy or drug store. The patient did not receive other vaccines in four weeks. In Mar2022 the patient developed bilateral pulmonary embolism due to clots coming from a large DVT in right thigh, above the knee. There was no known cause, injury or otherwise, to e plane the formation of the DVT and initial symptoms could be traced back to as early as Dec2021. Patient was treated with Heparin, followed by continued daily dose of Xarel. No covid prior to vaccination.
This spontaneous report was received from a medical assistant regarding unspecified number of patients. Patient demographics were not reported. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown date in March 2016 (starting on or after 09-MAR-2016) the patient was vaccinated with improperly stored ZOSTAVAX (lot/batch # L008351, expiry date 11-JUN-2016, lot # L028283, expiry date 28-OCT-2016 (dose, frequency, route and anatomical location were not reported) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Concern (PQC) involved. Temperature at which the administered product was stored as 9.3 Fahrenheit for 20 hours, there were no previous temperature excursions performed. This is one of several reports received from same reporter.
Patient says right upper arm has been hurting for 2 weeks since getting the shot. It hurts especially at bedtime. She has been taking ibuprofen for the pain. Mobiliy has not been affected.
Client states he developed blisters on  04/03-/21 starting at lower right buttocks radiating to the right leg onto his penis.  Client visited Dr and was diagnosed with shingles. Dr prescribed valtrex and prednisone. Client reports symptoms improving.
Pt returned to Public Shot Clinic approximately 2 hrs s/p injection c/o eyes tearing, nausea, difficulty breathing. Epi 1:1000 0.2ml, BENADRYL 50mg, LR 1 LITER. Transported to hospital ED vial ambulance.
pt recv vax & 10 min p/vax exp tachycardia, arrhythmia, high BP, flushing, chest pain, & generally was not feeling well;ER or MD visit was required;sx resolved;
Moderna 5/30/21, 6/28/21. Pfizer 9/9/21. Positive on 10/17/22
4 days after the 2nd Moderna Vaccine I began having tachycardia and runs of PVCs along with severe shortness of breath after walking only 100 feet. Now my heart rate began dropping in the 40?s for extended periods of time.
pt rcvd vax & exp episode where leg & arm shook; t 99.5 ax, reported to md; mom given apap; pt cranky;
Case had received both doses of Moderna Covid19 vaccine 1st  = 12/29/2021 Lot# 039K02A   2nd = 1/27/2021 Lot# 030L20A. Tested positive for Covid 19 on 8/11/2021 with symptom onset of 8/8/2021
Patient reported a fever on 11/09/2014 and presented to physicians office on 11/10/2014 with a rash that was diagnosed as chicken pox to which the patient has not been vaccinated against per the mother.
This spontaneous report was received from a health professional refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 09-FEB-2016, the patient was vaccinated with an improperly stored dose of oral, ROTATEQ (lot # L026741, expiry date: 18-MAY-2017). The temperature excursion details were reported as follows: temperature 0.6 degree C, time frame 30 hours, 20 minutes. COMVAX and GARDASIL appeared on the product list since they were involved in the excursion, however no improperly stored doses of these vaccines were administered. No adverse effect was reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Shortness of breath / Feelings of having a fast-beating, fluttering, or pounding heart, in addition to tingling and numbness throughout extremities, beginning in the hands, moving upwards to the neck, and downwards into the lower back and legs.
Immunosuppressed patient hospitalized for COVID-19 infection after COVID-19 vaccination. Received remdesivir and discharged to home medically stable.
Tested positive for Covid with a PCR test; Tested positive for Covid with a PCR test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus sle" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (unknown series of vaccination  (Manufacture unknown)), for Covid-19 Immunization. The following information was reported: SARS-COV-2 TEST POSITIVE (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 21Apr2022, outcome "recovering" and all described as "Tested positive for Covid with a PCR test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Apr2022) positive; (unspecified date) Negative, notes: antigen test; (unspecified date) positive, notes: antigen test. Therapeutic measures were taken as a result of sars-cov-2 test positive. Therapeutic measures were not taken as a result of drug ineffective.  Clinical Course: Clinical course: No other medication in 2weeks Anti viral details product COVID 19 treatment, brand Paxlovid, treatment start date 05Apr2022,treatment stop date 09Apr2022,indication, treatment of COVID-19. Adverse event Tested positive for Covid with a PCR test on 04Apr2022. After taking paxlovid, she felt better and tested negative on antigen test. 21 days later symptoms returned, and she then tested positive on an antigen test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient states next morning she had a small lump under the shot on her R. arm. On the 3rd day after getting the shot the lump increased dramatically in size and was red and warm to the touch. With several red spots at injection site. 1 week later small blist still present.
Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates in 2016 ("between 09-FEB-2016 and 03-MAR-2016"), the patients were vaccinated with doses of improper stored PROQUAD (Merck) (lot # L030591, expiration date 10-FEB-2017; lot # L032761, expiration date 24-FEB-2017) (dose and route were not reported). The vaccine was exposed to temperature 35F for 15 hours and 45 minutes. There was no previous temperature. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported in a literature article and described the occurrence of multiple sclerosis in a unk subject who received Hepatitis B vaccine. On an unknown date, 1 year after receiving Hepatitis B vaccine, the subject developed multiple sclerosis. Serious criteria included GSK medically significant. The outcome of multiple sclerosis was unknown. It was unknown if the investigator considered the multiple sclerosis to be related to Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of multiple sclerosis in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either ENGERIX B (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or RECOMBIVAX HB (Merck Sharp and Dohme Corp; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 1 year after receiving the vaccine, the subject developed new onset multiple sclerosis. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study show no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinising diseases. In younger subjects, they observed a short-term increase in risk after vaccination of any type, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinising diseases up to 3 years after vaccination. The results for human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinising diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinising diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article (see case US2014GSK053625).