chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effects; Improperly stored doses administered; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 21-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally (strength and dose were not reported) lot # R033252, expiry date 29-JUN-2020, for prophylaxis. The suspect vaccine was stored in a temperature below 36 Fahrenheit degrees (F) (34 F) for 24 hours. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.  This is one of six reports received form the same reporter.; Sender's Comments:  US-009507513-1907USA003061: US-009507513-1907USA003060: US-009507513-1907USA003059: US-009507513-1907USA002834: US-009507513-1907USA003058:
None from vaccines except sore arm; BNT162B2 Dose 1- 22Jan2021, Dose 2- 02Feb2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old patient received bnt162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL9266) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "allergies: Sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, vaccine brand: Pfizer / BioNTech,, vaccine brand unknown: False,, vaccine administration date: 22Jan2021,, vaccine lot number: EL9262, vaccine lot unknown: False, Vaccine dose number: 1, vaccine dose number unknown: False), administration date: 22Jan2021, for COVID-19 Immuniztion. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "None from vaccines except sore arm"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "BNT162B2 Dose 1- 22Jan2021, Dose 2- 02Feb2021". Therapeutic measures were not taken as a result of pain in extremity, inappropriate schedule of product administration.
In around December 2022, I began coughing up a large amount of mucus every day. This symptom has persisted and continues to this day. I went to my PCP on 3/20/2023. He determined that I had cobblestone throat and nasal passages. He said that my lungs and my ears were clear, however. He prescribed me pantoprazole. He also recommended OTC Claritin and Flonase. He instructed me to take all three medications for 30 days. Sometimes, I feel like there's been an improvement, but sometimes I cough up phlegm until I want to choke. The mucus I cough up now is thick, but usually clear, though it does sometimes have a yellowish tinge.
Redness/STS/tenderness extending  from RT deltoid down to upper biceps and around slightly to triceps. TX - prednisone taper.
Full body muscle, joint and bone pain. Joint inflammation, stiffness., storeness. Inability to stay in sitting or standing position for long periods of time. Difficult to walk for more than a few minutes.
Received both flu and pneumonia vaccinations in the right arm. The right arm ballooned up swelled up and warm to the touch. Went to urgent care. Dr. prescribed antibiotics.
She is 10 or 11 years old and had the vomiting and diarrhea.; She is 10 or 11 years old and had the vomiting and diarrhea.; Vomiting; Diarrhea; This is a spontaneous report received from a contactable reporter (Consumer).  A child female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "She is 10 or 11 years old and had the vomiting and diarrhea."; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Patient age was reported as 10 or 11 years old. All of the patient's family has a low temperature of 97.2 and for some reason it hit them. Patient's mother is a doctor and doesn't want to get involved. Patient's mother had taken of everything and doesn't know anything else about this case.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness Narrative:  Light headed (mild), dry cough (mild), chills that evening arm soreness at injection site only by touch.
12/27/15 Pt noticed itching, noticed swelling at injection Rt arm 12-28-15 describes as 3" welt oblong. 12-29-15 cool cloth to site encouraged.
multipule  bruse marks on my arms and face.  excessive bleeding  from small skin scrapes. I think  that the shot might have caused Thrombocytopenia
4 days after receving vaccine around mid-day, patient noticed a red rash across the groin, stomach, and lower chest. some of the bumps are raised and blister like. Rashes were not ther when she woke up that day
CHEST PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On SEP-2021, Laboratory data included: Blood pressure systolic (NR: not provided) 107 mmHg, Oxygen saturation (NR: not provided) 99-100, and Pulse rate (NR: not provided) 60. On 07-SEP-2021, the patient experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain. This report was non-serious.
[Janssen J&J] use for COVID-19 under Emergency Use Authorization (EUA):patient received J&J vaccine on 5/18/21. She called on 8/20/21 to say that she experienced both knee joints had formed plaques. She also experienced numbness on left arm on the inner part of the right side of arm. It occurred 1-2 inches to the right side of injection site. She just wanted to let me know.
Tongue liaisons; This is a spontaneous report from a contactable consumer (patient herself). A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8731, Expiry date: Unknown) via an unspecified route of administration in arm left on 04May2021 at 07:30, as dose 2, single for COVID-19 immunization. Medical history included, known allergies to Lactose intolerant and Amoxicillin. 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. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0153, Expiry date: Unknown) via an unspecified route of administration in arm left on 13Apr2021, as dose 1, single for COVID-19 immunization. On 04May2021 at 19:00, the patient experienced tongue liaisons. No corrective treatment was given for the event. The outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Received flu vaccine at clinic.  Vaccine had trace amounts of latex in rubber tip.  Patient has latex allergy.
Couldn't breathe,  nurse said i looked gray and i was sweating. Felt like i was going to throw up.  They moved me to an area to monitor me longer., gave me food and water. .  I still didn't feel good and they were holding down a 12- year-old girl who didn't want it.  So they were busy with her so i went and sat in my car for a while and went home some 4:15.pm.   My wife has a medical background and has a  pulse and oxygen thing and stuff still.  When i came home i immediately laid down.  I don't know how long after but i woke to my wife shaking me.  Mr pulse was 44 and blood oxygen was 88. She wanted to call 911. I refused.  This morning my oxygen is 92. Still monitoring for rashes.
worst headache ever experienced; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (worst headache ever experienced) 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. On an unknown date, the patient experienced HEADACHE (worst headache ever experienced). At the time of the report, HEADACHE (worst headache ever experienced) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information were not provided.
Headache, vomiting, extreme exhaustion.  Vomiting and headache lasted about 2 hours.  Slept afterwards for almost 12 hrs.  Thereafter, symptoms gone other than fatigue and sore arm.
Booster was given inadvertently 5 days early.   Vaccine card was different from information offered by patient and person giving the vaccination discovered this after vaccine was given.
I was given flu shot 10/09/04. Within 7 days began developing a rash within 2 weeks had leg weakness, balance issues, falling,  loss of reflexes. SS lasted 2 1/2 months, went away then returned in Feb. following removal of appendix removal. Now Dx. CIDP.   07/25/05 Neurologist's statement  GBS 'or initial episode of CIDP' ; EMG done 12/13/04 positive for diagnosis.    Notes from 03/15/05 visit includes information of pt's reporting being 'back to normal' in January, having surgery for a ruptured appendix late February and pt's perception of 'starting to go down-hill again'.  Visit of 04/19/05 includes details of exam confirming clinical symptoms with changes in vibratory sensation, continued areflexive, slowed gait.   Pt's diagnosis ws revised to CIDP and the decision to treat with IVIG is recorded.
Patient received Anthrax on 19 Aug 07 and 3 days later developed a large erythematous, edematous and warm patch to post LUE extremity past elbow joint to mid foreman. Decrease ROM and increase. No joint effusion.
This case was reported by a physician via sales rep and described the occurrence of pain in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain, erythema and swelling. On an unknown date, the outcome of the pain, erythema and swelling were unknown. It was unknown if the reporter considered the pain, erythema and swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient made a general statement regarding adverse event and BEXSERO that she stated that she had experienced pain, redness, and swelling.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of an improperly stored GARDASIL (lot #, expiration date, route and dose were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
a rash around hips and buttocks (since first dose) along with a headache; headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a rash around hips and buttocks (since first dose) along with a headache) and HEADACHE (headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-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 RASH (a rash around hips and buttocks (since first dose) along with a headache) and HEADACHE (headache). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency; MENTHOL (GOLD BOND MEDICATED ORIGINAL STRENGTH BODY POWDER) for Adverse event, at an unspecified dose and frequency and PARAFFIN (MOISTURIZER) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (a rash around hips and buttocks (since first dose) along with a headache) and HEADACHE (headache) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported.  Patient took second dose of Moderna COVID-19 Vaccine on 11-OCT-2021 in left arm (Lot number 040C21A).
5:50pm to around 8:30pm constant shivering no matter how many layers to heat up body.  Fingers and toes tingling and numb from cold. (It was 70 degrees in the house). Fingers under nails discolored bluish.  8:30pm shivering stopped, started getting a fever and headache, vomiting around 9:30pm.  Vomiting started and stopped within an hour. 9:30pm to 4:20am (this morning) fever, severe headache.  4:20am to 10:30am severe headache.
2 consecutive miscarriage; Posturl Orthostatic Tachycadia Syndrome (POTS); Pulmonary obstruction; Intermittent Chest pain; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2022 as dose 3 (booster), single (Lot number: FM0698) at the age of 38 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3248, Prev dose Product=COVID 19, Prev dose Brand=Pfizer,, Prev dose Brand unknown=False,, Is bivalent=False,, Prev dose Lot number=EL3248,, Prev dose Lot unknown=False,, Prev dose Administration date=25Jan2021,, Prev dose Dose number=2), administration date: 25Jan2021, when the patient was 37-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL0142, Prev dose Product=COVID 19, Prev dose Brand=Pfizer,, Prev dose Brand unknown=False,, Prev dose Lot number=EL0142,, Prev dose Lot unknown=False,, Prev dose Administration date=-04Jan2021,, Prev dose Dose number=1), administration date: 04Jan2021, when the patient was 37-year-old, for COVID-19 immunization. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 07Apr2022, outcome "not recovered", described as "2 consecutive miscarriage"; CHEST PAIN (non-serious) with onset 07Apr2022, outcome "not recovered", described as "Intermittent Chest pain"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious) with onset 07Apr2022, outcome "not recovered", described as "Posturl Orthostatic Tachycardia Syndrome (POTS)"; LUNG DISORDER (non-serious) with onset 07Apr2022, outcome "not recovered", described as "Pulmonary obstruction". The events "2 consecutive miscarriage", "posturl orthostatic tachycardia syndrome (pots)", "pulmonary obstruction" and "intermittent chest pain" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of abortion spontaneous, postural orthostatic tachycardia syndrome, lung disorder, chest pain. Patient was not taking other vaccine in four weeks and other medication in two weeks and COVID Prior vaccination was no. The allergy was not known.; Sender's Comments: Based on the available information in the case, the causal association between the reported event abortion spontaneous and the suspect drug BNT162B2 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
I felt fine until I woke up at 1am. I had extreme chills from 1am-4am. I felt really sick, nauseous. The chills broke in the morning at some point, then I just had a severe migraine and body aches. My migraine finally broke at 11pm. The following day 1/2/2021 I was back to normal and felt no more symptoms. The first day after the shot 1/1/2021 however was very bad.
1405 pt complains of SOA unable to speak. Epi pen administered 1412-1416 seizure activity 1418 EMS arrived 1419 verbal and A&O
Local swelling, pain and redness about a 6" diameter, lasted over 3 days. Not responding to to ice, finally better with po prednisone.
After administration of the vaccine, it was found that the vaccine expiration date had been 10/13/21 and the vaccine was expired by 7 days. The patient only reported and injection site reaction.
Pt states on Thursday evening she noticed right deltoid was tender to the touch with a lump. Pt states she tried to squeeze the lump to see if something would come out but nothing did. Pt states the site became warm to the touch on Saturday with "nerve" pain going down to elbow.
Information has been received from an office manager concerning a 17 year old female with penicillin allergy and a history of tonsillectomy (1994) who on 12-MAR-2008 was vaccinated with the first dose of GARDASIL vaccine 0.5 ml, IM and on 15-MAY-2008 was vaccinated with the second dose of GARDASIL vaccine 0.5 mL, IM.  The patient had not yet received the third dose.  Concomitant therapy included DEPO-PROVERA.  The office manager reported that in 2008, the patient experienced stomach pain, leg pain, back pain and her leg had been "sore" and limp.  The patient also had sleepy feeling.  The patient was also experienced increased incidence of headaches and she also had a thin white discharged in the vagina.  On 11-SEP-2008 the patient experienced green pink stool.  The patient felt nauseated after eating, she had no diarrhea and constipation.  As of 15-SEP-2008 the patient experienced green pink stool.  She had no diarrhea and constipation.  As of 15-SEP-2008 the patient had not recovered from the symptoms.  A vaginal specimen analysis was performed that were negative for vaginitis.  The patient sought medical attention by seeing the physician.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 10/14/2008. Follow-up information was received from a physician via medical record who reported that on 11-SEP-2008, the patient went to doctor's office complianing of vaginal discharge that she describe as burning, itchy, white, foul, smelling and thin. The doctor stated the patient had premenstrual dysmenorrhea. The duration in 5 days and was interfering with work and normal activities. It was reported that the patient was not going to take DEPRO-PROVERA anymore because she didn't like the way it makes her feel. It was also reported that the patient had an adenoidectomy in 1994. The patient had never had a PAP smear or a mammogram, she had no history of significant medical diseases. At the physical exam patient height: 64 inches, weight 105 pounds and blood pressure 103/60. The patient's pelvic exam was normal and she had no history of obstetrical or gynecological surgery. The patient denied previous exposure to STD. On 14-SEP-2008 the patient was having a lot of symptomatology. She was concerned it is for GARDASIL vaccine. On 16-SEP-2008 the patient's mother called the physician and stated that the primary care physician put the patient on prednisone and that did not work. The patient still had tingling in her legs. The patient was send to a Neurologist. Additional information has been requested.
Throwing up diarrhea, for  3-4 days. My whole body was shivering off and on in waves. I never had a fever. My whole body hurt I was unable to move for three days. I went to the emergency room 36 hours after receiving the vaccine.  They took my blood and  said my platelets were ok and my body was building immunity.
mom woke up & found pt deceased;MD office notified by ER;initial dx SIDS;
Fever, provided infant Motrin on first day, 24 hours after the fever my son started to develop a rash on his trunk, up his neck and leading down his shoulders and legs.  The rash was small red spots that eventually turned into a reddish/gray color.  The rash subsided after 4 days.  After the rash was gone, he developed several raised bumps that were red around the site.  These were located on his mouth, fingers, wrist.
This is one case out of a cumulative total of 246 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 13 January 2015. These 246 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 13 January 2015 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 16-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 1 dose of PENTACEL on 08 October 2013, batch number C4232AA, a second dose of PENTACEL on 07 February 2014, batch C4638AA and a third dose of PENTACEL on 07 March 2014, batch number C4638AA (routes and sites not reported). On 15 December 2014, the subject developed a cough and a paroxysmal cough with a whoop on 19 December 2014 approximately 9 months after the last dose. The subject experienced posttussive vomiting on an unreported date. The subject experienced cold symptoms starting on 15 December 2014. The subject experienced sleep disturbance and did not experience apnea. Laboratory testing included a positive PCR on 20 December 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 22 December 2014 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 09 January 2015, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Received 2nd Dose 53 Days After First Dose; Initial Report Received on 01-Mar-2023  A nurse  reported that a 67-year-old female received HEPLISAV-B for hepatitis B immunization.    Medical history was reported as unknown.  No concomitant medications were reported.   On 21-Dec-2022 the patient received dose 1 of HEPLISAV-B (Lot #, NDC#, Expiration Date were not provided) via unknown site.   On 11-Feb-2023, the patient received dose 2 of HEPLISAV-B (Lot #, NDC#, Expiration Date were not provided), 53 days after dose 1, via unknown site.  The patient received the second dose of HEPLISAV-B two months after the first dose.  The reporter noted that she had not been informed of any adverse reactions.   No other details were specified.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.