chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart failure; Weak; She wasn't sure if she was running a fever but feels really hot right now; She also mentioned she had started walking but she felt like she couldn't breathe. She had difficulty breathing while walking; felt weird; Headache; Extremely tired; received booster or third dose of product; a little ill; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received third dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number/ NDC number/ expiration date was not reported) via an unspecified route of administration on 13Sep2021 15:00 as dose 3, single for covid-19 immunisation. Medical history and concomitant medication were not reported. The patient previously took first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiration date: not reported), via an unspecified route of administration on as dose 1, single and dose 2, single both for COVID-19 immunisation. On an unspecified date, the patient experienced heart failure. On 13Sep2021 15:00, the patient received booster or third dose of product. On the same day at 17:00, patient felt weird, headache, extremely tired and at 17:30, patient felt weak, she wasn't sure if she was running a fever but feels really hot right now. On 13Sep2021, she also mentioned she had started walking but she felt like she couldn't breathe. she had difficulty breathing while walking and little il. Additional information included that the caller is calling regarding the Pfizer COVID-19 vaccine. She received her booster or her third dose yesterday and by the time she got home she felt weird and a little ill around 5:00PM. She also stated that she experienced a headache, weakness, and she felt extremely tired. She also mentioned that she is still not feeling that great right now. She stated that she did good with the 2 previous doses of the Pfizer COVID-19 vaccine and only experienced side effects with the third dose. She also stated that she wasn't sure if she was running a fever but feels really hot right now. She also mentioned she had started walking but she felt like she couldn't breathe. She had difficulty breathing while walking. She also brought up her medical condition that she had, she has heart failure and she is taking medication for that. The agent did not get name of that medication. It is not specified if the caller had the heart failure prior to receiving the Pfizer COVID-19 vaccines. Outcome of the events was unknown.  The lot number for [BNT162B2] was not provided and will be requested during follow-up.
Leg numbness. In able to walk or stand and later upper body numbness and chest tightness.
Palpitations; Rapid heartbeat; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient. A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 3 completed, Manufacturer: Unknown), for Covid-19 Immunization, reaction(s): "Covid-19"; Covid-19 vaccine (Primary immunization series completed, Manufacturer: Unknown), for Covid-19 Immunization, reaction(s): "Covid-19". The following information was reported: PALPITATIONS (non-serious) with onset 03Jan2023 at 12:15, outcome "recovered with sequelae"; HEART RATE INCREASED (non-serious) with onset 03Jan2023 at 12:15, outcome "recovered with sequelae", described as "Rapid heartbeat". Therapeutic measures were not taken as a result of palpitations, heart rate increased. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
chills; fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were recovered/resolved.   The reporter considered the chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was spoken from  the payment office. No further information was reported. The reporter provided limited information. This case was linked with case US2020219731 as reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020219731:same reporter
DTaP given on 07/29/2002 came to office 7/31/02with hot red area around injection site
Patient was in clinic 3/28/19 trying to get second dose of Varicella vaccine. He said  2 weeks after the Varicella injection, his left arm felt stiffness for 3 days,  he also had scattered small itchy raised rashes with no fluid inside on his upper body that increased in number gradually at about the same time . All rashes subsided within the next 2 weeks. He denies stiffness or any problem with his left arm and denies any other problem now. No Varicella vaccine was given on 3/28/19
Papular, pruritic erythema on hands and feet after receiving Smallpox vaccination.
First dose on 16Dec2020, second dose on 05Jan2021; Tinnitus; constant ringing in ears; louder this time; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient (no pregnancy) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), with first dose (lot number: EH9899) on 16Dec2020 via intramuscular route, with second dose (lot number: EK4176) on 05Jan2021 via an unspecified route of administration, both at single dose for covid-19 immunization. Medical history included allergies: penicillin. Concomitant medication included famotidine, ibuprofen (DUEXIS), iron (IRON) and multivitamins, all received within two weeks of vaccination. On 17Dec2020, the patient experienced tinnitus, constant ringing in ears that started 24 hours after first vaccine, lasted about 2-3 days and went away. Ringing in ears started again and is louder this time on 06Jan2021. Facility where the most recent COVID-19 vaccine was administered was in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event was identified as serious and resulted in disability or permanent damage. The outcome of event tinnitus was not recovered. The outcome of the other event was unknown.; Sender's Comments: Based on the compatible temporal association with positive rechallenge result, the Company considers the event tinnitus is possibly related to vaccination with BNT162B2. 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.
11/14/21 presents to EC ED with "intractable n/v" "SOB". PMHx " recurrent CVA" "metastatic pancreatic cancer"
Fever of 102 began the day after immunizations. Treated with TYLENOL\Ibuprofen.
Mis-read patients date of birth, patient was then given the high dose vaccine with thought of him being 65. Patient has no adverse effects to this injection.
4-5 episodes of diarrhea per day since vaccine administered 10-1-12.
Stated developed general malaise and weakness within 8 hrs. of receiving flu shot. Progressed into "really bad" rib case and bilateral thigh pain and inability to sleep that night. Had to call out sick the next day at work. States "It's gotten worse and worse each year for the last 3 flu shots I've gotten over the past 3 years".
THE PATIENT CAME TO GET A BIVALENT BOOSTER AND A MONOVALENT MODERNA WAS ADMINISTERED BY MISTAKE.
This study case was received from the investigator in a trial on 22 February 2012. A 23 year-old male subject with a past medical history of chest pain, an abnormal ECG, dizziness/fainting spells, myocarditis and pericarditis was found to have "other, chest pain" 12 days after the subject had received the following vaccines on 07 May 2010: an injection of ACAM2000 (lot number, route and site of administration not reported), an injection of TYPHIM VI (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory tests included an abnormal ECG on 19 May 2010. Troponin I and echocardiogram results were not available. A Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Flu Vaccine given 10/18/21 during school flu clinic with consent form completed by parent/guardian.  On 10/19/21 school contacted by parent/guardian stating child received flu vaccine the previous week at PCP.    Parent/guardian informed school she forgot to call school and notify of previous flu vaccine.
Received vaccine 7/18/16 - small amount of local redness noted after vaccines - thought to be due to band aids. They were removed. 3 days later, pt developed large hive type reaction to entire (R) thigh. No SOB noted. On day #4, reaction has improved and looks more  like dermatitis.
approx 12 hours after the shots my son became lethargic complaining of severe body aches, throbbing headache, pain at injection sites, blurred vision and had a fever of 102.4   ----------------------------------------------------Called pediatrician at 0500 hrs.  Was advised to give tylenol and motrin to combat the fever.  Approx 2 hours after doing this the fever subsided and he was finally able to sleep.
This spontaneous report as received from a health professional refers to a patient of unknown age and  gender. On 06-FEB-2015 the patient was vaccinated with a dose of M-M-R II 0.5 ml, subcutaneous, (lot # not reported) that had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Memory loss; LOSING TRAIN OF THOUGHT; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Memory loss) and THINKING ABNORMAL (LOSING TRAIN OF THOUGHT) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced AMNESIA (Memory loss) and THINKING ABNORMAL (LOSING TRAIN OF THOUGHT). At the time of the report, AMNESIA (Memory loss) had not resolved and THINKING ABNORMAL (LOSING TRAIN OF THOUGHT) outcome was unknown.            No concomitant medication was reported. On unknown dates, the patient experienced MEMORY LOSS and LOSING TRAIN OF THOUGHT. COVID-19 VACCINE MODERNA (ELASOMERAN) was also considered suspect.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of MEMORY LOSS with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of LOSING TRAIN OF THOUGHT was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This is my second dose, first was mid August 2018, and both times I have had very intense debilitating fevers. As I write this I am on Day Two of 101-102 fever, even with Tylenol the fever doesn't break. Dose 1 I had THREE days of high fever, 2 days of low fever=5 days.  I have a hard painful knot at the injection site now, same as Dose 1.  Dose 1 I developed a huge hot rash on arm a week later, went to Urgent CAre and they were clueless, called it cellulitis and put me on 2 weeks of antibiotics. But why? Dose 1 was at hospital, Dose 2 at pharmacy, both very clean and professional. This is very very difficult.
dizziness, clumsiness, chronic diarrhea, cognitive deficits, memory issues, fatigue. itching, heaches, feeling unbalanced, falling.  Currently  no treatment. Going to see neurologist, rheumatologist, hematologist.
Swelling from top of right shoulder to right elbow. Redness in the same area of arm. Arm was aching and still somewhat sore. Cold chills for about 12 hours, plus flushed feeling.
Looked her body full of welts; Her face was totally red; Got a rash all over her body, but more on her legs / Has rash on her legs / allergies only in her legs and a little in her arm; Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little sore arm), URTICARIA (Looked her body full of welts), ERYTHEMA (Her face was totally red) and RASH (Got a rash all over her body, but more on her legs / Has rash on her legs / allergies only in her legs and a little in her arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (Little sore arm), URTICARIA (Looked her body full of welts), ERYTHEMA (Her face was totally red) and RASH (Got a rash all over her body, but more on her legs / Has rash on her legs / allergies only in her legs and a little in her arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 16-Apr-2021, VACCINATION SITE PAIN (Little sore arm) had resolved. At the time of the report, URTICARIA (Looked her body full of welts), ERYTHEMA (Her face was totally red) and RASH (Got a rash all over her body, but more on her legs / Has rash on her legs / allergies only in her legs and a little in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
disoriented; not walking well and was saying peculiar things; not walking well and was saying peculiar things; chemical imbalance; fell in the garage and almost froze; This is a spontaneous report from a contactable consumer (patient's friend) communicated to a medical information team. A 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 10May2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced disoriented, not walking well and was saying peculiar things, chemical imbalance, fell in the garage and almost froze. It was reported that the patient was hospitalized for all events for 6 days. Reported that patient received treatment with rehab facility trying to get her memory and walking abilities back to where they were. Also reported that reporter took her 87 year old friend/older neighbour to get the first dose of the Pfizer Covid 19 vaccine on 10May2021. After the vaccine, the neighbour was disoriented, fell in the garage and almost froze. The ambulance came and took her to the hospital. She was hospitalized for 6 days. She was not walking well and was saying peculiar things. The hospital tests were negative and her son in law was told she had a chemical imbalance. Prior to this she was completely functionable and able to do everything on her own. She was in a rehab facility at that time and trying to get her memory and walking abilities back to where they were. Reporter wanted to know that, She get the second dose of the vaccine which was scheduled for 4 June or not and also about the chemical imbalance. Reported that the risks of the PFIZER-BIONTECH COVID-19 VACCINE. Reporter reffered to neighbour's physician or hospital physician to determine if she had a severe allergic reaction or not and if she should take the second dose of the vaccine. Reported that no information about a chemical imbalance being reported as a side effect. Reporter tried many ways to report, like spoke to DSU, attached fact sheet and website but unabled to do as mail was not correct then also reported that Pfizer online complain site was not reliable and it kicked them out. It didn't work and the other one they gave us didn't work either (email). The patient received the treatment for all events. The outcome of events was unknown.  Information about lot/batch number has been requested.
08/25/21: (1) day post vaccine-Event- had severe muscle pain, weakness from right arm to right foot, made walking difficult lasted a several hours then went away.  8/26/21: (2) days post vaccine- Event- nausea, with pre syncope feeling faint, profuse sweating, difficulty breathing and had to keep sitting down so I wouldn't pass out-lasted 1.5 hour then went away.
Receive FLUMIST 4 days prior to developing hives on back. Next day awoke with hives on abdomen. At school developed hives on face and mild swelling of eyes. No uri symptoms, cough, bellyache. Treated with ZYRTEC 10mg. daily and BENADRYL as needed.
Increase in seizure activity; tremors, lip smacking lasting up to 1 hr in duration. Within 24 hrs of receiving flu/Synagis - stopped eating from spoon. Lasting about 2 mo. Hospitalized d/t seizures.
Prior hx. of anapylaxis from ferrlicit, hives from gallalinium, sulfa drugs and clindamycin. Received Trastuzubam yesterday. Individual from pharmacy called and approved vaccine administration. At 11:37 am patient noted tingling in both arms and legs and slight light-headedness. Denied any trouble swallowing, facial or   tongue swelling. states a little chest tightness but not enough to take her inhaler. Vital signs at 12:09pm   BP 149/75, pulse 90, Pulse ox. 100%.At 12:20pm patient still admits to bilateral leg and   arm tingling, no facial/tongue swelling or difficulty swallowing. No change in chest tightness.
On July 8, 2011 clients (L) ankle started hurting. She stated she "noticed" the pain, pain was not severe. Then her knees bilaterally started hurting, then (R) hip. Reports morning of July 16 she woke up with both wrists swollen and could not bend them and painful wrist joints. She took Ibuprofen 600mg 3 times a day. July 17 her wrists continued to be like this (swollen and painful) the night of July 19 she experienced numbness in both wrists. The night of July 20 she states she was up every hour on the hour because of pain & numbness. The night of July 21 she states both thumb joints were numb & extremely painful & the tip of her thumb on (L) hand continues to be numb today. She reports trying heat on her thumbs at 4AM this morning but the heat intensified the pain. The only other tx used is ibuprofen at night the past week.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 24-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 03-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    On 14-Sep-2022, the patient received first dose of Moderna monovalent vaccine (Batch/Lot number: AS1414B and Dose/volume: 25 micrograms).  Concomitant product use was not provided by the reporter.  The route of administration of suspect Moderna monovalent was reported as Mono and bivalent was reported as BI.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
Information has been received from an investigator concerning a 15 month old male who received his first injection of Prevnar, his second injection of Recombivax-HB, and his third injection of Hib-Titer and Infanrix vaccines on 08/07/00. The child was found in his crib one morning not breathing and in cardiac arrest. The child was taken to a local emergency room where a heartbeat was re-established following a long code. The child was placed on a ventilator, but was unresponsive to light and painful stimuli. The patient was removed from the ventilator and died due to "SIDS-LIKE SYNDROME" on 01/11/01. Both the investigator and the medical monitor agree that this event was not related to vaccine administration. NOTE: This report is being submitted in a 15-day time frame as requested by FDA. F/U received on 4/25/02 from the study investigator contained autopsy results. The reported cause of death has been changed from "Sids-like syndrome" to "cardiorespiratory failure (cardio-respiratory arrest) secondary to possible sepsis, etiology unknown" as found upon autopsy. The investigator considered the event not related to vaccine administration.
Felt fine the day of vaccination. Woke up the next morning and as I rolled over to shut off alarm clock, I experienced strong bed spins (vertigo) and nausea.  I was able to control it by keeping my head still and oriented downward toward the floor. Symptoms eased later in the day. Mild symptoms still persisting today (3/2/21).
Fever ranging from101.3 to 102.4 without breaking. Still hasn?t. Sever body aches and severe headache.