chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was sore; felt really sick; dizziness; once he got the shot he just went downhill; nauseous; extremely fatigued; died on 28JUL2021, 4 days after receiving the vaccine, passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died on 28JUL2021, 4 days after receiving the vaccine, passed away) in a 31-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.     The patient's past medical history included Cirrhosis liver, Acute kidney failure, Hypertension, Immune system disorder (weak immune system) and Hospitalization from 03-May-2021 to 11-May-2021.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore), ILLNESS (felt really sick), DIZZINESS (dizziness), MALAISE (once he got the shot he just went downhill), NAUSEA (nauseous) and FATIGUE (extremely fatigued). The patient died on 28-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PAIN IN EXTREMITY (arm was sore), ILLNESS (felt really sick), DIZZINESS (dizziness), MALAISE (once he got the shot he just went downhill), NAUSEA (nauseous) and FATIGUE (extremely fatigued) outcome was unknown.            He had medications for his chronic illnesses. The patient had recent hospitalization from 03-May-2021 to 11-May-2021. No treatment information was reported.  Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested. Patient´s underlying Cirrhosis , Acute kidney failure, Hypertension and Immune system disorder could be confounding factors for the case.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Patient´s underlying Cirrhosis , Acute kidney failure, Hypertension and Immune system disorder could be confounding factors for the case.; Reported Cause(s) of Death: Unknown cause of death
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-OCT-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 5 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 152, 30, -1.111111111 and R; 184, 29, -1.666666667 and R; 24, 33, 0.555555556 and R; 320, 31, -0.555555556 and R; 160, 32, 0 and R. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to an 18-month-old male patient. The patient did not have any pertinent medical history, concomitant therapies and drug reactions or allergies. On an unknown date before 06-NOV-2017, the patient was vaccinated concomitantly with doses of M-M-R II, VARIVAX and unspecified influenza virus vaccine (manufacturer unknown) reconstituted with sterile diluent (for all of them doses, dose numbers, route of administration, lot# and expiration dates were not reported) as routine vaccinations. On an unknown date 2 hours later, the patient started having hives on an unspecified location on the body. It was unknown which vaccine caused the hives. There were no treatment given for the event and no lab diagnostics were performed. The patient saw pediatrician and went to allergist's office. On an unknown date, the patient recovered from the event. The relatedness between the suspect therapies and the event was not reported.
days after injection began to have weakness in left leg and would fall. several episodes of falls occurred after 1st injection. Patient was hospitalized on 3/5/21 at the hospital. Discharged on 3/11/21. After 2nd Pfizer dose exhibited worsening control of legs and was diagnosed with CVA to right side of brain. Hospitalized at Hospital x 1 week and then transferred to Hospital x 1 week. Discharged to home unable to walk. Has wheel chair. Has lost strength to hands and arms bilaterally and unable to use a walker for ambulation.
Pt received booster on 12/17/21.  Called hospital call center c/o  HA, injection arm pain and worsening, chills, dizziness, difficulty breathing s/p 5 days pfizer booster.
Didn't feel well; Fever; Arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting), VACCINATION COMPLICATION (Didn't feel well) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting) and PYREXIA (Fever). On 22-Mar-2021, the patient experienced VACCINATION COMPLICATION (Didn't feel well). At the time of the report, PAIN IN EXTREMITY (Arm was hurting), VACCINATION COMPLICATION (Didn't feel well) and PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 100.3 High. On 23-Mar-2021, Body temperature: 99.6 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were Pills for extra acid in stomach, Anti depressant pill, Pill for blood pressure.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This spontaneous report was received from a pharmacist via Pfizer refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration not provided). No concomitant therapy was reported. It was reported that the patient had a reaction to PNEUMOVAX 23. The patient had rash and swelling. The doctor suggested to try PREVENAR 13. The outcome of the event was unknown. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Severe chills for hours, fever 102.6, headache, body aches, injection site red swollen hot and huge. It burned  very badly when injected.  Felt deathly ill, similar to flu. 3 days later injection site redness has spread and is hot and huge.
Information has been received from a physician concerning a 11 year old female with allergy to codeine, who on 19-MAR-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL. Concomitantly, the patient was vaccinated with hepatitis A vaccine, MENACTRA and Tdap. On 19-MAY-2009, the patient was vaccinated intramuscularly with the second 0.5ml of GARDASIL. The physician reported that the patient experienced heart rate greater than 150. On 13-JUL-2010, the patient was vaccinated intramuscularly with the third 0.5ml of GARDASIL. The patient experienced uncontrollable shivering, nausea and vomited once. Two lot numbers were provided: Lot number # 666118/1539Y ad 661841/0653X, but it was not specified which one corresponds to each dose. Lot number # 666118/1539Y could corresponds first dose and 661841/0653X could be the second dose. At the time of the report, the patient was recovered (dates unknown). The patient sought medical attention and went to a ER. Additional information has been requested.
Hives, coughing starting 2/16/12 pm. Dr 2/17/12 ER 2/18/12 ER 2/19/12 & hospital. Dismissed hosp 2/21/12. Tx. BENADRYL, prednisone, PEPCID, albuterol inhaler.
Child had Hep A vaccine 7 hours ago, mom took child to ER for symptoms within 1 hour of vaccine, child was unable to walk, slurred speech, no symptoms now. Mom requests to speak with on call PCP.
Caller reports having a Covid infection after receiving the first dose of the Pfizer Covid vaccine/diagnosed with COVID-19 virus; Headache; Cough; feeling ill; Fatigue; feeling bad; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program COVAX Support. A58-year-old male patient received first dose BNT162B2 (Solution for injection, Pfizer-Biontech Covid-19 Vaccine, lot number: EN6208, expiry date: 30Jun2021) via an unspecified route of administration in left arm on 20Mar2021 at 10:05 AM at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Reports having a Covid infection after receiving the first dose of the Pfizer Covid vaccine on 25Mar2021. He wants to know if he should get the second dose of the vaccine. He states he got the first shot and then he got the COVID virus. He says he doesn't know if he got the virus before or after shot. He states he contracted the virus 4 or 5 days after getting the shot. He started feeling bad on an unspecified date in Mar2021. He has gone through the 14 days of quarantine and is suppose to get his second shot. He wants to know was it smart to get second shot on top of getting COVID? He states he was 6 foot or 72 inches. States he got the first shot 3 weeks ago, on Saturday 20Mar2021. He states that he started feel ill on the 25Mar2021 and went and got a COVID test. His results came back positive on Thursday 26Mar2021. On 25Mar2021, he states that he has a cough and a headache, and a few other symptoms as far as fatigue and things like that. He does not have a fever. He states that he has gone through the 14 day quarantine and was planning on going back to work tomorrow. He states that he was due to take the second shot this Saturday and he doesn't want to get sick all over again. He doesn't want to feel like this after being gone for two weeks. His headache, cough, and feeling ill started on 25Mar2021. He states that his symptoms are improving everyday seems like it is a little better. He left his vaccine card in his truck because he figured he would need it when he went back, and it was better than putting it in his wallet and loosing it. He got the vaccine because he didn't want to get the virus and then he got it anyway. He was tested for COVID on 25Mar2021 and got a positive result on 26Mar2021. Reported, as he had 1st shot 20Mar2021, but was diagnosed with COVID-19 virus. He was concerned about getting the 2nd shot scheduled on 10Apr2021. He was not yet getting better, and the caller still has the symptoms. (Name) calling also about his wife, named (Name) was in quarantine and also experiences an adverse reaction after the 2nd shot. Outcome of events was recovering.    No follow up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 18 year-old female patient of an unspecified race and ethnicity received at a physician's office the first dose of TRUMENBA via an unspecified route of administration on 10Apr2018 in the afternoon at 0.5 ml single in the right arm for immunization. No other vaccines were given on that day. The patient medical history and concomitant medications were unknown. The patient experienced pain injection site, headache, nausea, sweaty, shaky, cold, chills, stomach pressure sensation of, felt like she couldn't get up, weird dreams, didn't know if she was awake or asleep all on 10Apr2018. Events were described as follows: within an hour from the vaccination, the patient's arm vaccination site started to hurt. The office did explain to the patient that pain at injection site was expected. Later that evening at approximately 07:00 pm the patient had headache and nausea. The patient became very sweaty, shaky, cold and was experiencing chills. The patient felt pressure on her stomach like she needed to go to the bathroom, but she did not have to go. The patient felt like she could not get up, she felt like she had weird dreams and she did not know if she was asleep or awake. The patient got up in middle of night thinking she had to go to the bathroom, but she did not have to go. On 11Apr2018 she had no energy (the reporter was unsure if the patient went to school and then returned home early from school on 11Apr2018 or missed the full school day). She was also experiencing more sweatiness and nausea. The patient's mother called the doctor's office at 08:46 on 11Apr2018 and the patient returned to the physician's office. Events outcome was unknown. The reporter wanted to speak to a doctor to learn if she would still give the second dose to the patient in six months. The information on the batch/lot number has been requested.
Jynneos was administered intradermally instead of subcutaneously; Case reference number US-BN-2022-003166 is a spontaneous case report initially received from a consumer via Company (reference number: USBAV22-1499) on 22-Sep-2022 and concerns an elderly male patient.  The patient's medical history and concomitant medication details were not provided.  The patient's concomitant vaccine included Pfizer BioNTech COVID-19 vaccine (tozinameran).  On 23-Aug-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: not provided), administered intradermally (explicitly coded as 'intradermal injection'), at an unknown dose or site of administration, for monkeypox prophylaxis.   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.   Additional information received from Bavarian Nordic on 23-Sep-2022 included the local BN case ID.; Reporter's Comments: An elderly male patient was vaccinated with the first dose of Jynneos, administered intradermally, which is considered as intradermal injection, at an unknown dose or site of administration, for monkeypox prophylaxis. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. The event of intradermal injection is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided, and concomitant vaccine included Pfizer BioNTech COVID-19 vaccine. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An elderly male patient was vaccinated with the first dose of Jynneos, administered intradermally, which is considered as intradermal injection, at an unknown dose or site of administration, for monkeypox prophylaxis. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. The event of intradermal injection is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided, and concomitant vaccine included Pfizer BioNTech COVID-19 vaccine. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
I tested positive for Covid on 26Dec2021; I tested positive for Covid on 26Dec2021; dose_number=3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Nov2021 09:30 (Lot number: EW0217) at the age of 54 years as dose 3 (booster), single, administered in arm left, administration date 16Mar2021 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 24Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 04Nov2021, outcome "unknown", described as "dose_number=3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovered" and all described as "I tested positive for Covid on 26Dec2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid-19,vaccination failure, booster.
Approximately 10 minutes after administration of Moderna vaccine, patient complains with throat swelling, tingling throat, and itching in throat. Patient face flushed. Patient vitals monitored. EPIPEN administered along with Benadryl 50 mg IM.  911 contacted to have patient evaluated. Patient stated was feeling better but still felt some swelling in throat area. Patient declined transport to hospital via EMS. Wife did take patient to ER per follow up call. Nurse followed up with patient on 08/20/2021. Patient states was in ER for 3 hours and feeling went away right before left facility.
flu-like symptoms; fever; chills; First dose was received last year / second dose was received recently; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills and drug dose administration interval too long. On an unknown date, the outcome of the influenza-like symptoms, fever, chills and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever and chills to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received 1st dose last year and the second dose was received recently at the time of reporting, which led to lengthening of vaccination schedule. The patient received the first dose she had flu-like symptoms with chills and fever. The patient did not consent to follow up.
redness was going down; red; itchy; hard; sore; This spontaneous case was reported by a consumer and describes the occurrence of PRE-EXISTING CONDITION IMPROVED (redness was going down), ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (hard) and VACCINATION SITE PAIN (sore) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included VITAMINS NOS for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PRE-EXISTING CONDITION IMPROVED (redness was going down), ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (hard) and VACCINATION SITE PAIN (sore). At the time of the report, PRE-EXISTING CONDITION IMPROVED (redness was going down), ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (hard) and VACCINATION SITE PAIN (sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took thyroid medication on regular basis. Patient used cortisone cream to treat her symptoms
Off and on rumbling sound in both ears; Off and on rumbling sound in both ears; Other vaccine same date vaccine date 08Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 88 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Oct2021 14:00 (Lot number: FE3592) at the age of 88 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation, administration date 08Oct2021. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, brand:Pfizer, lot number:EL1283, administration time: 12:00 PM, dose number:2, location: Right arm), administration date: 13Feb2021, when the patient was 87 years old, for COVID-19 immunization; Bnt162b2 (Prev dose product: COVID 19, brand: Pfizer, lot number: E10142, administration time: 12:00 PM, dose number:1, location: Right arm), administration date: 23Jan2021, when the patient was 87 years old, for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 08Oct2021, outcome "unknown", described as "Other vaccine same date vaccine date 08Oct2021"; TINNITUS (non-serious), HYPERACUSIS (non-serious) all with onset 10Dec2021 13:00, outcome "not recovered" and all described as "Off and on rumbling sound in both ears". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, hyperacusis.  Additional information: No other vaccine was administered in four weeks. No allergies. No other medications taken in two weeks. No covid prior to vaccination. Covid tested post vaccination was reported as Yes. It was reported that off and on rumbling sound in both ears, day and night for past month to 6 weeks.   No follow-up attempts are possible. No further information is expected.
The patient stated he was getting tunnel vision. At this point I came to the site of the patient and his pupils dilated. He became unresponsive. The patient started responding after about 1 minute. When the patient finally became responsive he began sweating quite a bit. We immediately began the emergency response and called 911 and called for store help. I stayed with the patient and when the paramedics got there they took over in the patient's care. The patient remained hypotensive, so the paramedics advised him going to the hospital. The patient agreed and was taken to the hospital.