chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough COVID-19 case; Breakthrough COVID-19 case; This is a spontaneous report received from a non-contactable consumer (patient). This 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 at the age of 73-year-old (lot unknown) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medical history and allergies was Unknown. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient received any other medications within 2 weeks of vaccination. The patient experienced Breakthrough COVID-19 on 21Jul2021 and reported as Non-serious. It was unknown if treatment received for AE. Since the vaccination, the patient has been tested for COVID-19 which included Nasal Swab covid test on 21Jul2021 with Positive result. The outcome of the event was Recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Deep tenderness in and around joint for 72 hours with tenderness along right forearm; slight malaise; sore throat (inflamed R tonsillar pillar) for last 18 hours. Complete resolution at 72 hours
While sitting after receiving his vaccine he patient started to feel dizzy. Then his eyes rolled back and he went limp. He was unconscious for under a minute. A police officer came since we called 911 but the patient was already awake and felt better. He declined an ambulance.
PM nausea/vomiting, swelling, fever in deltoid, burning sensation to area from shoulder to neck; stiffness in shoulder; 415PM visited ER was given Phenergan sx later subsided;
pt recv vax;turned red,began to itch;dph taken;glands under arm & neck began to swell;T 102;to hosp;MD said bronchitis & CAt scratch fever;apap given;sleepy,n;no appetite;difficult time breathing, restless;weak;itching all over;face swell
Moderna Covid 19 Vaccine EUA Aprox. 5 minutes after injection entire head went numb, aprox 45 minutes later numbness moved to being left eye, aprox 2 hours numbness was gone. No other symptoms to report.
Intense itching in my arms, lower back.  Then I noticed little welts on my right arm.  I also had some larger welts on my left thigh at the location of a skin graft, anterior location.
Around a week and half after the second Moderna dose, I noticed my heart rate was sometimes higher than normal, as well as spiking to anywhere between 110 and 125 BPM when standing up after sitting or lying down. It's not very consistent but happens sometimes, usually after sleeping. Only treatment so far has been tests in an emergency room and doctors office including EKG and bloodwork.
Pt was given first MMRV vaccine at 12 month well-child check. Pt was supposed to be given Prevnar and was given MMRV again instead at his 15 month well-child check at approximately 10AM on 2/22/22. At 5:30 PM on 2/23/22 a hive presented to left cheek, 3 hours later the hives progressed to both cheeks and his left arm with redness and swelling. Pt was given 5 ml of liquid benadryl - the hives improved. Pt woke up with hives to face and was given another 5 ml of benadryl. I called the pediatrician's office that morning and was told to bring him in because he was having a reaction to his MMRV vaccine. I told them he was not supposed to get the MMRV as he was only supposed to have his 4th doses of DTAP and prevnar. Pt was seen by the pediatrician that morning. No further symptoms have appeared.
patient was inadvertently administered an expired dose of VAQTA; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   On 21-AUG-2020, the patient was inadvertently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S021729, expiration date: 20-AUG-2020), 1 milliliter (route of administration and anatomical location were not reported). No additional information was provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S021729; expirationdate: 20-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
On 3-10-2021, Covid Vaccine administered IM L deltoid at 12:15 PM.  At 12:25 PM Pharmacist was notified patient symptoms of head and face tingling and throat swelling.  BP 165/90 pulse 68 at 12:28PM.  Patient described s/sx rapidly developing and described severity as 10/10 with difficulty breathing.  Epinephrine (Epipen) administered in R thigh at 12:30PM.  By 12:34 patient described symptoms as already decreasing to a 7/10 severity.  EMS arrived, assessed patient.  Continued improvement with no residual effects.  EMS dismissed patient to care of her husband without further follow up needed.
Screening questionnaire from Immunizations all answered by mother as no.  8/7/07 Received Death Certificate from HD which reveals COD as positional asphyxia.  Received Autopsy Report from Coroner which reveals COD as same w/anatomic findings of pulmonary congestion, edema & petechial hemorrhage; petechial hemorrhages of thymus & heart; mild bilateral facial cheek abrasions; facial plethora; & pericardial effusion.  Report indicates patient found face down in bumper of the bed.  Manner of death is accidental.
After receiving a Jansen vaccine, pt got up to leave and started to complain that she was dizzy. Then, she slowly lost consciousness in this RN?s arms. Pt was lowered to the floor with her feet elevated in a chair. Pt regained her consciousness quickly and sat up for a while to make sure that pt was not dizzy any longer. After 15 minutes, pt went home with her mother.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnicity. 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, and batch number were not reported) dose, (dose number in series 1), one total, start therapy date were not reported 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 an unspecified date, patient had a break through case of Covid (suspected covid 19) even though was vaccinated and suspected clinical vaccination failure. The patient took immunosuppressants. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the suspected covid 19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint.; Sender's Comments: V0: 20211157677- covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Red; Itchy; Rashy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (Rashy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (Rashy). At the time of the report, VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (Rashy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided    Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: NNI
She woke up the next day covered  with rash/hives on her right arm from the top to her fingers and was itching
A spontaneous report had been received from a Health Professional concerning unknown number of patients of unknown gender. Lack of relevant history. No concomitant medications reported. The patients had received FLUMIST (intranasal), once/single administration started on an unknown date. The health professional reported that several people experienced severe Headache and sinus symptoms for one and half weeks after they were given the vaccine. Action taken with the FLUMIST was unknown. The outcome of the event of sinus symptoms and severe headache was unknown. The company physician assessed the event of sinus symptoms to be serious with the seriousness criteria of important medical event and the event of severe headache to be non-serious.
peanut butter tasted moldy, bell peppers and lettuce had the identical taste as well, jalapeño peppers also have the identical taste; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection) on 10May2021 14:00 (Lot Number: Ew0153, at the age of 48-years-old) as dose 1, single and on 02Jun2021 14:00 (Lot Number: Ew0164, at the age of 48-years-old) as dose 2, single, both via an unspecified route of administration, administered in the left arm for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), spinal stenosis, and COVID-19 (reported as If covid prior vaccination: Yes). Concomitant medications included gabapentin; hydrocodone; piperazine citrate (CITRAZINE) all taken for an unspecified indication, start and stop date were not reported. Patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced peanut butter tasted moldy, bell peppers and lettuce had the identical taste as well, jalapeño peppers also have the identical taste on an unspecified date in 2021. Three days after initial vaccine, on 13May2021, Patient noticed peanut butter tasted moldy. After a week, patient found bell peppers and lettuce had the identical taste as well. Four weeks after, on 12Jun2021, patient noticed jalapeño peppers also have the identical taste. No treatment was received and events did not result to either physician office or emergency room visit. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
June 1-3 Fever 101-103.4 June 4th Macular papular rash on trunk which spread to extremities June 4th in afternoon stiffened extremities & whole body, eyes rolled back - lasted Approx 5 seconds
Experienced light-headedness, heart palpitations March 31st, 6 days post receiving the Covid 19 (Janssen) vaccine. Pulse rate in the 170 range for around 3 hours.  Blood pressure elevated with the systolic in the 150's to to 170 range. Tachycardia noted during Emergency room stay.  Labs taken as well as EKG..  All within normal range.  Felt some mild tremors to head all the way down to my left foot.  This was intermittent and lasted around 20 minutes.  Had cardiac monitor applied for 24 hours and saw Cardiologist on April 8th.  EKG at this time was within normal range and vital signs all within normal limits.  No other symptoms noted since the one and only event on March 31st.
My dad has been on Pfizer vaccine and he passed away from the complications because of it; He passed away, because of your vaccine; your vaccine, that doesn't work; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on an unspecified date, my dad has been on Pfizer vaccine and he passed away from the complications because of it, he passed away, because of your vaccine. Reporter stated, he passed away, because of your vaccine. He never went to other house. Nobody came to his house. Last time he left the house when he got the vaccine and he died from it. Reporter want all to hold up to your vaccine because your vaccine, that doesn't work. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event was fatal.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: My dad has been on Pfizer vaccine and he passed away from the complications because of it; He passed away, because of your vaccine
Sneezing; Dry cough; His nose was dripping.; Bad migraine; Fever; Chills; Felt like they couldn't eat or swallow; Nauseous; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 29Apr2021 (age at vaccination: 54-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On 29Apr2021, the patient had fever since the night he took the vaccine, chills, felt like they couldn't eat or swallow, nauseous. On 05May2021, he experienced bad migraine. On 06May2021, he had sneezing, dry cough and his nose was dripping. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax & 7FEB97 pt exp pruritic red spots/chicken pox;
Rash on entire body, onset 8-8-07 5 pm. Treated by pediatrician with Benadryl
Extreme fatigue, Chills, Nausea, Body aches Headache HUGE painful swollen lymph nodes (right armpit, near injection site) Began Mar 11 (day after 1st dose of vaccine).  Mostly ended after Mar 12, except painful swollen lymph nodes remained until Mar 16
VACCINATED FROM OPEN PUNCTURED VIAL; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 09-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-NOV-2021, the patient experienced vaccinated from open punctured vial. On 09-NOV-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccinated from open punctured vial and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211121704.
red and itchy mark at the injection site; arm from first dose still redness, not as bad; first injection hurt the worst; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red and itchy mark at the injection site), VACCINATION SITE ERYTHEMA (arm from first dose still redness, not as bad) and VACCINATION SITE PAIN (first injection hurt the worst) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-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 INJECTION SITE ERYTHEMA (red and itchy mark at the injection site), VACCINATION SITE ERYTHEMA (arm from first dose still redness, not as bad) and VACCINATION SITE PAIN (first injection hurt the worst). At the time of the report, INJECTION SITE ERYTHEMA (red and itchy mark at the injection site), VACCINATION SITE ERYTHEMA (arm from first dose still redness, not as bad) and VACCINATION SITE PAIN (first injection hurt the worst) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant information were not provided by the reporter. Treatment information were not provided by the reporter.   This case was linked to MOD-2021-060419 (Patient Link).   Reporter did not allow further contact
I received the 2nd shingles vaccine in the series. 2 hrs later the pain was so extreme that I went to the ER. I have never experienced such pain. I have swelling and still very little use of my arm. I am also experiencing dizziness, hot and cold extremes and weakness.
FELT A LITTLE FLUISH; This spontaneous report received from a patient via a company representative 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced felt a little fluish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt a little fluish. This report was non-serious. This case, from the same reporter is linked to 20210327861.
soreness in the arm after all 3 shots; weak; sore; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm after all 3 shots), ASTHENIA (weak), PAIN (sore) and FATIGUE (tired) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in the arm after all 3 shots), ASTHENIA (weak), PAIN (sore) and FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (soreness in the arm after all 3 shots), ASTHENIA (weak), PAIN (sore) and FATIGUE (tired) outcome was unknown.            Patient was on no concomitant medication.  Treatment for the events included over the counter painkiller medication.   This case was linked to MOD-2021-409784, MOD-2021-409788 (Patient Link).
Information has been received from a registered nurse concerning her 46 month old grandson with no pre-existing allergies or medical conditions who on 04-Dec-2000 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Lot #635601/1148K) at about 15 months of age. Concomitant vaccines administered on 04-Dec-2000 included a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot #633094/0177K) administered SC in the "right", a second dose of hepatitis B virus vaccine rHBsAg (Engerix-B) (Lot #5166A2) Im in the "left", a fourth dose of HIB conj vaccine (CRM197) (Hibtiter) (lot #473-003) IM in the "right", and a third dose of pneumococcal 4 6B 9V 14 18C 19F 23 F conj vaccine (CRM197) (Prevnar) (Lot #473-010) administered IM in the "left". It was noted the patient was not ill at the time of the vaccination and did not have adverse events following prior vaccination. On 11-Oct-2003 the child was seen by another health care practitioner and was diagnosed with shingles. No other information was available. The child was reported as recovered. Unspecified medical attention was sought. There was no product quality complaint. The VZVID program was declined because of the reporter was not the treating health care practitioner. Follow-up information received from a registered nuse (also the patient's grandmother and physician indicated that the rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. The physician reported the date of adverse event onset was 10-Oct-2003 (also reported as 09-Oct-2003 by the registered nurse). The physician reported that the varicella zoster was diagnosedon 11-Oct-2003, on the left hand, and was treated with acyclovir 300 mg, 1 1/2 tablet TID for seven days. The herpes zoster "started at inside of the left hand between the thumb and the first finger and on the back of hand at the same site, then progressing up left arm". The patient was seen in the office on 14-Oct-2003 as the lesions had spread from his had up lower arm to distal half of left upper arm. The acyclovir was increased to 2 tablets TID for 10 days. Maximum temperature was 99.8 degrees Fahrenheit (also reported as 99/5 degrees Fahrenheit by registered nurse). The physician quantified the patient's patin as "0-1" on a pain scale (zero the least and 10 the most). The nurse, also the patient grandmother quantified the patient's patin as a 6 with most of the pain under his left armpit. There were no other systemic symptoms. There was no history of chickenpox. There was no recent exposure to chickenpox or herpes zoster. On 14-Oct-2003 a varicella zoster and herpes simplex antigen were collected. The varicella-zoster virus was positive by direct immunofluorescence and the herpes simplex virus was negative by direcet immunofluorescence. Photos were taken. The patient did not have a fever, "never actually ill", had no further spread of lesions after distal upper left arm and had no lymphadenopathy. The patient recovered on 17-Oct-2003. No additional information is expected.
Swelling on right side of neck above clavicle about the size of my palm arched up. Swelling lasts a day or so and has reoccured about 4-5 more times until present (10/19/21).   I sent pictures and asked my PCP about it. She recommended I see an ENT. I saw Dr. and  it was a mystery to him so ordered an MRI of my neck and recommended I see a Rheumatologist. Got MRI ( I think, or a CT?) on April 9, 2021. Saw Dr. on April 21. Dr. also said my problem was a mystery to her.