chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart attack; Initial information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a heart attack. As a result of these symptoms, the pt was seen and treated by medical providers and at the time of report was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered/not resolved. The reporter considered the event related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of myocardial infarction was determined to be medically significant. The reporter considered the event of myocardial infarction to be disabling.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with PROQUAD (subcutaneous injection, strength, dose number, lot #, expiration date not reported). The reporter stated that the patients were vaccinated with PROQUAD that was exposed to 15F intermittently throughout the day every day for an unknown period of time during the last. No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and nose tingling and then the whole face tingling and numb feeling as if I had gotten a novacaine shot.  This has continued all night but is currently more on my left side of face and down left forearm tingling/numb.
Child awakened with rash and swelling of face.  Was take to PMD on 4th day of rash and swelling.  Dr. told mother it was propabably an allergic reaction. Provided no treatment. All 3 sibs have had H1N1 without event.  Child completley recovered by day 7.  Was not given booster.
Extreme chills, headache all through the night & into the next day. Took advil.
Patient had a fever that went up and down for 7 days following the vaccine. The highest fever taken was 102.8 under the arm. If patient seemed uncomfortable, infant Tylenol was given in the proper dosage. No other obvious symptoms.
child 1 recv vax & sibling  devel forty lesions on 8FEB99;
Received second shot at 10 weeks pregnant (due 12/6/21). The night of 5/14 - started having night sweats, extreme lower back pain, nausea, and spotting from the vagina. All of these symptoms were new and none were experienced during pregnancy otherwise.  (After the first shot at 7 weeks pregnant, only had a sore arm at injection site) On 5/15 - multiple episodes of vomiting, excessive exhaustion, and bleeding continued. 5/16-5/25 - bleeding increased Went to OBGYN 5/17 & 5/25 to get checked and both times they were able to locate a heartbeat, but were unsure why bleeding continued to occur. 5/25 11:30pm woke up in excessive pain and bleeding, resulting in a miscarriage. 5/26 2:00am ER confirmed miscarriage.
Severe mid and upper back pain, abdominal pain, nausea, vomiting, fever, chills, cold sweats, body aches
About 5-10 minutes after the shot was administered, patient complained of some dizziness, nausea, lightheadedness. Few minutes later. some tingling of the lips. Patient was given about 50mg of diphenhydramine about 10 minutes after the shot, some water to drink and his blood pressure was checked. BP was 114/78 and heart rate was 68. Patient was allowed to sit for about an hour and felt better over that time and was able to go back to work cautiously
mom reported that pt had been to MD to assess rxn to vax;lt arm swelled w/in 2hr p/inj;w/in 2 days firm, red area size of softball had raised up @ inj site;MD noted some lymph node edema;tx ATB for suspicion of infect;bruising noted;
I have been having pins and needles, pain, and numbness in my feet and calves since June.  It feels like someone is squeezing my calves at times. I have tried gabapentin and lyrica to manage it and nothing is helping . There is not 1 day that my legs feel normal. A few months ago I went to the hospital because my face started to feel numb/tingly. My scalp is tingly as well.   I have been to my primary care physician multiple times, dermatologist for my scalp pain. I have  went to an urgent care twice regarding the pain/discomfort. I also went to the emergency room to address my face numbness.
RASH ON ARM OF INJECTION (SOME OF THE RASH WERE ALMOST LIKE SCABS), THE RASH ALSO SHOWED UP ON MY RIGHT BREAST. I ALSO HAD FATIGUE, HEADACHE, BODY ACHES AND NAUSEA
Full  body rash.  No itch,   Did not notice until  14 hours later.  No treatment,  no problem except the rash,    Went to dr  to so him my rash.  He checked me an  gave me his ok to get the 2nd shot, but to take a Benydril 1 hour before and another 4 hours after the shot. And to report the event. He described it as a ?reaction?  BUT NOT a sever reaction
Patient received 3 doses of Moderna. No adverse reaction noted. Facility notified and advised to monitor patient for signs and/or symptoms of adverse event. Aware to call 911 or go to nearest ER for treatment if needed.
Severe swelling, redness, dizziness, motion sickness, inability to control movement of both legs, could not stand. Treatment: taken to ER by ambulance. Overnight observe.
Patient died about a month later. Unknown whether she had a second vaccination for COVID. She was resident at Rehab Facility.
Information has been received from a physician concerning a 5 year old female with no medical history or concurrent condition who on 10-AUG-2009 was vaccinated subcutaneously with the second 0.5 mL dose or MMR II (lot # 663877/0356Y).  Second suspect vaccine included a dose of VARIVAX (Merck) and a dose of VAQTA on the same date.  On 26-AUG-2009 the patient "developed a measles-like rash that covered about 80% of her body."  The patient sought medical attention by visiting the physician's office.  At the time of report the patient was recovering.  Additional information has been requested.
Off-label dosing to 16 year old patient; Off-label dosing to 16 year old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Off-label dosing to 16 year old patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off-label dosing to 16 year old patient) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced OFF LABEL USE (Off-label dosing to 16 year old patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off-label dosing to 16 year old patient). On 17-Sep-2021, OFF LABEL USE (Off-label dosing to 16 year old patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off-label dosing to 16 year old patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter confirmed that patient hadn't experienced any side effects by the time of reporting. No concomitant medication information were provided.
2nd shot i could not walk the day after / Now / have a cane to get around; Kept falling down.; Pain and have a cane to get around.; This case was reported by a consumer and described the occurrence of walking difficulty in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles with an associated reaction of no adverse event.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced walking difficulty (serious criteria disability), fall and pain. The patient was treated with gabapentin. On an unknown date, the outcome of the walking difficulty, fall and pain were unknown.   It was unknown if the reporter considered the walking difficulty, fall and pain to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient could not walk the day after vaccination. Kept falling down. The patient was taking Gabapentin for the pain and have a cane to get around. The physician told to the patient not to even take the flu vaccine anymore.
Pt. called 2 days after immunization to say she had stiff neck, throat felt swollen on left side, gland felt swollen, & pt. had tingling in fingers left hand, with numbness in one finger. Pt. was advised to use pain reliever and to schedule office visit if no improvement by next day.
24 hour intermittent muscle spasm at injection site. Could be seen from a reasonable distance.
Rebound of covid symptoms and positive test 3 days after finishing full course of Paxlovid.; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: en6201), on 12Mar2021 as dose 2, single (Lot number: en6201) and on 22Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "eczema" (unspecified if ongoing); "migraines" (unspecified if ongoing); "known allergies: penicillin (hives)" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: allergies. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 31Aug2022, outcome "not recovered", described as "Rebound of covid symptoms and positive test 3 days after finishing full course of Paxlovid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Aug2022) Positive, notes: Rebound of COVID symptoms and positive test 3 days after finishing full course of Paxlovid. Therapeutic measures were taken as a result of covid-19, vaccination failure. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: The patient received Covid-19 treatment from 23Aug2022 to 27Aug2022. Rebound of covid symptoms and positive test 3 days after finishing full course of Paxlovid. Rebound symptoms severity and duration significantly greater than original. The patient had not received Other medication in 2 weeks.
Muscle close to hip that gave me a lot of pain; I had a short heart attack. It was a pretty severe pain.; mid chest, left side pain; Felt lousy; Had flu-like symptoms; Cough; Sore throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (I had a short heart attack. It was a pretty severe pain.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Scarlet fever (Patient had as a child, about 13 or 14 yrs old.) since an unknown date.   On 23-Apr-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. On 23-Apr-2021, the patient experienced MALAISE (Felt lousy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache). On 24-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (I had a short heart attack. It was a pretty severe pain.) (seriousness criterion medically significant) and CHEST PAIN (mid chest, left side pain). On 27-May-2021, the patient experienced MYALGIA (Muscle close to hip that gave me a lot of pain). At the time of the report, MYOCARDIAL INFARCTION (I had a short heart attack. It was a pretty severe pain.), CHEST PAIN (mid chest, left side pain), MALAISE (Felt lousy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) outcome was unknown and MYALGIA (Muscle close to hip that gave me a lot of pain) had resolved.            Concomitant medications were not provided.Treatment information was not reported.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Extreme Tinnitus, nausea, headache and fever over 100 for extended period of time currently at 14 hours. Also mild arm pain and extreme fatigue.
Fever 99 to 101 for 10 hr Chill for 7 hrs Fatigue  for 24 hrs and 2 days later for 4 hrs Painful to touch in Left Arm for4 days
DAY AFTER VACCINE:  PATIENT HAD MIGRAINE-LIKE HEADACHE, WHICH WAS NOT RELIEVED BY TYLENOL 2ND DAY AFTER VACCINE:  PATIENT IS DEVELOPING HIVES ON HER CHEST AND WHEEZING - RECOMMENDED BENADRYL, AND A TRIP TO URGENT CARE IF NO RELIEF
Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 1/20/21). Patient  was admitted to the hospital on 5/5/21 s/p fall. Patient was being transferred to HCF on 5/19/21 and on day of discharge was found to be positive for SARS-CoV-2 (5/19).
pain in his ankles; This case was reported by a pharmacist via call center representative and described the occurrence of pain ankle in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th May 2022, less than a day after receiving Shingrix, the patient experienced pain ankle. On an unknown date, the outcome of the pain ankle was not recovered/not resolved.   It was unknown if the reporter considered the pain ankle to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-JUL-2022 Reporter's Comments: The patient on that day he developed pain in his ankles. The pain persisted, was nothing else to report. The reporter consented to follow up with health care professional.
A report was received from a health professional on 11/19/2001 regarding a 44 year old female patient who was inadvertently given last year's Fluvirin vaccine on an unknown date. There was no adverse event reported. There was insufficient information to determine the reporter's causality assessment.
Patient states that he had swelling in his arm (larger area than the administration area) that lasted for approx. 8 days
Pt was given 1st dose of Moderna vaccine at another location on 4/25/21 and then was administered Pfizer at our location on 5/25/21. No known adverse effects from either vaccination at this point but vaccines were administered incorrectly based on current series guidance.
Pt mom stated baby received vaccine later that evening started with red circular non-raised at lower legs increasing to stomach then to arms. Measuring 2cm baby sent to ER for evaluation.
c/o diffuse myalgia, malaise, fever 101-102, +vomiting, abd cramps, diarrhea during noc;
Excessive swelling and Hives on right side of face, right eye,  neck back, right arm.  Benedryl 25mg, at 11pm. EpiPen injection at 12 midnight.  continued 50mg benedryl on 1/8; continued 50mg  benedryl on 1/9 and Cetirizine 10mg.   1/10 10mg Cetirizine;  1/11 10mg Cetirizine  1/12 Patient is calmer and swelling is decreasing;  pimply rash on forehead and top of head.   Followup with Pharmacist phone call on 1/11
a little achiness; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete: , Unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "a little achiness".  Additional information: Caller's husband, the patient, had the Pfizer BioNTech COVID-19 vaccine bivalent too, but didn't feel bad and didn't get arm thing like the caller did. Patient did have a little achiness.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Received varicella vaccine 2/28.  Now injection site is red, size of a half dollar, tender when touched.  Advised to treat with cool compress and observe and call back if symptoms worsen.
Malaise, chills, lightheadedness, localized injection site erythema / tenderness within Flu vaccine administration "Lung Burning" sensation within 12 hrs after .
Had a cold the day I received my Flu and Pneumonia shots but, generally I was in good condition. Next day 10/26/2006 I developed the shingles and had to go immediate Care and my primary physician out on Valtrex 21 pills and Triaminolone. No blisters at this time 1/2/2007. Can you get the shingles again?
pt recvd vax & 15-20 mins p/shot had numbness in lt arm moving across to shoulder area & down lt side of trunk; sweating & nausea; numbness of lt leg, loss of vision, passed out; fever & swelling of arm & shoulder area;
Felt fine during the waiting period after the vaccine on 08Apr2021.  Feeling of heat and  rash on right arm above wrist started to form around 3:30pm on 08Apr2021 and immediately took an antihistamine (Zrytec).  Intermittent dizziness/lightheadedness around 4pm continuing on and off every 30-45 minutes.  Called 9-1-1 at 4:30pm, EMT's said I was having an allergic reaction with a high blood pressure of 148/100 and to go to the ER.  Arrived at ER at 5:15pm, ER confirmed allergic reaction and monitored until 7:45pm.  Given a half dose of Benadryl prior to leaving the hospital at 8:00pm.  Arm pain at the injection site was instant after the shot and continued for 3 days following.  Swollen lympnode behind the knee of the left leg occurred on 11Apr2021 around mid day and subsided by 9pm.
Mottled discoloration to injection site. No pain or induration. Continues to be discolored 3 months after vaccine.
I felt fine for the rest of the day thru the evening. I thenI woke up around 1:30 AM and was extremely dizzy. Felt like the room was spinning. Then I had multiple bowel movements and eventually, early in the morning vomited fluids. I then fell back to sleep until that afternoon. I was feeling a lot better but still have some intermittent residual dizziness although I am functioning well.
Rash, local reaction; treatment: dexamethasone (steroid), outcome good.
This case was reported by a physician via sales rep and described the occurrence of shingles in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. It was reported that 3 days post vaccination with SHINGRIX patient broke out in shingles rash on left pectoral muscle and under arm.
Patient states that all of his joints hurt, muscles hurt, shivering, sweating, fever of 102 degrees, and his arm was very sore. He has had shingles before, and states that the feeling was "just like I had shingles again". Patient was advised to seek medical treatment if symptoms persisted or became worse. This patient could barely go to the medicine cabinet to see if he had some naproxen.
thrombocytopenia; she is not producing red blood cells; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was in the hospital for thrombocytopenia. The reporter stated that she was not producing red blood cells and they were saying that it was because of the vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Was given TRUMENBA and FLU vaccines on 8/15/16. She was observed in office without difficulty. Mother reports about an hour after vaccine she developed a bad headache. Eventually the headache resolved with Ibuprofen but complained of body/muscle aches for 2 days after.
near collapse in parking lot; extreme sweating all over like I fell in swimming pool; Extreme headache; extreme nausea; weakness in legs; This is a spontaneous report from a non-contactable consumer (the patient).      A elderly female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 08Apr2021 12:00 (Batch/Lot Number: ER8727) as single dose, for covid-19 immunisation  .  Medical history included cardiomegaly, mitral valve disease,  glucose tolerance impaired , milk , egg, gluten and soy allergy  , allergy to sunflowers,  smoke sensitivity.     The patient's concomitant medications were not reported.  The patient previously took ether and , codeine and experienced drug hypersensitivity. On 18Mar2021 the patientreceived the first dose  bnt162b2 for covid-19 immunisation.  The patient experienced near collapse in parking lot  (non-serious) on 19Apr2021 01:00 with outcome of recovered , extreme sweating all over like i fell in swimming pool  (non-serious) on 19Apr2021 01:00 with outcome of recovered , extreme headache  (non-serious) on 19Apr2021 01:00 with outcome of recovered , extreme nausea  (non-serious) on 19Apr2021 01:00 with outcome of recovered , weakness in legs  (non-serious) on 19Apr2021 01:00 with outcome of recovered.   The patient was not pregnant at the time of the vaccine. The patient felt going to die because of the event.  No follow-up attempts are Possible. No further information is expected.
The normal pain of injection was present and never stopped. The inflammation continued through February which limited arm motion, raising his hand, reaching back, and across chest. Physical therapy prescribed for 4 weeks, three times a week.