chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This study case was received from the investigator in a trial on 20 August 2013. An 42 year-old male subject with no significant past medical history was found to have "subendocardial infarction" 15 days after the subject had received the following vaccine on 30 May 2013: an injection of ACAM2000 (lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I on 15 June 2013 recorded highest value of 01.50 and a normal Echocardiogram on 16 June 2013. An ECG was not available. 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.
A patient older than 13 years of age was administered PROQUAD instead of MMR II and VARIVAX; A patient older than 13 years of age was administered PROQUAD instead of MMR II and VARIVAX; This spontaneous report was received from a nurse referring to an unknown age and gender patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 24-JUN-2022, a patient older than 13 years of age  was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection and  varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, doses, and routes of administration, lot numbers and expiration dates were not provided) (product administered to patient of inappropriate age)(wrong product administered).
Other than sore arm I had no side effects until the next morning,  hour 20 post vaccine. Heart rate elevated to 150bpm. Emergency room visit necessary.
Don't get it, it gave my uncle shingles/Suspected vaccination failure; Shingles; painful rash; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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 vaccination failure (serious criteria GSK medically significant), shingles and painful rash. On an unknown date, the outcome of the vaccination failure, shingles and painful rash were unknown.   The reporter considered the vaccination failure, shingles and painful rash to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 16-JAN-2023 Reporter's Comment: This case was reported by a patient's relative viainteractive digital media. The reporter stated that did not get the vaccine because it gave my uncle (patient) shingles. The reporter stated that take action. Find out more about the risk of shingles and take steps to help prevent this painful rash. The reporter thought that the event might had been related to the drug. The reporter did not agree that the company's safety team might contact their HCP to gather further information. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Chills, Fever and body aches x4 hours.  12 hours after Influenza Vaccination.
Patient presented to the ED on 3/26/2021 and was subsequently hospitalized for 3 days. She presented to the ED on 3/29/2021 and was hospitalized for 3 days.
Patient got diagnosed with Covid 19 on 05/19/2021 after becoming fully vaccinated. Patient has covid symptoms and is now in quarantine.
PT WAS ADMINISTERED ANTHRAX #4 VACCINATION ON 20 MARCH 06. APPX. 24 HRS LATER HE PRESENTED TO THE CLINIC STATING THAT HIS ARM WAS ITCHING SO HE TOOK HIS SHIRT OFF TO LOOK AT HIS ARM AND NOTICED A RASH. THE PATIENT DID HAVE VISIBLE URTICARIA FROM THE VACCINATION SITE (R ARM) TO ABOUT 2" BELOW THE ELBOW MEASURING ABOUT 12X28 CM. HE ALSO HAD A SMALL RASH ON THE LEFT ELBOW. PT WAS TREATED WITH ATARAX AND PREDISONE AND WAS ASKED TO RETURN TO THE CLINIC ON 22 MAR 06 AT 0630 FOR RE-EVALUATION. PT PRESENTED TO THE CLINIC ON 22 MARCH 06 WITH RASH COMPLETELY GONE. PT STATED THAT AFTER HE GOT HOME FROM THE CLINIC ON 21 MAR 06 THAT THE RASH HAD SPREAD TO HIS LEGS AS WELL.
2 hours after the vaccine I developed blurred vision and light sensitivity. I saw a Dr on Monday because nothing cleared. Tuesday vision began to clear and by a week later vision is finally back to normal.
Vaccine injection site was red, hot to touch, softball size red area. Vaccines given 10/20/2020 and noticed first reaction sign 10/21/2020. 10/22/2020 site was a lot more red and large. Was seen by PA-C and Pt was given decadron by mouth 0.7ml. Told to take motrin and cold compress, benadryl as needed
Hard time breathing; Pain during deep breath; High blood pressure; Sternum and lower rib cage hurts; Sore arm; Shortness of breath; Soccer punch me in my chest; Headache; Tired; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Hard time breathing), PLEURITIC PAIN (Pain during deep breath), BLOOD PRESSURE INCREASED (High blood pressure), MUSCULOSKELETAL CHEST PAIN (Sternum and lower rib cage hurts) and PAIN IN EXTREMITY (Sore arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-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 DYSPNOEA (Hard time breathing), PLEURITIC PAIN (Pain during deep breath), BLOOD PRESSURE INCREASED (High blood pressure), MUSCULOSKELETAL CHEST PAIN (Sternum and lower rib cage hurts), PAIN IN EXTREMITY (Sore arm), DYSPNOEA (Shortness of breath), CHEST PAIN (Soccer punch me in my chest), HEADACHE (Headache), FATIGUE (Tired) and MYALGIA (Sore arm). At the time of the report, DYSPNOEA (Hard time breathing), PLEURITIC PAIN (Pain during deep breath), BLOOD PRESSURE INCREASED (High blood pressure), MUSCULOSKELETAL CHEST PAIN (Sternum and lower rib cage hurts), PAIN IN EXTREMITY (Sore arm), DYSPNOEA (Shortness of breath), CHEST PAIN (Soccer punch me in my chest), HEADACHE (Headache), FATIGUE (Tired) and MYALGIA (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.    This case was linked to MOD-2021-114475 (Patient Link).
Approximately 5-7 mins after vaccine administration, pt became pale and slumped back in chair. Pt. was able to open eyes and respond to questions but stated she was dizzy. Breathing and respirations were normal. Episode lasted approximately 30 seconds. Pt. recovered to normal then had a repeat episode with same symptoms x 15-20 seconds. Pt. recovered and stated she felt okay and has had similar reactions with previous vaccines/injections. Pt. walked out of the store with companion with no additional symptoms.
I do not know the onset dates, but her Primary Care Doctor and Gynecologist should have all the records.
RINGING IN EARS; HEADACHE; SLEEP DIFFICULT; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included metformin for diabetes. On 20-APR-2021, the subject experienced ringing in ears. On 20-APR-2021, the subject experienced headache. On 20-APR-2021, the subject experienced sleep difficult. Laboratory data (dates unspecified) included: Blood glucose (NR: not provided) Unknown. The action taken with covid-19 vaccine s was not applicable. The patient had not recovered from headache, ringing in ears, and sleep difficult. This report was non-serious.
SYNCOPE, NAUSEA, VOMITING. BUMPED FOREHEAD AS A RESULT OF SYNCOPE. TREATMENT INCLUDED ICE PACK, COLD WASH CLOTH, ELEVATION OF LEGS/FEET
10MAR fever started 104.8 seen by MD on 12MAR; returned to nl had watery eyes-rash over entire body, rash remained until 17MAR; no ear infect; MD said it was reaction to MMR; was concerned about high fever, was given APAP for fever;
10/15/22 Pt admitted to hospital with altered LOC after falling with head injury; CT showed subarachnoid hemorrhage, subdural hematoma, intraparenchymal hemorrhage; transferred to ICU; found to be positive for COVID; respiratory status worsened; DNR/DNI; CXR showed multifocal PNA; pt transitioned to comfort measures and hospice; pt passed away in the hospital
Vomiting.  15 minutes in duration.  Mostly dry heaves although some liquid was expelled.
Pt recvd 3 doses of Recombivax on 6Mar91, 10Apr91 & 6Sep91. 4Nov91 titer result was negative. Recvd booster dose of Engerix B 13Dec91. 6Feb92 titer result was still negative.Will receive another booster.
Pain in injection site about an hour after and then area around was tender to touch, skin started turning red about 2 hours after,  and then the arm started getting swollen in and around injection site. Day after arm was warm to touch and painful hard lump started forming with redness and felt swollen from shoulder down to elbow area. Today is 2 days after and hard lump still there tenderness and discoloration still present. Painful to touch or move upper arm . Had headache first 2 days and very tired.
Within a few hours, patient spiked a fever of 103 degrees. The doctor was notified and we were told it was a normal reaction after vaccinating. The next day, she became almost totally lethargic, unresponsive to most light and sound. Patient had shrill screams, indicating she was in severe pain. She had lost most common learned words like, "mommy, daddy, dog, cup, ball" etc. In addition, she lost motor skills, and was unable to stand on her own, keep her balance or take small steps. Approximately 2 days later, patient had been seen by an emergency room (not primary care), diagnosed with an inner ear infection, Amox was RX, but we refused and cured naturally with garlic oil drops. Her infection cleared within 12 hours. Patient stayed in her lethargic state for almost 2 weeks.
felt lightheaded,  and as if she had phlem in her throat, and unable to clear,  harsh cough
Arm is sore; A very bad headache all day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore) and HEADACHE (A very bad headache all day) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First shot, lot number-EN6198, right dominant arm ) on 23-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (Second shot, lot number-EN6207 and Right dominant arm ) on 16-Mar-2021. Past adverse reactions to the above products included No adverse reaction with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced PAIN IN EXTREMITY (Arm is sore) and HEADACHE (A very bad headache all day). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm is sore) and HEADACHE (A very bad headache all day) outcome was unknown.            Concomitant medications were not reported.
Patient stated that he received his covid booster last Thursday and has had a  "bad case of covid arm." Patient describes this as redness and pain beginning at  the injection site down to just above the elbow. Patient states this began  immediately after immunization. Patient states he is unsure if area became  swollen or not as he has limited ROM in neck. Patient states the area became  itchy 2 days after immunization. Reports he took Tyenol for the symptoms. Patient states that the area is still red and itchy but not painful.  Denies any shortness of breath. Patient does state his chest felt tight on  Saturday but just assumed that was a side effect; states the pain lasted for 8  hours, rated a 4/10, described as intermittent, and felt like "pressure but not  severe, more like really congested ache." Denied check tightness at this time. Advised Patient to go to ER with any return of check pain.
Pain, tingling and weakness in legs, feet, arms, hands and face; first noticed numbness in feet end of October, 2008. Progressed to legs, arms, hands and then face. Also progressively got worse and more painful. Diagnosis GUILLAN BARRE.  3/16/09 Neurology consult received with assessment post-vaccinal AIDP (GBS). ROS (+) for difficulty sleeping, blurring of eyes, arthritis, rash, itching, tingling, weakness, numbness.  PE (+) for sensory disturbances toes, ankles and fingers and dysthesias to heels and fingertips. DTRS absent L achilles, depressed tricep, brachiorad, and R achilles. Has had 2 rounds of IVIG with lack of response.  3/31/09 Neuro consults dated 12/2/08 to 3/12/09 received.  Pt presented to neuro with 3 week hx of foot numbness and feeling swollen, tightness in the lower legs and numbness which progressed to the fingertips and hands. PE (+) for absent DTRs in UE and brisk DTRs in LE. Sensory loss in LEs. DX: Acute demyelinating polyneuropathy. 4/14/09 ER note from 12/2/08 received.  Pt sent in by PCP for testing r/t c/o acute numbness to all extremities.  Not seen by MD, only in for testing/spinal tap. Labs as above.
Around 9 pm after receiving the  vaccine, I started having chills, body aches, and a fever.  I still have these today.
This spontaneous report was received from a pharmacist regarding a female patient of unknown age who is her daughter. On a unknown date, the patient was vaccinated with a dose of ZOSTAVAX  (lot# and expiration date not reported). The pharmacist reported that on an unknown date, her daughter experienced similar reaction of reddened area at the injection site which was itchy and later was dark-reddish purple in color when she received ZOSTAVAX. The outcome of similar reaction was unknown. Causality was not reported. This is one of several reports received from the same reported. Additional information has been requested.
Swelling in the left arm the size of a golf ball; Mark on arm itched; Red brown circle; Head was pounding; Chills; Throbbing forhead headaches; Fever; Achy; Nauseated; Very tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Swelling in the left arm the size of a golf ball), HEADACHE (Throbbing forhead headaches), PYREXIA (Fever), PAIN (Achy) and NAUSEA (Nauseated) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Hives), Drug allergy (Hives), Asthma since 25-Aug-1999 and Lymphedema since 15-Jul-2021.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced HEADACHE (Throbbing forhead headaches), PYREXIA (Fever), PAIN (Achy), NAUSEA (Nauseated) and FATIGUE (Very tired). On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling in the left arm the size of a golf ball), PRURITUS (Mark on arm itched), ERYTHEMA (Red brown circle), HEADACHE (Head was pounding) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Throbbing headache, at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Headache, at an unspecified dose and frequency. On 29-Mar-2021, PERIPHERAL SWELLING (Swelling in the left arm the size of a golf ball), PAIN (Achy), NAUSEA (Nauseated), FATIGUE (Very tired), PRURITUS (Mark on arm itched), ERYTHEMA (Red brown circle), HEADACHE (Head was pounding) and CHILLS (Chills) had resolved. At the time of the report, HEADACHE (Throbbing forhead headaches) had not resolved and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up received contain Significant information- 2nd dose information, Contains updated adverse event information. Contains treatment medication information. On 05-Aug-2021: Follow up received contains Significant information-New event added-Fever,The start date of events- extreme fatigue, achy, nauseated changes from 23-MAR-2021 to 21-MAR-2021.Contains updated Event outcome-Recover, Contains new medical history, Reporter information-Address, Contains updated patient demographics- Patient, also include-Hight, Weight, Race and Ethnicity.
On November 8, 2023 when child woke up left thigh had a large softball sized hard knot that was raised, hot to touch and painful to touch.  The site was also itchy.  Mother presented child to ER.  Treatment prescribed was hydrocortizone cream and cold compress.
POTS; palpitations; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 18-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS) and palpitations. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered both events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Patient received GARDASIL #1, ADACEL, and Depo Provera. She stood up, felt dizzy, started to sit on the floor but passed out, striking her head on the canter. She was out for < 45 sec. She was hanseated, dizzy, and had a headache. She was watched for 20-30 minutes then released home with mom.
Rec'd injection 810/06 seen in office 8/15/06 with c/o redness, swelling, pain at site. Treated with NSAID, warm compresses. Returned for follow up 8/17/06, site without redness, less swelling, still tender, was to continue NSAID and warm compresses 1wk.
Sore left upper arm to start. As time passed arm became painful to raise arm. Various red rash type patches appeared on upper arm. Skin was very hot to touch. Some patches were elevated off skin. Areas of redness in upper arm were tender and hard to touch versus right arm for example. Upper arm was itchy. Also feels as if there are small knots/ball near one of the areas at end of tenderness.
redness, swelling and soreness around the site on her Rt arm. No weakness, headache, fatigue or problems breathing.
pt recvd Typhoid vax & arm became swollen from shoulder to elbow for 3 to 4 days; pt exp flu-like sx for 2 to 3 days;
8MAR92 815AM #2 HEp B vax 3PM h/a, chills-not feeling well; lt arm sore, @ h.s. cold & hot, tired in am-nausea, h/a, eyes hurt; took APAP;
strong menstrual cramps; bleeding bright red/Bright red spotting; hadn't had a period for over 9; This spontaneous case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (strong menstrual cramps), HEAVY MENSTRUAL BLEEDING (bleeding bright red/Bright red spotting) and MENSTRUAL DISORDER (hadn't had a period for over 9) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSMENORRHOEA (strong menstrual cramps), HEAVY MENSTRUAL BLEEDING (bleeding bright red/Bright red spotting) and MENSTRUAL DISORDER (hadn't had a period for over 9). At the time of the report, DYSMENORRHOEA (strong menstrual cramps), HEAVY MENSTRUAL BLEEDING (bleeding bright red/Bright red spotting) and MENSTRUAL DISORDER (hadn't had a period for over 9) outcome was unknown.            No concomitant and treatment medications were reported
This spontaneous report was received from a pharmacist and refers to a multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M035692 with an expiration date 07-NOV-2017 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered doses of ZOSTAVAX experienced the temperature excursion from more than 5 degrees Fahrenheit to less than 14 degrees Fahrenheit for 1 hour. There was previous temperature excursion from more than 14 degrees Fahrenheit to less than 46 degrees Fahrenheit for 12 hours. The digital data logger was involved. Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1703USA002290.
Mild difficulty breathing occurring 20-30 mins post FLUARIX shot; contacted EMS; they checked patient; she seemed ok; she went home.
headaches; weakness; chills; This is a spontaneous report received from a contactable consumer (the patient). A female patient (Age: 60, Units: unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine yesterday (unspecified date). She has been having headaches, weakness, and chills. She asked what she should do. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.