chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BREAKTHROUGH COVID: FULLY VACCINATED. PT HAD POSITIVE PCR FOR COVID 19. 57-year-old male who presented to the ED with complaints of chest pain. Pt's significant other has been feeling sick and he believes he caught a cold from her. Pt was found to be covid positive. Negative results for a cardiac event. Pt placed on 2L of O2 and weaned for room air.  Medicated during admission with aspirin, atrovastatin, DuoNeb, omeprazole, gemfibrozil.
I have been having chronic diarrhea, loss of appetite and nausea since receiving the 2nd shot. I have lost 6lbs since receiving the 2nd shot. Every time I eat, I get diarrhea and then have stomach pains after. I have not had any treatments to rectify these problems. I was hoping the would have went away after 48 to 72 hours.
8/18/2008 noon: Pediarix - Hib, PCV7, Rotavirus (1st) vaccinated.  8/2-/08 2pm: mother said baby started rashes from 8/19/2008 - all over the body - small scattered rashes.  8/21/2008 2pm:  F/u call.  Mother said rashes almost gone.
Pt vaccinated with OPV/DTP/MMR developed fever to 105F, irritability, vomiting, limp lasting a couple of days.
19-year-old student dies 6 hours after receiving Covid-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 19-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "19-year-old student dies 6 hours after receiving Covid-19 Vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: 19-year-old student dies 6 hours after receiving Covid-19 Vaccine
Patient got rash on left arm starting at injection site and extending 5 to 6 inches wide from shoulder and half way down the top of the arm. The rash was raised and hot to the touch but had no bumps nor welts. This rash lasted 9 to 10 days. She also had a fever of 101 degrees Fahrenheit for 4 days.
Patient said his skin on his entire torso and back "hurts". Also, he mentioned that the back of both upper arms he is experiencing a burning sensation.
Chills, fatigue, swollen joints, headache, body and muscle aches, fever, onset 12 hours after vaccine at 36 hours still experiencing symptoms with nothing subsided yet.
1st dose was administered on 15-JAN-2021 and 2nd dose was administered on 15-APR-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 15-JAN-2021 and 2nd dose was administered on 15-APR-2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 15-JAN-2021 and 2nd dose was administered on 15-APR-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 15-JAN-2021 and 2nd dose was administered on 15-APR-2021) outcome was unknown.            No concomitant medication information provided.  It was unknown if patient was enrolled in Covid-19 vaccine trial.  No treatment information provided.   This case was linked to MOD-2022-591448 (Patient Link).
This case was reported by a healthcare professional via a sales representative and described the occurrence of burning down arm in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced burning down arm. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 08 July 2008 indicated that the subject was a 39 year old male. At the time of injection of the 3rd dose of TWINRIX intramuscularly, the subject experienced burning down the arm and aching at the time of injection. The events resolved and were considered by the reporter to be related to treatment with TWINRIX. The reporter stated that she has had several clients in the past 2 to 3 months complain of these symptoms at the time of injection without ongoing effect.
Rash occurred away from injection site. Started with small bumps. Progressed to larger area of upper arm. Slight itching sensation.  Started to diminish day 11. Day 13 came back and spread to 75 % of upper arm was swollen, red, and itchy.  Clear line of rash surrounded and wrapped around arm. Slight pain from swelling.
Events:  Vaccine was given on 3/19/21; Hysterectomy on 3/25/21; blood clots diagnosed on 3/30/21  Left forearm was swollen, with a light reddish tint to it, and tender.  After getting an ultra sound on my forearm a DVT was found and I was sent to the emergency room.  I then had a CT scan done of my chest and it was discovered I had several pulmonary emboli.  I was admitted to the hospital and put on a heparin drip.  I am currently taking Eliquis and will be following up with a pulmonologist and a hematologist in a week or two.
This patient had a red area, swollen, hot about 4 inches in diameter. On the 5th day the area became very hard and reported to Health Dept on the 6th day for advice. Pinpoint papule noted with appearance of whitehead. The patient was sent to PMD. The patient had been using cold compresses and taking Ibuprofen. The PMD reports possible cellulitis, patient put on Keflex.
Loss of appetite; Diarrhea; Fever; Aches and pains; Chills; Soreness in all joints; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), PYREXIA (Fever), MYALGIA (Aches and pains) and CHILLS (Chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), PYREXIA (Fever), MYALGIA (Aches and pains), CHILLS (Chills) and ARTHRALGIA (Soreness in all joints). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of 1 dosage form twice a day. At the time of the report, DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), PYREXIA (Fever), MYALGIA (Aches and pains), CHILLS (Chills) and ARTHRALGIA (Soreness in all joints) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reporter was calling on behalf of their daughter who post receiving the vaccine dose experienced aches, pains, chills, fever, diarrhea, soreness in all joints, a cough and loss of appetite. The patient's symptoms began on 29-Apr-2021 and still not resolved.  The patient went to urgent care and got a steroid and anti-inflammatory shot. The patient also reported that they were taking Motrin then 6 hours later taking 2 extra strength Tylenol.
Fever, Diarrhea, NauseaVomiting, JOINT PAIN Narrative:   Other Relevant History:
Patient presented with hives on face, neck, upper extremities and torso about 1.5 hours after receiving this flu shot. Patient was given Benadryl 50mg PO, instructed to utilize Hydrocortisone cream he has on-hand and to contact facility officers/health services staff immediately if any anaphylactic symptoms should occur.
The night of the first dose, my arm became very swollen, not at the injection site. It is now 9 days later and it has only gotten worse. Swollen, hot to the touch. My energy level is the lowest I can ever remember feeling. I have also had a sore throat, headache.
Chills, nausea, body aches. I also had a extremely sore arm . My vaccine was administered  into the wrong site way above the deltoid.  We are almost a week out and my pain is still a 9 out of 10.
mild headache; achiness and stiffness through the whole body; achiness and stiffness through the whole body; slight chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 at 11:30 as dose 4 (booster), single (Lot number: fk9894) at the age of 79 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for covid 19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for covid 19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for covid 19 immunization. The following information was reported: PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 12Apr2022 at 08:00, outcome "not recovered" and all described as "achiness and stiffness through the whole body"; HEADACHE (non-serious) with onset 12Apr2022 at 08:00, outcome "not recovered", described as "mild headache"; CHILLS (non-serious) with onset 12Apr2022 at 08:00, outcome "not recovered", described as "slight chills". Therapeutic measures were not taken as a result of headache, pain, musculoskeletal stiffness, chills.  Additional Information: Reporter type: Patient. dose received More than 3. product: COVID 19. brand: Pfizer. lot number: fk9894, administration date: 11Apr2022. administration time: 11:30 AM. dose number: 4. vaccine location: Left arm. No other vaccine in four weeks. other medications in two weeks: Synthroid. adverse event: mild headache, achiness and stiffness through the whole body, slight chills. adverse event start date: 12Apr2022. adverse event start time: 08:00 AM. if patient recovered: Not recovered. No treatment ae. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history.  No follow-up attempts are possible. No further information is expected.
This case was reported by a pharmacist via sales rep and described the occurrence of welts in a 71-year-old male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced welts, erythema, swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the welts, erythema, swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the welts, erythema and swelling to be related to SHINGRIX. Additional details were reported as follows: The age at the vaccination was not reported. The patient received SHINGRIX subcutaneously, which led to intramuscular formulation administered by other route. The patient experienced large welt, clearly demarcated redness and swelling. The reporter had denied permission to be contacted for follow up.
Information was received from a physician concerning a 24 month old twin female with no known drug allergies or medical history, who was vaccinated IM on 21-MAR-2007 with a 0.5mL dose of hepatitis A virus vaccine inactivated (lot number 653619/0144F). There was no concomitant medication. It was reported that the same day she was vaccinated she developed a fever of 103 F. The physician prescribed MOTRIN and the fever resolved in 2-3 days without complications. The patient was examined on 28-MAR-2007 and had fully recovered. No product quality complaint was involved. The patient's twin sibling had a similar experience after therapy with hepatitis A virus vaccine inactivated WAES # 0707USA08856. Additional information has been requested.
Ten minutes after shot she began complaining of tightness in throat and chest.  Monitored for 45 min and then began throwing up at 7 pm.  Vomited rest of evening and all the next day.  Went to ER and given an injection of epinephrine.  Sent home.  Continued to vomit and went back into ER and admitted to hospital.
Swelling in left shoulder near neck; Dry heaves; Arm had swelling; Arm had redness; Fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling in left shoulder near neck), RETCHING (Dry heaves), PERIPHERAL SWELLING (Arm had swelling), ERYTHEMA (Arm had redness) and PYREXIA (Fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid operation (partial thyroid removal) in 2000. Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high, LEVOTHYROXINE for Thyroid operation, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for Vitamin supplementation, CALCIUM (ALGAE CALCIUM), MONASCUS PURPUREUS (RED YEAST RICE) and UBIDECARENONE (CO Q10) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced RETCHING (Dry heaves), PERIPHERAL SWELLING (Arm had swelling), ERYTHEMA (Arm had redness), PYREXIA (Fever) and FATIGUE (Tired). On an unknown date, the patient experienced JOINT SWELLING (Swelling in left shoulder near neck). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Swelling in left shoulder near neck) had not resolved and RETCHING (Dry heaves), PERIPHERAL SWELLING (Arm had swelling), ERYTHEMA (Arm had redness), PYREXIA (Fever) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 101.1 - 101.9 (High) 101 -109. On an unknown date, Body temperature: below 100 (normal) below 100. On an unknown date, Computerised tomogram: negative for lipoma (normal) Results were negative for signs of Lipoma.         Vaccine was administered via an injection to the patient.  Patient took concomitant medication algae cal plus, for bone strength and red yeast rice with Co Q10 for cardio health. Patient had consulted the doctor for the event swelling in the left shoulder and underwent CAT scan.   This case was linked to MOD-2021-012679 (Patient Link).
My first Moderna vaccine was fine with no side effects March 12,2021 at 12 noon. I was injected with my second dose of Moderna vaccine April 9, 2021 at 12 noon. Within 20 hours of injection of my second dose of Moderna vaccine I had severe dizziness and vomiting  which endured for 48 hours and some light, lingering mild dizziness after
injection site very tender; severely incapacitated; headache; body and headaches; chills; nausea; This case was reported by a physician and described the occurrence of injection site tenderness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea. On an unknown date, the outcome of the injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. After the 1st dose of Shingrix, the patient was severely incapacitated with body and headaches, chills, nausea for at least 24 hours. The injection site was also very tender. The patient considered it as an awful experience. For tolerance of 2nd dose of Shingrix, refer case US2020AMR215176.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215176:same patient, 2nd dose
Left deltoid redness and swelling. Muscle in area and left side of neck tender. Warm to touch. Patient treated w/ KENALOG 40 mg - 1mL administered 2/13/17 at office visit. Rx of Prednisone 20mg #10 given.
Patient went to med express sunday following administration of vaccine Friday 1-11, signs of redness and "lumps with fluid".
pt recv vax 11JUN98 & 16JUN98 pt was found to have a hard lump @ the inj site;
ELEVATED JUVENILE WHITE BLOOD CELLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin, and batch number: unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported No concomitant medications were reported. On MAR-2021, the subject experienced elevated juvenile white blood cells. On 21-MAR-2021, Laboratory data included: Blood test (NR: not provided) unknown. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of elevated juvenile white blood cells was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.
Tested for IGG levels test for antibodies, and they came back negative; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DRUG SPECIFIC ANTIBODY ABSENT (Tested for IGG levels test for antibodies, and they came back negative) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 24M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced DRUG SPECIFIC ANTIBODY ABSENT (Tested for IGG levels test for antibodies, and they came back negative). At the time of the report, DRUG SPECIFIC ANTIBODY ABSENT (Tested for IGG levels test for antibodies, and they came back negative) outcome was unknown.
Approximately 12 hours after receiving my 2nd dose of COVID vaccination, I fainted. This type of event is not normal and hasn?t occurred in more than 10 years.
Erythematous area, 12x12cm, appeared at left lateral to medial anterior thigh, one day after IM injection of DTAP.
10/22/21 Has cough since August evaluated with CT, D-dimer. Showed 4.3x5.3 cm mass in lungs.  Dx: ALK positive lung cancer.  Had hospital admission an and off throughout November as ALK (+) tumor was aggressive and compromising her airway  - ICU stay for 5 days and bronchial stent placement to help support airway until radiation started decreasing tumor.  11/9/21 Concurrent Chemo(Cisplatin/Pemetrexed) and radiation until 12/28/21.  11/14/21 Ultrasound of LLE showed DVT in L Post Tibia.  Lovenox started x 1 month then switched to Xarelto.  2/4/22 2nd opinion at MD Alk (+) cancer had spread in lungs with Mets to bones and lymph nodes.  started on Alectinib 1200 mg/day
Pt given immunization and within five minutes had localized swelling and redness. Had provider examine pt ordered Ice to arm applied x20 minutes. No further redness or swelling noted.
pt recv vax & c/o dizziness, weakness & paresthesia in lower extremities & sever vertigo accompanied by nausea & vomiting;it was thought to be a rxn to typhoid pt stopped the dosing;
normal chills 2nd dose; headache (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (normal chills 2nd dose) and HEADACHE (headache (2nd dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced CHILLS (normal chills 2nd dose) and HEADACHE (headache (2nd dose)). In April 2021, CHILLS (normal chills 2nd dose) and HEADACHE (headache (2nd dose)) had resolved.            Reporter informed that Lot number was illegible on vaccination card.  No Concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-395622, MOD-2021-395645 (Patient Link).
This spontaneous case reported by a consumer, describes the occurrence of nasal congestion (lot of congestion and excessive mucous), sinusitis (sinus infection) and sneezing in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced nasal congestion (lot of congestion and excessive mucous), sinusitis (sinus infection) and sneezing. At the time of the report, nasal congestion (lot of congestion and excessive mucous), sinusitis (sinus infection) and sneezing outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications reported. Treatment included 3 rounds of antibiotics.