chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was in resp distress/wheezing within 60 seconds of getting the vaccine.  We responded w/ our nursing protocol, gave 2 rounds of Epi 0.3mg IM (Right Thigh @1000 then Left Thigh @1005), 5mins apart followed by 50mg of benadryl IM @10:09 (pt unable to take PO) & 2 puffs of albuterol @10:11 b/c the pt continued to wheeze.  911 was called and pt was taken to ED.  Vitals: 0959 significant for HR 40, 85% O2 Sat -- > 169/95, 88, 85% on 2L NC Pt was given Epi 0.3mg and albuterol by EMS. Famotidine, steroids and racepinephrine in the ED.  Pt dischared same day.
Body itching; swollen lip; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Body itching) and LIP SWELLING (swollen lip) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031281) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    The patient's past medical history included COVID-19 on 02-Jan-2023.   On 10-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. In November 2023, the patient experienced PRURITUS (Body itching) and LIP SWELLING (swollen lip). At the time of the report, PRURITUS (Body itching) and LIP SWELLING (swollen lip) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was reported that vaccine was given by shot. Simultaneously with seasonal flu vaccine. Patient had Allergy-like reaction. Body itching and swollen lip.  It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. No treatment information was provided by the reporter.
Warm at the site of injection; Redness at the site of the injection; Itchy at the site of injection; A spontaneous report was received from a Reporter like Consumer concerning a 72 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness at the site of the injection, warm and slightly itchy.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 14-JAN-2021, approximately 12 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) unknown route of administration in the left arm for prophylaxis of COVID-19 infection.  On 26-JAN-2021, The patient experienced the events redness at the site of the injection, warm and slightly itchy were reported.Laboratory details not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events redness at the site of the injection, warm and slightly itchy was unknown.  The reporter assessed the events redness at the site of the injection, warm and slightly itchy as related to study drug.
pt recv vax 31AUG95 & LMP 18AUG95;a pregnancy test on 22SEP95 was positive;varicella antibody testing on 16NOV95 was negative;29APR96 a nl female infant was born;
Information has been received from a certified medical assistant and a physician via the Merck Pregnancy registry concerning a 16 year old white female with adjustment disorder with depressed mood and a history of atypical squamous cell of undetermined significance, HPV infection, cervical intraepithelial neoplasia I and herpes simplex type 1 who on 23-OCT-2006, was vaccinated with a first dose of Gardasil (lot 653736/0868F). On 27-DEC-2006, the patient was vaccinated intramuscularly with a 0.5 mL second dose of Gardasil (lot 653736/0868F). Concomitant therapy included ORTHO TRI-CYCLEN LO. On 27-DEC-2006, after administration of Gardasil, the patient stated "I may be pregnant". A urine HCG test was positive. The patient was sent for quantitative HCG levels and an abdominal ultrasound. On 27-DEC-2006, the patient started therapy with prenatal vitamins. The date of her last menstrual period was 22-NOV-2006. The patient's estimated date of delivery was 29-AUG-2007. On 09-FEB-2007, an ultrasound was normal, intrauterine pregnancy at 10 +2. On 16-APR-2007, a diagnostic laboratory test, maternal serum alpha-fetoprotein (MSAFP) was performed for screening purposes. The results were reported as negative. On 20-APR-2007 an ultrasound was performed for dating purposes and the confirmed estimated delivery date was 03-SEP-2007. On 01-JUN-2007 to 08-JUN-2007, the patient was prescribed clindamycin, 150mg 4 times per day for the treatment of paronychia. On 05-JUN-2007 to 10-JUN-2007, the patient was put on acyclovir, 200 mg 5 times per day for the treatment of a fever blister. On 09-JUL-2007 to 16-JUL-2007, the patient was placed on metronidazole, 500 mg two time per day for the treatment of bacterial vaginosis. Pregnancy outcome information stated that on 20-JUL-2007, the patient delivered a male liveborn infant weighing 4 pounds 5 ounces. She was 34 weeks and 2 days from her last menstrual period (LMP). The infant was reported as normal. There were no congenital anomalies. However, there were other complications such as respiratory distress syndrome and hyperbilirubinemia. The mother of the infant also had complications during the pregnancy reported as Hellp syndrome and she needed to have an emergency caesarean section for unknown reasons. On 02-AUG-2007, the infants length measured 17.5 inches and his head circumference measure 36.5 cm. At the time of this report, the patient's outcome was unknown. Upon internal review, unexpected emergency c-section was considered to an other important medical event. Additional information is not expected.
Numbness/ weakness vaccinated arm. Itchy throat. 11/18- school RN spoke with mother that night (11/3) - child given BENADRYL @ clinic - no symptoms at all that night and he has been in school ever since.
Came down with wheezing - high 104 temp for while, headache and muscle all over. Stiff neck. Landed in hospital with pneumonia.
A medical assistant reported that a 38 year old female received an injection of Pnu-Imune 23 on 01/22/01. That same day, the patient developed nausea and vomited. On 01/25/01, she developed an injection site reaction characterized by redness, soreness, and swelling the "size of a grapefruit". The patient was treated with Keflex and applications of cold packs.
No adverse event; 6 year old patient received dose from 6m-5y vial; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (6 year old patient received dose from 6m-5y vial) and NO ADVERSE EVENT (No adverse event) in a 6-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Aug-2022, the patient experienced WRONG PRODUCT ADMINISTERED (6 year old patient received dose from 6m-5y vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (6 year old patient received dose from 6m-5y vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (6 year old patient received dose from 6m-5y vial).    Concomitant medication details were not reported by the reporter.  The physician stated that the connection was not good, so requested to be called back on cell phone. The physician stated physician was so confused because physician thought only Pfizer was approved for aged 6 and older. Physician stated they were not giving Moderna for kids over 6 years and did not know any providers in area who were giving Moderna for that age group.  Treatment details was not reported by the reporter.
8/10/03 Presented to hospital with status epilepticus and agonal respirations. Temperature 41.2 degrees C. No prior history of illness; treated with Lorazepam which stopped seizure but child intubated for inadequate respiratory effort. She was stabilized and transferred to another hospital where she remained 5.5 weeks. Diagnosed with septic shock. Discharged on phenobarbital for seizure. Shows head lag and questionable visual acuity. The 60 day follow up received on 1/13/04 states generalized seizure disorder and diffuse encephalopathy.
Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 15 year old female with no pertinent medical history and no drug reaction or allergy who on 12-SEP-2011 was vaccinated with a dose of VARIVAX (Merck) (lot # 670099/0410AA). Concomitant therapy included MENVEO, BOOSTRIX and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid on 12-SEP-2011. Urine pregnancy test was performed on12-SEP-2011. It was learned "later that day" that the patient was pregnant (positive 5 weeks gestation). Last menstrual date was on 03-AUG-2011 and estimated delivery date was on 09-MAY-2012. The patient did not seek medical attention. At the time of the report, no adverse effects were seen. Follow up information has been received from registered nurse. She reported that the Health Department had no information regarding the patient or her pregnancy outcome. She stated that the patient had only came in for her immunizations and had no forwarding medical provider information to give to follow up regarding her pregnancy care. Additional information is not expected.
Vaccine given 10/12. Site was itchy, swollen, hot, and red Fri (10/13) night. She took benadryl. Symptoms better today (10/14) She stated she had itching with the last flu/covid shot. Did not let us know prior to getting this vaccine 10/12. Went over what to do for a severe allergic rxn. Advised she let her MD know Monday.
Tingling of the tongue and throat; BP 101/54 (pulse 70); final BP 109/70 (pulse 65), 100% O2 sat. Benadryl 25 mg PO x 2.
I had gone to a concert and the next day I had a sore throat. I took a COVID-19 home test and it was positive. I was having bad body aches, an ongoing headache and I lost my smell and taste. I was having chest pains as well. I reached out to my doctor who gave me PAXLOVID to treat my symptoms and that helped my symptoms a ton. I was feeling better very quickly.
No adverse event.  Patient received the 0.5ml dose of Moderna, not the 0.25ml booster dose.
Injection site very sore and hard within 2 hrs.  Took Tylenol.  Then headache around 4 hrs. Rest and took warm shower.  Total body aches and chills at 10 hours or so.  Took 2 Advil.   Then by 11 PM my skin from my shoulder blades down to mid thighs was very sensitive to touch like it was on fire.    At 22 hours now, full body soreness and stiff, continue to have headache , took 2 Advil.
This case was reported by a physician and described the occurrence of elevated liver function tests in a 26-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medications included Hydrocodone. On an unspecified date the subject received 3rd dose of ENGERIX B in the left arm. At an unspecified time after vaccination with ENGERIX B, the subject experienced elevated liver function test. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Information received from father of pt.  Redness with a "ring" on the right thigh noticed on 9/25/2023, motrin given to pt.,  redness is improving . No swelling, pain, or fever is present.
Arm pain; head ache; myalgia; fatigue; arthralgia; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain), HEADACHE (head ache), MYALGIA (myalgia), FATIGUE (fatigue) and ARTHRALGIA (arthralgia) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm pain), HEADACHE (head ache), MYALGIA (myalgia), FATIGUE (fatigue) and ARTHRALGIA (arthralgia). At the time of the report, VACCINATION SITE PAIN (Arm pain), HEADACHE (head ache), MYALGIA (myalgia), FATIGUE (fatigue) and ARTHRALGIA (arthralgia) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-019002 (Patient Link).
I dont get the flu shots anymore. When I did I got sick; Initial information received on 08-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via media.  This case involves an unknown age patient for whom patient did not get the flu shots anymore. when patient did he/she got sick (illness) was reported, while he/she received vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, for Prophylactic vaccination.  On an unknown date, it was reported that patient did not get the flu shots anymore. when patient did he/she got sick (illness) (Unknown latency) following the administration of influenza vaccine. So no more shots.  Final diagnosis was patient did not get the flu shots anymore. when patient did he/she got sick.   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  No further information was reported.
Onset with very sore arm 2 hours after injection. Day 2 - beginning about 10 am, extreme fatigue, extreme flu like symptoms including aches, chills, high fever, headache turning into very severe pain spasms around joints and internally, as well as rapid breathing.  Took tylenol every 4 hours, stayed hydrated. Day 3 - constipation, fatigue, minor aches.   Took tylenol and stayed hydrated Day 4 - black stool, fatigue - continue to hydrate.
Resident admitted to facility on 5/23/2023 on Hospice Care. Resident received vaccine at approximately 1000 on 5/30 at PRIVACY Pharmacy. On 5/31 at 0420, staff found resident unresponsive, not breathing. Pronouncement of death 0420 on 5/31.
red circle around the site of injection (left arm); received the first shot of Shingrix on 22 SEP  2020; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site erythema and incomplete course of vaccination. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's sister. The age at vaccination was not applicable for 2nd dose of Shingrix. The patient received the first shot of Shingrix in left arm and experienced a red circle around the site of injection (left arm) which lasted for 4 to 5 days.  Till the time of reporting patient did not received the 2nd dose of Shingrix, which led to Incomplete course of vaccination. No further information reported. The reporter did not consent to follow up.
Information has been received from a nurse referring to a patient of unknown age and gender. On 02-JUN-2015, the patient was administered with improperly stored doses of MMR II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
dry cough, sinus; achy body \  felt muscle soreness like hard cord working out; hard time sleeping; bad headache; chills; fever 103F; fatigue/tired; Patient received the second dose 37 days after the first dose; shakes; little cough/dry cough; heavier breathing; lost 8 lbs; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 37 days after the first dose), TREMOR (shakes), COUGH (little cough/dry cough), DYSPNOEA (heavier breathing) and WEIGHT DECREASED (lost 8 lbs) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, IMMUNOGLOBULIN HUMAN NORMAL (CUVITRU) for Antibody NOS abnormal, COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA) for HIV disease.   On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 37 days after the first dose), TREMOR (shakes), COUGH (little cough/dry cough), DYSPNOEA (heavier breathing), WEIGHT DECREASED (lost 8 lbs), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever 103F) and FATIGUE (fatigue/tired). On 16-May-2021, the patient experienced INSOMNIA (hard time sleeping). On 23-May-2021, the patient experienced SINUSITIS (dry cough, sinus) and MYALGIA (achy body \  felt muscle soreness like hard cord working out). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 1000 mg and IBUPROFEN for Symptomatic treatment, at a dose of 200 mg 3 tablets (600mg). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 37 days after the first dose), TREMOR (shakes), COUGH (little cough/dry cough), DYSPNOEA (heavier breathing), WEIGHT DECREASED (lost 8 lbs), INSOMNIA (hard time sleeping), SINUSITIS (dry cough, sinus), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever 103F), FATIGUE (fatigue/tired) and MYALGIA (achy body \  felt muscle soreness like hard cord working out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Body temperature: 103 (Inconclusive) 103F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was Not Applicable.
No adverse event; Incorrect product storage; This spontaneous report was received from a health care professional referring  to a 8-week-old patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.      On 11-MAY-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1741376, expiry date 06-MAR-2022 for prophylaxis (strength, dose, and frequency were not provided).  Other vaccines improperly stored were hepatitis a vaccine, inactivated (VAQTA)lot number 1741376, expiry date 06-MAR-2022, and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, strength, route of administration, lot number, indication and expiry date were not reported)      rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was exposed to a temperature frame between 36 and 46 Fahrenheit degrees for 15 minutes, recorded y a digital data logger  (product storage error).  No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033304; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a adult female patient who received SHINGRIX for prophylaxis. On 12th December 2018, the patient received the 1st dose of SHINGRIX. On 12th December 2018, less than a day after receiving SHINGRIX, the patient experienced joint pain, fever, nausea, headache and nocturnal awakening. The patient was treated with TYLENOL. On 12th December 2018, the outcome of the nausea was recovered/resolved. On an unknown date, the outcome of the joint pain and fever were not recovered/not resolved and the outcome of the headache was recovered/resolved and the outcome of the nocturnal awakening was unknown. It was unknown if the reporter considered the joint pain, fever, nausea, headache and nocturnal awakening to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. Less than 24 hours after, the patient experienced severe joint pain and awoke during the night with nausea and a fever of 102.7 degree F. In the morning she reported a headache and fever of 101.7 degree F.  After taking TYLENOL, the patient visited to urgent care. A few hours later the patient reported a fever of 101.5 degree F and persistent painful joints. The batch number and expiration date of SHINGRIX were not available at time of reporting. The emergency room visit required. The reporter gave consent to follow up.
This spontaneous report as received from a pharmacist refers to a 50 year old female patient. The patient's medical history and concurrent conditions were not reported. On 18-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # N030111, expiry date: 21-APR-2019) (route: intramuscular) for pneumonia prevention. Concomitant therapies included levothyroxine sodium and VAGIFEM. On 18-FEB-2018, the patient experienced injection site pain. On 20-FEB-2018, the patient noticed redness on the upper part of the left arm, above the injection site. No treatment was given for the events. The outcome of the events was reported as not recovered. The causality of the events was unknown.
The day after the vaccine, I had headaches and fatigue. The two days later, I noticed skin lesions. I called my PCP because I suspected shingles. He saw me but I didn't go on anything until the next day when it got worse. I started on Valtrex 5oomg (two tablets 3 times a day for ten days)for the shingles. My symptoms lasted about 4 to 5 days and then dried up after that. I have fully recovered from the shingles. Then on 4/24/2022, I had an episode of chest pain and jaw pain late at night. It passed within about ten minutes. On 4/25/2022 around 11, I had a similar episode and ended up in the emergency room. My EKG came back positive for a heart attack. I had a cardiac cast done that showed a blockage and they put a stint in. I am now on Metoprolol 25mg,  Prasugrel 10mg, Atorvastatin 80mg, and Aspirin 81mg.