chrisvoncsefalvay/vaers-outcomes huggingface dataset:
head hurts so bad this morning and it feels bad.; slept only 5 hours; fever; throbbing and dull headache (pain)that felt like someone was hitting her with a hammer; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (slept only 5 hours), VACCINATION COMPLICATION (head hurts so bad this morning and it feels bad.), PYREXIA (fever) and HEADACHE (throbbing and dull headache (pain)that felt like someone was hitting her with a hammer) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Cough variant asthma (History of asthma cough since 2 years of age. Has Asthma cough every morning.) since 1968.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (fever) and HEADACHE (throbbing and dull headache (pain)that felt like someone was hitting her with a hammer). On 03-Apr-2021, the patient experienced INSOMNIA (slept only 5 hours). On 04-Apr-2021, the patient experienced VACCINATION COMPLICATION (head hurts so bad this morning and it feels bad.). At the time of the report, INSOMNIA (slept only 5 hours), VACCINATION COMPLICATION (head hurts so bad this morning and it feels bad.), PYREXIA (fever) and HEADACHE (throbbing and dull headache (pain)that felt like someone was hitting her with a hammer) outcome was unknown.            Patient was taking asthma medication on the phone due to the cough but did not specify the medication. Patient tried icepack for 4 hours
VACCINATION WAS GIVEN ON WEDNESDAY (9/27) AND THAT AFTERNOON PT SAID HER LEFT ARM WAS EXTREMELY SORE. BY THURSDAY (9/28) THE SORENESS WAS IN THE UPPER SHOULDER, BY FRIDAY (9/29) THE SORENESS WAS UP ON HER NECK AND SHE COULDN'T LIFT HER ARM. SATURDAY (9/30) THE PAIN WAS ACROSS THE BACK OF HER HEAD AND SHE HAD DOUBLE VISION. TREATED WITH IBUPROFEN AND TYLENOL (IBUPROFEN WORKED BETTER).
2nd dose given from beyond use date vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   1 vial affected Lot# 041C21A Refrigeration expiration/ Beyond use date:10Jun2021. No concomitant medications was included. No treatment drug details was provided.
Fatigue, fever, full body chills, muscle ache, headache, pain at injection site
Hair loss; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number UNKNOWN) via an unspecified route of administration on 18Mar2021 at 11:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease). The patient had no known allergies to food, medication or other products. Concomitant medications included fluticasone propionate; salmeterol xinafoate (ADVAIR) and vitamin s (MANUFACTURER UNKNOWN); for an unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. On 15Dec2020, the patient underwent SARS-CoV-2 test as nasal swab and the result was negative. On 22Mar2021, the patient experienced hair loss. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event hair loss and included treatment with unspecified medication from an unknown date. The clinical outcome of the event hair loss was not resolved, at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
I95.9 HYPOTENSION 10/25/2021 RENAL FAILURE I95.9 HYPOTENSION 10/25/2021 ADENOMATOUS POLYP, COLON
presumed upper respiratory infection; chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain) and UPPER RESPIRATORY TRACT INFECTION (presumed upper respiratory infection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced CHEST PAIN (chest pain). On an unknown date, the patient experienced UPPER RESPIRATORY TRACT INFECTION (presumed upper respiratory infection). At the time of the report, CHEST PAIN (chest pain) and UPPER RESPIRATORY TRACT INFECTION (presumed upper respiratory infection) had not resolved. Not Provided          Treatment medications were not provided by reporter. No concomitant medications were reported by reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
After 2nd dose - Headache, low grade fever off 100, fatigue, joint aches, chills. loss of appetite.
RECOMBIVAX HB administered today prior to the nurse knowing there was a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 02-NOV-2020, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml once, therapy type: thimerosal-free, lot # S022584 with expiration date on 31-OCT-2021 (route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 12.8 degrees Celsius for 3 hours. Digital data Logger was not involved and there was no previous temperature excursions reported.   This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2011USA001271: US-009507513-2011USA001021:
Recived pfizer dose #3 on 10/07/21.Reports she had left facial pain that started on 10/17/21, she initially thought it was a dental issue. She felt like it was like "labor pain." No dental issue identified on 10/20/21. Her dentist made her a night guard and told her to f/u with her PCP. She saw her PCP on 10/21/21 who thought it was viral and prescribed flexeril, NSAIDS and tylenol. She stated that the flexeril helped with sleep not with the pain. She then went to another MD who diagnosed her with trigeminal neuralgia and started her on prednisone 40mg x 5 days, acyclovir, and gabapentin. The acyclovir was for suspected shingles although she denies any rash seen.
nausea, mild headache, shaky, weak, fatigue; lasted approximately 5 a.m. (12 hours after shot) until about 3 p.m. (might have started earlier but was in bed; tossed and turned all night, not sure if related). I assume this is a result of the Shingrix because I've never had a reaction to the influenza vaccine or any other besides the normal sore/warm arm at point of injection.
Information has been received from a consumer concerning her 3-year-old daughter with no pertinent medical history, who in approximately 2004 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no concomitant medication. After the vaccination, the patient developed a rash all over her body and digestive problems. Unspecified medical attention was sought. No laboratory tests were performed. Subsequently, the patient recovered from the rash after a few days and recovered from the digestive problems after a few months. No product quality complaint was involved. Additional information has been requested.
pt recvd vax & 7 days p/inject had a 5x4 cm ecchymosis (blue) on lt thigh; seen by MD;
R upper arm swollen erythematous rash on 4/2/03 and started on po Keflex and Pomdmin cold compress by Dr. Reviewed by me 4/8/03 same as above continueal with warm compresses. Swelling and by 25% as per RN.
This spontaneous report as received from an office manager via a company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with live (Merck) VARIVAX, which was administered subcutaneously at a dose of approximately 0.5 ml. The indication was reported as prevention of varicella. No other co-suspects and no concomitant medications were reported. In Fall 2012, after the administration of live (Merck) VARIVAX, the patient had a breakthrough case of chickenpox. No treatment information was reported. The outcome of breakthrough of chickenpox was unknown. The relatedness for breakthrough of chickenpox is unknown for live (Merck) VARIVAX. The action taken with live (Merck) VARIVAX was not applicable. Additional information is not expected.
A knot the size of a quarter rose up immediately after the shot was given.  After chectking with the patient, he did not have any apparent allergy or difficulty breathing.  Localized reaction only
Patient called health dept on 12/04/06 and verbally reported to nurse complaint of localized adverse reaction to IM injection side on left upper arm. Patient reported "swelling, pain and redness. Patient denies systemic fever.
Patient was administered Fluad  in the pharmacy and went home with no signs or symptoms.  A few days later, patient noted a severe rash around the site of injection.  Patient was advised to visit a doctor to get himself checked out.
Had extremely heavy extended period after covid shot - became iron deficient anemic: Extreme exhaustion and fatigue, restless leg syndrome, trouble staying awake and focus on tasks. Symptoms lasted approximately one week. Sleep and diet focusing on iron assisted in recovery.
Information has been received from a health professional concerning a 13 year old female who in August 2006, was vaccinated with a 0.5 ml first dose of GARDASIL. About three weeks after beginning therapy the patient experienced a numb tongue, headaches, and a tingling sensation in her head and tongue. The patient experienced the same after receiving each of the three doses. This effect would slowly go away until the next shot and then the effect would begin again. Unknown medical attention was sought. In April, 2007, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Patient received vaccine on evening of 7/19/22 and returned the following evening presenting with red welts on his chest and stomach. No life-threatening allergic reactions were reported and patient stated he had no issues breathing after receiving the vaccine or at any time after receiving it. I recommended that he take a diphenhydramine 25mg tablet to help with the redness and swelling along with using hydrocortisone 1% cream to help. I instructed patient to go to ER or Urgent Care if he experienced any problems breathing. It is unknown whether patient went to ER or Urgent Care.
Follow-up information was received regarding medical history, concomitant medication, change in event onset date and patient details. Information regarding PREVNAR 7 was received from a physician regarding a 3-year-old male patient who experienced bacteremic pneumococcal pneumonia. The patient received the fourth dose on 22-Mar-2007. The patient also received the fourth dose of Haemophilus Influenzae B (manufacturer unknown) on 22-Mar-2007. The patient experienced bacteremic pneumococcal pneumonia on 12-Oct-2009. The child was hospitalized and treated with IV ROCEPHIN and recovered. The physician stated to the company representative that serotyping will be performed. No additional information was available at the time of this report.
Irregular heart beat, fatigue, sore muscles, redness in arm, sore throat, congested sinuses, cough. Lasted 14 days.
My throat tightened a little 5 min after injection and subsided 25 min after injection.  I had hives following injection (2-3) and the hives increases (5-6) and have lasted for 4 days now.  It has turned into hives/rash
Pains; Eye pain; Muscle aches; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pains), EYE PAIN (Eye pain), MYALGIA (Muscle aches), CHILLS (Chills) and PYREXIA (Fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced PAIN (Pains), EYE PAIN (Eye pain), MYALGIA (Muscle aches), CHILLS (Chills) and PYREXIA (Fever). On 07-Mar-2021, PAIN (Pains), EYE PAIN (Eye pain), MYALGIA (Muscle aches), CHILLS (Chills) and PYREXIA (Fever) had resolved.            Concomitant medication included blood pressure medication and statin. Treatment information was not provided
This case was reported by a pharmacist via call center representative and described the occurrence of pneumonia in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several months after receiving SHINGRIX, the patient experienced pneumonia (serious criteria GSK medically significant). On an unknown date, the outcome of the pneumonia was unknown. The reporter considered the pneumonia to be unrelated to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced pneumonia months after receipt a dose of SHINGRIX. Only the patient's gender was collected. The healthcare professional stated that the pneumonia was not related to SHINGRIX.
Edema in both hands & feet. Crying, unexplained in 4 year old. Seen by Dr at urgent care & given Pediapred for edema.
aching in the body; aching in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching in the body) and PAIN IN EXTREMITY (aching in the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rhinitis.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aching in the body) and PAIN IN EXTREMITY (aching in the arm). At the time of the report, PAIN (aching in the body) and PAIN IN EXTREMITY (aching in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       As reported patient have rhinitis and normally use cetirizine. As reported patient wanted to know after getting the vaccine can they normally take their treatment.  Concomitant product use was not provided by the reporter. Treatment information was not provided.
3/6/21-About two in a half days following the 2nd dose, patient had sudden onset of right sided chest pain, pleuritic, lasted several days- did not seek attention.  3/17/21- Sudden onset of severe left sided pleuritic chest pain and dyspnea. Presented to ER, found to have extensive Bilateral Pulmonary Emboli. 3/17/21- Patient admitted to Hospital. Initially put on anticoagulation, but due to GI bleeding had placement of Inferior Vena Cava Filter.  3/23/21- Discharged from Hospital.
Pt started coughing approximately 5 minutes after vaccine administered. Cyanotic around eyes. Complained of palms, soles of feet, neck itching. Redness noted. Pt using accessory muscles with respiration. Definite retracting noted. Treated with 0.15 ml epinephrine given IM in the left thigh. Sxs relived at 4:15. Pt released into mother's care at 4:35. No complaints at time of exit.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 32 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On 12-APR-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, 1 total administered for prophylactic vaccination. On 05-FEB-2022, the patient received non-company suspect vaccine tozinameran (Pfizer vaccine) (dose number in series: 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered for prophylactic vaccination. No concomitant medications were reported. On 19-APR-2022, the patient experienced covid-19 symptom of headache (suspected covid-19 infection) (dose number in series: 2). On the same day, the patient then tested positive in a covid-19 Binax Now home test kit (suspected clinical vaccination failure) (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number was requested.; Sender's Comments: V0: 20220438211-COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Patient called roughly 4-5 hours after flu shot complaining of soreness, redness and swelling around the site of injection. Patient denied any throat tingling, itchiness, Shortness of breath or other signs of allergic reaction. Patient denied have any other swelling but at the site of the injection. Patient admitted to taking over the counter "pain powder" roughly an hour after the vaccination. Patient claimed to never have any reaction to flu vaccine previously. Patient stated she had a severe Bee allergy , but did not list under allergies in the vaccine consent form. Patient was told to try a cold compress to reduce swelling and redness. She was told to contact her doctor  if she was further concerned about the reaction or if the reaction did not get better or got worse.
No adverse effects; one expired dose of VAQTA was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions and allergies were not reported.  On 12-AUG-2019, the patient was vaccinated with one expired dose of Hepatitis A vaccine, inactivated (VAQTA) (lot # R022983, expiration date: 09-AUG-2019) (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported.
Fever, chills, generalized body aches, severe arm pain since Td injection. Saw another Dr was given KEFLEX.
Abdominal distress (first 1-2 days) followed by serious diarrhea (7 days; at reporting, symptoms are waning but have not abated)                  (Pain at injection site and severe swelling up to shoulder for 2 days also noted)               (General malaise for 2 days)
Fatigue, Nausea, Chills, Neck stiffness, Body aches the day after the vaccine
Swelling of tounge, problems with jaw muscles, weakness and numbness in arms and hands and difficulty swallowing and slurred speech.
I accidentally gave a pediatric dose (age 5y -11y) to a 12 year old patient
Patient came to the pharmacy on 10/2/2020 stating that they had a reaction to the 2 vaccines that they were given on 9/30/2020. At around 4:00pm on 10/2/2020 the patient showed the pharmacist the affected arm it was red and swollen down to the bend of the elbow. The area was also painful to touch. The patient reported that the pain and redness had been growing since the day that he recieved the vaccinations.
Per mom pt had diarrhea a few hours after receiving ROTATEQ #1 and number 2 per mom pt also developed a fever up to 103.5 both times.
Symptoms started around March 15th, 2022, originally it showed up as kidney pain and thought it was a bladder infection. Blood did come up in urine during doctor's visit. After she showed with blood in urine she was sent to nephrology and they could not find a reason for the symptoms. She had developed joint pain around late May early June, this prompted a referral to rheumatology. We met with the rheumatologist and they are going to get a full body MRI due to suspected Spondylitis Arthritis. Also with joint pain she had rough bouts of diarrhea, abdominal pains, or throwing up. She had gone from 110 pounds to about 83 now at this point due to these symptoms.  Because she had lost so much weight but the doctor sent her for a Celiac blood exam, after it was done the chemical that is looked for was as high as 496 which typically if someone doesn't have Celiac disease it would be below 15. Endoscopy has been set up for an appointment and appointments have been made to check out arthritis symptoms as well.  With all these health issues, she has developed depression as well since these are taking her out of sports and various other activities.
Pain, red, swollen arm where injection was given.  Severe sore throat and extreme fatigue.
Pt was given the Pediatric formulation of the Pfizer Vaccine at the time of vaccination. Pt was 12y.o at time of vaccination. No adverse reaction noted or reported.