chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on an unknown date, for tolerance refer case US2019AMR194568).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. The patient was treated with ibuprofen and paracetamol (Acetaminophen). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient was 50 plus. The patient had flu like symptoms for about 48 hours after receiving Shingrix. It was resolved on an unknown date. The reporter denied to follow up.
pt vaxed on 2JUN92; On 3JUN devel local reaction of erythema, induration, & tenderness 10 cm in diameter; seen by MD 4JUN; tx included APAP;
Approximately 16 hrs after injection -> developed erythema below injection site ((L) deltoid) erythema extends 18cm to elbow & 13cm width non tender, warm.
Generalized erythema warm to touch, minimally tender, (+) firmness in area approximately 2" x 2 1/2".
Inconsolable crying for more than 3 hours, from 6 pm to 11 pm on day of vaccination. Had vaccination at 5pm same day
Severe pain, chills and sweats, redness allover upper arm and spreading to lower, swelling could not raise arm higher then waist without extreme pain.
Patient experienced rapid heart rate, chills/fever, hoarseness, sore throat, red eyes that evening. She took a BENADRYL & went to bed. Was better the next A.M.
Fever 105l6 at ER. Fluids, iced down, Motrin and Tylenol,
Heart rate went up; Face swelling; A spontaneous report was received from a consumer, concerning herself, a 33-years-old female patient, who received Moderna's COVID-19 Vaccine and experienced heart rate went up and face swelling.  The patient's medical history was not provided. The patient's historical drug included Benadryl. The patient was had allergic. Concomitant product use was not provided by the reporter.  On 13-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unspecified date in Jan-2021, patient developed face swelling and her heart rate went up. Patient confirmed that she received Benadryl prior to administration of vaccine. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events were not provided.   The outcome of the events, heart rate went up and face swelling were not reported.; Reporter's Comments: This case concerns a 33 year-old, female patient, who experienced events of heart rate went up and face swelling. The events occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
AFTER BOOSTER, CONTINUES PAIN THROUGH MY ENTIRE BODY, PAIN MORE SERVERE ON THE LEFT SIDE, SHARP PAINS IN HEART, DIFFCULTY LIFTING LEFT ARM, VERY PAINFUL, RECTAL AREA PAIN. AT TIMES I CAN FEEL VERY BONE IN MY BODY.
After about 1-2 months, I started to experience a high pitched sound in both ears, but it is worse in my left. After my booster shot, 12/09/2021, the high pitch became worse. I saw the doctor and he requested that I have a hearing test performed. I do not need any treatment.
The patient had made an appointment for a flu shot on the computer.  I verified verbally with the patient that he was receiving a flu shot. When doing the paperwork later I noticed that it was checked for covid so to verify if he checked the wrong box I checked system and realized he had already received a flu shot on 9/7/23. I called patient to tell him what happened. I then called the doctor and let them know what happened. I also contacted the head of our clinical department to let them know as well. At this point, the patient has no adverse effects.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 25-JUL-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J014235 and expiry date: 07-MAY-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
His testicles grew the size of basketballs; This is a spontaneous report from a contactable consumer (patient). A 22-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported), on an unspecified date, via unspecified route of administration as a 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced his testicles grew the size of basketballs. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Initially, extreme tiredness, then aching joints.  Felt like I Had been hit by a truck.  Saturday included low grade fever and I didn't feel like getting out of bed.  By Monday I had what appeared to be shingles on the palms of my hands and soles of met feet that included severe itching and burning, like fire ant stings.  That continued for approximately 2 weeks.
SORE THROAT; DIARRHEA; CHILLS; HEADACHE; FEVER OF 101.7; STILL FEELS VERY LETHARGIC; BODY ACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 F. On 12-APR-2021, the subject experienced body ache. On 12-APR-2021, the subject experienced still feels very lethargic. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever of 101.7. On 13-APR-2021, the subject experienced chills. On 14-APR-2021, the subject experienced sore throat. On 14-APR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: acetylsalicylic acid, and hydrogen peroxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, and fever of 101.7 on 14-APR-2021, and diarrhea, was recovering from sore throat, and headache, and had not recovered from still feels very lethargic. This report was non-serious.
COVID-19; COVID-19; Fistula crack; Anxiety attacks; Flare; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4269028-00 (Agency).  A 42 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Mar2021 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single and intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1155990) at unk (cf) for crohn's disease, colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "COVID-19"; FISTULA (non-serious), outcome "not recovered", described as "Fistula crack"; CONDITION AGGRAVATED (non-serious) with onset 2022, outcome "not recovered", described as "Flare"; ANXIETY (non-serious), outcome "not recovered", described as "Anxiety attacks". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of fistula crack, flare, anxiety attacks and covid-19 was not provided.  Causality for bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE (Tozinameran):  The reporter's causality for the event(s) of fistula crack, flare, anxiety attacks and covid-19  was possible.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration. Based on the current available limited information in the case provided, the causal association between the events Fistula, Condition aggravated, anxiety and the use of suspect product BNT162B2 cannot be fully excluded.
Received first Moderna COVID vaccine on 27 October.  On 02 November, left deltoid swelled at injection site; it was a large red whelp 2 inches across and 4 inches long.  Experienced burning, itching and fever - injection site was 104.8, forehead temperature was 98.2.  As of 08 November, the site is still a red whelp, itches and fever of 100.8.
hardly got any sleep; hives all over their body; really red, really high and hard nut on the left arm; left ear ache; headaches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a patient and describes the occurrence of RASH MACULAR (really red, really high and hard nut on the left arm), EAR PAIN (left ear ache), HEADACHE (headaches), SLEEP DISORDER (hardly got any sleep) and URTICARIA (hives all over their body) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 14-May-2021, the patient experienced RASH MACULAR (really red, really high and hard nut on the left arm), EAR PAIN (left ear ache) and HEADACHE (headaches). On 19-May-2021, the patient experienced SLEEP DISORDER (hardly got any sleep) and URTICARIA (hives all over their body). At the time of the report, RASH MACULAR (really red, really high and hard nut on the left arm), EAR PAIN (left ear ache), HEADACHE (headaches), SLEEP DISORDER (hardly got any sleep) and URTICARIA (hives all over their body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
cough; chills; fatigue; fever of 99 degrees; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever of 99 degrees) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01M20A) for COVID-19 vaccination.     no medical history reported by reporter.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced COUGH (cough), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever of 99 degrees). The patient was treated with DEXTROMETHORPHAN POLISTIREX (ROBITUSSIN 12 HOUR COUGH RELIEF) ongoing since an unknown date at an unspecified dose and frequency; LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) ongoing since an unknown date at an unspecified dose and frequency and ZINC GLUCONATE (COLD-EEZE [ZINC GLUCONATE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COUGH (cough), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever of 99 degrees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Non significant follow up received on 25-MAY-2021, reporter stated that he did not reported any AE
pt into clinic 10MAR97 w/swelling, pain & redness @ inj site;area on rt arm reddened;area measured 3x5cm & hot to touch;given ATb;
Fever of 103 for 24 hours after injection 9/15/06. Began new daycare. Small bumps on face.
The patient described and showed swelling in the left arm starting in the bicep area (odd, but that's where it started) and it wrapped around and covered the entire upper arm. It had redness, was hot to the touch, and was painful. The patient took ibuprofen scheduled and iced the area. The reaction responded well to these treatments and the swelling began to subside by Sunday morning (3 days later). The patient said she would have seen a doctor if it had not started to get better or if it had gotten any worse, but she did not seek medical help.
Injection site pain that went from the patient´s shoulder to the elbow; Injection site pain that went from the patient´s shoulder to the elbow; Injection site pain that went from the patient´s shoulder to the elbow; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 1st dose of Shingrix. On 16th January 2020, immediately after receiving Shingrix, the patient experienced injection site pain, shoulder pain and pain in elbow. On an unknown date, the outcome of the injection site pain, shoulder pain and pain in elbow were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, shoulder pain and pain in elbow to be related to Shingrix.  Additional details were provided as follows: Some time after vaccination, the patient felt pain at the site of injection that went from the patient´s shoulder to the elbow. The reporter consented to follow up.
pt recv vax 17SEP96 & site of inj swollen (approx 2"x2"), red, warm to touch;23SEP96 woke up w/pruritus, raised rash on chest by 24SEP-alot pruritus/raised varicella lesions;vesicular lesions on trunk neck & arm was started on med;
Severe chills and sweats full body shakes 12am-4am Migraine like symptoms. Pounding head from 12am- present time 2:30 pm (April 30th)  High fever of 103-104 Tylenol helps lower it to 99.9
Fatigue; Swollen lymph nodes; Terrible aches in lymph node areas, especially in neck.; Sore muscles in entire body, especially in neck, buttocks, arms, and legs.; Stippling and bruising on back; This is a spontaneous report received from a contactable consumer, the patient. A 33-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613,) via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 hours (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient was not reported. Concomitant medications of the patient included levonorgestrel (IUD by MIRENA). The patient did not receive any other vaccine within the 4 weeks prior to the COVID vaccine.On 10Feb2021, the patient underwent nasal swab test for COVID-19 which was negative. Prior to the vaccination, the patient had not been diagnosed with COVID-19.  The patient was not tested for COVID-19 after the vaccination. On 18Mar2021 at 11:45 hours, the patient experienced the events extreme fatigue, muscle ache, swollen lymph nodes, terrible aches in lymph node areas, especially in the neck, sore muscles in entire body, especially in neck, buttocks, arms, and legs and stippling and bruising on back. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue, swollen lymph nodes, lymph node pain, muscle soreness, muscle ache and bruising were unknown.   No follow-up attempts are needed. No further information is expected.; Reporter's Comments: Stippling and bruising on back (possibly unrelated?)
Really tired; hypertension/blood pressure high; I was feeling light headed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm, administration date 06Feb2021 11:30 (Lot number: Em 9809) at the age of 79 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Low thyroid" (ongoing); "High blood pressure" (ongoing); "Irregular Heartbeat" (ongoing); "Stomach acid" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); LOSARTAN taken for hypertension (ongoing); FLECAINIDE taken for heart rate irregular; OMEPRAZOLE taken for hyperchlorhydria (ongoing). Vaccination history included: Bnt162b2 (Dose1, Time: 4:00 PM, Anatomical site of injection: Arm, Batch/Lot number: EL8982), administration date: 16Jan2021, when the patient was 79 years old, for COVID-19 immunization, reaction(s): "Hypertension", "Really tired", "Some stuff with her kidneys". The following information was reported: HYPERTENSION (non-serious) with onset 06Feb2021, outcome "recovered" (06Feb2021), described as "hypertension/blood pressure high"; DIZZINESS (non-serious) with onset 06Feb2021, outcome "recovered" (2021), described as "I was feeling light headed"; FATIGUE (non-serious) with onset 10Feb2021, outcome "recovered" (2021), described as "Really tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertension. Therapeutic measures were not taken as a result of fatigue. Additional information: The patient's blood pressure was taken soon after the second shot. She was feeling light headed and drank apple juice. She was fine after 10 minutes, went home and BP started to return to normal.  No follow-up attempts are possible. No further information is expected.
Severe dizziness I could not event wak for 5-6 hrs the day I rec'd the shot. The 2nd day I had mild dizziness.
Within 5 hours of vaccine- Vomitting, muscle aches, sweats, sore throat?? resolved within 36 hours  Menstrual Irregularities since +3 weeks from vaccine
on and off chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (on and off chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (on and off chills). At the time of the report, CHILLS (on and off chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were reported. No treatment was reported.
One week after vaccine I broke out in a full body rash. It began late on 07/22/22 with lower back itching. As the weekend/week progressed the rash and itching intensified. I was seen by my pcp on 3 different visits with lab work. I was prescribed antiviral, antibiotics, steroids, and Gapapentin.
Discharge Provider: Dr.  Primary Care Physician at Discharge: MD Admission Date: 9/9/2022  Discharge Date: 9/10/2022  Seizure disorder (HCC) [G40.909] COVID-19 [U07.1]   HOSPITAL COURSE:   The patient is a 18 y.o. male with PMH glutaric aciduria type 1 and focal epilepsy who is admitted for breakthrough seizure in the setting of covid and rhino/enterovirus infection.   Patient was brought to ED with a left sided seizure. He was found to be febrile and tachypnic upon arrival. He was placed on a valium 10 mg TID bridge while awaiting approval for Onfi per neurology recommendations. Pediatric metabolism was also consulted and did not have any further recommendations about the patients glutaric aciduria. He continued to improve while inpatient. Patient was discharged to home in stable condition on 9/10/2022.
Pt was in for her first does of the Covid Pfizer vac. At 10:44 pt requested water as she was feeling dizzy. Pt was given water. Vitals were WNL at this time. At 10:47 Pt reported seeings spots so pt was layed down.and at 10:48 pt was given a cold pack. At 10:50 pt reported chest tightness so a worker went to get a wheel chair wile two other clinic workers kept an eye on the pt. At 10:51 pt was forwarded to Clinic for further evaluation.  At Clinic, patient was 1st given the oral diphenhydramine 50 mg followed by Solu-Medrol 125 mg IM by nursing staff with provider. She stated that she continued to have this throat tightness and was done given epinephrine with an EpiPen 0.3 mg IM by provider in her right lateral thigh without difficulty. Within a few minutes patient stated that her symptoms were improving and after 20 minutes there had resolved. Provider recommended against taking 2nd dose of COVID-19 vaccine because of her reaction.  Diagnosis    Throat tightness (ICD10-CM R68.89, Working, Medical).    Chest tightness (ICD10-CM R07.89, Working, Medical).    Allergic reaction to vaccine (ICD10-CM T80.69XA, Working, Medical).    Course:  Well controlled.   Plan:  Follow up with resting at home with significant other monitoring and go to ER if worsening symptoms. , Patient had improvement of symptoms while in the clinic and stated the chest tightness and throat tightness had resolved and she was swallowing water and stating was much easier to do now.  She did have epi pens in her purse which had expired but stated she picked up new EpiPen yesterday at home and states she will make sure that they are available if needed.  Expired EpiPen were exposed in the clinic for patient as requested., Patient had a mask on while in the clinic. Provider had protected personal equipment on including mask, face shield, gown, and gloves.