chrisvoncsefalvay/vaers-outcomes huggingface dataset:
JOHNSON AND JOHNSON DID NOT HELP AT ALL; COLD; This spontaneous report received from other manufacturer (Company) via a patient concerned an adult male of unspecified age, race and ethnicity.  Initial information was processed along with additional information on 11-JUL-2022. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced johnson and johnson did not help at all, and cold (Dose number in series 1).  Non-company suspect drugs included: adalimumab (form of admin was not reported, subcutaneous, batch number: Unknown, expiry: Unknown) dose was not reported, frequency, and therapy dates were not reported for an unspecified indication.   The patient also received Pfizer biontech covid-19 vaccine (tozinameran) (Dose number in series 2) (form of admin was not reported, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, start therapy date were not reported administered on an unspecified date for covid-19 vaccination.  It was unknown whether the patient experienced any adverse events following vaccination with Pfizer biontech covid-19 vaccine (tozinameran) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the johnson and johnson did not help at all and cold was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000241676; Sender's Comments: V0: 20220716028-COVID-19 VACCINE AD26.COV2.S-johnson and johnson did not help at all. The event(s) has an unknown/unclear 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.
abdominal cramps; cough; congestion; she lost her sense of smell and taste; she lost her sense of smell and taste; body ache; chilis; ongoing fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal cramps), COUGH (cough), NASAL CONGESTION (congestion), AGEUSIA (she lost her sense of smell and taste) and ANOSMIA (she lost her sense of smell and taste) in a 44-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.     No Medical History information was reported.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (abdominal cramps), COUGH (cough), NASAL CONGESTION (congestion), AGEUSIA (she lost her sense of smell and taste), ANOSMIA (she lost her sense of smell and taste), MYALGIA (body ache), CHILLS (chilis) and PYREXIA (ongoing fever). At the time of the report, ABDOMINAL PAIN (abdominal cramps), COUGH (cough), NASAL CONGESTION (congestion), AGEUSIA (she lost her sense of smell and taste), ANOSMIA (she lost her sense of smell and taste), MYALGIA (body ache), CHILLS (chilis) and PYREXIA (ongoing fever) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Client reports started "running a fever" during the night (7/29/12 early morning) temperature was 101 at 0600. Client reports took ALEVE and is no longer febrile. Client also c/o headache. Client instructed to notify PCP of sx. Client verbalized understanding and reports will call at the end of call.
severe local rxn w/high fever; 2AM t103.9 & local rxn 1 1/4" diameter, APAP; site of inj has knot; DPH for inj site;
Swelling and hardness at injection site, redness, warm to touch, itching, soreness. Redness speading still on going 5 days after dose was received and itching still on going. The swelling and firmness is reduced.
There were no actual physical events, This was a medication error. Patient had reported that he had received the Pfizer vaccine for his 1st dose to the person registering him for his 2nd dose of vaccine, Therefore he was registered for a Pfizer clinic. When he presented to the clinic, the staff administering the vaccine did not observe on his vaccine card he had received Moderna for his first dose and gave him the Pfizer vaccine as his second dose in error.
About a half hour after the shot, my throat swelled some, and I started having a severe headache. The swelling went down that evening, but the headache has not stopped. It is intense, and ibuprophen and Tylenol will not touch it. I have sensitivity to light, and when I am around bright light it feels like someone threw sand in my eyes. Also, my right ear will not stop ringing.
Tingling /Weakness, went to ER, was admitted for observation, went back other times and was admitted again 2/9/17, no diagnosis made, sent home to follow up with neurologist for EMG, no appointment available until March 20, 2016.
I had a large, raised red area on my arm for 13 days. It was hot, itchy and hurt to touch for all 13 days. I took pictures if needed. The circumference of it was larger than a large egg.
shingles / from spine to navel from shoulder blade to navel / milder case / on left side; occassionall nerve pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles from spine to navel from shoulder blade to navel on right side for the 1st and 2nd time).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and nerve pain. On an unknown date, the outcome of the shingles and nerve pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and nerve pain to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported but was captured as adult as per vaccine indication. The patient got shingles twice from spine to navel from shoulder blade to navel on right side. Post vaccination, the patient had milder shingles on left side. It was for the third time the patient got the shingles. For the first time patient had it on left side of neck. The patient stated that shingles still lingers without rash, in occasional nerve pain. The patient was shying away from the second dose.
Pt reported a slightly scratchy throat, feeling a little "tightness" without difficulty swallowing Denies SOB, CP, rash.  No improvement after 5-10 minutes, seen by AMR EMT for physical assessment.  VSS: SpO2 100%, 96 HR, BP 157/107 Per EMS, lung sounds clear no wheezes noted. No hives noted on physical assessment Left building approx 1815, steady gait A&Ox3
Tested positive for COVID-19. Called doctor and was prescribed PAXLOVID. Took full course and felt better. Didn't retest.
My daughter began complaining of numbness in her chin which spread to her lips and cheeks.  She said her mouth felt as numb as when she's had a novacaine injection.
Patient had onset of low grade fever, decreased oral intake and rash for 2 days prior to er visit. Pt presented to the er with after febrile seizure, high fever (104) and inconsolable/lethargic approx. 2 hours after the seizure. Pt was examined by ems immediately after seizure. Patient was treated with ibuprofen/Tylenol and IV fluids and had comprehensive workup. Patient improved significantly and was cleared for d/c home with close f/u with PCP.
SYMPTOMS PRESENTED: SEIZURES, PALPITATIONS, FEVER, PULSE IN 125-130 FOR SEVERAL HOURS EVEN WHEN I WAS RESTING, BLOOD PRESSURE 86/66
patient came in for Moderna #2-reported she was hospitalized 2/14/2021-had GB removed-developed a stomach bleed which was cauterized-had a very fast heartrate that required IV medications to treat.  States she is now on several new medications.  Says she was hospitalized for 12 days.
12:43 pm Post vaccination reports c/o nausea, head ache, and cold hands; medical monitoring,  w/po hydration offered; BP 114/70 P 58 12:53 pm Symptoms subside, "feels better"; released w/self from facility
Swelling, redness, pain across anterior thigh, dusky coloring at vaccination site.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with VARIVAX (dose, strength, route and lot number were not provided). Other suspect therapies included ZOSTAVAX (dose, strength, route and lot number were not reported). Concomitant therapies were not reported. Pharmacist reported on behalf of his wife, who was also a pharmacist, that she inadvertently administered a dose of VARIVAX to a patient that was prescribed ZOSTAVAX (date unspecified). Additional information has been requested.
COVID Breakthrough case; Symptoms began:  Lab confirmed: 9/30/2021.
Systemic: Headache-Mild, Additional Details: Patient was given Tylenol and was told to hold off to monitor if the symptoms go away or they progress to more severe symptoms. patient stated the headache was going away a little before leaving.
burning discomfort @ site @ time  of inject-redness, heat tenderness @ site beginning few hrs later & increasing in size x days; On PM of inject felt lethargic & feverish also for several hrs; mild diffuse induration;
3-4 days later, got URI-like symptoms. No local reaction, rash, wheezing, etc. URI/cough.
Extreme diarrhea; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported. A 38-year-old female patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: ER8729), intramuscular, administered in Arm Left on 12Apr2021 as single dose for COVID-19 immunisation. Patient had diarrhea as well, after the first dose of the vaccine. Patient knows it came on hard, while patient was driving her car. Reporter states patient does not feel comfortable answering all of these questions for her daughter, states she is only on birth control, no further information required. The outcome of the event was unknown.
Pain and soreness in my arm around the  injection site; Body aches and tiredness; Body aches and tiredness; Pain and stiffness in ankle joint where I had a previous injury.; Pain and stiffness in ankle joint where I had a previous injury; This is a spontaneous report from a contactable Nurse. A 42-year male patient received (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EL3247; Expiry Date: Unknown) dose 1, on an unspecified date on 01Mar2021 at 15:00 (at the age of 42-years-old) into Arm left as a single dose for COVID-19 immunization. Medical history included Amoxicillin for allergy and Pain and stiffness in ankle joint where I had a previous injury. It was reported that the patient had no allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not received list of any other medications the patient received within 2 weeks of vaccination. On 01Mar2021 18:00 patient experienced pain and soreness in his arm around the injection site, body aches and tiredness, pain and stiffness in ankle joint where he had a previous injury. The patient did not receive any treatment for adverse event. The outcome of the events were recovering.  No follow-up attempts are needed. No further information is expected.
Pt presented on 01/03/03 to the office with red, swollen hot area on right upper thigh; Thought it looked like a bug bite at first; 3 X 1.5 cm in area. Whitish raised area in center with few blood red marks in center; Felt to be Varivax reaction.
Within 45 minutes of the shot I became dizzy with a severe headache and I started wheezing. I initially just thought it was a normal side effect as you hear everyone doesn't feel well. I am however still wheezing and was just at the urgent care this past week. My asthma is still really bad and not controlled.
I am an LPN and received my 1st dose of Moderna vaccine 2/5/21.  Immediately after I experienced episodes of dizziness and request to have blood pressure checked which was 160's/100's and did not seems to come down after 10 minutes.  Started to develop shortness of breath at about 20 minutes post shot and was immediately taken to ER in which I started to become hoarse and losing voice and heaviness in chest.  I was given solu-medrol, Benadryl, Pepcid and neb treatment due to wheezing also.  Chest xray , EKG done which remained normal.  D-dimer was slightly elevated so did do CT chest which was also normal.  Was in ER under observation for about 4 hours before discharge.  I continued to have shortness of breath and difficulty breathing with exertion/activity and blood pressure remained high over next few days.  I saw my PCP on 2/10/21 and was instructed to continue with albuterol inhalers and neb treatments as needed, and added Amlodipine for elevated blood pressures.
PATIENT REPORTED PAIN AT THE INJECTION SITE. MUSCLE SORENESS IN THE LEFT ARM. PATIENT STATES IT WAS HARD TO MOVE ARM ACROSS CHEST TO RIGHT SHOULDER OR LIFT ARM OVER HER HEAD. PATIENT STATES IT LASTED ABOUT 2 AND A HALF MONTHS. SHE DID REPORT IT TO HER DOCTOR BUT HE HAD NO REMARKS ABOUT IT.
Gave Menactra IM in (L) deltoid. Within 5 minutes, pt became weak, diaphoretic and pale. B/P dropped to 54/34.
DOWN THE DAY AFTER VACCINATION; This spontaneous report received from a patient via a company representative 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 were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced down the day after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of down the day after vaccination was not reported. This report was non-serious.
Shakes; fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), PYREXIA (fever), CHILLS (Chills) and MYALGIA (Body aches) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced PYREXIA (fever), CHILLS (Chills) and MYALGIA (Body aches). On 04-May-2021, the patient experienced TREMOR (Shakes). On 03-May-2021, PYREXIA (fever) and MYALGIA (Body aches) had resolved. At the time of the report, TREMOR (Shakes) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment drugs were reported.
Covid 19 PCR positive on 11/30/2021 Narrative: Patient was hospitalized for Covid 19 and covid pneumonia on November 30, 2021. He was on a nonrebreather /bipap. He was treated with monoclonal antibody therapy.
rash on arm, hot to touch, firmness lasted 2 days, rash is itchy and getting bigger
I had a heavy Menstruation. I had symptoms of cramping, heavy flow, feeling exhausted and weak. Over the course of 3 months, it only went away 4 days total in those three months. I went to a gynecologist that preformed a uterine biopsy which was unsuccessful.
Systemic: Allergic: Rash Generalized-Mild, Additional Details: Vaccine given around noon. Patient's father called at approximately 4:30 PM to let us know about patient's hives. He was advised to give patient Benadryl 25 mg, and to contact primary care provider if symptoms persist.
The patient received Hepatitis B and Hib immunizations. Parent returned to office with complaints of child crying 2-3 hours after administration; with swelling of the thigh. Treated with Tylenol.
Moderate redness, swelling, and warmth at vaccination site - same day. Convulsive episode with LOC that night prompting ER visit to hosp.
Bad vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Bad vertigo) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039821A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Nov-2021, the patient experienced VERTIGO (Bad vertigo) (seriousness criterion hospitalization). The patient was hospitalized from sometime in November 2021 to sometime in November 2021 due to VERTIGO. At the time of the report, VERTIGO (Bad vertigo) outcome was unknown.            No concomitant medications were provided. No treatment information was provided.  Company Comment: This case concerns a 83-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious event of vertigo. The event occurred 2 days after the third dose of mRNA-1273 Moderna vaccine (booster dose). The rechallenge was not applicable as the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 83-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious event of vertigo. The event occurred 2 days after the third dose of mRNA-1273 Moderna vaccine (booster dose). The rechallenge was not applicable as the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
multiple unspecified patients were administered a dose of improperly stored PROQUAD and VARIVAX; No adverse effects were reported.; This non-valid spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, concomitant therapies or medical history.   On multiple unspecified dates, multiple unspecified patients were administered a dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) rHA for prophylaxis (Lot number R015738 with expiration date on 12-FEB-2019, dose, route of administration were not reported) or varicella virus vaccine live (Oka/Merck) (VARIVAX) ) for prophylaxis (Lot number R018780 with expiration date on 01-JUL-2020, dose, route of administration were not reported).  The administered dose of the vaccines experienced a temperature excursion in the range of 15 F to 46 F of 15.1 F for 1 hour and 20 minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There were no adverse effects reported. Furthermore, no product quality complaint was involved.
Patient reported rash and itching around injection site starting a couple days after receiving the ZOSTAVAX injection.
Shot #1: First Primary monovalent dose on 10 FEB2021 (Lot# & Exp. Date: unknown). Shot #2: 2nd Primary monovalent dose on 19MAR2021 (Lot# & Exp. Date: unknown).; 2021 Heart enlargement but no symptoms.; This spontaneous case was reported by a patient and describes the occurrence of CARDIOMEGALY (2021 Heart enlargement but no symptoms.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Shot #1: First Primary monovalent dose on 10 FEB2021 (Lot# & Exp. Date: unknown). Shot #2: 2nd Primary monovalent dose on 19MAR2021 (Lot# & Exp. Date: unknown).) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Shot #1: First Primary monovalent dose on 10 FEB2021 (Lot# & Exp. Date: unknown). Shot #2: 2nd Primary monovalent dose on 19MAR2021 (Lot# & Exp. Date: unknown).). In 2021, the patient experienced CARDIOMEGALY (2021 Heart enlargement but no symptoms.). At the time of the report, CARDIOMEGALY (2021 Heart enlargement but no symptoms.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Shot #1: First Primary monovalent dose on 10 FEB2021 (Lot# & Exp. Date: unknown). Shot #2: 2nd Primary monovalent dose on 19MAR2021 (Lot# & Exp. Date: unknown).) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided.
COVID positive 11/2/2021.  Admission Dx:  COVID-19 and Atrial fibrillation with RVR.  This patient was admitted for  fatigue, weakness, some non-productive cough with some difficulty breathing. Because of his intermittent rapid rate, I have ordered a Cardizem drip. Continue eliquis.  Discharged to home.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/19/21 (ER2613) Pfizer Dose 2 4/9/21 (ER8732) COVID Positive 10/28/21  10/28/21: Patient is 61-year-old male past medical history significant for AIDS on ART , essential hypertension, obesity Presented to the clinic after he started to feel and fatigued significantly in the last 3 days.  Patient endorses that you also feels short of breath on ambulation and relieved by rest.  Patient also endorses that has non productive cough since 1 week back that progressively worsened in the last couple of days. At the clinic is pulse ox was noted to be 87% and was significantly tachycardic Had significantly loss of appetite in the last few days Patient also endorses that since 1 day back has been having frequent watery diarrhea and feels pain on the rectum area.  Patient denied any joint pain, or neck stiffness.  Patient is adherent to his air team medications and has taken COVID vaccine x2 doses  11/8/21:  COVID-19 precautions per CDC guidelines  Hemodynamically stable for discharge  Will discharge home  Follow-up with PCP in 3-5 days  Follow-up with Infectious Disease as outpatient  Follow-up with pulmonology as outpatient in 3 weeks  Patient agrees with plan of care