chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-FEB-2014, the patient was inoculated at a physician office with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 10-MAY-2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as herpes zoster along with neurological pain from herpes. The patient was prescribed VALTREX, tramadol, and triamcinolone for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Janssen COVID-19 Vaccine EUA very deep headache and fatigue Started about 20 hours after vaccination. Lasted about 16 hours then reduced in severity for the next 12 hours.  Over the counter meds did nothing to relieve symptoms.
real side effects of the second booster; eye problems; high blood pressure; This spontaneous case was reported by a physician and describes the occurrence of IMMUNISATION REACTION (real side effects of the second booster), EYE DISORDER (eye problems) and HYPERTENSION (high blood pressure) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (real side effects of the second booster), EYE DISORDER (eye problems) and HYPERTENSION (high blood pressure). At the time of the report, IMMUNISATION REACTION (real side effects of the second booster), EYE DISORDER (eye problems) and HYPERTENSION (high blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  Reporter stated that he listened about some people talking about the real side effects of the second booster. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-602077 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-602077:crosslinked case (same reporter)
I was having chest pain. I went to an urgent care and an EKG was performed. My results were normal. I went to my primary care and had an exam. My results were normal. I am still experiencing chest pain and under doctor's care.
Joint pain, severe itching, runny nose, runny eyes. Next day vision affected. After seeing opthamologist diagnosed with a stroke in the optic nerve.
Arm hurt her that afternoon, and most of the next day, red, swollen at the area of injection. As of 2/5/03 she has what feels like a knot, the size of a pimple underneath her skin. Overall she seems fine, although complained of headache. On 2/2 little congested. My question is what/why for the booster did she have a reaction and prior for the DTaP series never had one.
Numbness of tongue, lips, body rash away from injection site (trunk - stomach and back).  Numbness started within an hour, rash developed within two hours.  Treated with over-the-counter antihistamine (Benadryl)
Initial and follow-up information has been received from the Merck Pregnancy Registry via a registered nurse and a physician concerning a 26 year old female with anxiety and hay fever who on 06-AUG-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (lot # 658282/0929U). There was no concomitant medication. On 24-AUG-2007 the patient was seen in the office for pregnancy. The patient's last menstrual period was on 29-JUN-2007 (previously reported as 15-JUN-2008) and the estimated date of delivery on 21-MAR-2008. The physician reported that the patient had a miscarriage at 8 weeks and 6 days, on 29-AUG-2007. An ultrasound was done at 10 weeks, approximately on 13-Sep-2007, which showed demise from 2 weeks prior. Upon internal review, miscarriage was considered an other important medical event. Additional information is not expected.
12/29/21 presents to Triage for "with contractions" "Exposed to COVID-19 a few days ago, tested positive on 12/27, only symptoms are fatigue, runny nose, sore throat". PMHx of "Lupus"
shots given 930AM started fever @ 1230PM; t101 to 102; stayed 102 despite APAP & tepid bath; leg sensitive to touch but not red or swollen; fussy; on-going crying for over 3 hr, high-pitched unusual cry; went to ER 730PM; given Ibuprofen;
Erythema multiforme. Covered head to toe with erythematous wheals with dusky centers, dryness & itching.
diarrhea: ~13 times on 8/25, ~6 times on 8/26, 3-4 times on 8/27, once on 8/28  Arm soreness 8/25-8/27
swollen lips; swollen tongue; hoarsness; difficulty swallowing; This is a spontaneous report received from a contactable consumer (Patient). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot# EL3247), via an unspecified route of administration in the right arm on 10Feb2021 at 3:00 PM (at the age of 53 years-of-old) at single dose for COVID-19 immunization. Medical history included hypertension, hypothyroidism, GERD and tree nuts allergy. Concomitant medication(s) included NEXIUM, PEPCID, QVAR and AMLODIPINE BESYLATE. On 11Feb2021, patient experienced swollen lips, swollen tongue, hoarseness and difficulty swallowing which resulted in emergency room visit. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3247), via an unspecified route of administration in the right arm on 20Jan2021 at 2:00 PM at single dose for COVID-19 immunization. Therapeutic measures were taken for events which include included Prednisone 50mg/5days and Benadryl. The patient took the most recent COVID-19 vaccine at Workplace clinic. 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 and was not tested for COVID-19 since the vaccination. The outcome of all the events was recovering.
booster dose given to one patient where vial had been punctured for approximately 50hrs; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster dose given to one patient where vial had been punctured for approximately 50hrs) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster dose given to one patient where vial had been punctured for approximately 50hrs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (booster dose given to one patient where vial had been punctured for approximately 50hrs) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Swollen left side of face, swollen lips, it happened within 5 minutes of receiving injection (same side as injection).
The first day hours after vaccination, I had a sore left arm and slight sore throat that evening. The next morning, I had lethargy, cough, and a runny nose. The day after, I continued with the same symptoms and a fever of 102F onset; because of the fever, I took an at-home antigen test that came back positive for COVID-19. Awfully concerned, I sent my doctor a portal message to schedule an appointment. I went to my doctor on 04/25/2022 and took an antigen and COVID-19 PCR test; the antigen test came back positive, and we're still awaiting results from the PCR test. He started me on Paxlovid and the cough is continuing while waiting for results.
patient received vaccine past its 30 days expiry date/ vaccine went in to 2-8C thaw state; patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (patient received vaccine past its 30 days expiry date/ vaccine went in to 2-8C thaw state) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if the patient had acute illness at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long lasting health conditions.     On 02-Apr-2022 at 11:03 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 11:03 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received vaccine past its 30 days expiry date/ vaccine went in to 2-8C thaw state). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (patient received vaccine past its 30 days expiry date/ vaccine went in to 2-8C thaw state) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's Us Census ethnicity was reported as Black or African American. It was unknown if the patient received any prescriptions, over the counter medications, dietary supplements or herbal remedies at the time of vaccination. It was unknown if the patient received other vaccines given on the same day and it was also unknown if the patient received other vaccines within one month prior to Moderna vaccine. It was reported that, the vaccines went in to 2-8 C thaw state on or about 24-Dec-2021. It was unknown if the patient experienced any adverse events or not. No treatment medications were reported.
muscle weakness/muscle fatigue; just fallen while trying to beach the paddle board; shaky legs; walking has slowed; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (muscle weakness/muscle fatigue), FALL (just fallen while trying to beach the paddle board), TREMOR (shaky legs), GAIT DISTURBANCE (walking has slowed) and PYREXIA (fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ALGLUCOSIDASE ALFA (LUMIZYME) powder and solvent for concentrate for solution for infusion for Pompe's disease.    No Medical History information was reported.   On 12-Dec-2006, the patient started ALGLUCOSIDASE ALFA (LUMIZYME) (Intravenous) 1500 milligram once a week. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE FATIGUE (muscle weakness/muscle fatigue), FALL (just fallen while trying to beach the paddle board), TREMOR (shaky legs), GAIT DISTURBANCE (walking has slowed), PYREXIA (fever) and CHILLS (chills). At the time of the report, MUSCLE FATIGUE (muscle weakness/muscle fatigue), FALL (just fallen while trying to beach the paddle board) and TREMOR (shaky legs) outcome was unknown and GAIT DISTURBANCE (walking has slowed), PYREXIA (fever) and CHILLS (chills) had resolved.      This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medications were reported. It was reported that patient was being excited about the new drug as can see slow regression over time. Patient was discussed regression previously with HCP and states that Enzyme replacement therapy has probably flattened the progression of muscle weakness. Patient also talks about limitations and modifications were in order to paddle board. Patient reported that cannot push up and stand on knees and has to board from the shore in a standing position, backing up and sliding the feet gently as the stability of the board decreases as it moves from being grounded to floating. It was reported that patient also talks about having just fallen while trying to beach the paddle board. Patient talks about the muscle fatigue and shaky legs after paddle boarding for a while and the need to be extremely careful while stepping off the board onto the shore. No treatment medications were reported.   This case was linked to MOD-2021-624488 (Patient Link).
This spontaneous report was received from a licensed vocational nurse and refers to two patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # L045956, expiration date 17-NOV-2017 (dose, route and site of administration were not reported). There were no adverse symptoms reported. Administered doses of VARIVAX were exposed to the temperature of -14.4 degrees Celsius for 8 hours and 46 minutes. There were no previous temperature excursions reported. Data logger was involved. Additional information has been requested.
Received MMR vaccine on July21st, 2011. Had a fever on August 5th & 6th, 2011. Swelling of face, right side on the 10th August. Diagnosed with parotitis, checked amylase increased at 756. Did not have a fever, swelling resolved in 3 days.
On the 12/3 evening i had body aches then I had it on Friday and Saturday. Sunday, I had a little bit of a runny nose. Wednesday, I felt sick and didn't go to work and went downhill from there. I had symptoms for 10 days. on a scale of 1-10 I was probably a 7. I still have breathing issues and went to the doctor the other.
pt started having seizures; pt is still have the sz like every other day; pt recvd vax on Wednesday & started having the sz on Friday;
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable nurse (patient) from a Pfizer sponsored program. A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0170; Expiration Date: 31Aug2021), via an unspecified route of administration on Apr2021 (at the age of 30-year-old) as single dose, administered in Deltoid Left for covid-19 immunization. Medical history included allergy. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC ALLERGY) both taken for allergy (Further not clarified). On 17May2021, after the first dose (on last Apr2021), the patient was tested positive for covid-19. The patient was scheduled for her second dose on 18May2021 but missed the dose as she was tested positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17May2021. The outcome of the events was unknown.   Follow up needed, further information has been requested.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-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. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration was 07-may-2021 No concomitant medications were reported. No treatment medications were reported.
After around 5 minutes after the IM injection, the patient took off the bandage over the injection site and clear liquid ran down her arm. No reaction or symptoms occurred.
Swelling in left arm, tenderness, hard as a rock, red rash, feeling flushed, chills.
vibration, buzzing, electrical surge sensation in brain with odd loud low pitch sound vibrating through brain (15 minutes) vibration, buzzing, electrical surge in brain without noise (ongoing) vertigo (ongoing) weak muscles in legs, like a baby deer trying to stand (waxes and wanes, ongoing) weak muscles all over, including those that control pee and poop - muscles let go at times causing accidents swollen lymph nodes in armpit of arm receiving shot (10 days each shot) extreme fatigue (24 hours)
Patient started to develop rash, muscle weakness, etc the following Monday that continued until she went to hospital.
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 9:29 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:29 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 54.97   Concomitant products were not provided.  On 20-Mar-2021 Excursion time was reported at 09.00 AM and 10:00 A.M with  temperature as 34 and 37 degrees Fahrenheit, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021 , vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  Vial was stored on cooler 1, on 20-Mar-2021, Excursion duration At 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM : 44, 3 PM: 44, 4 PM: 44 and 5 PM : 43  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
9 days following vaccination pt developed 5cm x 5cm localized redness, swelling, warmth, induration, tenderness and pruritis of vaccination site
Patient did not state any problems prior to getting immunization. Patient stated "just fine" for the  few minutes immediately after receiving immunization. When patient attempted to walk he got dizzy and fainted. After event, patient stated he had previously been very anxious and not reported it. He stated he was very anxious and fainted for that reason.
Approx 2 min p/inject pt vomited clear fluid; became cold & clammy (skin), circumorial cyanosis & lethargic & confused; P 68, 70, 72 & 70, BP 72/43; 62/40; 75/50; Taken to Hosp & d/c same AM;
3 seizures morning after 15m vaccines given (DTaP, Hib, PCV). Admitted to hospital.
15 minutes after receiving IM inj. client presented with dyspnea, hoarse voice and inspiratory stridor. Nurse adm. 5ml sq Epinephrine(1:1000u/ml) . 2 minutes later client received 1mg IM BENADRYL during convulsion period. Rescued arrived 7 min. After 911 call. Client became responsive and transported to hospital via ambulance to hospital. 11/20/09 and 12/29/09 DC summary and medical records received for date 11/9/09 to 11/10/09. DX: abdominal pain, exit hospital AMA/AWOL. Chief c/o allergic reaction and pelvic pain.US was ordered. But pt signed out AMA med recs state pt could not wait any longer. Complete assessment not performed.
Noticed swelling and redness and soreness day after shot. Has persisted 5 days.