chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received 19 September 2011 from a health care professional which involved a cluster of two patients. The other patient has been captured in case number 2011-08894. A 14-year-old female patient had received an injection of FLUZONE, lot number UH467AB (date of administration not reported; route and site unknown) and on 17 September 2011 the patient developed muscle aches and arm soreness. The patient presented to the emergency room on 19 September for throat tightness. Outcome was not recovered. No additional information was provided at the time of the report. Follow-up information was received from a health care professional on 19 March 2012. Based upon the new information provided, this case has been upgraded to serious. The patient experienced throat swelling and numbness on 18 September 2011. The patient's outcome was not reported. Documents held by sender: None.
Severe nausea, headache, body aches,  fever and chills for 36 hours. Treated with tylenol and motrin which did not help.
Severe muscle pain (whole body); hurt to breath; Fatigue yet unable to fall asleep, feeling hot and cold, headache
Information has been received from a healthcare worker (medical assistant) referring to an unspecified number of unknown age and gender. The patient's medical history or concurrent condition were not provided. On unknown dates the patients received improperly stored doses of GARDASIL (strength, lot#, expiration date, dose and route were unspecified). No concomitant therapy was provided. No adverse effect was reported. This is one of the several reports that received from the same source. Additional information has been requested.
very intense headache; lot of pain; Fever; pain in my bones; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine (received first dose on unknown date).   On 19-JUL-2023, the patient received the 2nd dose of Shingles vaccine. In JUL-2023, an unknown time after receiving Shingles vaccine, the patient experienced headache (Verbatim: very intense headache), pain (Verbatim: lot of pain), fever (Verbatim: Fever) and bone pain (Verbatim: pain in my bones). In JUL-2023, the outcome of the fever and bone pain were resolved (duration 2 days). The outcome of the headache and pain were not reported.   It was unknown if the reporter considered the headache, pain, fever and bone pain to be related to Shingles vaccine.     It was unknown if the company considered the headache, pain, fever and bone pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-JUL-2023 The case was received from the patient via interactive digital media. The patient had already received the first dose of vaccine. On 19th July 2023 patient received the second dose and experienced lots of pain and very intense severe headache. But its better to be vaccinated. The follow-up would not required per process.
On Monday 2/15, the patient got vaccinations and was fussy afterwards. Mother states that this is normal for the patient following immunization. Around 6:00 PM that day the mother noticed the patient became rigid and was staring at nothing. She describes it as "seizure like activity" and lasted about 30 seconds. The patient then became responsive and screamed hysterically. Mother was able to console the patient and call EMS where she was recommended PCP follow up. 2/17/21 at approximately 10:00 PM, the patient had another episode of "seizure like activity" where the patient was sitting in the mother's arms when he became increasingly fussy then went limp and lost consciousness. Patient then began jerking his head and arm. Mother reports this episode was approximately 1 minute long. Mother called the non emergent line and they recommended coming to the ED. Mother additionally notes the patient had significant decrease in PO intake. She reports associated fevers, cold sweats, and fatigue.
This spontaneous report as received from a registered nurse refers to a 5 years old patient of unknown gender. On 14-OCT-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008579, expiration date 13-DEC-2015, (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Severe Fever of 105 F, Bowl disturbance, projectile vomiting, Febrile seizure @ 6 weeks of age, sluggish recovery after each vaccination until eventually developmental regression occurred @ age of 24 months. I have evaluated the patient on 8/1/98 and 9/26/98, and he fits criteria for autistic disorder, with moderate impairment. Special educational interventions would be very important to facilitate the progress of this child.
Initial unsolicited report received from a pharmacist on 03 June 2015. A female patient, whose medical history and concomitant medications were not reported, had received a dose of Tdap vaccine (batch number, expiry date, dose, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date, after vaccination, patient had experienced symptoms headache and didn't feel well for days which diagnosed as flu. It was also reported that, patient was not pregnant during the Tdap vaccination. Laboratory investigations and corrective treatments were not reported. At the time of this report, patient had recovered. Documents held by sender:: none.
Prolonged fever 104 to 104.8 started on day of immunizations for 1 week.Monitor and treat with tylenol and ibuprofen, follow up office visit the day of and 4-1-09. Follow up phone calls.
This spontaneous report was received from a physician via a company representative refers to a patient of unknown age and gender. On 23-FEB-2015 the patient was vaccinated with M-M-R II and PROQUAD (Merck) (dose, route of administration and lot # were not reported). No adverse effects reported. Additional information is not expected due to the reporter did not want to be contacted again.
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 09-AUG-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (incorrect product storage) (lot # L030587, expiry date 10-FEB-2017) (dosing regimen and frequency unknown) for an unknown indication. No concomtiant medications were reported. It was reported that the PROQUAD was stored at a temperature of 4 degrees centigrade between 06-OCT-2015 to 09-AUG-2016. It was reported that there was no previous temperature excursion. No adverse effects were reported. The action taken with the therapy with PROQUAD was unknown. The outcome of the events was unknown. There was no product quality complaint reported. This report was not because of a data logger.  This is one of the many reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA005074: US-009507513-1612USA011225: US-009507513-1612USA011226.
Uncontrollable shivering, fever, nausea, dizziness, stomach cramping.
First ER visit: Sudden rapid heart rate on 7/4, ekg vent rate at 123 when checked at facility. Slowed itself over the course of 1.5 hours at facility. Second ER visit: Bad GI pain in specific areas one on right and one on left abdomin. Difficulty walking, laying, sitting etc unable to sleep due to abdominal pain, loss of appetite, mild dehydration. Became more intermittent over 2 weeks, after a month became mild and intermittent but still present at 4 months after vaccination.
This serious case was received from a health professional on 16 October 2008.  A 29-year-old female patient, with a history of malignant hyperthermia, received an intramuscular right deltoid injection of FLUZONE (lot number U2804AA) on 26 September 2008.  Within five to eight minutes of vaccination, the patient began complaining of tingling in her lips and right-sided facial numbness.  Within 30 minutes of vaccination, she "felt very hot and could not cool down".  Within an hour of vaccination her face became flushed, and she complained of tingling and numbness in the right arm radiating to the neck, face, and mouth.  She was seen in the emergency room and treated with Benadryl.  The symptoms "gradually cleared", and the patient was discharged.  She denied any illness at the time of vaccination, and had not experienced any adverse events following previous vaccinations.  Concomitant medications included Tylenol and Aleve as needed.  The event was considered to be resolved.  Documents held by sender: None.  The reporter in this case also reported an event for another patient, captured in case number 2008-03233.
Expired 3rd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-372320 (Patient Link).
SWELLING IN CALF; VOMITING; NAUSEA; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroid, joint pain, macrobid iv dye allergy, and bowel impacting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included oxybutynin for bowel impacting.  On 30-MAR-2021, the subject experienced nausea. On 04-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced swelling in calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 05-APR-2021, and had not recovered from swelling in calf, and nausea. This report was non-serious.
Abdominal discomfort, nausea, sick feeling after vaccination. Went home slept for 6 hours and felt better.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 03-FEB-2015, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 22-SEP-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Reddened area 4.5 cm width by 9.0 cm length at just inferior to injection site.
Seizure x's 1.  Was laying in bed and started having convulsions.  After the seizure she seemed to have a period that the mother describes as post-ictal.  She was brought to the local ER.  The attending physician felt it may have been related to having the Flu Mist administered earlier.
Numbness and tingling in arm for 1 1/2 weeks. Unable to lift arm.
I'm not sure of the exact date, but within a few days I was having a severe burning pain in my shoulder where I got the tenanus/whooping cough booster.  After 2 weeks the doctor had me come in and ordered an ultrasound to see if I had a blood clot.  The tissue looked fine.  It's been nearly 5 months now and I still have trouble taking off my shirt, holding my baby, and other day to day activities.  The pain has subsided substantially but still is bothersome.
Day 1-2: malaise, fatigue, muscle aches, chills, sweats, began ibuprofen Day 3 (12/24) sudden onset of severe L sided chest wall pain, lasting for several hours, other symptoms continued requiring ibuprofen. Day 4: moderate L chest wall pain,  Day 5: In the AM pain was reduced, but at about noon after a 17 minute exercise program, pain was severe associated with SOB, went to ER and found to have a L pleural effusion, no pneumonia, no PE on CT angio.  Due to lack of clear causative process: began augmentin, azithromycin, prednisone, aspirin and Tylenol... Day 6: Much improved, but still L chect pain with deep breathing coughing and recurrent hiccups. Day 7: a little worse in AM until prednisone 40 mg,  aspirin 162 mg  and  1000mg Tylenol
On day 8 post injection, injection site started itching, then progressed to a 2 inch round, red, swollen, feverish, painful knot.  Patient presented the reaction site for viewing, early on day 9 post injection.  Patient took 12.5mg diphenhydramine the evening of day 9.  On day 10, the site started improving over the next 3 days.
Body aches started Saturday evening.  Ran a temperature of 101 to 102.5 for 4 days.  She had lower back pain "ovary pain" she describes worse than labor pains
Within a few days, I had some joint pain, headaches and fatigue. I was also disoriented. Those symptoms lasted 1 week to 10 days. I took Tylenol. This is long term issue (happening before the vaccine): Thyroid- I was going through a series of tests that the doctor was doing. My diet was changed and the medications were changing. I called the doctor most recently about Pinworm- went to see grandchildren and got that from them. They prescribed me Pinworm Medicine - the active ingredient is - Pyrantel Pamoate. I started taking that on June 10th. That's helping with my symptoms. I have to wash everything all the time. I have to repeat the Pinworm medication on the 24th of June.
Numbness on the left side of face; Tongue is numb; This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA (Numbness on the left side of face) and HYPOAESTHESIA ORAL (Tongue is numb) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced HYPOAESTHESIA (Numbness on the left side of face) and HYPOAESTHESIA ORAL (Tongue is numb). At the time of the report, HYPOAESTHESIA (Numbness on the left side of face) and HYPOAESTHESIA ORAL (Tongue is numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medications were not provided by reporter.  The patient stated that five days after the shot, showed up in clinic complaining that the left side of his face was numb and his tongue was numb.  The patient did not have difficulty breathing and performing tests.  patient does not have a family history of Bell's Palsy.; Sender's Comments: This case concerns a 51-year-old male patient with no relevant medical history, who experienced the unexpected events of Hypoesthesia and Hypoesthesia Oral. The events occurred 5 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Rash onset 6/24/03. Rash arms and legs, "small, tiny dots" over arms and legs. Child has no complaint of itch. No fever present. No other complaints.
Caller reports that they had a temperature excursion 3/31/2023 which they called into the Center.; the products were labeled but still accidentally administered after the new short dated expiration date; This spontaneous report was received from an office manager and referred to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 30-JUN-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection 0.5 milliliter, lot #W031816, original expiration date was reported 05-OCT-2024, upon internal validation, it was established as 16-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided) (product storage error and expired product administered).  It was reported that the suspect vaccine was exposed to a temperature of 50 Fahrenheit (F), the time frame: 6 F up to 14 F for 4 hours 0 minutes; 14 F up to 46 F for 4 hours 0 minutes; 47 F to 77 F (50 F) for 3 hours 57 minutes (total: 11 hours 57 minutes) (date excursion on 31-MAR-2023). The short dated expiration date from the temperature excursion given was 30-JUN-2023. The vaccine was labeled but still accidentally administered after the new short dated expiration date.   This is one of the several cases reported by the same reporter.
CLL, autoimmune hemolytic anemia (severe hgb 5.5), shortness of breath, chemotherapy, blood transfusions
ITCHING; arm is swollen; he does not feel like doing anything; Fatigue; Tired; Swollen injection site; He had no energy; Itching injection site; felt like he had the normal flu, not the COVID flu; Same side effect with booster but worse; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like he had the normal flu, not the COVID flu), CONDITION AGGRAVATED (Same side effect with booster but worse), PRURITUS (ITCHING), ASTHENIA (He had no energy) and VACCINATION SITE PRURITUS (Itching injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like he had the normal flu, not the COVID flu), CONDITION AGGRAVATED (Same side effect with booster but worse), ASTHENIA (He had no energy), VACCINATION SITE PRURITUS (Itching injection site), FATIGUE (Fatigue), FATIGUE (Tired) and VACCINATION SITE SWELLING (Swollen injection site). On 30-Nov-2021, the patient experienced PRURITUS (ITCHING), VACCINATION SITE SWELLING (arm is swollen) and FATIGUE (he does not feel like doing anything). On 29-Nov-2021, INFLUENZA LIKE ILLNESS (felt like he had the normal flu, not the COVID flu), CONDITION AGGRAVATED (Same side effect with booster but worse), ASTHENIA (He had no energy), VACCINATION SITE PRURITUS (Itching injection site), FATIGUE (Fatigue), FATIGUE (Tired) and VACCINATION SITE SWELLING (Swollen injection site) had resolved. At the time of the report, PRURITUS (ITCHING), VACCINATION SITE SWELLING (arm is swollen) and FATIGUE (he does not feel like doing anything) had not resolved.            There are no treatment or concomitant medications provided. The patient reported With the Booster dose, he had the same side effect, but it was worse this time.   This case was linked to MOD-2021-403070 (Patient Link).
Pain in injection site area and swelling with pain in the lymph node area of the right arm/armpit area (arm where the injection was given)
Fever; Chills; Myalgias; This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (in November 2015, received Zostavax).   On 1st April 2019, the patient received the 1st dose of Shingrix. On 1st April 2019, less than a day after receiving Shingrix, the patient experienced fever, chills and myalgia. On an unknown date, the outcome of the fever, chills and myalgia were recovered/resolved.   It was unknown if the reporter considered the fever, chills and myalgia to be related to Shingrix.  Additional details were provided as follows: The age group of the patient was not reported, but selected as an adult as per vaccine indication. The medical assistant reported that, after vaccination with dose of Shingrix, the patient had very unpleasant side effects with fever, chills, myalgias for 36 hours. The reporter did not consent to follow up.
Covid arm, red, swollen, itchy and painful rash at injection site.  Started 6 days after the shot.
After receiving the second dosage of the Covid-19 vaccine, I had an appointment with the obgyn. At my appointment the fetus no longer had a heartbeat and was measured at about 6 weeks which was around the time I recieved the vaccine. I had a miscarriage and the DNC was performed on 11/3/21.
On set March 6th, 2021: brain fog, fatigue, mild body aches. Took celebrex, 100 mg twice a day. Had to stop exercise routine. Side effects decreased after three and a half weeks. Side effects reappeared after odd gastrointestinal issue with chills. Side effects currently present.