chrisvoncsefalvay/vaers-outcomes huggingface dataset:
03/25/23 presents to ED for "SOB, cough and fevers". PMHx of "DM, sleep apnea, obesity"
after receiving / first dose / experienced mild myalgia; This case was reported by a physician via call center representative and described the occurrence of myalgia in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included myopathy (myopathy after treatment with statins), metal poisoning (cobalt metallosis after a joint replacement failure in 2012) and joint replacement (failure in 2012). Concomitant products included rosuvastatin calcium (Crestor).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced myalgia. The patient was treated with naproxen. On an unknown date, the outcome of the myalgia was recovered/resolved.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional information was provided as follows: The patient who was also a rheumatologist and the reporter. The age at vaccination was not reported. The patient received 1st dose of Shingrix approximately one year before the date reporting. Shortly after receiving the first dose of Shingrix, the patient experienced mild myalgia (exact dates were not provided). The patient took Naproxen as a treatment to myalgia. The patient was expecting to undergo further laboratory investigations including more specific muscle damage markers. The reporter consented to follow up. For the tolerance of 2nd dose, refer the case US2020AMR211918, reported by the same reporter; Sender's Comments:  US2020AMR211918:same reporter
facial swelling, Vomiting for 8 hours, dehydration, extremely tired, headache
Bells Palsy; Left side facial paralysis (remained through approximately 6/28/21). Eye sight issues (now have to wear glasses all of the time to see computer and read). Migraines (continue to cause issues even currently.)
Chills, fatigue; redness, swelling, and itching at injection site lasting days after injection
10/26/10 at 6:15 pm client received flu vaccine with thimerosal. At 7:52 pm on 10/26/10 client reported slight swelling in lips and light hives on abdominal area. At 7:45 pm client took 50 mg. BENADRYL and client took another 50mg BENADRYL at midnight. All hives and swelling cleared on 10/27/10.
Dizziness; Weakness; Sweating hands; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2022, the patient received the 1st dose of Shingrix (intramuscular). On 1st November 2022, immediately after receiving Shingrix, the patient experienced dizziness, weakness and sweaty hands. On 1st November 2022, the outcome of the dizziness was recovered/resolved. On 2nd November 2022, the outcome of the weakness and sweaty hands were recovered/resolved.   It was unknown if the reporter considered the dizziness, weakness and sweaty hands to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comments: The case was self reported by the patient. The patient received first dose of Shingrix into left deltoid and started feeling of dizziness, weakness and his hands were sweating immediately after vaccination. Dizziness lasted 20 minutes and the weakness and sweating hands went away the following day. The reporter reported that education provided on adverse reactions per package insert. The reporter consented to follow up. Additional supportive information: As per narrative outcome date captured for event dizziness, weakness and sweaty hands, conservatively.
cough; phlegm; don't have the energy as before; Lack of drug effect; sick/pretty sick; Tested positive for covid; Didn't feel well at all; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (cough), ILLNESS (sick/pretty sick), COVID-19 (Tested positive for covid), MALAISE (Didn't feel well at all) and PRODUCTIVE COUGH (phlegm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 1015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced ILLNESS (sick/pretty sick), COVID-19 (Tested positive for covid), MALAISE (Didn't feel well at all) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced COUGH (cough), PRODUCTIVE COUGH (phlegm) and ASTHENIA (don't have the energy as before). On 02-Sep-2021, DRUG INEFFECTIVE (Lack of drug effect) had resolved. At the time of the report, COUGH (cough) had not resolved and ILLNESS (sick/pretty sick), COVID-19 (Tested positive for covid), MALAISE (Didn't feel well at all), PRODUCTIVE COUGH (phlegm) and ASTHENIA (don't have the energy as before) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Her daughter took her to urgent care and they decided she needed the infusion to keep her out of the hospital. She still has a cough and is slowly getting her energy back.   On the 3-SEP  infusion treatment was given.  No concomitant product information was provided. No treatment information was provided. Company comment This case concerns an 84-year-old female patient, with no reported medical history, who experienced the unexpected non-serious event of COVID-19 (AESI). The events occurred approximately 6 months after the administration of the second dose of mRNA-1273 vaccine. Drug ineffective was considered as an additional event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 30-Dec-2021: Follow up received contains significant information new event added.; Sender's Comments: This case concerns an 84-year-old female patient, with no reported medical history, who experienced the unexpected non-serious event of COVID-19 (AESI). The events occurred approximately 6 months after the administration of the second dose of mRNA-1273 vaccine. Drug ineffective was considered as an additional event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
The day after receiving the vaccine I felt tired, and my arm was sore for about a day. One 09/25/2022 I started breaking out in hives on my arms and forehead. This continued all week, but the rash and itching would never stay in one spot, it would disappear. On 10/01/2022, I went to my doctor to get a diagnosis and he said it was hives or an allergic reaction and gave me a prescription for prednisone. As of today, I continue to be itchy, but I don't have outbreaks of hives.
Resident was admitted to hospital with Ax mania episode early August, Hx of CoVid and Completed a Pfizer vaccination series in February.  While in hospital, they contacted the POA and administered a Janssen vaccination as well.  Resident did not seem to have severe reaction post administration of vaccine.
Got second shingles vaccine injection about 6PM. Just as I was about to fall asleep in bed (11:30PM) I began to shiver. It lasted about 2 hours.
limited medical records received on this pt; pt presents to hospital being positive for COVID; HX of A Fib, CAD, CKD stage III, HTN; pt actively dying in the hospital; comfort care measures; family agrees to reduce O2 by mask; pt died in the hospital
My daughter was supposed to receive her last Prevnar vaccine. She was given the pneumovax 23 by mistake. This is a never event.
Patient has had tingling sensation in left arm and itchiness on left hand since day of vaccination. No other symptoms. Reported it today, two months after vaccines.
Redness, warm, hard to touch, itchy upper left arm mod. eryth and swollen. Approx 8.5 X 10cm from non tender no pain.
Broke out in hives covering face, chest and arms. Benadryl eased the symptoms.
Information has been received from a physician concerning a 16 year old female, who on 12-JUL-2007 was vaccinated with a 0.5mL first dose of Gardasil. Concomitant vaccinations included Menactra and DTaP (+) tetanus toxoid. On 12-JUL-2007 after receiving the vaccination, the patient "stood and passed out", experienced a small seizure, regained consciousness and experienced another seizure. The patient went to the emergency room and was admitted to the hospital. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
This spontaneous report ws received from a physician via a company representative refers to a 22 year old female patient who was not pregnant. On 18-AUG-2014 the patient was vaccinated with PNEUMOVAX23, 1 single shot, Lot # reported as K004542, Expiration Date reported as: 19-AUG-2015 (dose and route of administration was not reported). On 18-AUG-2014 the patient developed fever, nausea, redness and pain near the injection site. Patient sought medical attention. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Progressive weakness and paresthesias in BLE and BUE over 3 weeks. Workup suggests guillain-barre syndrome.
Information has been received from a physician, via a company representative, concerning an 18 year old female patient who on 08-JAN-2007 was vaccinated with the first dose, 0.5 of Gardasil, and on approximately 08-MAR-2007 ("two months later") was vaccinated with the second dose, 0.5 ml, of Gardasil. The physician reported that on 08-JAN-2007, soon after receiving the first vaccination, the patient passed out, "she recovered after a short while in the physician office." Following the second vaccination, the physician reported the patient "had no ill effects". Additional information has been requested.
headache; Bodyache; Nauseous; Fatigue; tired; chillness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Bodyache), NAUSEA (Nauseous), FATIGUE (Fatigue; tired), CHILLS (chillness) and HEADACHE (headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (Bodyache), NAUSEA (Nauseous), FATIGUE (Fatigue; tired) and CHILLS (chillness). On 11-Mar-2021, the patient experienced HEADACHE (headache). At the time of the report, PAIN (Bodyache), NAUSEA (Nauseous), FATIGUE (Fatigue; tired), CHILLS (chillness) and HEADACHE (headache) outcome was unknown.
BUD 4/7/2022 administered 4/10/22. Pfizer could not provide stability data beyond 4/9/2022 and recommended revaccination with booster administered 05/04/2022
Received injection on 9/13/2021  at approximately 13:00.  Approximately 3-4 hours after injection, headache that got worse through the night.  Approximately 6 hours after injection,  severe body aches and pain, freezing chills, sweating, with worsening headache.   Took advil and excedrin for the pain.   Symptoms peaked about 3 or 4am on 9/14/2021, then gradually went away.   Symptoms were completely gone by 11am on 9/14/2021.
The three menstrual cycles following the vaccination were highly abnormal; irregular dates; with cycles beginning much closer together at a higher frequency. Much heavier blood loss than is typical, and extreme pain, in the back, hips and legs causing loss of consciousness, on one occasion. In the period of time following the vaccination no changes in birth control, sexual partners, diet or stress level occurred.  These symptoms have persisted for three months.
MA administered Pfizer booster vaccine at 9:47am. MA came to this RN to notify that pt felt nauseous at 9:50am. Instructed MA to give pt graham crackers and cranberry juice. After 3 minutes, this RN went to check on pt. Pt stated she felt chest pain and pointed to her mid sternum. Pt stated it was a dull, throbbing pain and 8/10 on pain scale. Pt is an asthmatic and stated "she never felt like this before." This RN informed MA to call the medical emergency phone number and instructed MA to get AED in parking garage office and notify manager.    This RN asked if pt had difficulty breathing or throat swelling. Pt stated she felt fine. This RN determined to place the pt on 2L of O2 via venturi mask. Pt stated she could breathe better, but still felt nauseous. 3 minutes later, pt stated, "her throat was closing in." This RN administered epi x1 0.3mg IM at 10:10am. Removed pt from car and placed on ground. Pt stated she felt nauseous and started coughing. Turned pt to left side. Pt asked if she could sit up and use her inhaler in the car. RN manager arrived on scene. This RN gave pt's inhaler and she administered 2 puffs every 2 minutes that totaled 6 puffs. Pt remained on 2L of O2 . At 10:20am, pt stated she "felt better." Ambulance and public safety arrived to scene. Safety report submitted
A couple days later I developed awful nausea, loss of appetite and energy but never ran a fever. Which lasted 9/19 I developed a really bad headache and severe congestion preventing me from laying down. My symptoms got worse triggering my Asthma to flare up. My cough got so bad it had my lungs hurting so bad. Loss of appetite and energy and I developed a fever of 103 so on 9/22 I got a COVID test and it was positive. 9/28 I went to the Center and was administered the monoclonal infusion and IV fluids because they stated I was severely dehydrated. My breathing treatments have been increased to every 4hrs now and my 02 level is being monitored and if it drops to a certain level I have been advised to call 911.
Patient received 2nd dose vaccine of Moderna and should have received 2nd dose of Pfizer
Vanishing point syringe used for dose of 0.05mL . Pushed to retract and needle did not retract from arm. Slight reddness to Deltoid. Area marked and pt sent to local ER to have needle removed.
pt presented to office w/rash on upper legs & abd w/spots on lower legs, arms, chest on 10APR97;pt had fever 8APR97 tx w/zovirax & APAP;
Pt recvd vax 14AUG92 & on afternoon of 14AUG92 pt devel fever, generalized aches & pains, h/a, sore arm & swelling @ the inject site;
This spontaneous report as received from a medical assistant regarding a 26 year old female patient. The patient´s concurrent conditions include gastrooesophageal reflux disease. The patient did not have pertinent medical history, drug reactions or allergies. Concomitant medicines include an unspecified birth control pill and unspecified multivitamins. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, lot# and exp date were not provided) for prophylaxis. The dates of administration for the three doses of GARDASIL were unknown, but it was confirmed that the patient received the full 3-dose series, and completed the GARDASIL  series when she was around 12 years old. The reporter mentioned that around December 2017 the patient had a "pap smear" and the results showed she was "positive for human papillomavirus (HPV)  18". The primary reporter reported that around December 2017 the patient also had a cervical biopsy performed that resulted positive for "squamos intraepithelial lesion" (Cervical dysplasia)". On 08-JAN-2018, the patient underwent an unspecified "Cryosurgery" in the office to treat the 8HPV) 18 and Squamous Intraepithelial Lesion. The patient´s outcome was reported as recovering. The relatedness of GARDASIL and the adverse events was not provided. Upon internal review squamous intraepithelial lesion and positive for human papillomavirus (HPV)  18 requiring cervical cryotherapy were considered medically significant.
Physical Aches; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.            No treatment medications were provided.   Reporter did not allow further contact
Patient stated that he had permanently lost sense of smell after the second dose.  Stated he started the day after and has not returned.  Denied that he has or had covid.  Advised patient to seek medical care from primary care doctor, but stated he does not have primary care doctor and was not going to seek any additional care.
This was my 1st shot of the Moderna Covid vaccine. I was fine after the shot was made but as the evening came towards the night, I started having the chills, lots of shivering and a slight fever (99 degrees). It felt as if I was having Covid again.  I took 2 - 500 mgs of Tylenol Extra Strength as a precaution in case it got worse.  The next day I felt very tired throughout the day and at night time I didn't feel as bad as the 1st night but I felt nauseous and muscle pains everywhere so I took another 2 Tylenols, it got better then went to sleep.
Information has been received from a registered nurse concerning a 27 year old female mall carrier with sulfa, penicillin, amoxicillin, lidocaine and Ceclor allergies who on 02-MAY-2007 was vaccinated IM into the left deltoid a third dose of GARDISIL (lot # 653938/0954P). The patient received her first dose of GARDISIL on 02-NOV-2006 and her second dose on 04-JAN-2007. Concomitant therapy included "Queruatin". On 02-MAY-2007 the patient experienced prolonged injection site pain and decreased range of motion in her arm. The pain began on the day of the of vaccination and had become more severe since that time. The patient called the office on 08-MAY-2007 and complained of very sore arm and "clicking sound in arm" with no redness or swelling. The patient was seen in hte office on 09-MAY-2007. No inflammation or edema was noted at that time. It was noted that the patient had missed 3 days of work. No labs were performed. At the time of this report, the patient had recovered. Additional infortmation is not expected.
Had vaccine and had them 4 times after/Suspected vaccination failure; had them 4 times/has had them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 2 times prior to the vaccination).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 30-Sept-2022 Reporter's comment: The case was received from the patient's children via interactive digital media. The patient has had them, a total of 6 times. The patient had the vaccine after the 2nd time and had them 4 times after. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Stroke; BNT162B2 (First dose: 28-DEC-2020;  second dose: 14Jan2021); BNT162B2 (First dose: 28-DEC-2020;  second dose: 14Jan2021); This is a spontaneous report from a contactable other health professional (patient). A 57-year-old male patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 14Jan2021 (at the age of 57 years; as reported) at a single dose in the left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 28Dec2020 in the left arm for COVID-19 immunization. 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 had a stroke on 01Feb2021 at 15:00. The event resulted to  emergency room/department visit and physician office visit but was not given any treatment (as reported). The patient was hospitalized for stroke for 27 days. The event was considered serious, life threatening, and disabling/incapacitating. Patient's nasal swab test on an unspecified date was negative. The outcome of stroke was not recovered.; Sender's Comments: Based on know n drug profile  it is unlikely that the reported cerebrovascular accident was causally  related to  BNT162B2.  This is probably an intercurrent medical condition.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the product and on the conduct of the study are evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Patient reported red, itchy rash approximately 4 inches above to 4 inches below left elbow. Started about 1 week after dose 1 of SHINGRIX, seemed to improve after about 1 week, but then got worse again. Pt visited pharmacy for consultation on 3-1-19. RPh logged info and called GlaxoSmithKline to report event. Spoke with medical info. who stated prior anecdotal reports.
A few hours post vaccination I had a metallic taste in my mouth.  Approx. 12 hours post vaccination I awoke with chills and muscle ache and headache.  The headache lasted the entire day along with moderate fatigue. (took two naps during the workday totaling 2 1/2 hours and went to bed a 9pm).  When I awoke the following day all signs were gone (except for mild arm soreness that lasted another 24 hours but not an impairment)
soreness from shot, some traveling of pain through arm immediately after shot. Did yard work to keep movement, soreness subsided.  Approx 6:00 am  developed chills, dizziness with movements, nausea, stomach cramps, constipation, fatigue, stomach discomfort when drinking water, or eating, slight headache, gradually chills increase,  stayed in bed, no medications taken. 24 hours no chills or nausea or stomach pains. Just a slight headache.
I had a runny nose, cough, fatigue, nausea, was lightheaded, body aches, congestion, mucus drainage. I had to sleep sitting up, fever, chills. I used a home COVID-19 test that came back positive right away, I had a fever of 102.2F. I called and had a telehealth visit and was prescribed PAXLOVID, that I started taking immediately. I did get rebound COVID-19 and was prescribe a Z-PAK and KEFLEX that took care of the lingering COVID-19.
Arm got more sore as the day progressed. Then later abdominal pain and slight chills. Then body aches for the evening/night and a very intense headache. By late morning the headache improved with the aid of Tylenol. Still some joint pain.
60 year old female received the HIGH Dose Fluzone Vaccine for people >65 years old.