chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain on the right side of her face; Earache; Jaw pain; Headache; Linear rash along her jawline; Soreness at the injection site; Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th May 2022, the patient received the 1st dose of Shingrix. On 13th May 2022, 1 days after receiving Shingrix, the patient experienced injection site pain and muscle pain. On 23rd May 2022, the patient experienced facial pain, ear pain, jaw pain, headache and rash. On an unknown date, the outcome of the injection site pain, muscle pain, facial pain, ear pain, jaw pain, headache and rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, muscle pain, facial pain, ear pain, jaw pain, headache and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-MAY-2022 Reporter's Comments: The reporter was patient who called to report side effects from Shingrix vaccination. She stated she received her first dose of Shingrix and the following day after vaccination, she developed soreness at the injection site and muscle pain (Myalgia). The patient states these symptoms was gotten better but not completely resolved. The patient also stated that early week approximately 23rd May 2022, 11 days after receiving Shingrix she began to develop pain on the right side of her face, an earache, jaw pain, headache and a linear rash along her jawline. These had not yet resolved. The patient was referred to healthcare professional and provided medical advised disclaimer. The reporter was consented to follow up.
Muscle fatigue; Chills; Headache; Fatigue; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on an unspecified date at a single dose then intramuscularly (left arm) on 05Jan2021 18:30 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. There was no relevant medical history. The patient had no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Jan2021 19:00, the patient experienced Muscle fatigue, chills, headache and fatigue. No treatment was provided in response to the events. The patient assessed the events as non-serious. The patient underwent COVID test post vaccination via nasal swab (PCR) on 21Dec2020 and was negative.  The outcome of the events was recovering.   No follow-up attempts are possible, information about lot/batch cannot be obtained.
Muscle soreness at injection site. Chills starting 18 hours after injection & lasting for several hours.; Muscle soreness at injection site. Chills starting 18 hours after injection & lasting for several hours.; This is a spontaneous report from a non-contactable consumer (patient).  A 51-year-old female patient received the second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot EL3248), via an unspecified route of administration in the right arm 02Feb2021 08:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included high blood pressure. She had her first dose of bnt162b2 (lot EL3248) in the right arm and she had muscle soreness at injection site. Concomitant medications included lisinopril, amlodipine and potassium. The patient experienced muscle soreness at injection site and chills starting 18 hours after injection & lasting for several hours on 02Feb2021, no treatment reported. The outcome of events recovered.    No follow up attempts are possible. No further information is expected.
Huge hives on my arm at first then in my stomach. After second dose, swollen lips every few days for months after shot.
Within first six hours: localized and systemic muscle soreness, mild nausea; Nausea and systemic muscle soreness resolved within 6 hours, localized site soreness resolved within 48 hours
second dose of Shingrix outside of the time frame recommended due to the COVID; This case was reported by a physician via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 6 months ago on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The physician stated that, several of their patients would be receiving the second dose of Shingrix outside of the time frame recommended due to the COVID vaccine, which led to social problem. The reporter stated that, approximately 10 or 20 of the patients did not yet receive the second dose of the vaccine and 6 months from the first dose already passed. There were no details on each one of the patients and the doctor preferred not to be contacted for follow up. No further events were reported. The reporter did not consent to follow up.
Ache; Tiredness; Fever/LOW GRADE FEVER; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), FATIGUE (Tiredness) and PYREXIA (Fever/LOW GRADE FEVER) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced PAIN (Ache), FATIGUE (Tiredness) and PYREXIA (Fever/LOW GRADE FEVER). At the time of the report, PAIN (Ache), FATIGUE (Tiredness) and PYREXIA (Fever/LOW GRADE FEVER) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: 24.83 out of 25, Very high.         No concomitant medication information provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication information provided.
I had a headache, left ear hurt, I never had a fever, I used a home COVID-19 test that came back positive, I called my doctor let her know. She prescribed the PAXLOVID, that I was able to start the next. I started to feel better two days later, I did have fatigue, but I was feeling better. Within two days I started testing negative and was never positive again. I attribute this to my having all the vaccines.
Got the third shot and felt the same way: It gave him energy too; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Got the third shot and felt the same way: It gave him energy too) in a male patient of an unknown age 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) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Got the third shot and felt the same way: It gave him energy too). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Got the third shot and felt the same way: It gave him energy too) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
fever; Chills; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-020771.
Several pts recv vax & devel low-grade fever,chills, nausea, h/a, & redness @inj site. This is 1 of 2 reports from this facility of adverse rxn after vax with this lot #.
NOT FEELING GOOD; This spontaneous report received from a patient 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 not reported, batch number: Unknown) dose, start therapy date were not reported 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 subject experienced not feeling good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling good was not reported. This report was non-serious.
HEALTHY FIT GOLFED 3-5 DAYS PER WEEK FOR PREVIOUS 12 MONTHS; NINE DAYS AFTER FIRST DOSE 'HIT A WALL' ON HOLE 5...DIDN'T KNOW IF I HAVE ENOUGH ENERGY TO WALK TO CAR.  MULTIPLE DRS OVER MONTHS LATER, HAVE 'ADRENAL INSUFFICIENCY'  4 MONTHS OF EXTREME FATIGUE, BRAIN FUZZY MUDDLED WHICH CYCLES DURING DAY.  ONLY 'REMEDY' MEDROL DOSE PACK.  ON HYDROCORTISONE NOW 15 MG + 5 MG PER DAY WITH LITTLE RELIEF.  UNKNOWN TREATMENT OR CURE AT THIS TIME.
Fully vaccinated patient who tested positive for COVID with admission testing to hospital.  Patient admitted 05/25/21 after an out of hospital cardiac arrest with return of spontaneous circulation after EMS arrival and administration of epinephrine and shock.  Patient intubated upon arrival to ED and provided hypothermia protocol.  Patient did not have return of consciousness.  Encephalopathy and acute to subacute brain infarct per MRI and "severe diffuse encephalopathy" per EEG. Family requesting continuation of "aggressive care."  PEG tube placed, feedings were not tolerated so patient was sent back to surgery for removal of PEG and placement of J tube for feedings during which time she was found to have necrotic stomach from ischemia.  Family meeting including Palliative Care team and family chose to change to comfort care.  Patient was removed from ventilator on 06/24/21 and died shortly after.
Infection of finger-swollen-puss under skin-before after-within 20 minute of shot in the sun, felt very weak-just funny feeling-out of sun ok-later 10 min in sun again, sick again-been weak-sleepy-since.
Muscle aches, joint pain, fatigue, headache, chills, redness 4mm around injection site, enlarged lymph nodes, arm swelling
Swelling , redness , warmth at injection site. Area the size of a baseball slightly raised , itchy and then tender - lasted 4-5 days. Treated with prednisone x 7 days.
neck pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination.     The patient's past medical history included Angina pectoris since an unknown date. Concomitant products included GLYCERYL TRINITRATE (NITROGLYCERIN TRANSDERMAL SYSTEM) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced NECK PAIN (neck pain). At the time of the report, NECK PAIN (neck pain) outcome was unknown. Not Provided          Treatment information was unknown   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up received on 03-MAY-2021, contains no new information.
Vaccine given 09/17/2020. Rash started over the weekend. Flat, blanching blotchy rash on face/abd, non pruritic, non tender.
Pt's left arm was bruised and painful from the left shoulder down to the elbow, black and blue.
Redness noted on upper arm on 3/28/2017 that gradually spread towards elbow. Redness and warmth noted. Doxycycline 100mg bid and hydroxyzine prescribed for itch.
12/22 vaccination 12/24 48 hour after started to have nasal drip, sore throat. 12/26/2020 low grade fever  12/28/2020 chest congestion; COVID 2nd test; negative  sore throat, nasal drip x2 weeks
Pfizer / BioNTech / Treatment of COVID-19; Pfizer / BioNTech / Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1 , single (Lot number: EN6206), in left arm, on 07Apr2021 at 01:00 as dose 2 , single (Lot number: EW10151), in left arm and on 10Nov2021 at 01:00 as dose 3 (booster) , single (Lot number: FF2588), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Hight cholesterol" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Chest X-ray: Unknown Result; SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course Completed Paxlovid on 08May2022. On 14May2022, developed runny nose, low grade fever, cough, congestion. Went to the ER on 15May2022 to rule out pneumonia. Negative for that. Negative for flu. Prescribed antibiotics. Fever gone within 48 hrs. Was still testing positive for Covid throughout. dr wasn't convinced my symptoms were Covid related. the patient was not so sure. The patient's husband tested positive on May2021, 17 days after the patient originally tested positive. It's baffling. The patient believed that patient may have experienced rebound symptoms after taking Paxlovid. The patient was still experiencing some nasal congestion and cough.
Scratchy, dry throat at 18:00 1/6/2010 turned to sore throat by 05:00 1/7/2010. Other symptoms at this time included nasal congestion, aches, skin hypersensitivity. Fever of 101 degrees Fahrenheit noted at 21:35 on 1/7/2010.
No adverse event; Vaccine was administered to 8 patients after 1 day of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 prophylaxis.     Medical History or Condition was not reported.     On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry).      Reported patients were both male and female, none of the patients reported being pregnant or breastfeeding. Concomitant product use was not provided by the reporter. Expiry date of the vaccine was 04-Apr-2022. All of the vaccine administered were boosters. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided.   This case contains information about patient 8th out of 8 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735621:Master case, Patient 8 out of 8
Within minutes arm swollen - "Size of a pigeon egg". Receiving Epinephrine SQ, paramedics called. Was not transported to hospital.
No additional AEs or PQC reported; expired dose of VARlVAX administered; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 28-JAN-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 mg, lot # T002846, expiration date 23-JAN-2022; strength and anatomical location were not reported) subcutaneously (SQ) for prophylaxis (expired product administered). No additional adverse event (AE) or product quality complaint (PQC) was reported.
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot# not reported). It was reported that on an unknown date a female patient fainted after receiving GARDASIL (MARRS# 1408USA015205). The male patient experienced the same reaction after receiving GARDASIL. The outcome of the event was unknown. It was unknown if the patient sought medical attention. This is one of the reports from the same reporter. Additional information has been requested.
pt mom noticed a rash 9JUN98 gave DPH rash worsened;came to office 10JUN98;cont tx w/DPh & prelone;
After vaccination, patient fainted  and by the time got over to him he was alert.  He was able to sit up and then was able to get into the chair. While in the chair he appeared to faint again ( looked like he was asleep in chair)  and 911 was called.  Patient states he had not eaten today and this was late afternoon.  He also said he was nervous.  EMS arrived and he agreed to go get checked out.
This spontaneous case, initially received on 19-Dec-2016, was reported by a health professional and concerns a(n) 44-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 22-NOV-2016 to 22-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT57008. No additional suspect drugs. Between 20-Nov-2016 and 21-Nov-2016, the AFLURIA vaccine underwent first excursion. The vaccine was stored at 35.78 degree F for about 2 hours. The pharmacist stated that the thermometer was fluctuating in the previous location in the refrigerator and was moved to the top shelf. On 22-Nov-2016, the patient received the vaccine that underwent temperature excursion. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
Pt describes that she felt symptoms after vaccination. She felt "light-headed", "shaky", "racy heart". Today she awoke this morning feeling numbness in the left leg. Advised her to consult her PMP. Conformation that 25 year old female had reported recovery by 10/12/01. Best information available indicates that pt has had no previous doses of flu vaccine and that she has no history of adverse events related to vaccines.
The patient reported severe burning hours later. The is a retired pharmacist and said it was nothing like anything she had ever experienced before in her vaccine history. She stated the pharmacist who gave the vaccine had good technique.
pt recvd vax; during noc noticed feeling of warmth & soreness; in am, site was swollen & red which has spread from inject site to elbow; warm to touch & pink; called MD but MD did not return call & redness is almost gone; feel better;
Other than manageable high blood pressure, I have never had a medical event  in my life.  Never admitted to a hospital.  Until April 2021 and continuing through this date.  The few days following the 2nd Moderna received on 4/1/21  were uneventful.    But, 4/11 I started getting dizzy and the morning of 4/12  I could not walk and was throwing up from dizziness for 3 days.  It then subsided somewhat, but I have continued to be dizzy and have a dull throb in my head through this date. On 4/18 I broke out in shingle for the first time in my life.  On 4/30  I was admitted to Emergency for very low blood pressure and high heart rate. I have had Echocardiograms,  chest MRIs,  Head and Neck MRI's.  A Heart Monitor.   Nothing has shown anything more than an average 59 year old.   I have seen my Primary,   A Cardiologist and a Neurologist.  Nobody knows what the answer/diagnosis is.
in a lot of pain could not walk p/3rd inject; completed series but cont to c/o severe pain & will not walk; pain mostly in achilles tendon area; bitten by cat 4-5 wks ago;
This spontaneous report was received from a registered nurse, referring to an 85 year old patient of unknown gender. Information about the patient's medical history, concurrent conditions and concomitant medication were not reported. On 03-JAN-2015, the patient was vaccinated with PNEUMOVAX 23 (dose and route were not provided, lot # K008927, expiration date was not provided). Then, on 13-NOV-2015, patient received another dose of PNEUMOVAX 23 (dose and route were not provided, lot # K021881, expiration date 30-JUL-2016). No adverse event was reported. Additional information has been requested.
On Oct. 25, I had a sore throat. Over the next few days, I developed a cough and lots of sinus drainage. Soon, the sinus drainage became mainly congestion with an occasional cough. Within a week or a week and a half, it started to feel like I was getting a sinus infection (cough and pain in my upper molars). On Oct. 30, I went to an immediate care facility and got a rapid COVID test, which came back negative. A few days later, I went on a strong, 12-hour decongestant (generic of Claritin), which helped a bit but not much. After being sick for two and a half weeks, I went to the doctor, on Nov. 11.  He informed me that this kind of ongoing sinus congestion has commonly been seen in those with the COVID vaccine that came down with COVID, but he did not say for sure that this was my case. Since I was past the two week point of sickness, he didn't feel it was necessary to test me for COVID, so I chose not to be tested that day. He prescribed an antibiotic, which has helped my congestion and illness go away.