chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; Nausea; Fever; Shivers/ Chills; Shakes; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of lethargy (on 9th or 3rd March the patient received 1st dose and experienced lethargy, reference case US2023AMR120465) and Tylenol (did take 4 Tylenol over the course of the lethargy). Concomitant products included TETANUS VACCINE TOXOID (TETANUS SHOT).   On 28-AUG-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. In AUG-2023, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: Fever), shivers (Verbatim: Shivers/ Chills) and tremor (Verbatim: Shakes). On 31-AUG-2023, the patient experienced diarrhea (Verbatim: Diarrhea) and nausea (Verbatim: Nausea).  The outcome of the fever, shivers, tremor, diarrhea and nausea were not resolved.   It was unknown if the reporter considered the fever, shivers, tremor, diarrhea and nausea to be related to Shingrix.     It was unknown if the company considered the fever, shivers, tremor, diarrhea and nausea to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR120465   Additional Information: GSK receipt date: 01-SEP-2023 Reporter was the wife calling on behalf of her husband. The patient received the 1st dose of Shingrix most likely in his left arm (reporter was not sure), on either March 3, 2023 or March 9, 2023 (reporter was not sure), and reports the patient was lethargic. The patient received his 2nd dose of Shingrix, and had fever of 102 degree Fahrenheit, chills, shakes, and shivers that night, and is still experiencing these adverse events today (on the day of reporting. The fever went up to 102.7F the next day, 29 August 2023.  The patient also started having diarrhea and nausea yesterday (the day before reporting), and still had those adverse events.  The Patient did go to his health care professional (HCP) office today (on the day of reporting) and had a Covid and Flu test that were negative, and blood work drawn that was not back yet. Reporter also reported the patient had a Tetanus shot (no further information provided), 3 weeks before the 2nd dose of Shingrix, at his HCP office. The wife consented to follow up with HCP, and said she had power of action  (POA) for her husband. For the tolerance of 1st dose reference case US2023AMR120465, by same reporter.; Sender's Comments:  US-GSK-US2023AMR120465:Second dose
Left hand numbness. Tingling - bilateral hands, feet & legs(bilateral) tingling, couldnt get up to walk at one point. lower legs weak, difficulty walking. Right leg is dragging. Severe fatigue. Blood Pressure very high. Arm weakness.
Pain in arm that received the shot.  Could not move arm laterally from her side without experiencing pain.
INCORRECT PRODUCT STORAGE; RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional 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: 1822809 expiry: UNKNOWN) dose was not reported, administered on 25-FEB-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported.  On 25-FEB-2022, the patient experienced received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649370, 20220649804, 20220649045, 20220649137, 20220649417, 20220649421, 20220649488, 20220649626, 20220649884, 20220649915, 20220649803, 20220650014 and 20220650185.
Shortness of breath on 12-31-20 about 9 hours Numbness in legs and feet on 12-31-20 about 9 hours Weakness on 12-31-20 about 9 hours Tiredness from 12-31-20 for 6 days
Warm to touch; Hard shaped; Big red spot at injection site; Muscle shaking from knee t upper head; Felt weaken; Muscle soreness that extended trough left arm; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE TWITCHING (Muscle shaking from knee t upper head), ASTHENIA (Felt weaken), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hard shaped) and VACCINATION SITE PAIN (Muscle soreness that extended trough left arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011320A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anal dilation procedure. Concurrent medical conditions included Allergy to nuts, Drug allergy (allergic to cipro, morphine and ibuprofen products.) and Ulcerative colitis. Concomitant products included LORATADINE (ALLERCLEAR) for Allergy, RAMIPRIL for Blood pressure management, VITAMIN D NOS for an unknown indication.   On 06-Jan-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Muscle soreness that extended trough left arm). On 09-Jan-2021, the patient experienced MUSCLE TWITCHING (Muscle shaking from knee t upper head) and ASTHENIA (Felt weaken). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hard shaped) and VACCINATION SITE ERYTHEMA (Big red spot at injection site). On 08-Jan-2021, VACCINATION SITE PAIN (Muscle soreness that extended trough left arm) had resolved. On 10-Jan-2021, MUSCLE TWITCHING (Muscle shaking from knee t upper head) and ASTHENIA (Felt weaken) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE INDURATION (Hard shaped) had resolved and VACCINATION SITE ERYTHEMA (Big red spot at injection site) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MUSCLE TWITCHING (Muscle shaking from knee t upper head), ASTHENIA (Felt weaken), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hard shaped), VACCINATION SITE PAIN (Muscle soreness that extended trough left arm) and VACCINATION SITE ERYTHEMA (Big red spot at injection site) to be possibly related.    This case was linked to MOD-2021-075517 (E2B Linked Report). This case was linked to MOD-2021-075536, MOD-2021-075536 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Medical history, concomitant medications, suspect product details, event details and reporter causality was updated.; Sender's Comments:  MOD-2021-075517:Reporter's mother case
Patient reported itchiness all over body while in the after vaccination monitoring area. No hives, redness or swelling present. Symptoms improved after 15 minutes. Patient reports she will take an antihistamine at home. Patient reports using a new detergent that could have caused this.
trouble earing; lost domain little bit; some swollen on her hand, arm and feet's; couldn't do very much; Low energy; arm sore; chills; Fatigue; occasional headache; body ache; some swollen on her hand, arm and feet's; many strong palpitation/constant palpitation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (many strong palpitation/constant palpitation), HYPOACUSIS (trouble earing), DISSOCIATION (lost domain little bit), PERIPHERAL SWELLING (some swollen on her hand, arm and feet's) and MOBILITY DECREASED (couldn't do very much) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.  The patient's past medical history included Coronary artery disease since 18-Jun-2019, Atrial fibrillation in 2009 and Primary progressive multiple sclerosis on 31-Mar-2016. Concurrent medical conditions included Hearing decreased and Hypertension. Concomitant products included RIVAROXABAN (XARELTO) for Atrial fibrillation, PRAVASTATIN for Cholesterol, AZILSARTAN KAMEDOXOMIL (EDARBI), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and HYDRALAZINE for Hypertension.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PALPITATIONS (many strong palpitation/constant palpitation), DISSOCIATION (lost domain little bit), PERIPHERAL SWELLING (some swollen on her hand, arm and feet's), MOBILITY DECREASED (couldn't do very much), ASTHENIA (Low energy), AXILLARY PAIN (arm sore), CHILLS (chills), FATIGUE (Fatigue), HEADACHE (occasional headache), MYALGIA (body ache) and VACCINATION SITE SWELLING (some swollen on her hand, arm and feet's). On an unknown date, the patient experienced HYPOACUSIS (trouble earing). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. On 03-Mar-2021, PERIPHERAL SWELLING (some swollen on her hand, arm and feet's), MOBILITY DECREASED (couldn't do very much), ASTHENIA (Low energy) and VACCINATION SITE SWELLING (some swollen on her hand, arm and feet's) had resolved. At the time of the report, PALPITATIONS (many strong palpitation/constant palpitation), DISSOCIATION (lost domain little bit), AXILLARY PAIN (arm sore), CHILLS (chills), FATIGUE (Fatigue), HEADACHE (occasional headache) and MYALGIA (body ache) was resolving and HYPOACUSIS (trouble earing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Patient demographics were updated, Medical History information added, concomitant medications added, new events added and outcome of events updated.
In both instances after receiving the vaccines she initially felt tingling in her lips for about 20 minutes; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (In both instances after receiving the vaccines she initially felt tingling in her lips for about 20 minutes) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 073A21A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia, Arthritis, Temporomandibular joint dysfunction, Neck pain and Muscle pain.   On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 22-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 19-Apr-2021, the patient experienced PARAESTHESIA ORAL (In both instances after receiving the vaccines she initially felt tingling in her lips for about 20 minutes). At the time of the report, PARAESTHESIA ORAL (In both instances after receiving the vaccines she initially felt tingling in her lips for about 20 minutes) outcome was unknown.            No concomitant medication details were provided. No treatment medication details were provided.
Pt reported that she experienced pain in the affected arm about 2 hours after the injection and was "unable to lift groceries" that evening.  Pain persisted, and she reports having needed f/u with her primary care provider twice.  Pt reports that she was treated with oral steroids and pain medication, and reportedly missed work for a few days.
10/16/02 pt reported symptoms of chills, achiness, diarrhea, cramps 2 1/2 hours after receiving typhoid VI and yellow fever vaccines. pt also c/o night sweats night of 10/15/02. By 10/17, pt states she was feeling "better" but still "a little under the weather with 'dragging' feeling." Pt states she is fuller functioning and is able to work.
Couple of us in our office received the moderna vaccine and had the COVID arm; rash; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Couple of us in our office received the moderna vaccine and had the COVID arm) and RASH (rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Couple of us in our office received the moderna vaccine and had the COVID arm) and RASH (rash). At the time of the report, PAIN IN EXTREMITY (Couple of us in our office received the moderna vaccine and had the COVID arm) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Bells Palsy 20days after dose. 1-08-2021 Right facial paralysis with frequent watering of the eye and nose on the right. Fatigue, cough
Second Dose Less than 21 Days After the First Dose; Chills; Couldn''t Sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 01Feb2021 (Lot number: EN5318) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "he has a form of cancer" (unspecified if ongoing); "CLL" (ongoing), notes: For several years, Pertinent details: None. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Lot number: EL1284, Anatomical site of injection: Arm), administration date: 14Jan2021, when the patient was 71 years old, for COVID-19 immunization, reaction(s): "couldn''t sleep", "nauseous", "chills". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; INSOMNIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Couldn''t Sleep"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Second Dose Less than 21 Days After the First Dose".  Additional information: He had chills and could not sleep and was better the next day.   Follow-up attempts completed. No further information is expected.
1 day after: sore arm, fatigue, hot flashes and sweats  8 days after: rash on left arm. itchy, hot, swollen, and sore. Rash began 3/19/2021 and is still spreading.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 21-MAY-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H020002, expiry date 08-AUG-2015), with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Beginning approximately 72 hours after receiving his first dose of the Moderna, he noted redness around the injection site of the left arm. He said the area felt warm to the touch and was slightly itchy. This lasted for 3-4 days before it resolved on its own without treatment.  Today (13 days post vaccination) he noted the rash on the left arm return but it was fainter than when it first came up around 72 hours after vaccination. He states the area today is 3.5 inches by 1.5 inches in size on the left arm only.  He denies other symptoms or changes in  skin care routine.
NAUSEA, DIZZINESS, INJECTION SITE SORENESS/PAIN, LOW GRADE FEVER, BODY ACHES.
Pt developed swelling of her arms and shoulders towards the later part of the summer with muscle pain and hardening of the muscles beginning in September 2007.
Vaccination site became large red circle and has itched since day one. Approximately 48 hours later I began to have a headache and ran a fever of 101.4 with body aches and slept almost the entire day. The next day my temperature was 100.6 with headache but no body aches but I had nausea for the next for the next 48 hours. I had really bad night sweats for 3 nights. On 3/8 I developed a red bump the size of a dime in the center of my rash on my arm.  The arm has itched the entire time. On 3/9 I woke up feeling better finally but itching still persists but compared along with the other side effects it?s nothing.
I started to feel my leg starting to shake on and off but when the weekend came around , it started to shake more and more and the pain started to spread
Red lump at site of injection noted 24h after injection - also sore. Advised to apply ice and may take OTC TYLENOL or Ibuprofen for discomfort control.
Headache every day since shot wife also..shot injection site sore 10 days..sore throat sinus issues..
Not too many adverse symptoms the day of and after vaccine... tired at times and sensitivity to light but continued to eat and helped w energy.   Also, warm left side of neck and slight red rash.  Not expecting to have leg pain in my calf 6 days later then moved to quad muscle and entire left leg felt achy.  CDC at this point said to check out any leg pain.  Pain was not severe but bothersome... had STAT ultra sound at ER on day 7, turned out negative for blood clots.  Returned to my physicians office day 8... still not feeling right with more of a rash on left side of neck and warm to the touch. Tired and slightly light headed and slight pain in left upper chest.  Digestion not the best starting day 5 thru 10.  Blood test returned normal for platelet levels but low eosinophils... either allergies or body is fighting the vaccine and creating antibodies (most likely).  No known allergies besides maybe skin reaction to Timothy Bluegrass.  Moderate headache day 9 and 10 which made me more fatigued (pain on both sides of head above ears and temples)... normally I do not get headaches.  Also, loss of appetite or feeling slight nauseous on day 8, 9, and 10 after the vaccine.   Now on day 11 and 12.. feeling better but still not quite right.  Lightheaded and feeling fullness in head but more energy than day 9 and 10 by far.  Never heard of people having symptoms after day 1 or 2 of the vaccine, so obviously I think this should be more documented for patients especially after blood clotting as a possibility 6 days after the vaccine.
2 days p/vax pt exp a varicella like rash all over body. addl info requested
Headache, very tired, muscle aches, joint pain, muscles aches, soreness in arm and I really didn't feel well.They were alot more intense symptoms than the first dose. I was down and couldn't function. I took Ibuprofen and tylenol - and it helped with aches and pains a little but not with tiredness and overall feeling bad. I took the 3rd and 4th off but went back to work on 5th although I was sluggish. Felt a lot better on Saturday.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Pt felt weak after vaccine, I asked if she would like further medical attention and me to call 911. She said yes, Ambulance and medical team came, she declined treatment. Pt left about 2 hours after recieving vaccine
p/vax pt exp fatigue (chronic); tiredness; night sweats & weakness; symptoms still persist; symptoms appear to be occurring on a more rapid time of onset & for a longer period of time (following each anthrax shot); pt has had 3 to date
Immediately after injection I had a hot flash, then passed out. Just for a moment. A EMT was at my side. I sat until able to stand and was put in the EMT area. I sat for an hour and then drove back to school. I realized I should not have driven, feeling quite "drunk". Once I arrived back at school I asked to go home and one of my co workers drove me. I went home and went to bed. At about 10:00 p.m. I noted a fever of 103. The fever and headache lasted for a day. The flu like symptoms for two days. I returned to work after that and had no further issues.
The patient reported feeling very sick to her stomach, nauseous, had burning sensation in the left arm, redness, and swelling in the left arm. She said she took BENADRYL which made her feel better.
Anaphalaxis, began as red face within 15 minutes. (prepped for injection with 50mg of Liquid benadryl 1/2 hour beforehand). On left side of face, swollen eye, swollen gland swelling and numbness left side of mouth.  Treated with 2 epipen injections, Bendryl IV and predinisone. Swelling  began to withdraw over 3 hours. Continued Benedryl every 4-6 hours for two additional days
A report has been received from a health professional concerning a, subject of unknown gender, who had been receiving FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres. FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that FLUMIST that was in a fridge that went down to temps as low as 0.8 degrees Celsius nightly from 15-Oct-2015 to 05-Nov-2015 and that there were greater than 3 freezing episodes and the fact that it may not be stable any more which started on 15-Oct-2015. FLUMIST QUADRIVALENT (intranasal) was continued. The outcome of the event of FLUMIST that was in a fridge that went down to temps as low as 0.8 degrees Celsius is unknown. The report was considered to be non-serious.
Second dose of Shingrix administered on 8/15/20, pt reported having normal pain at injection site that day, but placed cold compress on arm at that time.  Pt woke up on 8/16/20 and indicated that she had a fever of 99.7, and now had a red splotchy area  around the injection site.  Pt took Motrin and temp went down to 98.2.  Pt reported temp now gone, but red splotchy area has gotten larger and is moving down the arm.  Recommended she contact her physician and call us when done.  Follow up message left for pt to call us back.  Pt reported not having this reaction with her first dose of Shingrix 5/2020.
Arm pain for several days after injection.  Ongoing numbness, pain radiating up & down arm into hand and neck