chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatigue; swelling; vomiting; pain; chilis; fever; This case was reported by a physician and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fatigue, swelling, vomiting, pain, chills and fever. On an unknown date, the outcome of the fatigue, swelling, vomiting, pain, chills and fever were recovered/resolved.   It was unknown if the reporter considered the fatigue, swelling, vomiting, pain, chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient received 2 months ago the first dose of Shingirx and had fever, pain, chilis, swelling, fatigue and vomiting. The reporter did not provided patient's identifiers, no lot number nor expiration date provided, no vaccination date provided no date when the adverse events appeared and recovered provided. The reporter consented to follow up. This case has been linked with the case US2021010469 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021010469:same reporter
Nausea, vomiting and Diarrhea lasting for 30 minutes to 2 hours occurring every 10-12 days since second vaccine. 10 times so far since second vaccine. Not food or drug related, just out of the blue.
ON THE MORNING AFTER I RECEIVED THE FIRST DOSE OF THE COVID-19 VACCINE, I WOKE UP WITH PAIN IN MY RIGHT EYE AND THE RIGHT SIDE OF MY HEAD. AS THE DAYS PROGRESSED , I NOTICED THAT MY VISION IN THAT RIGHT EYE WAS BECOMING LESS AND LESS. I WAS ONLY ABLE TO SEE CLEARLY WHAT I WAS DIRECTLY LOOKING AT. THE REST WAS VERY CLOUDED AND HARD TO SEE THROUGH. ON 07/04/2021, I WENT TO THE EMERGENCY ROOM BECAUSE MY VISION WAS GETTING WORSE EVERY DAY AND I COULD NOT SEEM TO GET RID OF THE HEADACHE. THE EMERGENCY ROOM DOCTOR DID NOT KNOW WHAT WAS WRONG AND HE ADVISED ME TO MAKE AN APPOINTMENT TO SEE MY EYE DOCTOR. I SAW DOCTOR, EYE ONE, ON 07/07/2021. HE ADVISED ME THAT MY OPTIC NERVE WAS SWOLLEN AND THAT WAS WHAT WAS CAUSING THE LOSS OF VISION IN THAT EYE. DOCTOR M. DID NOT SAY WHAT HAD CAUSED THE SWELLING AND SEEMED TO THINK THAT THE ISSUE WOULD RESOLVE ON ITS OWN. HE ADVISED THAT IF MY VISION GOT WORSE TO COME BACK. OVERNIGHT THE VISION GOT WORSE SO I CALLED AND MADE ANOTHER APPOINTMENT. THIS TIME IN A DIFFERENT OFFICE OF EYE ONE BECAUSE DOCTOR M. WAS IN SURGERY THAT DAY. I SAW DOCTOR L. AND HE CONFIRMED THAT THE NERVE WAS SWOLLEN. HE HAD ME GO TO THE EMERGENCY ROOM AND GET A CT SCAN, MRI SCAN AND A LUMBAR PUNCTURE. EYE ONE ALSO REFERRED ME TO A NEUROLOGIST, DOCTOR H. I SAW HER ON 07/13/2021. SHE ADVISED THAT MY MRI CAME BACK FINE TO HER AND SHE SEEMED TO THINK IT WAS NOT ON THE NEUROLOGY SIDE BUT THE EYE DOCTOR M. I WENT BACK TO SEE DOCTOR M. ON 07/16/2021. AT THAT TIME HE COMPLETED A VISION FIELD ACUITY TEST, WHICH WAS ABLE TO ALLOW HIM TO SEE HOW MUCH OF A VISION LOSS WAS IN THAT EYE. HE THEN PRESCRIBED ME A MEDPAK OF PREDNISOLONE, 5 DAY SUPPLY. AT THE END OF THAT 5 DAYS, I HAD NOT SEEN ANY CHANGES. DOCTOR M. THEN PRESCRIBED A HIGHER DOSE OF PREDNISOLONE (60MG). WHEN I FINISHED THIS, I STILL DID NOT SEE ANY CHANGE. HE STILL HAD NOT GIVEN ME ANY DIAGNOSIS YET. ON 08/04/2021, I WENT TO SEE DOCTOR S. FOR A SECOND OPINION. AT THIS VISIT, I HAD ANOTHER VISUAL FIELD ACUITY TEST WHICH SHOWED THAT MY VISION HAD GOTTEN WORSE THAT THE FIRST ACUITY TEST. AT THIS VISIT, DOCTOR S. FINALLY GAVE ME A DIAGNOSIS. HE STATED THAT IT APPEARED TO HIM THAT I HAD HAD 2 STROKES IN MY OPTIC NERVE. HE SAID THAT MY VISION MAY IMPROVE A LITTLE BUT IT WOULD NOT GO BACK TO NORMAL COMPLETELY. HE PRESCRIBED ME SOME EYE DROPS THAT ARE GENERALLY USED FOR GLAUCOMA TO SEE IF THEY MIGHT HELP RELIEVE THE PRESSURE IN MY EYE. SO FAR IT HASN'T DONE MUCH. HE SAID THAT HE COULD NOT GUARANTEE THAT THE VACCINE CAUSED THIS BUT THAT IT WAS SUSPICIOUS THAT IT HAPPENED THE DAY AFTER THE VACCINE. HE RECEOMMENDED THAT I NOT RECEIVED THE 2ND DOSE BECAUSE IT COULD CAUSE ME TO LOSE THE VISION IN MY RIGHT EYE COMPLETELY AND/OR CAUSE THE SAME THING TO HAPPEN TO MY LEFT EYE. I ALSO HAVE AN APPOINTMENT ON 10/22/2021 WITH A SPECIALIST AT MEDICAL. THIS IS A NEURO-OPHTHAMOLOGIST, TO SEE IF SHE HAS ANY OTHER IDEAS ON WAYS TO GET MY VISION BACK.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: In June or July 2018, the patient received 1st dose of SHINGRIX injection in left arm. In 2018, the patient's arm hurt when the vaccine was injected. Later that evening, the patient's arm became very sore and lasted for a couple of days. The patient did not had a primary physician. She goes to a clinic only when she needs to and she said she was in good health. For tolerance to 2nd dose refer linked case US2018169203, reported for the same patient.
Pt presented for 1st dose moderna. Pt has hx of anaphylactic rx, personal epi pen with her. Pt received her dose, within 10 minutes patients stated she had tightness in her chest. Prior to the medical OICs arrival patient took 2 puffs from her personal albuterol inhaler. No hives, rash or redness present. 50 mg Benadryl given and pt observed for 5 minutes. VSS, lung sounds clear and O2 Sat 100%. Pt stated the tightness was progressing, along with numbness circumorally and tingling of her tongue, no swelling noted. Pts personal epi pen utilized with .3 mg epi. 911 called and arrived, upon standing to get onto the stretcher, the patient lost conciousness due to her POTS, EMS caught her and moved her to the stretcher,
Ringing in my ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in my ear) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bicuspid aortic valve, Cholesterol total abnormal NOS and Tinnitus. Concomitant products included ROSUVASTATIN, METOPROLOL, UBIDECARENONE (CO-ENZYME Q10) and VITAMINS NOS (MULTIVITAMINUM) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced TINNITUS (Ringing in my ear) (seriousness criterion medically significant). At the time of the report, TINNITUS (Ringing in my ear) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Prednisone, four tablets per day for five days. Approximately 30 to 45 minutes post administration of the vaccine, the patient experienced ringing in his ear.  Based on the current available information and temporal association between the use of the product and the onset date of the reported event of tinnitus, a causal relationship cannot be excluded. Prior medical history of tinnitus is considered a risk factor.   This case was linked to MOD21-072080, US-MODERNATX, INC.-MOD-2021-071450 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of tinnitus, a causal relationship cannot be excluded. Prior medical history of tinnitus is considered a risk factor. MOD21-072080:Crosslink US-MODERNATX, INC.-MOD-2021-071450:
Discovered that vaccine in frig and in use had a bud of 4/20/23 on 4/28 after administering vaccine 4/28
Developed chicken pox documented on 1/22/03 after receiving Varivax in past 4/26/99
1 of 2 pt from long-term care facility, out of 50 vaccinees, to die (of unspecified causes & p/an unspecified interval) following flu vax;
pt recvd vax & started staring off into space NOV90, DEC90 & JAN91; had high pitched hyena laugh NOV90 & DEC90; no response to conversation DEC90 & JAN91; decline in language NOV90 & DEC90; no language DEC90; babbling senseless sounds;
fatigue; Low grade fever; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fatigue, fever and incomplete course of vaccination. On an unknown date, the outcome of the fatigue and fever were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fatigue and fever to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. Over 7 months ago from the date of reporting, the patient received dose of Shingrix and experienced fatigue and low grade fever for a couple of days and did not received 2nd dose yet, which led to incomplete course of vaccination. The reporter consented to follow up.
thymus spasm; took the immune response/their immune system was unable to deal with something they normally have.; all intestinal functions stopped; 100% constipation/utter shut down; stopped eating/just eating liquids; cold from hell/the cold was affecting his lungs; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (thymus spasm), IMMUNE SYSTEM DISORDER (took the immune response/their immune system was unable to deal with something they normally have.), FUNCTIONAL GASTROINTESTINAL DISORDER (all intestinal functions stopped), CONSTIPATION (100% constipation/utter shut down) and EATING DISORDER (stopped eating/just eating liquids) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient do not having any medical conditions or being on any medication prior to the vaccine.     On 27-Jan-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2022, the patient experienced NASOPHARYNGITIS (cold from hell/the cold was affecting his lungs). On an unknown date, the patient experienced MUSCLE SPASMS (thymus spasm), IMMUNE SYSTEM DISORDER (took the immune response/their immune system was unable to deal with something they normally have.), FUNCTIONAL GASTROINTESTINAL DISORDER (all intestinal functions stopped), CONSTIPATION (100% constipation/utter shut down) and EATING DISORDER (stopped eating/just eating liquids). At the time of the report, MUSCLE SPASMS (thymus spasm), IMMUNE SYSTEM DISORDER (took the immune response/their immune system was unable to deal with something they normally have.), FUNCTIONAL GASTROINTESTINAL DISORDER (all intestinal functions stopped), CONSTIPATION (100% constipation/utter shut down) and EATING DISORDER (stopped eating/just eating liquids) outcome was unknown and NASOPHARYNGITIS (cold from hell/the cold was affecting his lungs) was resolving.            Patient received Bivalent booster dose. No concomitant medications was reported. On the 21-Sep-2022 they had a orthopedic appointment and everything was just fine. Patient says the events are starting to recover. Patient tried different laxatives and enemas for the intestinal stop. Patient had to go on nebulizer because the cold was affecting his lungs, patient has taken different herbal approaches like tea, honey and ephedra.  Patient don't think its the vaccine that caused the cold but took the immune response.   This case was linked to MOD-2022-651522, MOD-2021-032238 (Patient Link).
rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash at the injection site) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE RASH (rash at the injection site). At the time of the report, INJECTION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment or concomitant medication reported. Patient reports rash 9days after 1st dose of the moderna vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient came in for first dose of Covid 19 vaccine.  Pfizer given, she was given 0.1 mL VS 0.3mL dose. No adverse effects noted.
Discovered that patient was 17 years and 9 months of age later in the day after vaccine was administered. No adverse reaction reported from patient, however when I reached out to mother on 3/12/21 (the next day) to discuss age guidelines the mother reported that patient did have a fever of 104F and a headache. The mother states she is/will give OTC fever reducers and monitor her for further adverse reaction.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Mar-2021 at 12:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 12:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 61.92. Concomitant products were not reported. On 20-Mar-2021, Excursion time was 09 AM and 10 AM, temperature was 34 and 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021. Vial was stored on cooler 1, on 20-Mar-2021, Excursion duration At 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM : 44, 2 PM : 44, 3 PM: 44, 4 PM: 44, 5PM: 43. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Pfizer-BioNTech COVID vaccine booster resulted in patient feeling dizzy and hot right after receiving the third booster shot followed by syncope and seizure. Patient then had a second syncopal episode and seizure shortly after.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.  No Medical History information was reported.On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.The vial was initially stored in the refrigerator was 11-NOV-2021. The vial was first punctured was 18-NOV-2021 at 10 am. Date of administration of vaccine was 19-NOV-2021.Concomitant medications was not provided by the reporter.Treatment information was not provided.
Headache and fatigue , extreme feeling of heat with no fever . Feel like I have the flu with no other symptoms.
shingles; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 19th March 2020) for prophylaxis.   The patient's past medical history included rash.   On 19th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated on left arm. The patient reported that she had a rash prior to receiving Shingrix. On an unknown date, Several days after the injection, the patient went to see the physician for her rash and was diagnosed as having shingles. It was not known if the preexisting rash prior to the injection was confirmed as shingles. The reporter consented to follow up.
Site of injection is itching; developed red rash.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE RASH (developed red rash.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE RASH (developed red rash.). At the time of the report, VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE RASH (developed red rash.) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There is no concomitant medication listed. treatment provided was unknown.
Fever, Tachypnea, HYPERtension, Tachycardia & HYPERglycemia Narrative: Was inpatient overnight in a telemetry until. DC with diagnosis of DM and CHF
shingles; This is a spontaneous report from a contactable consumer. A female patient (reporter's mother) of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration as single dose for COVID-19 immunization. Medical history, concomitant conditions or past drug history of the patient were not reported. On an unspecified date within days after receiving first dose of vaccination patient experienced shingles. Patient now fear to get the second dose. Outcome of the event was unknown.  No Follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
02/19/2021 - woke up with a rash at the injection site of my left arm. I took a photograph and looked on the internet. Covid arm is a side effect.  02/04/2021 - Moderna vaccine administered via injection
Patient presented to the pharmacy with a swollen forearm and hand associated with tiny bumps. Complained of itching also.
Fever, chills, nausea, diarrhea, vomiting lasting for over 12 hours.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 4 (booster), single at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 03Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2023) Negative, notes: Test negative 31Jan2023; (03Feb2023) Positive, notes: Tested positive 03Feb2023; (04Feb2023) Positive, notes: Tested positive 04Feb2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient was treated with anti-viral PAXLOVID from 25Jan2023 to 29Jan2023. Test negative 31Jan2023. Felt sick again 02Feb2023, tested positive 03Feb2023 with stuffy nose, coughing, chills, body aches; Tested positive 04Feb2023 with all previous symptoms. 07Feb2023 feeling better but tired, coughing and short of breath after walking.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.