chrisvoncsefalvay/vaers-outcomes huggingface dataset:
complaints of scratchy throat after 15min of receiving dose, Benadryl given with some releif and Rx called in for prednisone for 5 days and instructed to pick up benadryl and take 3 days and zantac to take for next 5 days
Patient received vaccine at 11:45 AM.  At 12:05 PM Patient c/o itchiness to both hands and redness to top of nose.  Patient given 50 mg of Benadryl PO for symptoms.  Vital signs stable. Patient monitored for 45 minutes. Patient  left at 1:00 PM with husband.
Breakthrough case admission after 4 vaccines Pfizer 2/16/21 Lot# EN6200 ; Pfizer 3/9/21 Lot# EN6207;  Pfizer 10/6/21 Lot# FC3181;  Pfizer 9/8/22 Lot# GH9702
Felt faint; Experienced late that night chills; Shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 30 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Felt faint"; CHILLS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Experienced late that night chills"; TREMOR (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Shaking". Therapeutic measures were taken as a result of dizziness, chills, tremor included Tylenol.  Additional information: Reporter's daughter, 30 years old, received the Pfizer Covid 19 vaccine second dose on Sunday and experienced late that night chills, shaking, and felt faint. She took Tylenol, went to sleep, and was fine the next morning.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
20 min after shot, arm tingled, then lower lip went numb, then tongue swole up. Fire dept personnel had me take 2 of my own 12.5 chewable benedryl that were dated 2018. Then i left approx 20 min later with tongue almost at normal size, on the way home it started to swell again so i went to the emergency rm at hosp. They gave me iv benedryl, iv steroids, 1 hrs later i started coughing and lungs nurning, they gave me a chest xray and more iv benedryl. In about another hour or 2 they. Decided i had stabilized and sent me home with a prescription of prednisone 40mg for 2 days and then 20 mg for 2 days.
Stated developed raised red "bumps"  all over (L) arm 2 days after shot.  States area itching but better now.  Instructed to notify MD for further instructions & to not receive 2nd dose in 6 months.
No adverse event reported - Vaccination given to someone under 16 years of age. Patient and guardian completed the vaccination consent form with the incorrect DOB.  At time of administration patient/guardian did not acknowledge that the DOB submitted and confirmed prior to administration was incorrect.  So dose was given. Even though the true DOB was.
Induration at vaccine injection site, no redness noted,  no pain, no shortness of breathe or difficulty breathing.
This spontaneous report as received from a Nurse, via a company representative, referring to a patient of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated wit an expired dose of PNEUMOVAX 23. Dose, route, lot # and expiration date were not reported. No adverse effect was reported. It was not a product quality complaint involved. Additional information has been requested.
toothache / tooth throbbing; lessions on chest and back; blisters in throat; sore throat; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of throat blister in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included root canal procedure.   On 28th May 2019, the patient received the 2nd dose of Shingrix. On 28th May 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 29th May 2019, the patient experienced throat blister (serious criteria GSK medically significant) and sore throat. On 7th July 2019, the patient experienced skin lesion. On an unknown date, the patient experienced toothache. The patient was treated with Antibiotic (Details Unknown) and antivirals nos, antivirals nos, antivirals nos, antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the throat blister, sore throat and toothache were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved and the outcome of the skin lesion was unknown.   It was unknown if the reporter considered the throat blister, pain in arm, sore throat, toothache and skin lesion to be related to Shingrix.  Additional information was reported as follows: The patient experienced a sore arm after the injection. The day after the injection, the patient started having a sore throat. By the end of the week, her throat was still sore, so the patient looked at it and saw blisters in her throat. Around 16th June 2019, after 3 weeks the blisters and sore throat were resolved. The patient did not seen her physician, she thought did place a call towards the end and an antiviral was prescribed which she never took because the symptoms resolved. On 7th July 2019, the sore throat and blisters were returned, along with lesions on her chest and back and lasted another 2 to 3 weeks. This time the patient had visited her physician and she was prescribed an antibiotic and antiviral. A culture of the throat was also taken, which was negative for strep. The symptoms were resolved about 4 days after starting the medications. Less than two months after vaccination, during this 2nd outbreak the patient also started having a toothache in a tooth that previously had a root canal. The patient had a regular dental visit scheduled on 19th July 2019, which happened to occur shortly after the resolution of the second outbreak of blisters. The patient's physician referred her to another provider, who advised that she would need to get an implant.  On 24th September 2019, the patient started having another outbreak of blisters in her throat that was still ongoing. The patient also noted that, her tooth was not aching and throbbing as much as it was, but she can still feel it when using her water pick. The reporter consented to follow up.
Difficulty breathing which progressively got worse over a two month period.   Treatment was for blood cots in lungs and heart on July 1, 2021 spending five days in ICU.
Patient administered Pfizer for 1st dose, and Moderna for 2nd dose.  At this time no medical adverse health conditions noted.
12 m.o Female received varicella vaccine 2-3-12. Full blown chicken pox today 2-9-12. Dx: made by clinical indicators. In Box 9, wrote: will run its course.
a temperature excursion for PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 05-AUG-2021 the patient was vaccinated with temperature excursion measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (0.5 milliliter, 1 dose, lot # T016990, expiration date 11-NOV-2021) via subcutaneous (SQ) for prophylaxis (product storage error).       The administered dose of the vaccine experienced a temperature of 6 Fahrenheit (F) to 14°F (9.9F) for 2 hours and 11 minutes (on 14-SEP-2021) and 6°F to 14°F (6.6F) for 59 minutes (on 15-SEP-2021). There was previous temperature excursion 6°F to 14°F (7.3F) for 37 minutes (on 25-JUL-2021).
This spontaneous report as received from a registered nurse refers to an unspecified number of patients. The following vaccines were improperly stored and it was unknown if they were administered or not, to unspecified patients on unspecified dates. ROTATEQ lot # H011443 expiration date 15-NOV-2013, GARDASIL lot 1495AA with expiration date 22-AUG-2014 and MMR II lot number H020255 was expiration date 08-NOV-2014 and H012142 with expiration date 29-JUN-2014. Additional information has been requested. In the report received on 17-SEP-2013 the nurse reported that also VARIVAX has unspecified temperature excursions over the last year and it was administered to an unspecified number of unspecified patients on unspecified dates. As per correspondence from 31-MAR-2014 lot number H020255 for MMR II has been found to be as a batch number and it was valid with lot number 1500AA. The albumin status RHA (recombinant human albumin) for that lot. As regards MMR II with lot number H012142 the albumin status was HSA (human serum albumin) for that lot.
FEELING UNWELL; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805022, expiry: UNKNOWN) 1 in total, dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced feeling unwell. On 16-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and feeling unwell was not reported. This report was non-serious.
30 min post-injection the following anaphylactic reactions occurred; swelling of tongue, difficulty swallowing, swelling in face focused under my eyes. No medication was taken for these symptoms. Around 3 hours post-injection the reactions began to dissipate with full resolution by 4 hours post-injection.
HAVE HAD CHEST PAIN FOR THE LAST SIX MONTHS AFTER RECEIVING VACCINE; WENT FROM EXERCISING 3 TIMES PER WEEK TO BARELY ABLE TO WALK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced have had chest pain for the last six months after receiving vaccine, and went from exercising 3 times per week to barely able to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from have had chest pain for the last six months after receiving vaccine, and the outcome of went from exercising 3 times per week to barely able to walk was not reported. This report was non-serious.
Approx 7:00pm  on the 22nd of January had a dull headache.  The next day had muscle pain, joint pain,  and chills.  Also injection site was sore.  Took Advil for pain and aches.
Right UE Cellulitis 3pm/per pt. pain UE started in AM with decreased ROM progressively increased swelling to left neck.
Patient was inadvertently administered DHI instead of DTAP.  He did not have any adverse effects from immunization.
I received the PNEUMOVAX 23 injection from a pharmacist at the pharmacy. The injection hurt more than any I've ever received and the pharmacist told me he used a special syringe that withdrew the needle when a "trigger" was pulled. About 4 hours after the injection was administered, I started feeling extreme deep muscular pain in my upper left arm near the injection site, and I could hardly lift my arm at all. I also started experiencing a dull headache. By next morning, the majority of my upper left arm had started turning a very inflames looking bright red, was extremely painful to the touch.
Pt recvd 3 doses of vax & exp elevated liver function test p/vax;
A physician reported that a child developed a fever and experienced a seizure. No further information was available at the date of this report. Seizure is considered medically important. Follow-up info received from the physician on 01/02/2002 indicated that the child did not experience a seizure. The pt did develop a fever of 104 deg. F. As a result of this follow-up info, this report has been reclassified as non-serious. As a result of additiona follow-up info received on 01/10/2002 and verification by telephone from the physician on 01/15/2002, no adverse experience occurred. Consequently, this case has been cancelled.
On 9/12/01, received DTAP and IPV in the left thigh "IM". On 9/14/2001, pt developed a palm sized warm, swollen and red area at the injection site. Advised HC 1%, ice and Benadryl, 2 tsp every 6 hours. On 9/15/01, the injection site was red, hard and surrounding redness was increasing. Continue present medications and start ibuprofen. On 9/16/01, pt was seen in ER and given Solu-Medrol and Keflex. He had a fever on 9/15/01. On 9/17/01, pt had 25cm X 16cm erythema with vesicles. Pt had a fever on 9/16/01 up to 102.6F.
Vails that were expired on 01-Apr-2022, was stored in refrigerator on 20-Apr-2022 and administered on 23-Apr-2022; Patient administered vaccine on 23-APR-2022, which was expired on 01-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 23-APR-2022, which was expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 20-Apr-2022 and administered on 23-Apr-2022) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     Patient did not had any allergies to medications, food and other products. It was unknown patient neither diagnosed with COVID-19 nor tested positive.  Concomitant products included ZOLPIDEM, MELOXICAM, ZOLPIDEM, FLECAINIDE, DILTIAZEM and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 23-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 23-APR-2022, which was expired on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 20-Apr-2022 and administered on 23-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 23-APR-2022, which was expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 20-Apr-2022 and administered on 23-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported patient did not had any other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not seek for medical care and it was unknown whether patient experienced a similar event in the past. It was reported that the vial was initially stored in the refrigerator on 20-Apr-2022 06:44PM. The vial did not undergo any temperature excursion.  Patient had taken primary series (dose 1 and 2) of vaccination from unknown manufacturer on unknown date The vials had not undergone temperature excursion.  Treatment medications were not reported.
Fever cleared next day however slept the whole day on the second day due to headache and fatigue. Headache and fatigue still ongoing at the time of reporting (a week after receiving the 2nd shot); Fever cleared next day however slept the whole day on the second day due to headache and fatigue. Headache and fatigue still ongoing at the time of reporting (a week after receiving the 2nd shot); Fever started around 11PM on the day receiving my 2nd shot. Fever cleared next day however slept the whole day on the second day due to headache and fatigue; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08May2021 at 09:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received other medication within two weeks of vaccination which included birth control pill (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Fever started around 23:00 on 08May2021, the day patient received her second shot. Fever cleared next day however she slept the whole day on 09May2021, the second day due to headache and fatigue. Headache and fatigue was still ongoing at the time of reporting (a week after receiving the second shot). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event fever started around 23:00 was resolved with sequelae on the next day on 09May2021. The clinical outcome of the events slept the whole day the second day due to headache and fatigue, headache and fatigue was still ongoing at the time of reporting (a week after receiving the second shot) was not resolved at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; Wrong vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Wrong vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Wrong vaccine administered).    Concomitant medication was not reported.  Patient went back to the pharmacy for the 2nd dose of the bivalent vaccine on 12-Aug-2023, they were told that they should wait 8 weeks after the 1st dose. When further enquired it was found patient received first dose from pink cap vial and not from blue cap vial which was recommended. Reporter stated that patient was okay. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-737804 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2023: Event and narrative were added. On 16-Aug-2023: Upon internal review on 21-Aug-2023, it was identified that the information in the case MOD-2023-737804 is a follow-up to the existing case MOD-2023-737496. Hence, the case MOD-2023-737496 will be retained for further follow-up and all the information from the duplicate case MOD-2023-737804 has been incorporated into the retained case MOD-2023-737496. The case MOD-2023-737804 will be nullified and deleted from the safety database.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737804:Non Retain case
Headache, fever, sore body, weakness, strange taste in my mouth after eating, light headed ness
Patient experienced "vibrations in her head" within 24 hrs of having received the H1N1 vaccine. She also experienced tingling in her neck, left arm, & left leg. At times, her symptoms became intense, and she felt tightness in her face/neck at its worst point. On 1/4/2010, patient reported that all of her symptoms had been "easing off" for approximately 2 weeks. She is being seen by a neurologist.
This spontaneous report as received from certified medical assistant refers to 2 unspecified patients of unknown age and gender. On an unknown date the patients were administered doses of GARDASIL (lot #, dose and route not reported) that were improperly stored. Concomitant therapies were not reported. NO adverse effects reported. Additional information has been requested.
suspected vaccination failure; he went and got the shot and got the shingles again / Even if you get the shingles shots you can still get the shingles; he's had him the third time shot; This case was reported by a consumer via  media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was patient's brother. The age at vaccination was not reported. The reporter stated that, the patient had the shingles 6 weeks later he went and got the shot and got the shingles again and guess what he's had him the third time shots does not do any good at all based on nervous condition and other stressors in your life you would get the shingles. This case was considered as suspected vaccination failure since the time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Woke up 3/28 in the morning feeling lethargic, nauseous, massive headache, congested, sinus pressure, facial pain, and it feels like I've been smacked in the face. Been taking OTC drugs and SUDAFED for symptoms. Took two at home COVID-19 tests and one was negative and one positive. Two days later took two at home COVID-19 tests and both were positive. Have not reached out to PCP as of yet.
pt. recvd. vax & developed a fever 25FEB91,& 28FEB91 developed a rash consistent w/ measles,cough,coryza,& conjunctivitis.
ON SEPTEMBER 22,2021. PATIENT STARTED EXPERIENCING WEAKNESS AND NUMBNESS AND UNSTEADY GAIT. SHE WENT TO THE HOSPITAL AND HAS A SERIES OF TESTS RAN. SHE WAS DIAGNOSED RECENTLY WITH TRANSVERSE MYELITIS. PATIENT WAS DISCHARGED FROM CLINIC ON 10/09/2021 PER HER HUSBAND AND DAUGHTER.