chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5-10 minutes following administration of Pfizer Covid vaccine, patient ( 13 year old) complained of light headedness and the inability to hear with ringing in his ears and diaphoretic.  Patient did not have any complaints of difficulty breathing.   Patient became pale and lowered to floor with feet elevated.  Blood pressure taken by RN at that 9:30 was 89/60 with HR at 60.    Nurse was initiated and arrived at the clinic for assessment.  Observation was continued with the ER team present.  Blood pressure at 9:36 was 108/60 and then again at 9/40 was 100/68.  Patient did state his symptoms improved and was transported to the ER via the ER team for continued monitoring with mother and his sister.  Report given to ER Nurse.
12/22/2021:  mild shortness of breath for a few days, used ProAir inhaler. 12/25/2021:  throat sensation as if I swallowed wrong, like food/drink down "wrong pipe," progressing to typical sore throat.  Started at evening meal.  Cough/congestion began. Ensuing days:  GI symptoms with soft stools/diarrhea for about a week.  My physician, Dr., prescribed Lomotil and azythromycin.  I did not take Lomotil since GI symptoms had cleared by the time it was prescribed.  Azythromycin 5-day course ineffectual.  Cough/congestion continued. Food and drinks, including water, tasted and smelled spoiled, like garbage.  Therefore, appetite was greatly reduced.  I had to force water intake.  Eight pound weight loss. Temperature remained normal during this time.  Home pulse oximetry readings were 92 to 94 during this time.
chest pain and rash; chest pain and rash; neck and upper chest became red; BP was180/110; This is a spontaneous report from a contactable physician. A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EM9810; Expiration date was not reported), dose 1 intramuscular route of administration in the left arm on 13Feb2021 14:45 (at the age of 44-year-old) as dose 1, single for covid-19 immunisation. The patient's medical history included thyroid disorder, urticaria, hypersesnitivity from an unknown date and unknown if ongoing. Patient gave history of allergies to cipro and levaquin with history of hives. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); levothyroxine sodium (SYNTHROID); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. The patient previously took ciprofloxacin, levaquin and experienced drug hypersensitivity. Patient received vaccine in doctor's office/urgent care. It was reported unknown if patient took other vaccine in four weeks. Patient did not have covid prior vaccination and covid was not tested post vaccination. The patient experienced chest pain and rash, neck and upper chest became red on 13Feb2021 14:45. Patient developed left sided chest pain immediately after being given first dose of covid vaccine. No radiation to neck or jaw. Patient denied any cardiac history, nausea or prb breathing, HR was 90, BP was180/110, pulse oxygen was 96%, unlabored resp. Patient neck and upper chest became red but no edema or facial redness. Patient improved immediately after 0.3 mg epi IM and 50 Mg benadryl injected with resolution of chest pain and rash. Repeated exam showed HR 79 and BP 120/72. Ambulance transported for evaluation of chest pain. AE resulted in Doctor or other healthcare professional office/clinic visit. Clinical outcome of neck and upper chest became red was unknown and other events recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient taken to School Nurse with c/o's of itching of neck (wearing high neck sweater.  1:15PM c/o itching of left arm.  1/2" hive noted @ injection site of left deltoid (vaccine was administered with bioject- using #3 syringe).  Dr. consulted; Benadryl 50mg po given to patient, and she was sent to local doctor.    1:30PM nurse @ local doctor notfied.  11/02/09 Report from school Nurse stated patient is in school, and ok.  Patient did not go to doctor on 1/30/09, but has appointment 11/04/09.  Still has "bump" on left arm (looks like an insect bite.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a low grade fever and began to break out in a varicella like rash. He initially had approximately 10 lesion on his face and within a few days he had more than 50 generalized lesions predominantly on his trunk.
Patient reported palpitation and rash on the opposite arm after receiving the shot. Blood pressure was 164/89 and he was alert and able to communicate. He took 50 mg of Benadryl and 911 was called. Patent then reported shortness of breath but he was able to talk. 911 operator advised against epipen shot and recommended to wait for paramedics. Patient was asked by paramedics if he wants to be taken to hospital and he said yes and was taken to hospital
Had Pneumovac 23 vaccine on 6/01/2020. Within three hours arm became very sore. Could not sleep on that side for two nights. Felt lethargic the next day. Injection site became red, swollen and feverish within one day and red "ridge" about one inch wide and two inches long appeared below inject site after two days. On third day got severe headache and extreme hypertension. Went to doctors office. Received toradol injection for pain. Sent to ER. After two hours BP even more elevated. Began Hydrozaline to "drive BP down". Admitted to hospital and BP still elevated and severe headache for three days. Still getting Hydrozaline and Valsartan and HCTZ and Amlodipine for BP. Xanax for anxiety. Began throwing up on third day. Then dry heaves. BP began to drop. Sent home. Next day BP bottomed out and almost fainted. Now not on BP meds at all. I attribute all of this to the Pneumovac 23 because I have never had a reaction or headache of that nature before.
Mild swelling and erythema at injection site. Recommended cold compress 10 minutes an hour when able for the next 24 hours. MOTRIN as directed for the next 24-48 hours.
By the time I took the 3rd pill, I was experiencing 1 episode of vomiting and when I took the 4th pill, I had moderate diarrhea for several hours.
Moderna COVID-19 Vaccine EUA:  Vaccine recipient was administered their 3rd dose with vaccine vial that was beyond 12 hours after the first puncture.
(6.12.18) Pt had an allergic reaction to the vaccine within 15 mins of injection. Pt R thing broke out into hives with redness. Pt given 2 tsp of BENADRYL based on her weight. Pt was kept in the office for an additional 40 mins, responded well the BENADRYL and pulse ox was 100 the whole time, no resp distress, or facial/tongue/lip swelling, no itch. Pt was also given ice to the area after 20 mins. Rash had improved after 40 mins, pt feeling well. Pt was able to go home, informed that if it comes back, spreads, to give more BENADRYL and take pt to the ER. 1:30 am (6.13.18) the rash came back, this time all over pt body, itchy, BENADRYL was given and 911 called. EMS arrived and assessed pt and stayed with patient for 15 mins, decided pt was doing better and was OK to stay home.  9:00 Am (6.13.18) mom called the office stating her rash had returned, still in no distress, just itchy.  Mom did not want to give another dose of Benadryl.  At this time mom was recommended to take pt to CHOA ER. mom agrees and called was ended.  10:00am (6.14.18) Follow up to mom , left message to call  office.
splenic infarctions; Disorder spleen; Radiating pain; some issues with her pancreas; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of SPLENIC INFARCTION (splenic infarctions) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) and TACROLIMUS for an unknown indication.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SPLENIC INFARCTION (splenic infarctions) (seriousness criterion medically significant), SPLEEN DISORDER (Disorder spleen), PAIN (Radiating pain), PANCREATIC DISORDER (some issues with her pancreas) and MYALGIA (Myalgia). At the time of the report, SPLENIC INFARCTION (splenic infarctions), SPLEEN DISORDER (Disorder spleen), PAIN (Radiating pain), PANCREATIC DISORDER (some issues with her pancreas) and MYALGIA (Myalgia) outcome was unknown.            No treatment information reported.   Company Comment: This case refers to a 57-year-old female patient with no specified medical history who experienced the unexpected events of Splenic Infarction, Spleen Disorder, Myalgia, Pain and Pancreatic Disorder on an unspecified date after the administration of  COVID-19 Vaccine Moderna. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-320491 (Patient Link).; Sender's Comments: This case refers to a 57-year-old female patient with no specified medical history who experienced the unexpected events of Splenic Infarction, Spleen Disorder, Myalgia, Pain and Pancreatic Disorder on an unspecified date after the administration of  COVID-19 Vaccine Moderna. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.
This spontaneous report was received from a physician refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date (reported as "many years ago") the patient was vaccinated with ZOSTAVAX (strength, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent. On an unknown date the patient experienced problems with arm mobility getting vaccinated. The outcome of the event was unknown. The relatedness between the movement disorder and ZOSTAVAX was not reported.
Second dose received on March 17, 2021 (same clinic).  Starting on Wednesday, March 24 my tongue felt numb (dime size, center of tongue) - could not taste in that spot but rest of tongue was ok.  It progressively got worse - Saturday, March 27 and Sunday, March 28 felt foggy, more numbness on left side of face, specifically lip area.  On Monday, March 29 speech was slurred, numbness was worse.  Sent photos to neurologist due to concern for stroke and he said call my PCP and my PCP said to go to the ER.  Diagnosed with Bells Palsy.
supposed to get her 2nd dose but got Covid; I received the first dose of the Pfizer vaccine on march 6 2021. I got COVID; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer sponsored Program . A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER COVID-19 mRNA VACCINE, Lot number- UNKNOWN) via an unspecified route of administration on 06Mar2021, as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient had COVID (encoded as Covid-19 and drug ineffective). Her second dose of vaccination was scheduled for Saturday (prior to this report, 27Mar2021), however she could not receive it due to COVID. The outcome of the events of COVID-19 and drug ineffective was not reported.  No further information was available.
Her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today; her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today), PRODUCT AVAILABILITY ISSUE (her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today), PRODUCT AVAILABILITY ISSUE (her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today), PRODUCT AVAILABILITY ISSUE (her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTRATION INTERRUPTED (her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today) and PRODUCT AVAILABILITY ISSUE (her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today).    Concomitant medication was not provided.   Treatment information was not provided.   Reporter did not allow further contact
No additional AEs; administration of expired lot of PNEUMOVAX 23 on 1/30/2023; This spontaneous report was received from a medical assistant referring to a 62-year-old male patient. Information of the patient's pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On 30-JAN-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (0.5 milliliter, once, lot # U026796, expiration date upon internal review was established as 28-JAN-2023, strength and route of administration were not provided) for prophylaxis (expired product administered). No additional AEs (no adverse event).
Following the vaccination, my dissociation got incredibly bad, I became dizzy, and I felt like I was going to die. All three sensations have lasted since the second dose.
Information has been received from a doctor's nurse concerning an either 18 or 19 year old female patient who on 09-MAY-2011 was vaccinated with the second dose of GARDASIL (lot #, expire date and route not reported), 0.5 ml. The doctor's nurse stated that the day after the patient got her second GARDASIL shot on 10-MAY-2011, her arm was covered with red bumps and was itchy. The patient sought unspecified medical attention. At the time of the report, patient's outcome was unknown. Additional information has been requested.
I was eating breakfast, experienced a weird taste in my mouth (thought it was the cereal) and my throat started getting itchy, had diarrhea several times. My throat started swelling and by the time I arrived at the ER, my air passage way was almost closed.  I was treated for a severe reaction. I was referred to an Allergist.
Breakthrough case admission after 2 vaccines Pfizer 3/20/21 Lot# ER2613;  Pfizer 5/1/21 Lot# Ew0
had shingles after I had the vaccine/ suspected vaccination failure; mild shingles; slightly uncomfortable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had 1st horrible episode of shingles on an unknown day before vaccination) and shingles (had 2nd horrible episode of shingles on an unknown day before vaccination).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and discomfort. On an unknown date, the outcome of the vaccination failure, shingles and discomfort were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and discomfort to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. Post vaccination the patient again had shingles but very mild and only slightly uncomfortable. The patient did not need steroids or anything, just a little patience and time to recover. The reporter stated that for anyone who was at risk for having shingles, should get the vaccine as soon as they can.  This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Narrative:  69 YO MALE reported palpitations after receiving the second dose of modern vaccine on 3/6/2021 during his PCP visit on 4/28/2022. Mild symptoms reported.
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Expiration Date for the lot 048C21A was reported as 09-Nov-2021 with total of 168 doses. The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was reported as unknown. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received contains non-significant information.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age, sex, race, and ethnic origin. 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 administration, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid 19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20210945662-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Client vaccinated with First Dose Moderna at 3:20 pm. 10 minutes later reported feeling light headed and faint. BP 130/100; P 85, 02 sat 99%. Laid client down for 20 minutes and sated felt better and sat up. Provided crackers and juice. No itching or welling. BP taken every 5 minutes until 4:05 when it was BP 122/80; P 74 and 02 sat 100%. Suggested client get someone to pick him up but he declined and left at 4:15.
RECOMBIVAX HB expired on 08-JUN-2021 and was administered 16-AUG-2021; No additional AE reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 16-AUG-2021, the patient was vaccinated with expired hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # R028384 with expiration date 08-JUN-2021, for prophylaxis (strength, dose, route of administration and anatomical location were not reported). No additional adverse event (AE) was reported. It was stated that the vaccinated did not undergo any temperature excursion.
nerve pain, numbness, burning, twitching, which have waxed and waned in severity over the past several months.
This spontaneous report as received from the mother refers to her 21 year old son with no pertinent medical history or drug reactions/allergies. On 17-JUL-2014 the patient was vaccinated with a dose of GARDASIL (dose, route and lot# not reported). There was no concomitant therapy included. On 17-AUG-2014, after one month, the patient developed 3 blisters with fluids at the injection site. Patient was upset and went to emergency room. And the patient was told by physician that blisters looked like shingles, so culture was obtained for that. One culture for unspecified criteria and a specific culture to test for shingles were performed. Patient sought medical attention by visiting emergency room and valacyclovir was given as treatment. It was reported that the patient was admitted to a hospital on an unknown date. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.