chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feel lightheaded that has not resolved; Arm was sore at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 9th June 2021, 1 days after receiving Shingrix, the patient experienced injection site pain. On 11th June 2021, the patient experienced light headedness. On an unknown date, the outcome of the injection site pain and light headedness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and light headedness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself. The patient received 1st dose of Shingrix  in the left arm and his arm was sore at the injection site and has yet to resolve. The patient also began to feel lightheaded that did not resolve. The reporter would contact health care professional if the light headedness does not resolve by the afternoon, at the time of reporting. The reporter did not consent to follow-up. Note- there is discrepancy in the age at vaccination and administration. after adding age at vaccination as 57 year its still get auto coded as 56 year instead of 57 year
With the first series of the  vaccine I started to experience some subtle, but progressive stomach/digestion issues. Would get full eating a tiny meal. Some times go by and all my joints seem to get weaker. Upon getting MRIs both my right shoulder and hip labrum are torn without a traumatic cause.  In the 2-3 weeks after  getting the booster shot my connective  tissue became so weak all over my body. My wrist could fall off carrying 5 pounds. Can?t even lay on my side because my rib cage collapses over itself.  Along with this I haven?t been able to perform a normal blood draw or get an IV since the booster. My veins are so inflamed and blood is so hypercoagulated that they will not flow. I?ve been to over 20 MDs and many nurses, none of them have seen anything like it in their career.  To this day my joints remain ~80% weaker than before the covid vaccines. I?m 26 years old an ex-football player and can hardly even ride a  train or bus into the city because of the weakness. I have not been offered any worthwhile treatment options by traditional medicine, despite multiple attempts
18AUG92 hive like rash on arms-legs; 19AGU92 rash cont covers body-no itch trunk-limbs-face; knees swollen-lt elbow & lt wrist swollen red & hot very sore; will not walk or bear weight; fever 99.8 (in ear); very irritable;
requested pt's medical records, but never received them; pt had a positive COVID test on 10/5/21; per death certificate, pt died in the hospital with the cause of death being COVID 19
PT reports some numbness in left middle finger x approx 2 hrs on day following immunization. Also reports swelling in left deltoid (inject site) w/a knot present and intermittent aching pain in left elbow and wrist. States pain worsening.
Pt got very dizzy & pale. Father escorted son to restroom where pt vomited.
He got COVID; He got COVID; This is a spontaneous report from a contactable consumer(patient).  A 78-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot numbers and expiration dates were unknown), first dose on 31Jan2021 and second dose on 21Feb2021, both via unspecified route of administration at single doses for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  Patient reported that he was diagnosed with COVID almost exactly 6 months from the first dose of vaccination, 5 months from the second one. At the time of report, he was waiting to get an infusion. The patient underwent lab tests and procedures which included rapid BD Veritor COV-2 Rapid antigen swab on 04Aug2021, and the results showed he had COVID.  The outcome of the events were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
THE PATIENT STATED THAT 2 WEEKS AFTER SHE RECEIVED THE FIRST DOSE OF SHINGRIX VACCINE, SHE BROKE OUT ON SHINGLES, THE REACTION STARTED ON THE LEFT SIDE OF HER FOREHEAD AND SPREAD AROUND HER EYE, NOSE AND FACE ( ALL IN THE LEFT SIDE). SHE WENT TO THE DERMATOLOGIST  WHO PRESCRIBED HER ZOVIRAX CREAM AND ZOVIRAX TABLETS. SHE ALSO STATED SHE RECEIVED ZOSTAVAX 5 YEARS AGO BUT DIDN'T HAVE A REACTION.
Patient was a 74 yo female admitted with acute GI bleed secondary to ischemic colitis.  She had PMH of cirrhosis.  She developed worsening renal failure and metabolic acidosis.  She  Also developed worsening hypoxemic respiratory failure and tested positive for COVID-19.  She had development of metabolic encephalopathy and was made comfort care per husband's wishes.  Time of death 0207, cause of death ischemic colitis, acute renal failure, acute hypoxemic respiratory failure, COVID-19.
Patient experienced left arm pain after receiving TDaP vaccine.  Pain began shortly after administration.  At the time of follow up visit on 10/1/19, patient reported improvement of about 10 percent.
sore arm for 3.5 days;  day 1 muscle aches in both shoulders and upper back, from 6pm to bedtime at midnight, responded well to Motrin 800mg;  days 2-4 headache located in upper back, right of head, had no response to Tylenol or Motrin but felt better when I was lying down
Gout; Swelling of Ankle; Headache; This is a spontaneous report from a contactable consumer reported for himself. A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, in arm on 24Mar2021 00:15 am (at 64-years age) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included hypertension. The patient's concomitant medications were not reported. The patient experienced gout, swelling of ankle and headache on 25Mar2021 12:00 pm. Patient was not allergic to any medications, food, or other products. No treatment received for any reported adverse event. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and since the vaccination, the patient was not tested for COVID-19. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed.; patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed.) and PRODUCT STORAGE ERROR (patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed.) and PRODUCT STORAGE ERROR (patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed.) and PRODUCT STORAGE ERROR (patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided. This case concerns a 73-year-old patient, unknown gender, with no known medical history, who experienced the non-serious events of expired product administered and product storage error. The events occurred  on unknown date after third dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-381132.; Sender's Comments: This case concerns a 73-year-old patient, unknown gender, with no known medical history, who experienced the non-serious events of expired product administered and product storage error. The events occurred  on unknown date after third dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
This report was received form agency and was assigned manufacturer report number SR1-38257463 concerning a 39 year old female who on an unspecified date was vaccinated with Pneumovax 23. Subsequently, the patient developed a skin reaction at injection site. At the time of the event, the patient was also taking REBIF. At the time of this report, the outcome of the event was unknown. This was originally reported by a consumer. No further information is available.
pneumonia; A spontaneous report (United States) was received from a consumer concerning about a female patient of an unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced medically significant event pneumonia.  The patient's medical history was not reported. Concomitant medications were not reported.  On an unknown date in 2021, the patient received their first planned doses of mRNA-1273 (Batch number: unknown) via intramuscular for the prophylaxis of COVID-19 infection.  Later, the patient experienced pneumonia.  Laboratory details was not mentioned.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events are unknown.  The outcomes of the event, pneumonia, remains unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
7:45 pm 8-21-09 nausea, headache not feeling well began vomiting 12:45 am which continued throughout the night given ondansetron ODT 4 mg tab at 6:15 am 8-22-09.
Developed bumpy rash around administration site. Progresses down left side arm to hand, itching. On 12/24/2010, rash on right arm which progresses in next days to torso, back, legs to feet. Very itchy. After scratching, developed welts. Went to ED on 12/27/2010. Treated w/ antihistamine, antibiotics, and 2 other unknown meds.
Information has been received from a licensed practical nurse concerning an 8 month old male with oesophageal reflux and no drug reactions/allergies who vaccinated with a first and second oral dose with a 2mL of Rotateq on 18-SEP2006 (lot # 654248/0577F) and 30-NOV-2006 (lot # 654489/0941F). There was no concomitant medication. Illness at the time of vaccination included viral gastroenteritis. On 26-FEB-2007 the patient developed diarrhea. The infant had diarrhea in which there were 9-10 stools a day. The patient vomited "last night" after eating. The nurse mentioned that in general the infant spits up eating after eating. On 28-FEB-2007, the infant had one diarrhea episode and one vomiting episode. Unspecified medical attention was sought. No labs were performed. The nurse felt that the physician giving the infant ZANTAC for reflux and Culturelle for the diarrhea was intervention. At the time of the report the patient was recovering. The third dose was not given. There  was no product quality complaint involved. Vomited and diarrhea were considered to be other important medical events. Additional information has been requested.
Left upper arm rash with red base and vesicles overlying.  Area circular and measures approximately 6.5 x 5.5 cm.
At about 10 to 12 minutes after she received the vaccine she felt that her throat "felt numb" and had trouble swallowing her own saliva.  Approximately 30 minutes after the vaccine she noticed significant tongue and oral itching and then hoarseness.  Vitals were normal.  Did not notice any flushing, rash under skin or swelling.  The symptoms all resolved after she received a dose of Benadryl (which she was able to swallow) followed by a dose of Zyrtec.   3 days after she received her injection she developed sore throat and body aches.
tiredness; chills; headache; achiness of joints; congestion(hard to breathe); This is a spontaneous report from a contactable consumer (patient). A 37-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot # EL-3247, in Workplace clinic, via an unspecified route of administration on 11Feb2021 at 23:30 (at 37 years of age) at single dose in left arm for COVID-19 immunization. The patient's medical history was not reported. The patient didn't receive any concomitant medication. The patient was not pregnant at the time of vaccination. She had received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot # EL-3247, via an unspecified route of administration on 21Jan2021 at 23:30 (at 37 years of age) at single dose in left arm for COVID-19 immunization. She was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 11Feb2021 at 20:00 (to be clarified) the patient experienced tiredness, chills, headache, achiness of joints and congestion (hard to breathe). The patient didn't receive any treatment. The reported events were resolving at the time of the report.
Adverse reaction to vaccine.  About 10 minutes after receiving vaccine became dizzy, light headed, nauseated, had a headache and blood pressure was elevated.  Patient took a Toprol XL and was taken to the ER for further evaluation.  Discharge diagnosis Adverse reaction to vaccine felt better prior to discharge from ER.
Initial information received from a health care professional on 25 October 2012. A female patient (age and date of birth were unknown), had received an intradermal dose 1 of FLUZONE ID (Batch number: UT4466BA) on left deltoid on 24 October 2012. The patient had no illness at the time of vaccination. The patient's concomitant medications included Ibuprofen and Aspirin. The reporter stated that on 24 October 2012, after vaccination, the patient experienced immediate redness. On 25 October 2012, 1 day after vaccination, the patient developed 6 cm diameter area at injection site with some hardness, induration and hot to touch which was very painful. Laboratory details included none. Corrective treatment included cold packs, TYLENOL and BENADRYL on unspecified dates. At the time of this report, the patient had not recovered. Documents held by sender: none.
I felt the injection fluid go into my arm with pain and a few hours later my arm pain was so severe I could not even move my arm without excruciating pain. I could not sleep or lay down. I had to pack my upper arm with ice for 72 hours. I have had flu shots before and never had a painful reaction that brought tears to my eyes for 72 hours.   I don't know what size the needle was used on me, but it almost felt like it hit the bone. I am a thin person.  It probably did not hit the bone, but it felt like the fluid was forced into the muscle. My husband did not have this same reaction, so I don't know if it was the person who gave the shot, or wrong needle size or what made my arm hurt like it was hit with a hammer.  I now have slight itching at the shot site and there is a bump the size of a mosquito bite.
PASSED AWAY FROM THE J&J BOOSTER SHOT; HEART ATTACK; This spontaneous report received from a consumer via social media through company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose not reported, frequency 1 total, start therapy date were not reported for prophylactic vaccination (dose number in series 1). It was unknown if the patient experienced any adverse event with covid-19 vaccine ad26. cov2. s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose not reported, frequency 1 total, start therapy date were not reported for prophylactic vaccination (dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced heart attack (Dose number in series 2). On an unspecified date, the patient died from unknown cause. It was unspecified if an autopsy was performed. It was reported that "my brother just passed away from the Johnson and Johnson booster shot, he had a heart attack". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient passed away from the Johnson and Johnson vaccine booster shot on an unspecified date, and the outcome of heart attack was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20211262986-covid-19 vaccine ad26.cov2.s-passed away from the J&J booster shot, heart attack. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
pt recv vax 16JAN96 cried for 1hr, had inject site rxn, red & swollen
Trouble breathing with chest pressure; Trouble breathing with chest pressure; Rash on face with swollen fingers; Rash on face with swollen fingers; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received first dose of BNT162B2 (Lot number: 9264), via an unspecified route of administration on 31Jan2021 10:15 at single dose in the left arm for covid-19 immunisation. Medical history included hypertension and penicillin allergy. The patient's concomitant medications were not reported. On 03Feb2021 09:30, the patient experienced rash on face with swollen fingers and trouble breathing with chest pressure. The events result in Emergency room/department or urgent care. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 underwent lab tests and procedures which included Nasal Swab: negative on 03Feb2021. The outcome of the events was recovering.  The following information on the lot/batch number has been requested.
very sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13th December 2021, the patient received the 2nd dose of Shingles vaccine. On 14th December 2021, 1 days after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reported reported that he/she had second shot and he/she was very sick at the time of reporting.
Cold; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Cold) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunization.    Co-suspect products included non-company products TREPROSTINIL SODIUM (TYVASO) for Secondary pulmonary arterial hypertension and INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for Influenza immunisation.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included NINTEDANIB ESILATE (OFEV) for an unknown indication.   In 2022, the patient started TREPROSTINIL SODIUM (TYVASO) (Inhalation use) 16 microgram four times per day. In 2022, TREPROSTINIL SODIUM (TYVASO) (Inhalation use) dosage was changed to 32 microgram four times per day. On 19-Sep-2022, TREPROSTINIL SODIUM (TYVASO) (Inhalation use) dosage was changed to at an unspecified dose. On 24-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 24-Oct-2022, the patient experienced NASOPHARYNGITIS (Cold). The patient was treated with OXYGEN at a dose of 2 liters as needed. At the time of the report, NASOPHARYNGITIS (Cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2022, Oxygen saturation: 83-85%.         It was reported that on an unreported date in 2022, the patient was experiencing headaches with Tyvaso DPI (headache) that relieved with Tylenol (paracetamol) and he had missed a few doses in the last 2 weeks of Tyvaso (product dose omission issue). Action taken with Tyvaso DPI was not reported for the event of headache. At the time of reporting, the outcome of headache was resolved on an unreported date in 2022. The reporter's causality for the event of headache with Tyvaso DPI was considered to be possibly related. On 25 Oct 2022, 1 month 7 days, after initiating Tyvaso DPI, his oxygen saturations was dropping down to 83 to 85% (oxygen saturation decreased). He was using oxygen 2 liters as needed. He was having headaches with Tyvaso DPI increase (headache previously reported). Action taken with Tyvaso DPI was not reported for the events of nasopharyngitis and oxygen saturation decreased. At the time of reporting, the outcome of nasopharyngitis, oxygen saturation decreased, and headache was unknown.
"A number of pts" experienced injection site pain within a few hr of receiving Flu Shield (1997-98 Formula). The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying info is provided.
Injection site is red and swollen. Entire upper arm sore. Spent a sleepless night.
pt recvd vax & devel a fever & gen raised bumpy rash w/in 24hrs of vax;It was noted that the rash was not varicella-like;2 pts were reported & given WAES95110709 & 95110710;no further details were provided
Strong migraines; Hot flashes; Numbness in the legs; Sore arms; Sore joints; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Er8738) via an unspecified route of administration in the left arm on 06Apr2021 at 11:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had history of known allergies to NSAIDS and ibuprofen (MANUFACTURER UNKNOWN). The patient did not take any concomitant medications. 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 COVID vaccine. On 06Apr2021 at 12:00, the patient experienced strong migraines, hot flashes, numbness in the legs, sore arms and joints. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of strong migraines, hot flashes, numbness in the legs, sore arms and joints were unknown.   No follow-up attempts are needed. No further information is expected.