chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: COVID infection following completion of COVID vaccine series 03/04/21 COVID vaccine dose #1 03/31/21 COVID vaccine dose #2 04/07/21 Pt reports diarrhea for 2.5 weeks with no improvement with ammonium and pepto 04/08/21 COVID NEGATIVE; lab orders and stool tests placed 04/21/21 Pt reports continuing diarrhea while on acidophilus, loperamide, and melatonin; tests came back positive for lactoferrin - GI consult placed 05/06/21 Pt presents to clinic for ear infection; rx given for hydrocortisone/neomycin/polymyxin ear drops 06/22/21 Pt presents to clinic reporting shortness of breath while walking short distances - Cardio consult placed given CAD history 07/22/21 Pt reports continuing ear pain 07/30/21 Pt presents to screening reporting close exposure to COVID positive person and fever of 101.1 on 07/29, temp at screening 100.9; COVID POSITIVE 07/31/21 Pt reports baseline cough, minimal fatigue, and fever of 101.1 on 07/29, temp at screening 100.9; COVID POSITIVE 07/31/21 Pt reports baseline cough, minimal fatigue, and fever (101.8); rx given for vitamin C, DM/guaifenesin, zinc 08/02/21 Pt reports fatigue, runny nose 08/04/21 Pt reports cough is nearly resolved but fatigue remains; improving
Presents to the ED via EMS after being d/c from the hospital yesterday. Pt was admitted 12/27 to 1/5 for intraventricular hemorrhage and was sent back to his long-term care facility who then sent pt back here due to pt testing COVID+ today; they reported that they could not care for him b/c he is COVID+. Pt asymptomatic and returned to LTAC.
Customer called within 1.5 hours of receiving vaccine and indicated that she had developed a headache " a couple of hours after" receiving vaccine. She asked if anyone else had reported getting a headache (she was told that I had not heard of anyone expressing this side-effect), was it the normal vaccine that people were getting this year (yes), was it a live virus vaccine (no), how many strains did it contain (four) and what were the names of the strains (I told her that I did not have that information in front of me but should be able to be accessed online). She was given the VIS at the time she filled out her vaccine questionnaire form, prior to getting the vaccine. She was also told that the side-effects could be mild cold, or flu-like, symptoms.
After the vaccine you were fine. A month later, on the 17th, I had itchy throat, but I felt fine. On the 18th I developed cough, my husband tested positive, I did a home test, and it was negative. My temperature was 101.6 on the 18th and then I went to the pharmacy to get a test, I went, and the test came positive. The evening of the 18th, my symptoms were bad, chills, very bad cold, it carried to the 19th. I scheduled another appointment to get medication and doctor prescribed medication, I took that, and the fever went away by the 20th, I still have body ache. The mid-day of the 20th I felt better with no chills, not body ache, by the 21st I had more energy than the previous days. Today I don't have all my energy, but I felt better.
Fever of 100°, runny nose, coughing, diahrrea, body aches, facial pain. Suffered from vertigo for 2 weeks afterwards.
Patient called 10/27/2017 stating that she was still having pain and stiffness from the pneumonia shot. She said she felt that it was getting worse. She also felt that it was getting worse. She also felt that the immunization was given too high on the arm.
PATIENT STATED HAVING HISTORY OF FAINTING.  UPON ASKING, PATIENT STATED FAINTING ON THE SIGHT OF BLOOD, AND SHE WAS NERVOUS. WITHIN 5 MINUTES OF THE VACCITATION, PATIENT WAS SHAKING AND WARM/ SWEATING. SHE WAS BREATHING WAS NORMAL. PATIENT SAT DOWN IN A CHAIR, WE GAVE HER SOME WATER AND AN ICE PACK. PATIENT THEN DECIDED TO LAY DOWN AFTER 5 MINUTES. HER HUSBAND WAS CALLED, SHE STARTED FEELING BETTER. SHE STAYED SITTING/LAYING DOWN FOR AT LEAST 30 MINUTES. PATIENTS HUSBAND TOOK HER HOME.
Lips are swelling up; bottom lip; Lymph node are inflamed; Had a little bit of tiredness and stuff like that; This is a spontaneous report from a contactable consumer (patient wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 12Jun2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had the Pfizer shot last Saturday (12Jun2021) and his lips were swelling up right now, his bottom lip, his lymph node were inflamed. The patient had a little bit of tiredness and stuff like that but today (16Jun2021) his lips swell up like just now about an hour. Reporter need the information as far as how to proceed, if patient took Benadryl but reporter trying to figure out to take him in or call a doctor or what. Reporter wanted to know, its after hour so what do they do. Reporter was advised to contact the Healthcare professional. Outcome of the events was unknown.  Information about batch/Lot number has been requested.
BURNING TOES OF THE LEFT FEET; STINGING TOES OF THE LEFT FEET; This spontaneous report received from a patient concerned a 57 year old female. 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: 1808978, and expiry: 03-JUN-2021) dose was not reported, administered on 31-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced burning toes of the left feet. On 31-MAR-2021, the subject experienced stinging toes of the left feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning toes of the left feet, and stinging toes of the left feet. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure, since case assessed as non serious.
This spontaneous report as received from a other health professional (physician assistant) who was mother of patient via company representative refers to a female patient of unknown age. In April 2007 the patient was vaccinated with GARDASIL dose 1. Approximately in 2007 the patient experienced seizure (medically significant) sometime after the first vaccination. Unspecified Laboratory test was done on an unknown date with result of elevated white blood cell count after the vaccination. The outcome of seizure and elevated white blood cell count was unknown. The relation between the event and the vaccine was unknown. It was reported that the series of vaccination has been completed. Upon internal review event seizure was considered medically significant. Additional information has been requested.
tingling and twitching in lips, face, feets, all the body; tingling and twitching in lips, face, feets, all the body; "buzzing inside my body"; This spontaneous case was reported by a dentist (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (tingling and twitching in lips, face, feets, all the body), MUSCLE TWITCHING (tingling and twitching in lips, face, feets, all the body) and FEELING ABNORMAL ("buzzing inside my body") in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced PARAESTHESIA (tingling and twitching in lips, face, feets, all the body), MUSCLE TWITCHING (tingling and twitching in lips, face, feets, all the body) and FEELING ABNORMAL ("buzzing inside my body"). At the time of the report, PARAESTHESIA (tingling and twitching in lips, face, feets, all the body), MUSCLE TWITCHING (tingling and twitching in lips, face, feets, all the body) and FEELING ABNORMAL ("buzzing inside my body") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Had new shingles shots had shingles last October/Suspected vaccination failure; Shingles / on d and left side of face; Pain; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2020, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got Shingles on head and left side of face after new shingles shots. At the time of reporting only pain was relief as acupuncture done by chiropractor to patient best thing ever. This case was considered as suspected vaccination failure as details regarding, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Adult patient received doses after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022).    No concomitant medications were reported.  It was reported that, the patient received vaccine from expired vial. Further it was stated that, there were no remaining vials unused of expired lot number.  The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 14th of 56 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
I was approximately 4 weeks pregnant at the time that I received dose #1 (12/23/20)- I was unaware of the pregnancy. I was diagnosed with COVID on 12/28/20, but was first symptomatic on 12/24. I attributed my s/s initially to the vaccine. I was eventually tested on 12/28/20, as my symptoms worsened and I was positive for COVID.  On 1/14/21 I received my second dose, my COVID s/s had been resolved since 1/4/21. On the evening of 1/18/21 I started experiencing mild abdominal pain. This progressed, on the evening 1/20 the pain was no longer tolerable. I went to the ER where I hemorrhaged and needed emergency surgery and a blood transfusion for a miscarriage. The surgery ultimately took place in the early morning hours of 1/22/21, followed by the blood transfusion.
2 papular vesicular lesions. Sibling with past vaccine varicella. Dx varicella, Tx symptomatic.
10 episodes of diarrhea with tinge of blood, fussy & fever of 100.
Liver discomfort; This spontaneous case was reported by a consumer and describes the occurrence of LIVER DISORDER (Liver discomfort) in a 15-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER DISORDER (Liver discomfort). At the time of the report, LIVER DISORDER (Liver discomfort) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  Company comment: This spontaneous case concerns a 15 year old female patient, with no reported medical history, who experienced the unexpected non serious AESI of Liver disorder (latency unknown), after receiving the second dose of COVID -19 vaccination with mRNA-1273 vaccine. No further information on clinical course and management of the event was available in the report. The outcome of the event was unknown'. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-551822, MOD-2022-551703, MOD-2022-551797, MOD-2022-551805 (Patient Link).; Sender's Comments: This spontaneous case concerns a 15 year old female patient, with no reported medical history, who experienced the unexpected non serious AESI of Liver disorder (latency unknown), after receiving the second dose of COVID -19 vaccination with mRNA-1273 vaccine. No further information on clinical course and management of the event was available in the report. The outcome of the event was unknown'. The benefit-risk relationship of mRNA-1273 is not affected by this report.
generalized itchiness, itchy scratchy throat, vertigo.  She was monitored for 2 hours and these symptoms resolved with 50mg oral Benadryl.
Tested positive for COVID two days after receiving the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for COVID two days after receiving the Moderna COVID-19 vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced COVID-19 (Tested positive for COVID two days after receiving the Moderna COVID-19 vaccine). At the time of the report, COVID-19 (Tested positive for COVID two days after receiving the Moderna COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of tested positive for COVID-19  and mRNA-1273 use is assessed as unlikely.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow up included updated medical history of COVID-19 which the patient reported as retroactive.; Sender's Comments: Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of tested positive for COVID-19  and mRNA-1273 use is assessed as unlikely.
Pt. developed cellulitis to Left upper arm 6 days after Shingrix injection. Pt. given antibiotic injection in clinic and an oral antibiotic prescription for 10 days. Pt. has a follow up appt. scheduled.
a rash on her legs and it is almost like dermatitis; a rash on her legs and it is almost like dermatitis/; the rash is real light pale red bumps and itches like crazy from her knee cap; the rash is real light pale red bumps and itches like crazy from her knee cap; dry skin; This is a spontaneous report from a contactable consumer(Patient). A 73-years-old female consumer had receivedbnt162b2 (Pfizer-biontech COVID-19 vaccine, Solution for injection, Batch/lot number: EN6200) via an unspecified route of administration on25 Feb2021into left arm at 10:00 as DOSE 2, SINGLE for covid-19 immunization (at age of 72 years). The patient medical history had included blood pressure and concomitant medication involved Amlodipine besilate, valsartan (EXFORGE,5/160 mg; take once daily by mouth) for the blood pressure. It was reported that patient did not receive any vaccination within 4 weeks prior to vaccination. The patient did not have any family medical history. The patient previously took bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: EL9265) via an unspecified route of administration on 05Feb2021at 10:00 AM (at 72-year-old) in the left arm as DOSE 1, SINGLE for covid-19 immunization and experienced rash(on11Feb2021), soreness in her arm (on 5Feb2021), slight burning sensation on her left breast(on 06Feb2021) left arm shoulder pain(06Feb2021) and tired(06Mar2021). On Mar2021 the patient had experienced a rash on her legs, and it is almost like dermatitis/the rash is real light pale red bumps and itches like crazy from her kneecap all the way down to the ankle on both legs/also peppered on her arms, a little on both top part of her arms and dry skin. Therapeutic measures were taken as a result of AE and treatment included with moisturising cream and dermatitis cream. The patient did not visit to physician office. The clinical outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). Pertinent medical history, drug reactions or allergies were not reported. On 30-JUN-2014 the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot number: J011548, expiration date: 19-DEC-2014, (dose, route not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a healthcare professional (nurse) and described the occurrence of injection site soreness in a 48-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2012 at 13:00 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm). On 1 October 2012, immediately after vaccination with FLULAVAL, the subject experienced injection site soreness, arm swelled at injection site and erythema of arm at injection site. The nurse stated that the subject "experienced a swollen red arm at the injection site that was the size of a dollar piece and very sore." The subject was treated with Ice pack. On 2 October 2012, the events were resolved within 24 hours. The healthcare professional (nurse) considered the events were probably related to vaccination with FLULAVAL.
Fever to 102 cranky, fever decreased with Tylenol. Rash on R thigh at immunization site.
Initially, no reaction until the next day tenderness statrted, the swelling and redness. Very tired.
Severe diarrhea; Stomach crumps; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe diarrhea), ABDOMINAL PAIN UPPER (Stomach crumps) and PYREXIA (Fever) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M-20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced DIARRHOEA (Severe diarrhea), ABDOMINAL PAIN UPPER (Stomach crumps) and PYREXIA (Fever). At the time of the report, DIARRHOEA (Severe diarrhea) and ABDOMINAL PAIN UPPER (Stomach crumps) had not resolved and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medication include Gas tablet.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the event, a causal relationship cannot be excluded. Fever is consistent with the product safety profile
May1,2021 Loss of strength in arms legs and hands.   June 4, 2021; Diagnosis CIDP.   Being treated with IVIG.
Headache, Myalgia, CoughWheeze, fatigue, chills, extra BM (not loose/diarrhea), productive cough, spot of blood in sinus Narrative:
left upper arm edema from detoid to elbow, was hard per parent, soft and pliable to my exam, without pain, without redness
A cluster of 2 unidentifiable patients, who received on an unspecified date FLUZONE (lot # U2484AA) and experienced "staph infection".  Initial report received on 22-October 2007 from a health care professional.  2 unidentifiable patients received on an unspecified date FLUZONE (lot # 00464AA) and experienced "staph infection".  There were no proven cultures.  No other information was provided.  Follow-up information received on 10 January 2008 from the original reporting health care professional.  The two patients have been identified, and this case will now serve as the case for the 55 year-old female patient.  Who had no concurrent illness, pre-existing medical conditions, or use of other medications at the time of administration was not provided.  The following day, after receiving the FLUZONE vaccine, the patient experienced the "staph infection."  No relevant diagnostic tests, or laboratory date were performed to confirm the diagnosis of "staph infection."  At the time of this report, the patient had recovered.  No other relevant radically significant information was provided.  Follow-up information was received 21 July 2008 from a health care provider.  The reporter reviewed the case information and had no new relevant medically significant information to provide at this time.  Follow-up information was received on 11 August 2008 from a health care provider.  The patient received an injection of FLUZONE in the left deltoid.  The patient's staph infection occurred at the injection site.  The reporter for this case is the same as for case 2008-00094, which is the case for the other identified patients, who was a 39-year-old male patient who developed a "staph infection" after administration of the FLUZONE SV 2007-2008 on 18 October 2007.