chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical receptionist refers to a 80 year old female patient. In March 2008 the patient was vaccinated with ZOSTAVAX (lot # 659323/1613U) (dose and route not reported). On 05-NOV-2014 the patient developed shingles after receiving ZOSTAVAX. The patient sought medical attention in the emergency room and was treated with VALTREX. The outcome of the event was unknown. Additional information has been requested.
Patient had started noticing right hand PIP tenderness in the 4 weeks prior to the vaccine. Within 4 weeks after the vaccine he had developed bilateral, polyarticular inflammatory arthritis and diagnosed with Rheumatoid Arthritis.
She just had this red, splotchy rash on her ankle/legs are more red and splotchy/Little red rash on right pinky; Really itchy rash on her ankle. Super itchy. There are other places she may not see and it is very itchy; Rash is on both of her arms, legs and other parts of her body. The rash is a little on her lower back, but mostly on legs and both arms.; This is spontaneous report from contactable consumer. A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0170; Expiration Date: 01Aug2021) via an unspecified route of administration, administered in Arm Left on 20Apr2021 13:30 (age at vaccination 32-years-old) as dose 1, 0.3ml single for covid-19 immunisation. Medical history included ongoing anxiety, ongoing sleep and stuff, ongoing attention deficit hyperactivity disorder, migraine from an unknown date and unknown if ongoing. Concomitant medication included galcanezumab (EMGALITY [GALCANEZUMAB]) taken for migraine she took it Saturday, so she was not sure if there was any relation to the reaction she is having after the vaccine; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for attention deficit hyperactivity disorder Usually takes 15mg. She is supposed to take every day, but she does not take on her days off. She takes it maybe 4 to 5 days a week. She has been taking more than 10 years, clonazepam (KLONOPIN) taken for anxiety, sleep disorder from an unspecified start date and ongoing. On 20Apr2021, patient experienced she just had this red, splotchy rash on her ankle/legs are more red and splotchy/little red rash on right pinky, itchy rash on her ankle. super itchy there are other places she may not see, and it is very itchy, rash is on both of her arms, legs and other parts of her body, the rash is a little on her lower back, but mostly on legs and both arms. Consumer stated that, that it was about an hour or hour and a half later, she wondered if she had a bug bite at first because she just had this red, splotchy rash on her ankle. It feels like she has been bitten by a bunch of ants. But the rash is on both of her arms, legs, and other parts of her body. The rash is a little on her lower back, but mostly on legs and both arms. The legs are more red and splotchy. There are other places she may not see, and it is very itchy. There is a little red rash on her right pinky. For the treatment she took Benadryl she stated that her boyfriend took the vaccine at the same time and had no reaction. The pharmacist told her to monitor this and if it gets worse, go ahead, and go to the emergency room. Prior vaccination within 4 week was no. consumer was not allergic to anything. The only thing was an antibiotic in the early 90's that they stopped making. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Bloating; Covid like symptoms; This is a spontaneous report from a contactable consumer. A 29-year-old male patient (reporter's grandson) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 29Apr2021 15:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included allergy; allergies to penicillin and Ibuprofen; reaction to Ibuprofen is lip swelling;  patient hasn't taken Penicillin in years but believes the it is like a rash; localised infection (Was taking it for his finger). Concomitant products included unknown antibiotic, which was taking for a short time, temporary; it was taking at the time of the vaccine but is not taking anymore; He didn't finish it, he just stopped taking it; it was taking it for his finger. The patient experienced bloating in May2021 with outcome of recovered in May2021, covid like symptoms on 30Apr2021 with outcome of recovered on 01May2021. The seriousness cirteria for event bloating was disability. It was reported the day after the vaccine, he got side effects. He had Covid like symptoms for like 1 day, until the day after. After about 7 days or so after, he felt like his stomach was bloating. It was all right now. Lasted less than a week. The patient underwent lab tests and procedures which included weight: 280 or something.  Information on the lot/batch number has been requested.
rash on the top of her arm; rash goes under her armpit as well; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm sore), VACCINATION SITE RASH (rash on the top of her arm) and RASH (rash goes under her armpit as well) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm sore). On 28-Jan-2021, the patient experienced VACCINATION SITE RASH (rash on the top of her arm) and RASH (rash goes under her armpit as well). The patient was treated with DIPHENHYDRAMINE ongoing from 03-Feb-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (arm sore), VACCINATION SITE RASH (rash on the top of her arm) and RASH (rash goes under her armpit as well) outcome was unknown.        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.   No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: No new information was updated.
woke on sunday 3/7 with lymphnodes under both arms swollen. right larger than left. a week later lymph on L side of neck swelled with pain. neck has resolved however every morning I wake up both arms still have swelling. goes down a bit as day progresses.
Stomach pain and bloating and intestinal pain, lack of appetite.  Lasted for about a week and then for the most part went away - my stomach was a bit sensitive for about a week or so after that but not like as painful as it was initially.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified dates, the RECOMBIVAX HB had two temperature excursion, one for 168 hours with a lowest temperature of 33 F (0.555555556 Celsius) and the other one for 264 hour with a lowest recorded temperature of 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". On 05-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10 Pk 5mcg/0.5ml SDLLokCap Ped" which had a lot number of K018986 and expiration date on 03-APR-2016 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
On interior of vaccinated arm there was extreme swelling, skin turned bright red, hot to touch & very painful. Treated with ice packs as instructed. Vaccines was administered on Thursday 8/19 by Sunday reaction had subsided. No other vaccines were administered
RECEIVED AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 30 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 24-AUG-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-AUG-2021, the patient experienced received an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of received an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931844, 20210931810, 20210931951, 20210931982, 20210932240, 20210932036, 20210932593, 20210932874, 20210933129 and 20210933076.
skin hot; skin sore to touch; inward pain where there was lesion; This case was reported by a consumer via interactive digital media and described the occurrence of feeling hot in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling hot, skin pain and skin lesion. On an unknown date, the outcome of the feeling hot, skin pain and skin lesion were not recovered/not resolved.   It was unknown if the reporter considered the feeling hot, skin pain and skin lesion to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingle vaccine years ago and reported that going on six weeks with skin hot and sore to touch and inward pain every where there was a lesion. The patient reported that surely vaccine did not helped. The follow-up would not possible as no contact details were available
vaginal bleeding; This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration in left arm on 08Jan2021 at single dose for COVID-19 immunization. The patient have family history of diabetes mellitus from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took Vitamin B12 [cyanocobalamin] and experienced allergy rash and levothyroxine for hypothyroidism for more than a year. The patient received the first dose of the vaccine on 08Jan2021 at 11:20 or 11:25AM and at around 3 PM, she had noticed some vaginal bleeding. She thought it was her period but it stopped during the night (she mentioned she worked that night). She asked if this was a side effect from the vaccine. It was light, like when a person's period was coming but it was a brownish color, not red. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment given to the patient for the event. The outcome of the event was recovered on 08Jan2021.
Patient reported to my immunizations department at Clinic and stated that she had a reaction to a vaccine that she received two days ago.  Pt stated that she had received two immunizations on 27 Oct 2015, one immunization in each arm, and states that she believes it was the TDAP vaccine which is causing the reaction. Pt states that she felt febrile last night has Urticaria swelling and erythema at the site of the injection. Pt denies any other symptoms.  I reported the patients symptoms to the medical department at our clinic where she is being seen by a provider.
Supervisor was notified by state that this patient had received this vaccine but did not quality for it due to her age (she is 17). Supervisor contacted patient's mother. Patients mother denies any questions or complaints regarding child. She states patient has not had any side effects at this point in time.
Received vaccine 6-15-12. For 3 days the left upper arm was painful. When the pain resolved he noticed weakness in his LUE which is still present.
Information has been received from a Certified Medical Assistant concerning to multiple unknown patients who on an unknown dates were vaccinated with a dose of GARDASIL 9 (Lot No. M009116, exp. 13-JUN-2018) (route and site not reported) for prophylaxis. No adverse effects were reported. The excursion details were: Temperature: 32F: 32F to 35F Time frame: 4 hours  Temperature: 32F: 32F to 35F Time frame: 4 hours   Temperature: 32F: 32F to 35F Time frame: 4 hours Temperature: 32F: 32F to 35F Time frame: 4 hours Total cumulative hours: 16 hours. The vaccines were administered. There was no previous temperature excursion. No data logger involved. Additional information has been requested.
12 days post vax MD dx frank arthritis w/significal effusion in large joints; MD followed pt while hospitalized & stated pt had a clinical course similar to serum sickness following therapy for presumptive dx of streptococcal otitis;
Rash; Rash; Flu like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On 19th October 2019, less than a year after receiving Shingrix, the patient experienced red rash and rash. On an unknown date, the patient experienced influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the red rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, red rash and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with dose of Shingrix, the patient had flu like for 3 days. 2 days ago from the date of reporting, the patient had rash with large red circle on arms back and chest. This case was 1 of 2 linked cases.
Sarcoidosis; experience breathing difficulties; received a third dose; This case was reported by a pharmacist via call center representative and described the occurrence of sarcoidosis in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2019.) and Shingrix (2nd dose received in September 2019.).   On 12th October 2020, the patient received the 3rd dose of Shingrix. On 12th October 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On 13th October 2020, the patient experienced difficulty breathing. On an unknown date, the patient experienced sarcoidosis (serious criteria GSK medically significant). On an unknown date, the outcome of the sarcoidosis and difficulty breathing were not recovered/not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the sarcoidosis and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 3rd dose of Shingrix, the patient experienced breathing difficulties and sarcoidosis. The patient inadvertently received a third dose of Shingrix, which led to extra dose administered. The pharmacist reported that, breathing difficulties which potentially could be related to a recent diagnosis on an unknown date within a month of this report of sarcoidosis. The reporter consent to follow up. The case was considered as medication error with harm.
Reports fever of 104. headache, Leg aches, and back of neck. Went to ER. Wa given IV fluids and Toradol.  Labs were normal.  Was discharged and now feels better.
Had Moderna Covid 19 Vaccine one week ago.  Received Besxero and Menactra Today.
Patient reports redness and swelling 55 mm diameter @ injection site, Left deltoid. States developed fever for 24 hrs 101 days after the shot.
Televisit on 10/17/20 with patient's mom. Patient received routine one year old immunization of MMR/Varivax/Hept A + flu shots on 10/4/20. PE at that time was WNL except mild development delay. According to Mother, he developed fever + small, red spot on face 2 days after the shots, then faded away in a few days. Again he developed low grade fever (99-100 degrees F) on 10/16/20 with slightly bumpy rash all over the body. He was doing ok, not fussy but slightly decreased appetite. No vomiting or diarrhea. On Televist screen I observed generalized maculopapular rash (not the best screen) over face, trunk + some over the extremities No blisters or petechiae. I explained to the mother that the rash seems most possibly MMR reaction. If so pt is not contagious and advised mother to observe. I again talked with mother next day (10/17/20) She said that patient has no fever for today. Rash was slightly getting better. I advised to get Covid test but mother declined. I talked with mother on 10/23/20 Mother said that rash faded away after 2 - 3 days but the 2 - 3 days after that another eczema like rash appeared on face She used Hydrocortisone cream + it faded away in 2 - 3 days Currently patient was doing fine, no complaints
Information has been received from a physician concerning an approximately 10-year-old female who, on an unspecified date, was vaccinated with a dose of Varivax. In April 2006, the patient developed a mild breakthrough case of varicella. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
After 12 hours of vaccinated. Pt. felt fever, headache, pain in injected arm, redness and swelling around site of injection. Continue after 2 days of vaccination.
2:01P PT RECEIVED VACCINE. 2:02P PT MOVED TO LOBBY AND SAT AT BP MACHINE. STATED HE FELT DIZZY AND LOST CONSCIOUSNESS AND FELL TO THE FLOOR. REGAINED CONSCIOUSNESS BY 2:04P ASKING WHAT HAPPENED, STATED HIS WRIST HURTS. ACKNOWLEDGED HE ALWAYS FAINTS WITH VACCINES/NEEDLES. BY 2:08PM PT REPORTED FEELING BACK TO BASELINE BESIDES HIS WRIST. EMS ARRIVED BY 2:18PM. WHEN GETTING HIM TO SIT UP HE FELT DIZZY AGAIN AND LIED BACK DOWN. WAS ABLE TO SIT THEN STAND BY 2:25PM. DUE TO THE DIZZINESS AND FAINT FEELING LASTING GREATER THAN 10 MINS, EMS RECOMMENDED AMBULENCE TRANSPORT TO HOSPITAL. PATIENT REFUSED STATING HE FELT EXACTLY AS HE HAD IN THE PAST WHEN HE HAD FAINTED PREVIOUSLY FROM VACCINES. NO REDNESS/ITCHING/SWELLING/PAIN AT SITE OF INJECTION. DECLINED TRANSPORTATION TO HOSPITAL. ONLY COMPLAINT WAS WRIST PAIN WHICH WAS A RESULT OF FALLING.
Child had MMR #2 at 4pm on 8/15/02. Child got sick at 2am 8/16/02-fever 102 degrees, headache, tired, vomiting. Mom called MD at 2pm on 8/16/02-stated if not better in 24 hrs. to go to ER. Client saw MD on 8/19/02. Did raid strep test-was negative, placed on Cefzil-rest of family having flu-like symptoms. Still recovering.
Itchy; Red spot moved toward the elbow; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), PAIN IN EXTREMITY (Sore arm) and ERYTHEMA (Red spot moved toward the elbow) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 26-Feb-2021, the patient experienced ERYTHEMA (Red spot moved toward the elbow). On 27-Feb-2021, the patient experienced PRURITUS (Itchy). At the time of the report, PRURITUS (Itchy), PAIN IN EXTREMITY (Sore arm) and ERYTHEMA (Red spot moved toward the elbow) was resolving.
Fever of 102F; Injection site pain; Chills; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102F), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and MYALGIA (Muscle ache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (Fever of 102F), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and MYALGIA (Muscle ache). At the time of the report, PYREXIA (Fever of 102F), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and MYALGIA (Muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature: 102f 102F.         Concomitant medications were not provided.
1st dose in 2021, not gotten 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose into left arm intramuscularly on 25th September 2021 from batch number 3s3x7 with expiry date 20th March 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-DEC-2022 Reporter's comment: The case was self reported by the patient. The patient did not receive second dose of Shingrix yet. The reporter reported that they do plan to get the second vaccine. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.