chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hearing loss in right ear; the ringing was much louder now than ever before; the ringing was much louder now than ever before; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date in 2021 (Lot Number: EX 6200), as single dose, for COVID-19 immunisation. Medical history included ongoing tinnitus (before the 2 vaccinations). Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation on 17Feb2021 (lot# EL9262, at 12:00 PM, in left arm). The patient experienced hearing loss in right ear (medically significant) in 2021 with outcome of not recovered, the ringing was much louder now than ever before (non-serious) in 2021 with outcome of not recovered. The patient reported to have mild to medium ringing in ears before the injections. She reported the ringing was much louder now than ever before. The tones were different in each ear. It was almost unbearable at times. She also lost some hearing in right ear, left ear was fine. Since the vaccination the patient was not tested for COVID-19.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 29-MAY-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J006955, expiration date: 07-JUN-2015. That may have been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed to 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the temperature stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a medical assistant concerning a 4 year old male patient with no recent varicella exposure who on 09/10/2001 was vaccinated with Varivax. On 03/13/02, the patient was seen with 20 lesions, a low-grade fever and was diagnosed with varicella. The patient was treated with calamine/camphor/pramoxine hydrochloride (Aveeno) and diphenhydramine (Benadryl) as needed. The patient's other brother was never vaccinated with Varivax and had varicella on approximately 02/27/02. His brother had at "uncountable" number of lesions. Additional information has been requested.
05Oct2022 she self-tested and tested positive for COVID-19; 05Oct2022 she self-tested and tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9269), in arm, on 10Mar2021 as dose 2, single (Lot number: EL9269), in arm and on 05Aug2021 as dose 3 (booster), single (Lot number: EW0182) at the age of 89 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Skin cancer", start date: 2013 (ongoing), notes: Skin cancer, Diagnosed 3or 4 years ago.  Still affected just a little in small areas.; "Waldenstrom's macroglobulinemia", start date: 2013 (ongoing), notes: Waldenstrom's macroglobulinemia; "blood cancer" (unspecified if ongoing), notes: She has blood cancer. The patient took concomitant medications. Past drug history included: Rosuvastatin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Oct2022, outcome "unknown" and all described as "05Oct2022 she self-tested and tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Oct2022) positive; Weight: (unspecified date) Used to weigh 125; (2013) Has lost a lot of weight from COVID-19; (Oct2022) lost 2, notes: lost 2 pounds since having COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient tested herself for COVID-19 on 05Oct2022 and her symptoms had started two days before that. She had a headache in the back and top of her head. Normally doesn't have headaches. Her chest hurt. Usually she gets a cold in the spring and the fall. Two days before she had the headache she felt like she was getting a cold and congestion. 05Oct2022 she self-tested and tested positive for COVID-19.; Sender's Comments: Based on available information in the case a possible causal association between the reported event Vaccination failure and COVID-19 and the suspect drug BNT162B2 cannot be excluded and also a contributory role of medical history.The case will be reassessed once new information is available.
pt recvd vax; exp fever;10jul95 vaccinated w/ hep B and on 11jul95 exp vesicular rash w/ 25 lesions which subsequently dx as  chicken pox;reporter stated that pt exposed to chicken pox;
I was ok after receiving the vaccine. Just a bit nausea and then everything was ok. I received the vaccine on 5th of may and i had a severe headache and fatigue on 11th may (evening) i couldnt figure out the reason. I had a Tylenol and rested for sometime. At night the headache started again severely on the right side of my head and right leg also had muscle aches and i had zero energy. On the 12th it was the sane and blood pressure was on a lower side. On the 13th it was ok in the morning but after noon i had no energy and pain in both legs. I had a blood pressure of 90/48 which was quite low, i never had such an episode of low or a high blood pressure. I had a few boiled eggs with salt and 4-6 dates and i was able to get rid of aches in my body but not fully. At night of 13th may i was able to maintain a blood pressure of 104/55.
Pt called the store and left a message with the  front end manager stating that she received an infection from the vaccine she was given.
Patient  felt right  arm pain on same day of vaccination .  However , still 2 months  after  vaccination , the  patient is complaining of very severe pain limiting her activity and she's being prescribed Diclofenac
3RD DOSE COVID VACCINE GIVEN 11/20/21, MODERNA, #058F21A;  pt passed away at home; DC COD:  probably cardiac arrest, COVID, Cerebrovascular disease
Act-HIB for which cold chain break is reported with no reported adverse event; Poor quality vaccine administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to cases 2023SA124713 and 2023SA129811.  This case involves Infant and unknown gender patient for whom poor quality vaccine HIB (PRP/T) vaccine [ACT-HIB] administered of which cold chain break with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection with unknown strength, dose, batch number, expiry date via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the cold chain break is reported with no reported adverse event (product storage error) and patient received a dose of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection with unknown strength, dose, batch number, expiry date via unknown route in unknown administration site for prophylactic vaccination was administered with no reported adverse event (poor quality product administered) (latency: same day).  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
rash on chest; Stiffness in arm; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in arm) and RASH (rash on chest) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 vaccination.     The patient had never been tested positive for Covid-19.  Concurrent medical conditions included Drug allergy (Neoprene allergy) and Allergy to antibiotic (bacitracin allergy). Concomitant products included APIXABAN (ELIQUIS), FLECAINIDE ACETATE, METOPROLOL SUCCINATE, SIMVASTATIN, CENTRUM SILVER ADULTS 50+, FAMOTIDINE and FISH OIL for an unknown indication.    On 10-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Oct-2022, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in arm). On 11-Oct-2022, the patient experienced RASH (rash on chest). The patient was treated with CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL [CAMPHOR;DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]) on 11-Oct-2022 for Rash, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness in arm) outcome was unknown and RASH (rash on chest) had not resolved.            On 26-Jan-2021, the patient received first dose of Moderna vaccine (lot no.: 010M20A).  On 25-Feb-2021, the patient received second dose of Moderna vaccine (lot no.: 013A21A).  On 26-Oct-2021, the patient received third/first booster dose of Moderna vaccine (lot no.: 012F21A).  On 10-Oct-2022, the patient received the second booster dose of Moderna vaccine, and she felt stiffness in her arm.  On 11-Oct-2022, the patient developed a rash on her chest and took Benadryl for it, but it would nor disappear. She called the pharmacy where she received the vaccine and they told her to take Zyrtec and if it does not get any better, then the patient was advised to consult healthcare provider.   This case was linked to US-MODERNATX, INC.-MOD-2022-658626 (Linked Report). This case was linked to MOD-2022-658814 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2022: Live follow up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658626:Husband case
About 2 weeks after 3rd dose, I began to get itchy, near vaccination site first. Noticed near my watch band bumps below the skin. Seems like they follow blood vessels up my left arm to shoulder. Always there, sometime itchier than other times, sometimes they are very itchy.. Sometimes arm feels tingley, like my arm falls asleep. Bumps on upper arm are above skin, resemble small mosquito bites.
This case was received from a health professional on 07 November 2007. Seriousness Criteria: Other-Medically Significant A four-year-old male patient with no reported medical history received Fluzone (lot number U2448AA) on 23 October 2007; route and site were not reported. Within ten minutes of vaccination, the patient developed stridor and sternal retractions while still at his physician's office. He was treated with oxygen, breathing treatment, steroid injection, and Benadryl. He fully recovered after approximately 90 minutes. Per the reporter, the patient had received Fluzone in previous years. No additional information was provided.
After my first dose of Shingrix I became nauseous; This case was reported by a consumer and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received 1st dose of Shingrix and became nauseous. The patient wanted to know was there any advice to minimize this side effect.
This spontaneous report was received from a nurse and refers to a 9 week month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 10-OCT-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N009802, expiry date: 19-DEC-2019) and ROTATEQ (dosing details not reported) (lot # N009948, expiry date: 12-OCT-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA007011:
Headache, Myalgia, Fever, sore left arm, chills Narrative:
When administered the vaccine needle was too short (< 130 lb patient). We need to re immunize with proper needle Spoke to doctor, we will re-immunize.
Constant urinary urgency / urethra irritation that still persists to this day. I think partially is my fault because around the same time I was doing aggressive masturbation up to 5 times daily which I think caused the issue. Normally I recover within a week from urgency symptoms after such behavior, but now it's been months and I have not recovered, even after minor urology intervention while in a foreign country   I'm not sure if  vaccination was directly involved, or if I caught covid around the time of second vaccination without realizing it, but it started around the same time which is why I am logging out of an abundance of caution.  Treatment:      - Was prescribed a 21 Day Course of treatment:         - Levofloxacin 750mg after breakfast         - Doxazosine 8mg daily after dinner  During this course of treatment I realized symptoms could be less if I delayed myself to peeing no more than once hourly.
Pt. seen 8/28/17 in office for check up. Rec'd 5 yr immunizations. (*Declines Hep B #'s 2 and 3 and Hep A #2). Pt. seen again 8/29/17 for S/S=(Rt) arm with redness/edema/warmth to area app. 4-5" diameter pt denies pain; moving arm well. (Lt.) upper arm with 2-3 cm redness; no edema. Tx with PRN IB. and BENADRYL and ice.
no adverse effect; administered improperly stored dose; This spontaneous report was received from nurse refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. The patient's concomitant medication included sterile diluent. On 21-JUN-2019, the patient was vaccinated with an improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and frequency were not reported) (lot # S002874 and expiration date: 29-JAN-2021) for prophylaxis. It was reported that the sterile diluent used to reconstitute varicella virus vaccine live (oka/merck) (VARIVAX) was properly stored. The temperature excursion was noted at 7.64 fahrenheit for 20 minutes. No previous temperature excursion was noted. This call was because of digital data logger. No adverse effects were reported. Product quality complaint was not involved.
Narrative: Provider History This 52-year-old male complaining of dry cough for the last week. Patient states his roommate was diagnosed with covid one week ago. He started having productive green sputum yesterday with body aches and a fever. Temperature is 100.9 last night. He is complaining of shortness of breath. He denies any hemoptysis. He has a history of arthrisis is not on is on steroids which she's been titrating down and is on immunosuppressive drugs. He denies any hemoptysis arm jaw pain palpitations or syncope. No urinary complaints. He states he has chronic diarrhea without melanotic hematochezia. Patient is had his coded vaccination series with his last inoculation and 6/3/21 Provider History This 52-year-old male complaining of dry cough for last week. Patient states his rommate was diagnosed with covid one week ago. He stated having productive green sputum yesterday with body aches and a fever. Temperature is 100.9 last night. He is complaining of shortness of breath. He denies any hemoptysis. He has a history of arthritis is not on is on steroids which she's been titrating down and is on immunosuppressive drugs. He denies any hemoptysis arm jaw pain palpitations or syncope. No urinary complaints. He states he has chronic diarrhea without melanotic hematochezia. Patient is had his coded vaccination series with his last inoculation and 6/3/21
poor antibody response; This literature marketed report has been received from the authors of a published literature article, entitled as stated below, and refers to an infant male patient. The patient had recurrent infections, which included oral candidiasis, influenza, otitis media, and presumed osteomyelitis and myositis without positive cultures, hypergammaglobulinemia, recurrent fever, leukocytosis, and elevated inflammatory markers.  On unknown dates, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) and pneumococcal vaccine (reported as Streptococcus pneumoniae vaccine) (doses, routes and sites of administration, lot numbers and expiration dates were not reported) for prophylaxis.  On an unknown date, the patient experienced a poor antibody response to haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) and pneumococcal vaccine (antibody test abnormal). On an unknown date, at the age of 9 months, he was referred to allergy/immunology due to poor antibody response to above mentioned vaccines, recurrent infections and hypergammaglobulinemia. Rheumatology was consulted due to recurrent fever, leukocytosis, and elevated inflammatory markers. Treatment with colchicine was initiated on an unknown date and his symptoms improved. He developed skin nodules, sparse hair, and conical teeth, raising concern for defects in the nuclear factor-k B essential modulator (NEMO) pathway. Whole exome sequencing was non-diagnostic. Deep sequencing of the IKBKG gene revealed a variant of uncertain significance in exon 7. Further evaluation at the Agency was planned. The authors reported that it was a challenging case with a working diagnosis of NEMO deficiency.  The outcome of antibody test abnormal was unknown. The authors considered antibody test abnormal to be related to suspected vaccines.  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report:
Information has been received from a registered nurse concerning a 10-year-old female with drug allergies to sulfa, Zithromax and amoxicillin, who on 23-SEP-1997 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There were no illnesses at the time of vaccination. On 26-JUN-2007, the patient come to the office with her mom and presented with headache and a rash on her trunk and face which had about 20 papules, some clustered, on an erythematous base. No laboratory or diagnostic tests were performed. On 09-Jul-2007, the patient recovered. This is one of several reports from the same reporter. Additional information has been requested.
Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 25-Mar-2021, the patient started COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) at an unspecified dose. On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021). On 10-Nov-2021, PRODUCT ADMINISTRATION ERROR (Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
This spontaneous report was received from a nurse. No patient identifiers were provided. The nurse reported that the VARIVAX (Merck) in her facility had been stored in a 'dorm style' freezer unit with no thermometer for an unknown amount of time. The nurse stated that she was not sure if any of these doses have been administered to patients. No adverse effects were reported. Additional information has been requested.
It started with flu like symptoms, upset stomach, not feeling well according to my husband who was present, fast onset of vomiting and continued to vomit for 24 hours many times, complete loss of memory for 24 hours, this started around 3:00 p.m. on 3/14/21, started to feel better about 24 hours later.  Next event, 4/19/21, 7:30 a.m. had a very bad nose bleed with two large clots coming out of my nose.   Nose bleed stopped after about 15 minutes.