chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough case admission after 2 vaccines Moderna 6/15/21 lot# 054C21A;  Moderna7/21/21 lot# 040B21A;
got the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a dentist (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (got the vaccine while pregnant) in a 32-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Miscarriage (Miscarriage at 6 weeks) on 10-Oct-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 04-Nov-2020 and the estimated date of delivery was 16-Aug-2021. On 21-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (got the vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy. The delivery occurred on an unknown date.  On 21-Jan-2021, EXPOSURE DURING PREGNANCY (got the vaccine while pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Ultrasound foetal: findings unknown. On 03-Mar-2021, Prenatal screening test: normal. On 30-Mar-2021, Ultrasound foetal: (abnormal) baby normal and maternal low placenta noted.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient wants to register her pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up information was received on 19-APR-2021. Added medical history (Miscarriage at 6 weeks)
had full blown clinical varicella 20APR97 recv vax 4DEC96;
2-3 days after vaccination, swollen lymph nodes under left arm and L breast was out of proportion to the right. L arm I could barely lift it. Went to the doctor and she said that it would go away and it did. 3-4 weeks after the vaccine, behind the sinuses felt swollen. When I ate food or drank, it felt like it was getting stuck in the wrong area. Went to an ENT and there was no blockage and he gave me steroids that didn't work. 2 days after that, I went to urgent care and the doctor gave me Amoxicillin and that helped. I was doing the Amoxicillin and the Zyrtec. Zyrtec took the swelling down.
Received smallpox vax 2/27/03. Proceeded w/course w/o incident. Minimal c/o tiredness "No fever" Scab off? 3/16/03 No report of Sx's. 3/4, upon questioning PT, stated did have some palpitations on 4/2 & 4/3.
This spontaneous report as received from a nurse practitioner, refers to a 19 year old male patient. The patient did not have any medical history, historical drugs, concomitant therapies and concurrent conditions. On 20-SEP-2017, the patient was vaccinated with GARDASIL 9, intramuscular, for prophylaxis (reported as vaccination) (strength, dose, frequency, lot # and expiration date were not reported). On an unspecified date in September 2017 the patient developed lower extremity petechiae and hematuria, so on 29-SEP-2017, he sought for medical attention and went to the emergency room, where he had a a computed tomography (CT) Scan of the abdomen and a complete blood count was performed. The patient was found to have a platelet level of 7 (units not provided) and on an unspecified date in September 2017, was admitted to a hospital for treatment of thrombocytopenia. No intervention to prevent serious criteria was performed. At the time of reporting, the outcome of thrombocytopenia was reported as not recovered. Additionally, the assessment causality between thrombocytopenia with GARDASIL 9 was not provided. The reporter considered thrombocytopenia to be a life threatening event. Upon internal review, thrombocytopenia was determined to be medically significant.
Very sudden Extreme pallor, looked grey. Very suddenly felt extremely cold. Those two symptoms lasted about an hour or two. Bad headache. Needed to lay down and could not continue normal activities. The third and fourth symptom lasted over night. 30 hours lingering headache. Gave fluids and many layers of clothes and blankets. It looked severe.
A tech gave pt pfizer shot instead of flu shot. Pt is doing okay so far. Company is following up
I was diagnosed with reactivated mononucleosis and went down for several days as a result. I am not certain if they are related but I experienced headache and extreme exhaustion. They placed me on a lot of antiviral medications and it took about a month to have the symptoms subside. I was placed on valacyclovir, lysine, and monolaurin. I am still be treated and estimated to be in treatment for a year. I was diagnosed on August 30th.
Patient reports that she had a sore arm. However, the adverse reaction started that evening/early morning of the next day.  She woke up itching and chills.  She continues to have a few chills every now and then.  She is covered in a morbilliform rash sparing hands, feet, and face.
Pain after injection in R deltoid.  1 week following injection massive amount of swelling, heat, redness, nausea, headaches, muscle cramps
Pt vaccinated with DTP experienced cold, pale, crying x 2 hrs (shrieking) temp 101.
Information has been received from a consumer and a physician concerning his 12-month-old son with no allergies or medical history, who on 11-MAY-2006 at 10:00 am was vaccinated subsequently in the right arm with a single first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 652483/0148F). Secondary suspect therapy included a first dose of varicella virus live (MSD) (lot# 65219/1022R) given on 11-MAY-2006 in the left arm, subcutaneously. At the time of vaccination, he had an ear infection and was amoxicillin (AMOXIL). It was previously reported that on 17-MAY-2006 the patient experienced flu-like symptoms including a runny nose, fever and watery eyes. On 21-MAY-2006 the patient developed a rash on his forehead which subsequently spread to his upper torso, back, arms and legs. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been received indicating that the patient recovered as of 27-MAY-2006.
Erythematous rash on the lower legs and some on the upper arms. No fever. No local redness or swelling.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 19-DEC-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 14-JAN-2016, the patient was treated by a physician, for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed Acyclovir for management of his painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
3.5 swelling, redness, induration at injection site, headache, pain, loss of appetite, arthralgia, malaise, chills, fatigue.
PRN visit for complaint of SOB, productive cough, body aches and chills. Febrile (101.9). Temporal crackles in all lobes. Spouse reported productive cough with brown sputum x2 days.
anterior uveitis / can't see well enough; it was getting better, but it was not happy; This is a spontaneous report from a contactable physician reported for herself. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, deltoid right on 10Mar2021 (batch/lot number EN6208 and expiry date not reported) at 66 years of age as single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included some over the counter B12 (unspecified). The patient informed that she developed an anterior uveitis which started 2 days post her COVID injection (12Mar2021). The patient informed that she will be reporting online but she can't see well enough (Mar2021) to report online. The patient informed that "it was getting better, but it was not happy". The patient informed that in response to the vaccine she was on Prednisolone 1 percent ophthalmic eye drops. The patient confirmed that she was taking Prednisolone as a treatment (for the events) and was still on it. The outcome of the event anterior uveitis was not recovered, while unknown for the other event. The physician informed that causality was "yes".; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event iridocyclitis cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Started with stomach pain when she ran.  Continued to have stomach pain on and off throughout the day.  Received second dose on 12/21/2011.  Now is having chronic stomach pain and nausea.  Also had an anxiety attack and said she felt short of breath.
Information has been received from a healthcare worker concerning a male who on 09-MAY-2006 was vaccinated with pneumococcal 23v polysaccharide (lot#651319/1007P).  Subsequently, on 10-MAY-2006 the patient experienced cellulitis of the upper arm.  The patient was recovering.  Additional information has been requested.
Patient received 2nd rotavirus vaccine. The second vaccine was a Rotarix, and 1st vaccine received on 12-01-2022 was a RotaTeq. Rotarix was given not related to RotaTeq being out of stock. No adverse event observed or reported. Patient's mother notified via telephone on 02-09-2023, but mother had to cut call short, she stated "I have to call you back later, my kids are crying" no further calls received. GSK was notified at approximately 11:10 AM, spoke to representative, who provided RN with information related to Rotarix to present to patient's mother.
12 hrs at 66.92 °F and  42 hrs 24 minutes at 65.6 °F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th November 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-NOV-2022 Reporter's Comment: The reporter reported that the Bexsero vaccine had a temperature excursion lasting 12 hours with maximum temperature of 66.92 Fahrenheit, and then a second excursion lasting 42 hours 24 minutes, with a maximum temperature of 65.6 Fahrenheit. The reporter reported that the vaccine was administered to the patient after the second excursion occurred. At the time of reporting, the reporter did not had patient specific identifiers. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The Bexsero vaccine temperature was exposed 66.92 Fahrenheit for 12 hours and 65.6 Fahrenheit for 42 hours and 24 minutes, which led to incorrect storage of drug. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022179395:same reporter US-GSK-US2022AMR179996:same reporter
HOT-COLD CHILLS; POSSIBLE PARTIAL DOSE ADMINISTERED; MUSCLE SQUEEZED; EXTREME BODY ACHES; LEFT LEG PAIN; HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included high cholesterol, and concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug abuse/illicit use and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and  expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced hot-cold chills. On 08-APR-2021, the subject experienced possible partial dose administered. On 08-APR-2021, the subject experienced muscle squeezed. On 08-APR-2021, the subject experienced extreme body aches. On 08-APR-2021, the subject experienced left leg pain. On 08-APR-2021, the subject experienced headache.  Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and hot-cold chills, had not recovered from extreme body aches, left leg pain, and muscle squeezed, and the outcome of possible partial dose administered was not reported. This report was non-serious.
On 04/23/2021 I pressed my finger on my right ear to clear pressure. When I did so, the entire room went silent and I realized I wasn't hearing in my left ear. I knew that I had been having trouble hearing my phone on my left ear for about two or three weeks (so starting around April 1, 2021), but I blamed the phone, thinking it was directional.  I immediately made an appointment with my ENT who on 4/30 said that my sinuses and ears were clear. On 05/10/2021, the Audiologist confirmed that all lower range is gone. ENT said no tumor was detected on the scans, so this is due to some nerve damage of undetermined origin. I will be fitted with a hearing aid. I have no prior hearing issues.
Woke up with headache at 9am.  Fatigue, achy,  sweats and chills starting around 10am and ongoing at present time of 245pm.  Vomiting three times (as of now) between 12pm and 245pm.
I was already experiencing migraines from my first dose. The problem continued after my 2nd dose. Migraines caused ear ringing, eye pain. Sometimes would see a shimmering light during migraines.
Seen on 11/23/18 for febrile seizure in CHO Seen on 11/26/18 for macular, blanching rash on arms, trunk, and back - similar to measles rash + fussiness.
Swollen lymph node in armpit; Malaise at injection site; Jaw popping; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Malaise at injection site), JAW DISORDER (Jaw popping) and LYMPHADENOPATHY (Swollen lymph node in armpit) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE and LOSARTAN for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION COMPLICATION (Malaise at injection site) and JAW DISORDER (Jaw popping). On 17-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node in armpit). On 15-Mar-2021, VACCINATION COMPLICATION (Malaise at injection site) and JAW DISORDER (Jaw popping) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph node in armpit) 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 treatment  was provided.
Suffered a massive MCA stroke; This is a spontaneous report from a Contactable Nurse. A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), intramuscularly in left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization.  Medical history included covid prior vaccination.  Known allergies: None. The patient's concomitant medications were not reported. The patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1685), intramuscularly in right arm on 21Dec2020 03:00 PM at single dose for COVID-19 immunization. The patient was not pregnant while receiving vaccine. Facility type vaccine: Hospital. If other vaccine in four weeks: No. Other medications in two weeks: No. The patient suffered a massive MCA (Middle cerebral artery) stroke on 21Jan2021 08:00 after getting second covid vaccine with outcome of not recovered.  No history of hypertension, elevated cholesterol or medical issues. No medication being taken. Daily BP (Blood pressure) reading normal. Covid test post vaccination: Nasal Swab-PCR on 22Jan2021 with result negative. If treatment for AE: Unknown. The event was resulted in: Emergency room/department or urgent care, Hospitalization (Number of days hospitalization: 4), Life threatening illness (immediate risk of death from the event), Disability or permanent damage.; Sender's Comments: The event middle cerebral artery stroke appeared 8 days after administration BNT162B2. The Company considers that the event is less likely related to suspect BNT162B2 injection given the weak time association. The status (bleeding or infarction) and cause of the stroke would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Yesterday patient told me before taking this IMZ she seems to get exaggerated responses to IMZ and preferred only 1 at a time. Today she calls me and discusses side effects. She said her side effects seem to match the literature she was given by us. She is having fatigue, muscle pain, neck pain, head ache, chills and shaking, decreased appetite. Patient has arm tenderness at the injection site. She asked for me to report these effects. I told her to contact her doctor if needed.  She responded that she felt most likely a doctor would not be necessary. I told her I would contact her later today or in the morning to check on her. I cannot adequately fill out Item 20 or 21 at this time.
12 YO patient received infanrix; Received  infanrix instead of dTpa vaccine; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Jul-2022 Reporter's Comments: Medical assistance (MA) reported a 12-year-old patient received an Infanrix on left deltoid instead of the tdap vaccine. The consent to follow up was granted. Additional Supportive Information: As 12 year patient received an Infanrix instead of the tdap vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Mom called 6/6/11 to report baby began running fever after getting shots 6/1. Additionally, developed a rash which worsened over the next 4 days. Took baby to be checked at ED on 6/6/11.
This case was reported by a consumer and described the occurrence of sore arm in a 31-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (manufacturer unspecified) given in 2011 following the the birth of a child. There were no concurrent medications. On 13 July 2012 the subject received a dose of BOOSTRIX in the left deltoid at the advice of her physician following, cutting her foot on a rain downspout. The subject experienced a sore arm on 13 July 2012 following BOOSTRIX administration. The subject also experience extra dose administered as she also received a Tdap vaccine following the birth of a child in 2011. At the time of reporting the event of arm soreness was improved. The subject noted that her arm was more sore than other injections she received.
Right arm and legs looked like hives; Rash was burning; left arm got a raised rash; Left arm got itchy; Sore arm/left arm got tender; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm/left arm got tender), RASH PAPULAR (left arm got a raised rash), PRURITUS (Left arm got itchy), URTICARIA (Right arm and legs looked like hives) and RASH (Rash was burning) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm/left arm got tender). On 28-Feb-2021, the patient experienced RASH PAPULAR (left arm got a raised rash) and PRURITUS (Left arm got itchy). On 01-Mar-2021, the patient experienced URTICARIA (Right arm and legs looked like hives) and RASH (Rash was burning). At the time of the report, PAIN IN EXTREMITY (Sore arm/left arm got tender), RASH PAPULAR (left arm got a raised rash), PRURITUS (Left arm got itchy), URTICARIA (Right arm and legs looked like hives) and RASH (Rash was burning) outcome was unknown.        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 concomitant medication details was reported. No treatment medication details was reported.