chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse effects; One female patient was administered improperly stored ROTATEQ; This spontaneous report has been received from a vaccine coordinator, concerning a 6 months-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were not reported.  On 05-MAR-2020, the patient was vaccinated with an improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form for prophylaxis (product storage error) (lot number 1658255 has been verified to be a valid number; expiration date reported and validated as 07-FEB-2021) (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported).  The reporter stated that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) underwent multiple temperature excursions below 2 degrees Celsius.  On 02-MAR-2020, the temperature was 0.8 degrees Celsius for a time frame of 5 hours and 9 minutes, on 04-MAR-2020, the temperature was 0.9 degrees Celsius for 11 hours; and on 05-MAR-2020, the temperature was minus 1.3 degrees Celsius for 9 hours and 29 minutes as recorded by the data logger.  Other temperature excursions occurred on 25-FEB-2020 and the temperature was above 9 degrees Celsius (9.3 degrees Celsius) for 3 hours and 33 minutes and on 03-MAR-2020, the temperature was below 2 degrees Celsius (0.8 degrees Celsius) for 11 hours and 39 minutes, also recorded by the data logger.   No adverse effects were reported.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-2003USA006325: US-009507513- 2003USA006317:
This spontaneous report as received from a healthcare worker concerning an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of GARDASIL (dose, frequency, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that on an unknown date, an improperly stored GARDASIL may have all been administered. The healthcare worker that she would call back once she knows for sure which vaccine had been administered. The healthcare worker reported that the GARDASIL were exposed to a temperature of 1.5C for 25 minutes. No adverse effect reported. These is one (1) of five (5) reported from the same reporter. (MARRS 1405USA012173, 1406USA000568, 1406USA000568, 1406USA000569, 1406USA000570 and 1406USA000571). Additional information has been requested.
diagnosis of post-herpetic neuralgia; persistent strain of herpes zoster or shingles; The vaccine did not prevent shingles as intended; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On or about 29-OCT-2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 16-DEC-2015, patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. Patient was prescribed acetaminophen (+) hydrocodone bitartrate (VICODIN) for management of his painful symptoms and chronic pain. On or about 22-JAN-2016, patient was treated by the physician for the diagnosis of post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. He was prescribed gabapentin for management of his painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered all events to be related to Zoster Vaccine Live (ZOSTAVAX).
Received vaccine #1 Phizer on Jan 5th 2pm. Started to feel tired by 7pm. 5am woke up achey with general malaise. Took Tylenol 500mg and came to work. I started the attestation form and called employee health to let them know about my aches. They recommended me getting tested for Covid 19 in which I did before I left at 8:30am. My health continued to decline as I became ferverish, with a headache, nauseas, foggy, and exhausted. When I got home, I couldn't get off the couch. I felt horrible for 36hrs. My headache lasted for 5 days. Covid 19 test and flu test negative.
Large raised red area surrounding vaccine site that remains two days later. Have had flu shot for many years without a previous reaction.
Received call from mother on 02-19-2013 who stated child had reddened warm area on leg who shot was given, spoke w/father on leg who shot was given, spoke w/father on 02-20-13 who stated rt Leg is still reddened and swollen but swelling is decreased. No answer at home on 02-25-13, spoke with grandmother 02-26-13 (at above number) who stated "child is allergic to vaccine-area size of quarter at present no MD visit site improved per grandmother.
Welt on arm noticed on 1/6/21.  Next morning on the 7th, noticed it was bigger, red, swollen and warm.  Called my workplace's health line and got antibiotics.
I had an unbearable headache, along with stomach cramps. Leg cramps and body aches started a couple days into the five day reaction. I did not go to my primary doctor.
This case was reported by a lawyer and described the occurrence of seizures in a male child of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. A physician or other health care professional has not verified this report. On 3/21/02, the subject received third dose of Infanrix. On 3/21/02, the subject also received hepatitis B vaccine, Haemophilus influenzae type B conjugate vaccine, inactivated poliomyelitis virus vaccine, and 7-valent pneumococcal conjugate vaccine. At an unspecified time after receipt of the vaccinations, the subject experienced seizures, neurological deficit, learning disability, developmental delay, gastrointestinal problems and toxic neurological effects of mercury poisoning. The outcome of the events was not reported. Comment: Seizure was assessed as medically serious (OMIC).
Starting about 1 week after receiving the vaccine, I developed patches of rash in random places over my body and a severe cold sore that spread across my lip. My doctor said it was likely an immune response. He put me on antibiotics and antivirals. The symptoms lasted for about a week after starting the meds and resolved on their own.
Pt recvd vax 4APR91 & following day had t103 x 2 days, then devel maculo papular rash which involved the palms, soles &face; rash was itchy & somewhat relieved w/DPH; rash lasted 4-5 days; pt also fussy & irritable; assoc facial edema;
The evening of the vaccine,  felt like the flu, my body was hurting, fever, very tired, fatigue. These symptoms lasted 4 or 5 days. I took Tylenol, Contact flu medication. I had  Diarrhea, and black stool .
Patient received the Pfizer vaccine on 4/9/21 and 4/30/21, so was fully vaccinated when they tested positive for COVID-19 on 9/13/21.
Clarified that she is currently experiencing allergies.; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support a contactable consumer (Patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 17Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Clinical course reported as caller has taken the 1st dose on 17Apr and wants to know if she is cleared to take allergy pills. On 19Apr2021, Clarified that she is currently experiencing allergies. The outcome for the event was not recovered.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
I woke up and had nasal congestion and runny nose.  I also had a headache.  I noticed body aches and in my joints, hips, knees, ankles and shoulder.  I had a cough.  I did not have fever.  The cough was fairly productive. I tested positive from home on Sunday July 10,, 2022. I got Paxlovid on Monday, the next day, it did help the symptoms.  But after the 5 days of Paxlovid, the symptoms returned slightly.  As of today I still have congestion, runny nose and some body aches.  I tested positive again today.
Fever; Chills; very slight headache that appears and then goes away; Sore joint and arm; Nausea; sore muscles; Fatigue; Feeling foggy / Brain fog; Urination problem : urination was not normal (hardly urinated , even drinking lots of water); Sore joint and arm; Dizzines / Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling foggy / Brain fog), DYSURIA (Urination problem : urination was not normal (hardly urinated , even drinking lots of water)), PAIN IN EXTREMITY (Sore joint and arm), DIZZINESS (Dizzines / Lightheadedness) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Sulfa) and Iodine allergy. Concomitant products included VITAMIN D3, UBIDECARENONE (COQ10 [UBIDECARENONE]), GINKGO BILOBA (GINGKO BILOBA) and NATTOKINASE for an unknown indication.    On 02-Mar-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling foggy / Brain fog), DYSURIA (Urination problem : urination was not normal (hardly urinated , even drinking lots of water)), FATIGUE (Fatigue) and NAUSEA (Nausea). 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore joint and arm), DIZZINESS (Dizzines / Lightheadedness) and MYALGIA (sore muscles). On 11-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), HEADACHE (very slight headache that appears and then goes away) and ARTHRALGIA (Sore joint and arm). On 25-Mar-2021, DYSURIA (Urination problem : urination was not normal (hardly urinated , even drinking lots of water)) had resolved. At the time of the report, FEELING ABNORMAL (Feeling foggy / Brain fog), PAIN IN EXTREMITY (Sore joint and arm), DIZZINESS (Dizzines / Lightheadedness), PYREXIA (Fever), CHILLS (Chills), HEADACHE (very slight headache that appears and then goes away), FATIGUE (Fatigue), ARTHRALGIA (Sore joint and arm), NAUSEA (Nausea) and MYALGIA (sore muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-219973 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Initial additional On 02-Jun-2021: Initial additional On 03-Jun-2021: Initial additional
Very tender erythematus, 5x6 cm area at injection site. 100 degree temperature 48 hours later.
Numbness and tingling in the face; Numbness and tingling in the face; This is a spontaneous report from a contactable consumer reported for herself. A 24-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on right arm on 20Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported.  Concomitant medications include multivitamins [vitamins nos]. The patient experienced numbness and tingling in the face on 20Jan2021 12: 30 pm. Started after injection, in the lips, spreading to the mouth, chin, and lower face. Within two or three hours, it spread to the ears and upper face, lasting the entire evening. No treatment received for the events. Outcome of the events was recovered. The patient was not pregnant at the time of vaccination.
was extremely exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (was extremely exhausted) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (was extremely exhausted). At the time of the report, FATIGUE (was extremely exhausted) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Red splotchy rash noted on lower extremities. No swelling or wheezing noted. Given 10 mg of liquid Benadryl. Continued to monitor for s/s of distress.
significant rash on both shoulders and 2/3 of back starting the second day after vaccination.  Redness went away by the 4th day but still itchy after 1 week.  No blisters.
passed away; This case was reported by a consumer via media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be related to Shingles vaccine.  Additional details were reported as follows: The patient was reporter's sister in law. The age at vaccination was not reported. The patient passed away from getting the Shingles shot during the night she received it. The follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
HUGE Welt on my arm that remained for a week that was EXTREMELY itchy.  As it disappeared, my skin got SUPER itchy on my hands, scalp and feet (all areas where my psoriasis has flared up in the past).
Hives that spread from injection site down to below elbow. Special needs and unsure if he was also having trouble breathing which is why an emergency visit was warranted.
Rash to entire body. Fine raised itchy rash over trunk and extremities started 24-48 hours after vaccines. Treated with MEDROL Dose Pack, CLARITIN, BENDARYL.
Information has been received from an 81 year old male patient with high blood pressure, who in September 2009 was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included ibuprofen, ENAPRIL and "nurton". In October 2009, the patient experience shingles. The patient reported he had broken out with shingles twice. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Unspecified labs diagnostics studies were performed. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 26-OCT-2012, the patient was inoculated with ZOSTAVAX by a certified medical assistant at a primary care office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 27-SEP-2013, the patient was treated at the same primary care office for a vesicular outbreak which was diagnosed as herpes zoster. On or about 27-APR-2015, she sought subsequent treatment at the primary care office for the diagnosis of post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient was prescribed prednisone for management of her painful symptoms and chronic pain. On or about 12-OCT-2016, she sought additional treatment at the primary care for a vesicular outbreak which was diagnosed as herpes zoster. She was prescribed VALTREX for management of her painful symptoms and chronic pain. On or about 28-JUL-2017, the patient sought further treatment from the primary care for a vesicular outbreak that was diagnosed as herpes zoster. 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 proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sored arm; Tiredness; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Sored arm) and FATIGUE (Tiredness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 016B21A and 025A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (Sored arm) and FATIGUE (Tiredness). At the time of the report, VACCINATION SITE REACTION (Sored arm) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medication reported.  Patient states that with the previous dose 2nd primary and first booster doses  she just experienced sored arm and tiredness. She did not take any treatment for these symptoms.   This case was linked to MOD-2022-615640 (Patient Link).
Colorful flashes of vision/ she seen in both eyes different colored flashes okay some are like a line or zig zag; I got the Johnson and Johnson in April/ I had a Pfizer booster shot; I got the Johnson and Johnson in April/ I had a Pfizer booster shot; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 30Dec2021 (Lot number: SD7218) at the age of 45 years as dose 2 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Johnson and johnson (DOSE 1), administration date: 28Apr2021, when the patient was 44 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 30Dec2021, outcome "unknown" and all described as "I got the Johnson and Johnson in April/ I had a Pfizer booster shot"; IMMUNISATION (non-serious) with onset 30Dec2021, outcome "unknown", described as "booster"; PHOTOPSIA (non-serious) with onset 02Jan2022, outcome "unknown", described as "Colorful flashes of vision/ she seen in both eyes different colored flashes okay some are like a line or zig zag". Therapeutic measures were taken as a result of photopsia.   Additional information: The anatomical site of vaccination was right side. The patient had ibuprofen in response to adverse event as treatment. The patient had only one shot dose on 28Apr2021 before booster. The patient seen in both eyes different colored flashes, some are like a line or zig zag. The patient had no event like this before vaccination. The patient developed on Sunday which is just about 2 and half or 2 days after the shot. Reporter seriousness for Colorful flashes of vision; she seen in both eyes different colored flashes; some are like a line or zig zag: Unspecified  No follow-up attempts are possible. No further information is expected.
The day I received my Pfizer booster, my lower lips swelled up and lips became all cracked and started bleeding.
15 minutes post vaccine patient said she did not feel well. I noticed her arms starting to tremor she then went into a seizure. She had 2 seizures lasting about 1 minute a piece a few minutes apart. An ambulance was called. Patient refused to be seen at the hospital.  The person with her stated she has seizures and has had one recently.
1 of 3 pts vaxed from the same lot who exp an adverse event;pt vaxed 21JUN94 & 22JUn began projectile vomiting & was crying unconsolably (not high-pitched) for several days;MD visit nl, PE exam afebrile;MD assumes sx resolved
Pt's mother reported headache and dizziness, which prompted ER visit. Event was reported on 7/28/14 at 3:00pm. Unable to reach her to determine when the symptoms started.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for an unknown indication.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-395985.
Patient had rash on chest. Itching occurred on chest and face. Tingling of tongue, Blood pressure and heart rate increased. This occurred 5 minutes after vaccine
About two months after my second injection I started developing impingement in pain in my left shoulder joint. This has become progressively worse necessitating  an evaluation by orthopedic surgeon.
This 86 year old male received the Covid shot on  3/16/21    and went to the ED on 04/19/21     and was admitted  on 4/21/21 with the following diagnoses listed below. G51.0 - Bell's palsy