chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed practiced nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-DEC-2015, the patient was vaccinated with improperly stored doses of GARDASIL 9 was vaccinated with improperly stored GARDASIL 9 (lot# was reported as L014239, expiration date 21-JUL-2017, dose and route were unknown). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a pharmacy intern referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant therapy were not reported. The patient's drug reaction/allergy was unknown. On 01-DEC-2016, the patient was given PROQUAD injection and VARIVAX (both lot #, expiration date, dose and route were unknown, for prophylaxis) (overdose). No adverse reaction was reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 54 years old male patient. The patient had no history of drug reactions/allergies. He never had chickenpox. The patient was vaccinated with a dose of ZOSTAVAX (lot number not specified) on 08-OCT-2012. Route was not reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed an injection site reaction after vaccination with ZOSTAVAX. The patient had a quarter size area which was inflamed at the injection site and had burning and itching. No treatment was given for the events. The patient had sought medical attention by contacting the pharmacist. At the time of report the patient had not recovered. The reporter did not provide a causality assessment. Additional information is not expected.
5/18/04: Mom noted left arm red and swollen . No fever. 5/19: seen with 6x5cm area of erythema, induration. Treated with Keflex 520 mg, bid, 10 days. , Benadryl 19.5mg
On 1/9/2021 I had pain on the vaccine site, I touched it it was warm when I looked on the mirror it was red. It was swollen about the size of a dime & itchy. As the days passed it got progressively swollen & I went to the doctor on Monday. They prescribed me medication. It took 2 days from that Monday to go away.
Patient received 2nd dose of Moderna vaccine, and started hyperventilating/anaphylasis after 10 minutes. Pharmacy manager gave patient a dose of epipen 0.3mg & call 911. Patient taken to ER.
got the shingles within days of the 2nd shot/Within days I got shingles; I was so sick; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced shingles and sickness. On an unknown date, the outcome of the shingles and sickness were unknown.   It was unknown if the reporter considered the shingles and sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 03-AUG-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient had no intention of getting the vaccine. One of his/her friends talked him/her into it. After the second dose the patient was so sick, he/she thought that they gave him/her the Covid vaccine by mistake. The patient reported that the Shingles shot did not prevent you from getting it.  The patient got the shingles within days of the second shot. Once the patient posted it so many others said, it happened to them as well. Same thing happened to the patient.  Additional supportive information: This case was linked with case US2022AMR119367 reported by same reporter.  The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR119367:Hearsay case/Same reporter
She passed one to two days after the shot; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient died after receiving the COVID vaccine. She passed one to two days after the shot. It was not expected. Waiting on the autopsy.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: She passed one to two days after the shot
soreness / at the injection site; swelling / at the injection site; redness / at the injection site; "baseball sized" knot at the injection site; first dose of Shingrix on 10/2/2020; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site mass and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and injection site mass were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and injection site mass to be related to Shingrix.  Additional details were provided as follows: This case was reported by pharmacist on behalf of the patient. The age at vaccination was not applicable for 2nd dose. The patient received 1st dose of Shingrix in right deltoid and experienced redness, swelling, soreness, and a baseball sized knot at the injection site.  The reporter was unaware of how long after receiving the 1st dose that these symptoms began and lasted. Reporter stated all symptoms had resolved. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
30-centimeter-wide round raised rash on her right arm; itching on her entire body (including arms); red rash all over her body; rapid heartbeat; dizziness; tingling in her right arm; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heartbeat), DIZZINESS (dizziness), PARAESTHESIA (tingling in her right arm), PRURITUS (itching on her entire body (including arms)) and RASH ERYTHEMATOUS (red rash all over her body) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHROID) for an unknown indication.    On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced HEART RATE INCREASED (rapid heartbeat), DIZZINESS (dizziness) and PARAESTHESIA (tingling in her right arm). On 15-Feb-2021, the patient experienced PRURITUS (itching on her entire body (including arms)) and RASH ERYTHEMATOUS (red rash all over her body). On 17-Feb-2021, the patient experienced RASH (30-centimeter-wide round raised rash on her right arm). On 17-Feb-2021, HEART RATE INCREASED (rapid heartbeat), DIZZINESS (dizziness) and PARAESTHESIA (tingling in her right arm) had resolved. At the time of the report, PRURITUS (itching on her entire body (including arms)) and RASH ERYTHEMATOUS (red rash all over her body) outcome was unknown and RASH (30-centimeter-wide round raised rash on her right arm) was resolving.            Treatment information was not reported.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 24-MAR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M029598, expiration date 09-JAN-2018, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Patient received TDAP on 9-6-15 it was administered in back of left arm instead of in Deltoid IM. Patient came back to clinic on 9-8-15 with redness and swelling. No further treatment was indicated.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates in 2017 (reported as from 15-FEB-2017 to 15-MAR-2017), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M038846, expiration date 26-APR-2018, orally; exact doses were not reported). The vaccines were exposed to temperature of 32 to 36 Fahrenheit degrees for 8 hours before administration to the patients. No previous temperature excursion was reported. Digital Data Logger was not involved. No adverse effects were reported. Additional information has been requested.
Guillian Barre Syndrome, inability to walk. I am currently still doing at home physical therapy to regain my ability to walk.
Sweats, fever, extreme joint and muscle pain, fatigue, flu like symptoms. Foggy brain, mood change. I do not have insurance or I would have gone to doctor.
Information has been received from a physician concerning a 10 week old female patient who on 27-DEC-2011 was vaccinated orally with the first dose of ROTATEQ (lot number and dose not reported). On 02-JAN-2012, the patient was seen in the office with watery diarrhea stools. The stool sample was sent to lab and came back positive for "rota" antigen. The patient did not develop intussusception. The patient did not reintroduce in ROTATEQ therapy. At the time of the report, the patient was recovering. Follow up information has been received from a physician who reported that the female patient with no illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions specify was vaccinated with a first dose of ROTATEQ, PO, (Lot # 0885AA) (dose not reported) on 27-DEC-2011. The physician also reported that on 02-JAN-2012 at 2 am, the patient experienced diarrhea persistent for ten days watery and haemoccult positive. Labs performed included: stool rotavirus antigen test: positive and stool occult blood test: positive. The patient sought unspecified medical attention. On 13-JAN-2012, the patient had recovered. Diarrhea persistent for ten days watery, rotavirus test positive and haemoccult positive were considered to be an other important medical event by the physician. No further information is available.
Stroke occurred January 5 , 2022. Admitted to hospital January 7 to January 22.
Sudden loss of hearing in the right ear with associated pain. Vertigo, Tinnitus, gait disturbance due to vertigo, light headedness.   Hearing test x 3. MRI with contrast, Oral Prednisone, then intertympanic injection with steroids. F/u visit with  audio - neurologist. Currently going to cognitive therapy once weekly  due to auditory dysfunction  Profound, permanent hearing loss in the right ear. resulting in cognitive impairment
14 hours after the vaccine was received, I woke up so uncomfortable, no matter how I moved I couldn?t get comfortable. It was the kind of uncomfortable where I swear I could feel it in my bones. Laid in bed until 8:30 when baby boy woke up, promptly threw up, got so nauseated and dizzy that I could not move from the bathroom floor, and had to ask grandma to bring me my medicines. The mix of ibuprofen, migraine medication, and anti-nausea all combined made me feel no symptoms for several hours until they wore off and I lost all ability to stand. My legs just felt so weak. And now I?m finally starting to feel a little better, and it?s been 2.5 days now. Boy, those side effects are no joke. Still worth it though so I don?t bring a deadly virus home to my baby boy ?????
Right arm swelling, flushed. No c/o infection. KINRIX given (R) deltoid.
injection site redness; Injection site swelling; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (Injection site swelling) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included MELATONIN for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE SWELLING (injection site swelling). On 25-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (Injection site swelling). On 22-Jan-2021, INJECTION SITE SWELLING (injection site swelling) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Daughter experienced fever; Daughter experienced fever; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer reported on behalf of her 12-month-old female daughter.  A 12-month-old female patient received first dose of bnt162b2 (BNT162B2, PFZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07May2021 as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that mother received Pfizer Covid-19 vaccine first dose on 07May2021 and experienced sore in the arm. She was a breastfeeding mother with her 12-month-old baby girl (patient). In the middle of the night her baby daughter (patient) experienced fever and Vaccine exposure via breast milk. The outcome for the event was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
blood in her urine; Bringing on a period once again seems odd after having this inoculation; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; NDC number: 59267-1000-01), via an unspecified route of administration in the right arm on 05Jul2021 at 19:15 (Lot Number: EW0198) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included patient had not had a period in probably 3 years. The patient had never been vaccinated before other than her childhood vaccinations. Patient stated she didn't get flu shots. None of family medical history relevant to event(s). Concomitant medications reported as none. No prior vaccinations (within 4 weeks). No history of previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered on same date of the Pfizer suspect. The patient received first dose yesterday on 05Jul2021. About three hours after receiving vaccine, when she came home after doing some shopping, she used the bathroom and there was blood in her urine on 05Jul2021 at 22:00. By the time she got home, 3 hours later she went to bathroom and that's when she noticed blood in the toilet. Patient stated it may have occurred sooner, but she hadn't used the bathroom. She stated she had not had a period in 3 years. Patient stated she had not heard of that adverse reaction, blood in the urine, she thought it was kind of a concern and bringing on a period once again seemed odd after having this inoculation on 05Jul2021. Events did not require a visit to emergency room or physician office. The patient asked if should seek professional advice. Patient stated she actually went online and was reading that people were reporting irregularities and reporting heavy bleeding, abnormal bleeding and also post-menopausal women reported getting a period again. Patient asked if this was something that Pfizer had been hearing about. Outcome of the event blood in her urine was not recovered, while of the other event was unknown.   Follow-up attempts are completed. No further information is expected.
had the shot and have gotten the shingles twice/Suspected Vaccination failure; have gotten the shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient after vaccination, gotten the shingles twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were provided.
Information was received on 11-MAY-2017 from a physician via a company representative. The physician reported that a patient who was seen by a partner in the practice,  a 12 year old of unknown gender, who was vaccinated with the first dose of GARDASIL 9 (lot, expiration, dose and site not reported) on an unknown date. About a day later, the patient presented with a high fever. The patient recovered on an unknown date. The patient received their second dose of GARDASIL 9 (lot, expiration, dose and site not reported) months later. About a day after receiving the second dose, the patient presented with a high fever. The outcome of the fever was not reported. No other information was reported. Additional information has been requested.
Fever - 12 hours post injection onset, continuing at least 72 hours Body aches severe - 14 hours post injection lasting 72+ hours Diarrhea severe - 48 hours post injection lasting 72+ hours
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe, Systemic: Shakiness-Severe, Additional Details: Approximately 2-3 minutes after administration pt became extremely dizzy, sat on the floor then laid down on the floor. He was laying on the floor for approximately 5-8 minutes before the dizziness subsided enough that he was able to sit up in a chair. He was also experiencing extreme sweats and shaking. At that point we checked his bp, his normal bp is 115-120/70-75 his bp at this time was 144/84. He sat in the chair for approximately 10 more minutes and was beginning to feel better bp 134/74
Information has been received from a healthcare worker (immunization official) referring to a 5 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 29-JUL-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K015970 (expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
I developed a rash that will not go away. I was ordered labs, and was started on Fexofenadine 180mg, TID to QID.
On 2/1/21 her arm started getting red, and on 2/4/21 her husband noticed a rash breaking out on the arm.  She saw her doctor on Thursday, yesterday.   They gave her Levocetirizine, Methyl Prednisolone, Cephalexin which these seem to be helping her.  She is scheduled for the 2nd vaccine on 2/22/21.
2-3 days after shot I became so thirsty drinking up to 2-3 gallons of water a day!  My vision has now became blurry  and I?m having to urinate 10 times a night.  I was in the hospital 2 weeks prior and my chart was fine I?m in the hospital as we speak and I haven hyperglycemia!! Now diabetic after the shot my life has changed!!!
Pt found dead in crib on 8/14/09. Preliminary autopsy showed no cause of death. 12/29/2009 Autopsy report received. Cause of Death: Sudden Unexplained Infant Death. Additional information abstracted: History of prone sleep position, Intrathoracic petechia (pleural and thymus involvement). Toxicology: acetaminophen (+), carbon monoxide <5 % Sat. Skeletal Survey - Hypoventilatory chest.
I95.9 HYPOTENSION 9/1/2021 ADENOMATOUS POLYP, COLON I95.9 HYPOTENSION 9/1/2021 ACUTE PYELONEPHRITIS    PROSTATE CANCER I95.9 HYPOTENSION 9/1/2021 CANCER METASTATIC TO BONE I95.9 HYPOTENSION 9/1/2021 SEPSIS WO ACUTE ORGAN DYSFUNCTION I95.9 HYPOTENSION 9/1/2021 ANEMIA
premature exhaustion/ fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (premature exhaustion/ fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (premature exhaustion/ fatigue). At the time of the report, FATIGUE (premature exhaustion/ fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported.  No treatment medications were provided.
Injection site is still swollen about 2 weeks later. It?s very hard and hurts a little with pressure. Sometimes I still get random shooting pains throughout my body that I didn?t get before my vaccination.
Dizziness; Sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepiness) and DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepiness) and DIZZINESS (Dizziness). At the time of the report, SOMNOLENCE (Sleepiness) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication was reported by patient.   Reporter did not allow further contact
The night of 6/18/18, the patient experienced fever, malaise and chills that required him to lie down. The vaccine was administered in the afternoon.