chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 45 year old patient (JC) experienced body aches, injection site pain, fatigue, headache and myalgia while receiving RabAvert. The patient received RabAvert on 06/18/04 via injection into the deltoid. She has no past medical history or concomitant medications. The patient received her first dose of RabAvert for pre exposure prophylaxis and developed arm soreness, tiredness, headache, overall body aches and sore muscles. The events improved but were still persisting at the time of this report. Follow up received 06/06/04: The patient was vaccinated intramuscularly with RabAvert on 06/18/04 in her right arm. By that afternoon she developed right are soreness, headache, body aches and muscle soreness. The symptoms lasted approximately two to three days and abated. The patient did not receive any further RabAvert injections.
I believe that this vaccine caused my son to contract pneumonia. At the time of the shot I had informed the office that my son was sick and questioned if it was okay to get the vaccines. I was told that it was better to get the vaccine when the child was sick and was told that all he had was a common. Three days later I brought my son in and he was diagnosed with pneumonia. At the time I did not know that certain vaccines can cause illnesses when the immune system is compromised. A few weeks later my son was diagnosed with RSV after recovering from pneumonia.
This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. On an unknown date the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (doses, routes and anatomical locations were not provided). The lot numbers used were: K020751, expiration date: APR-2016; L007231, expiration date: 03-SEP-2016; L004007, expiration date: 05-AUG-2016; L044056, expiration date: 02-MAY-2017 and lot number L0501098, expiration date 17-JUN-2017. it was reported that the vaccines had an excursion of -10 celsius degrees for 30 minutes. There were no previous temperature excursions. No adverse symptoms were reported. This is one of two reports received from the same source. Additional information has been requested.
Patients upper arm got swollen, red and painful around the area of the injection. Was very painful according to the patient but she did not get any fever. It was like that for 1 month until it finally was better.
This spontaneous report was received via a company representative from a physician and a licensed practical nurse regarding a non-pregnant female patient of unknown age. In approximately 2015 (reported as "about a year ago"), the patient received PREVNAR 13. On an unknown date in September 2016 (reported as "on an unspecified day this week"), the patient came in and received PNEUMOVAX 23 (lot#, expiration date, dose and route of administration were not reported). After an unspecified time, in September 2016, the patient called the office and stated "I have redness, soreness and swelling where I received my shot". The outcome of the events and causality assessment were not reported. Additional information has been requested.
12 hours post injection 7:30p, low grade fever 99F, queasy, brain fog and exhaustion. Fever went away over night, the rest of the symptoms stayed through the day.
Swollen, pain lymph nodes in the axilla of the side where the flu shot was administered. This also happen the first time flu shot was administered. This was my second injection.
Patient presented at 9 month well child check with lump on leg. Mom noticed this lump about 6 hours after the vaccines were given at 6 month well child check, but did not report until 9 month well child check. Mom did notice any other symptoms. Patient is to be scheduled for ultrasound of lump.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-JUL-2014 tha patient was inadvertently vaccinated with a second dose of ZOSTAVAX (0.65 ml, subcutaneous, anatomical location, lot number was not reported). No adverse effects reported. Additional information has been requested.
After the first day of getting the shot, I had no fever but an extremely bad headache for the majority of the day. After that I didn't have any more problems. 8/3/2021 I went to an ER, and they did several tests. They determined I had issues with my bladder and that I had gallstones. They didn't know what I had except possibly a blockage and that I may have to have surgery to get my gallbladder removed. They prescribed me pantoprazole 40mg 1xday and ursodiol 300mg 2xday.
Patient presented to pharmacy and requested a "Covid shot". Patient was informed that pharmacy only had bivalent booster doses available. She said that will work. When questioned if she had a previous dose within the last two months she stated "no". Patient completed a VAR and informed consent form. Patient received vaccine from vaccinating technician. Technician showed patient location for digital vaccine record and asked if patient wanted her physical covid card updated. Patient said she didn't have one. Upon further questioning it was learned from patient that this was her first dose. Pharmacy contacted CDC for guiadance. Patient was informed that a complete series with monovalent vaccine would need to be completed. Patient was informed of the consideration of an 8 week separation from bivalent to reduce the chance of cardiac adverse events as seen in teens.
severe burning sensation when injection site is touched. this did not appear until three weeks after injection . Painful area is a band running horizontally around front and side of arm.
Individual felt numbness in her lips and around mouth approximately 10 minutes after injection. She did not alert any medical/ public health personnel and stayed in the monitoring area for 30 minutes. She states the symptoms subsided and thought she was just "anxious". Later in the afternoon, individual felt like she had a "bad case of the flu", nausea and fatigue-symptoms resolved the next day.
extreme muscle aches lasting all day the day after injection, drowsiness, very mild headache, fever lasting no more than 1-2 hours around the middle of the day
Lightheaded, dizzy for 4 hours; Toes, fingers and lips numb and tingly for 2 hours; Toes, fingers and lips numb and tingly for 2 hours; Toes, fingers and lips numb and tingly for 2 hours; Toes, fingers and lips numb and tingly for 2 hours; This is a spontaneous report received from a contactable physician (who is also the patient). A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown), via an unspecified route of administration in the left arm, on 19Jan2021 13:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included asthma and environmental allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not have other vaccine in four weeks. Concomitant medications were unspecified (had other unspecified medications in two weeks). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date unknown), via an unspecified route of administration in the left arm, on 31Dec2020 13:30, for COVID-19 immunization. The patient was lightheaded, dizzy for 4 hours and experienced toes, fingers and lips numb and tingly for 2 hours, all on 19Jan2021 16:45. The events resulted in emergency room/department or urgent care visit. No treatment was provided. The patient recovered from dizzy for 4 hours on 19Jan2021 20:45 and from toes, fingers and lips numb and tingly for 2 hours on 19Jan2021 18:45.
This spontaneous report has been received from the patient's best friend's wife, referring to a male patient of unknown age. The patient's medical history and concurrent conditions were not provided. On 02-FEB-2016, the patient was vaccinated with PNEUMOVAX 23, (lot #, route, dose and expiration date were not provided). Concomitant therapies were not reported. On 10-FEB-2016, the patient became ill developing trouble breathing, coughing, and laryngitis. On an unknown date in February 2016, the patient was admitted to the hospital for acute respiratory distress syndrome (ARDS). The patient also developed respiratory failure and renal failure, and the patient was treated with dialysis. The patient also was being treated for pneumonia. The onset date of the events was reported as 10-FEB-2016. On 17-FEB-2016, the patient died, the cause of death was reported as pneumonia related issues. The outcome of laryngitis, and renal failure, was unknown. Upon internal review renal failure, acute respiratory distress syndrome and respiratory failure were considered to be medically significant events. Additional information has been requested.
PATIENT STATES SHE HAD NUMBNESS AND TINGLING IN THE OPPOSITE ARM (HER LEFT) AND NUMB LIPS SIMILAR TO WHEN SHE HAD A MINN-STROKE. ALSO, HAD A METALLIC TASTE IN HER MOUTH
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 16-JAN-2014, the patient was inoculated with ZOSTAVAX at a pharmacy 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. Later in 2014, the patient was treated by a Dermatologist for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (temp currently 103.3ºF/102.3ºF) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (temp currently 103.3ºF/102.3ºF). At the time of the report, pyrexia (temp currently 103.3ºF/102.3ºF): not resolved. Diagnostic results: On an unknown date, body temperature: 103.3ºF (high) 103.3 and 102.3ºF (high). The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant production use and treatment information not reported.
This spontaneous report was received from a Medical Assistant  referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (strength, dose, frequency, route of administration were not provided) lot # M036458 with expiration date of 02-MAR-20178 for prophylaxis. No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 16 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006516: US-009507513-1707USA008773:
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
I had the shot had shingles/ suspected vaccination failure; 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 provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingles shot and had shingles twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Underarm swelling, redness, and pain - in armpit and down inside of left arm. Starting  Saturday - started 1 day after injection and has gotten worse each day.
MIGRAINE HEADACHE DEVELOPED WITHIN 6 HOURS OF VACCINE.,   CHILLS, 101 DEGREE FEVER, MUSCLE CRAMPS AND HEART PALPATATIONS (TACHYCARDIA) DEVELOPED WITHIN 9 HOURS OF VACCINATION.  SYMPTOMS PERSISTED FOR OVER 12 HOURS.  48 HOURS LATER STILL HAVING COLD SWEATS.
This spontaneous report as received from a nurse refers to a 3 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 01-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was 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 involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Fever overnight followed by complex (likely febrile) seizure. Localizing features, 20 min duration
Left arm has pain from shoulder to fingers can't lift arm above head or to the right pain at night that keeps me awake most pain from shoulder to elbow took pain pills.
Hives all over body; This is a spontaneous report from a contactable healthcare professional, the patient. A 26-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via intramuscular route of administration in the right arm on 13Sep2021 at 14:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 14Sep2021 at 13:00, the patient experienced hives all over body. The event resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hives all over body was not resolved at the time of this report.
a little bit of a sore arm; The initial was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 13Sep2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Mar2021 15:00 (Lot number: ER2613) at the age of 62 years as dose 2, single and intramuscular, administered in arm left, administration date 04Mar2021 14:30 (Lot number: EN6202) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sarcoidosis" (ongoing), notes: Diagnosed in 1981-1982. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a little bit of a sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient reported receiving his first Comirnaty vaccine on 04Mar2021 and his second dose on 25Mar2021. He took an rapid antibody test for the detection of SARS-COV-2 1gG/IgM antibodies using the premier Biotech covid 1g IgG/IgM rapid test on 11Sep2021 for no specific health reason and reported having a negative antibody test. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. AE(s) did not require a visit to emergency room and physician office. No prior vaccinations within 4 weeks to the first administration date of the suspect vaccines. The patient received 3rd Dose on 21Sep2021 at 10:00 AM on Right arm Intramuscularly (Batch/Lot number: 30133BA Hard to Read Handwriting).  No follow-up attempts are possible. No further information is expected.
VACCINE ADMINISTERED ONE WEEK TO 10 DAYS PAST EXPIRATION DATE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, the patient experienced vaccine administered one week to 10 days past expiration date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered one week to 10 days past expiration date was not reported. This report was non-serious.
Itch; red blanches and blotches around injection site; a little swelling on the blanches; Headache; pain at the injection site, very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itch), VACCINATION SITE ERYTHEMA (red blanches and blotches around injection site), VACCINATION SITE SWELLING (a little swelling on the blanches), VACCINATION SITE PAIN (pain at the injection site, very sore arm) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX (shingles) and PERTUSSIS VACCINE. Concomitant products included HYDROCHLOROTHIAZIDE and FAMOTIDINE for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site, very sore arm). On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itch), VACCINATION SITE ERYTHEMA (red blanches and blotches around injection site), VACCINATION SITE SWELLING (a little swelling on the blanches) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site erythema, Vaccination site swelling, Vaccination site pruritus and Vaccination site pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itch) had not resolved and VACCINATION SITE ERYTHEMA (red blanches and blotches around injection site), VACCINATION SITE SWELLING (a little swelling on the blanches), VACCINATION SITE PAIN (pain at the injection site, very sore arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 11-Jan-2021, the patient rubbed her arm with her sponge and noticed it was very itchy, rubbed it a little bit and looked at it closer and noticed red blotches and was swollen around the injection area. It had been a week and still itchy, could feel it through her shirt. It just felt a little strange, like heavy.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Developed a fluid-like pocket under my left arm as well as in the area of my left collar bone.  They were there for about 3-4 days and then slowly went away.  The one on my collar bone was slightly tender, and that is what caused me to notice it.  The one under my arm was not tender at all.
Weakness, Nausea. Seen by onsite EMS.  16:23 HR 84 regular Spo2=96%   BP=79/55 16:31   Reported symptoms resolved. left with parent. HR 83 regular  Spo2=97%  BP=105/84 Discharged with mother at 16:35. Recorded by  RN.
At 10:37AM PT complain of shakiness, chest tightness, numbness, RN assessed PT vital sign taken. Ice pack was applied.PT was stable in 32mins and left.
pt recvd vax & exp h/a,elevated BP,nausea,pain @ inj site;addl face flushed;adverse event were not treated;pt no longer works @ this facility & did not return reporter's call;it is not known when sx resolved;
MIGHT HAVE GOTTEN AN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202F21A expiry: 07-FEB-2023) dose, start therapy date were not reported for covid-19 prophylaxis. The drug was associated with Medication error. No concomitant medications were reported. On an unspecified date, the patient experienced might have gotten an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of might have gotten an expired vaccine was not reported. This report was non-serious. This case is a duplicate of 20230309055.
2 days after the vaccination, 02/14/2021, my forehead was inflamed, red and very itchy and I had enlarged lymph nodes in my gland area. I went to urgent care 2 days later, 02/16/2021. The doctors diagnosed me with an allergic reaction. They treated it with a steroid injection and week worth of steroid medication.