chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 20 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 01-JUL-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # J009788, expiry date: 17-MAR-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
PAIN INJECTION SITE,HEADACHE,CHILLED,FEVER, SWELLING INYECCION SITE AND INFLAMATION IN GANGLIOS.
This case was reported by a pharmacist and described the occurrence of injection site pain in a 68-year-old female patient who received SHINGRIX (batch number T5242, expiry date 8th February 2019). On 9th February 2018, the patient received SHINGRIX. On 10th February 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain and injection site lump. On an unknown date, the outcome of the injection site pain and injection site lump were not recovered/not resolved. The reporter considered the injection site pain and injection site lump to be related to SHINGRIX. Additional details were provided as follows: The reporter was a pharmacist at the pharmacy where the vaccine was administered to the patient. On 11th February 2018, this pharmacist was notified last night by the consumer that an incredibly painful lump about 4 inches below the injection site just started yesterday morning. The administration site was the upper deltoid, but the pharmacist did not know which arm. The consumer had no other medications on her profile, and the reporter was unaware of any other concomitant medications or the vaccine's exact dosing, because the vaccine was administered by one of the other staff pharmacists. The reporter did not yet know which pharmacist administered the vaccine. The pharmacist already referred the consumer to her health care provider regarding the reported pain if necessary. The reporter suspects this was an injection site reaction but was not certain.
Slight swelling right eye (left corner) small mole - swelled up no other affects surfaced about 1 hr after vaccine.
30 minutes post vaccine pt verbalized 5/10 on pain scale headache. Rested an additional 15 minutes and claimed pain subsided.
Severe chills, high fever, and severe muscle pain all over body for approximately 2 days; muscle aches and extreme fatigue lasting approximately 3 days; red rash on left arm that spread downward toward elbow on days 3 and 4. Left arm extremely sore for 5 to 6 days.
missed the second dose by more than 42 days interval.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the second dose by more than 42 days interval.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the second dose by more than 42 days interval.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the second dose by more than 42 days interval.) had resolved.        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 relevant concomitant medications were reported.   Treatment information was not provided.
On 5/20/99, post vax, pt experienced injection site pain, which resolved. Seven days later, he had joint and muscle pain. He also experienced pain in left heel which DR dx'd as possible Achilles tendon. Two days later, he had the same pain in the right heel and was treated with anti-inflammatories for a few days and used crutches. In June or early July, 1999, he was dx'd and treated gouty arthritis in his right large toe joint, with colchicine and allopurinol. Cytosac was prescribed to buffer his stomach. In August he was treated with an antibiotic (in case he had Lyme disease) for 10 days, which did not help the muscle and joint pain, so it was stopped. Today his right elbow is sore. His present treatment is Indomethacin and Tylenol. Colchicine and allopurinol were discontinued. Lymerix was also discontinued. The most recent information, received on 10/12/1999, reports the condition of the pt is ongoing.
Several weeks after having my second dose of the Pfizer vaccine, I began having infrequent internal body tremors, primarily in my extremities. Infrequent meaning on the order of once a week or so, primarily at nighttime while laying in bed. This went on for a few months, then I got Covid in mid September. Then, several weeks after recovering from Covid, I began having the internal tremors every single night. Then they became worse and were happening throughout the day as well. As of writing this, I am still having them every single night, but for the most part do not notice them during the day anymore.
fever of 100.7 (F) and yesterday her temperature was 99.8 (F); Does not feel well (malaise); Pain in Arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included autoimmune disorder.   On 26th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced pain in arm and malaise. On 26th February 2020, the patient experienced fever. On an unknown date, the outcome of the pain in arm, fever and malaise were recovering/resolving.   It was unknown if the reporter considered the pain in arm, fever and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  After receiving Shingrix, the patient had pain in her arm. The patient had a fever of 100.7degrees Fahrenheit and on 26th February 2020, her temperature was 99.87 degrees Fahrenheit. The patient also stated that, she did not feel well (malaise) and would go to the doctor. She mentioned that, she had an autoimmune disorder. Reporter declined to provide more information for safety report.  Limited information was provided.
left leg DVT diagnosed clinically with swelling, pain, redness.  Instituted treatment with resolution of sx's in 2 weeks.  Continued Eliquis for 6 months
Red arm after receiving the vaccine; Some kind of a hard mass underneath; Rash moved down and now it is on her breast, not painful or itchy; This spontaneous case from was received on 08-Sep-2020 from a pharmacist via Agency (reference number: SEQW20-01321) and concerned a 74-year-old female patient.   The patient's medical history was not reported. The patient's concomitant medications included atorvastatin and levothyroxine, both for unreported indication.   On 01-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for an influenza prophylaxis. The batch number was not reported, and expiry date was 12-May-2021.   On the same day, after receiving Fluad Quadrivalent, the patient had a red arm and some kind of mass underneath.   On an unspecified date in Sep-2020, after that (as reported), pharmacist called to check on the patient and she said that her arm was no longer red, but the rash moved down and was on her breast. It was not painful or itchy.  At the time of initial reporting on 08-Sep-2020, the patient had not recovered from 'rash'.    The outcome of upper extremity mass' was not reported.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  Company comment: The patient developed erythema and limb mass on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. The event of rash occurred on an unspecified date, making temporal relationship unclear. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and the event of rash is assessed as unassessable, while for other two events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed erythema and limb mass on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. The event of rash occurred on an unspecified date, making temporal relationship unclear. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and the event of rash is assessed as unassessable, while for other two events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
1/6 received vaccine at 8p and started feeling sick around 10am on 1/7 chills, fatigue, severe muscle aches and headache temp as high as 103.5 for 72hrs. 1/8 I had diarrhea. I took Tylenol right after I was vaccinated
Approximate 5~6 weeks from my first Pfizer Covid-19 vaccination and 2~3 weeks from my 2nd dose I started having symptoms of excessive thirst and frequent urination. I did not think anything of it at the time and continued on as normal. I did think at the time that maybe it was just some side effect associated with the vaccination; however, these effects did not go away over time. I continued having these side effects for months. During this time, I also started to get cramps in my legs when I slept and lost around 20 pounds. A friend who is an RN suggested I go to the doctor to get checked out because the side effects were worrying. I scheduled an appointment for early February, but it had to be rescheduled to early March due to work. In March I finally proceeded to explain my symptoms to a doctor at Medical Center  and I was told that blood work would be needed to be done as I was showing symptoms of diabetes. These results came back positive for Type 1 diabetes. Before the vaccination I showed no symptoms of diabetes. Before the vaccination, I was a healthy 26 year old male. I exercised more than average and had a healthy diet. There is no history of diabetes in my family. I am reporting this due to the fact that the only abnormal major event leading up to the symptoms was receiving my two doses of the Pfizer Covid-19 vaccine.
severe pain, redness & pain in lt site; lt shoulder pain up to ear (lt); pain resolved in 36 hrs;
No Adverse event; received Moderna Bivalent vaccine on as their first primary series dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received Moderna Bivalent vaccine on as their first primary series dose) and NO ADVERSE EVENT (No Adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received Moderna Bivalent vaccine on as their first primary series dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received Moderna Bivalent vaccine on as their first primary series dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received Moderna Bivalent vaccine on as their first primary series dose).    Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Reporter did not allow further contact
I felt like a polar bear just sleeping all day; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (I felt like a polar bear just sleeping all day) and FATIGUE (Fatigue) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient had no known drug allergies. Patient had no acute and chronic illnesses at the time of vaccination.  The patient's past medical history included COVID-19 (Patient had COVID positive test or diagnosis and no hospitalizations.) in January 2022. Previously administered products included for Product used for unknown indication: Pfizer (Patient's previous doses were all Pfizer doses and route intramuscular.). Past adverse reactions to the above products included No adverse event with Pfizer. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On 15-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Oct-2022, the patient experienced SOMNOLENCE (I felt like a polar bear just sleeping all day) and FATIGUE (Fatigue). At the time of the report, SOMNOLENCE (I felt like a polar bear just sleeping all day) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that the adverse event did not cause the patient to seek medical care and the patient had not experienced a similar event in the past.  Treatment medication was not provided by the reporter.
No additional AEs or PQC reported; Caller reports expired dose of PNEUMOVAX 23 was administered.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 23-AUG-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter, intramuscularly (IM), lot number U035117 with expiration date 18-AUG-2023 (anatomical location was not reported) for prophylaxis (expired product administered). No additional adverse events were reported.
Patient developed rash on arm 5 days after vaccination. Pt states that it is just warm and not painful or itchy.
mom states pt had sx x3 on 15MAY97 & was hosp for 3 days;pt has appointment w/neuro 17JUL97;
Itching on arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on arms and legs) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PRURITUS (Itching on arms and legs). The patient was treated with HYDROCORTISONE for Itching, at a dose of 1 percent; CAMPHOR, MENTHOL (SARNA [CAMPHOR;MENTHOL]) for Itching, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching on arms and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator
This is a prospective pregnancy case. This 31-year-old female subject was enrolled in a study. The subject received BOOSTRIX .5 ml on an unknown date. The subject received BOOSTRIX at week 31 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: the patient did not experience any adverse reactions.
No adverse event; expired dose of MMR-II was administered to a consumer; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's current condition, historical condition and concomitant medications were not reported.  On 20-APR-2021, the patient was vaccinated with an expired dose (expiration date: 17-DEC-2020) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route of administration, anatomical location and lot number were not reported) for prophylaxis. No additional adverse event was reported.
Patient experienced reaction to 2009 and 2006 INFLUENZA vaccines. Patient  did NOT experience reaction to 2008 or 2007 vaccines.  PLEASE NOTE THAT  THIS IS A LOCAL REACTION, NOT A SYSTEMIC REACTION.
On 5/19/2001 began having fatigue and backache. On 5/23/2001 developed fever to 100.1 and dark urine. Symptoms resolved 24 hours after fever began. Peak bilirubin 3.4. Exam notable only for mild jaundice. Seen in office 5/24/2001 and asymptomatic. no alcohol.
7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date of 30Dec2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date of 30Dec2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date of 30Dec2021). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date of 30Dec2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator 1 Dec 2021. 7 booster doses of the Moderna Covid-19 Vaccine given on 3 Jan 2022 were past the 30-day Use By Date of 30 Dec 2021. Vial does not undergo any temperature excursions.  No concomitant product information was provided. No treatment information was provided.
NO Known adverse event but patient was given Proquad vaccine instead of MMR. This resulted in an additional VARIVAX being given as he was also given a separate VARIVAX.
A physician reported that a patient received an injection of Hib-Titer and developed an immediate hypersensitivity reaction. No further info was available at the date of this report. MANUFACTURER'S COMMENT: The reporter indicated that 3 patients experienced this event, however; they are not presently identifiable. Additional reports will be generated when identifying information is provided.
After the first shot, I did get very sick during  the wee hours of the morning (shot was in the afternoon). I had chills, severe nausea and vomiting. It ceased about six hours later, though I was extremely tired the next couple of days. ***What I'm most interested in reporting*** is that my fingertips started tingling/numb/little "electric shocks" a couple or so weeks after the first shot, and are ***more intense and frequent after the second dose,***& which was given 04/02/21 (same location as first). My toes also tingled a bit after the first shot (several times a day), but that stopped and didn't happen after the second dose. I had no vomiting , chills, nausea or other traditional effects after the second dose. My fingertips tingle/are numb nearly all the time. The little shocks are several times a day (5-10+). It's not painful, per se, but is disconcerting and I'm concerned the effect is permanent.
2nd dose given too soon- administration error  1st dose on 2/25/21. 2nd dose on 3/11/21.  Patient did not remember he had already received first dose. Came in to health center on 3/11/21 to receive first vaccine. Later, when documenting in PA-SIIS, we identified that he had actually already received first dose previously <24-28 day interval.
Cellulitis in arm patient received vaccine. Treated with KEFLEX 500mg x7 days.
This spontaneous report was received from a registred nurse referring to an unknown number of unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies from the patients were not provided. Since 05-SEP-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # N014369, expiration date: 09-MAY-2019, and lot # N001527, expiration date 13-JAN-2019, for prophylaxis. Concomitant therapies included sterile diluent. The doses were exposed to 6°F to 14°F for one hour. No previous temperature excursion was reported. Data Logger was reported as "Yes". No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004164.