chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and gender 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 an unknown date, 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 an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    No concomitant medication was reported.  No treatment information was reported.   This case contains information for patient 9 out of 25.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
Immunized (R) deltoid with PNEUMOVAX 23 on Sept 9, 2014. Seen on 9/11/14 with tenderness over injection site, red streaking noted inner upper right arm, axillary lymphadenopathy, tenderness. Patient reported to office soreness of arm and nausea 9/10/14 - then on 9/11 reported about 2 am (9/11) chills/malaise.
Symptoms began with a redness, slowly progressed to a larger area. The middle is now white with a purple spot, with surrounding redness.
This is a spontaneous report from a contactable physician through a Pfizer sales representative. This physician reported for the same patient for three different events. This is the third of three reports. A 4-year-old male patient receive PREVNAR13 on an unknown dose at an unknown time in the thigh on an unknown date. Relevant medical history was unknown. Relevant concomitant medications were reported. Vaccines given on the same day were unknown. On an unknown date the patient experienced redness on the thigh. At the time of report clinical outcome of the event was not reported.
Patient reports severe facial itching and redness and swelling 12-24 hours post treatment.  Redness and swelling significantly reduced at 72 hours.  Patient continues to have severe pruiritus.  Atarax 25mg 4 times daily prescribed for patient for continued symptoms
fatigue; Tactile fever; Arm pain MODERATE; Arm swelling mild; This case was reported by a physician via sales rep and described the occurrence of fatigue in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   On 14th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received PREVNAR. On 14th August 2020, less than a day after receiving Shingrix, the patient experienced fatigue, fever, pain in arm and swelling arm. On 15th August 2020, the outcome of the fever was recovered/resolved. On 16th August 2020, the outcome of the fatigue, pain in arm and swelling arm were recovered/resolved.   The reporter considered the fatigue, fever, pain in arm and swelling arm to be probably related to Shingrix.  Additional details were provided as follows: The case was reported by the physician for himself. The patient received the vaccine to prevent herpes zoster. The patient was not admitted to the hospital overnight or prolong an existing hospitalization. The Health care professional did not consider the events to be life threatening. The health care professional did not consider the events to result in persistent or significant disability and incapacity. No surgical or medical intervention to prevent one of the outcomes described in preceding questions. The patient did not result in a congenital anomaly or birth defect. This case has been linked with case US2020AMR174300 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR174300:Same reporter
A serious report of sleep apnea and tonsillitis has been received from a study investigator concerning a 43-month-old female subject participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 09-Jan-2009, the subject received FLUMIST. The subject was admitted to the hospital for sleep apnea and tonsillitis on 16-Jan-2009. The length of stay was one day. The outcome of the events was not reported. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was mild. The sponsor also assessed the causality for the events as not related to FLUMIST.
diagnosed with spasmodic dysphonia; headache/The headaches were so bad that I felt like I was going to die; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SPASMODIC DYSPHONIA (diagnosed with spasmodic dysphonia), HEADACHE (headache/The headaches were so bad that I felt like I was going to die), VOMITING (vomiting) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (headache/The headaches were so bad that I felt like I was going to die), VOMITING (vomiting) and NAUSEA (nausea). In August 2021, the patient experienced SPASMODIC DYSPHONIA (diagnosed with spasmodic dysphonia). At the time of the report, SPASMODIC DYSPHONIA (diagnosed with spasmodic dysphonia), HEADACHE (headache/The headaches were so bad that I felt like I was going to die), VOMITING (vomiting) and NAUSEA (nausea) outcome was unknown.            The patient took some pain and anti nausea medication that she had on hand from a previous surgery. No concomitant medication was reported.   This case was linked to MOD-2022-512516, MOD-2022-512562 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2022: Follow up received on 16-MAR-2022: No new information received
three months after vaccination i came down with a headache, fluctuating fever (97-102) queasy stomach, loss of energy.  syptoms have lasted for three days now
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates the patients were vaccinated with improperly stored (Merck) VARIVAX (lot#L010148, expiration date 24-MAR-2017; lot#L001324, expiration date 13-JAN-2017; lot#L019999, expiration date 02-JUN-2017; lot#L024252, expiration date 30-JUN-2017; lot#L016123, expiration date 06-MAY-2017; lot#L021216, expiration date 10-JUN-2017, strength, dose and route were unknown). No adverse effects reported. Additional information is not expected as the reporter did not wish further contact.
This initial spontaneous case, received from pharmacist on 19-Oct-2017, concerns a 33-year-old, adult, female patient. The patient had no relevant medical history. The patient's concomitant medication included unspecified birth control medication. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 195126, expiry date: Apr-2018 and anatomical location: not reported). On an unspecified date, after the administration of the vaccine, it was reported that, the patient's period was late by 14 days. No treatment was taken for the event. At the time of this report, the outcome of the event was not reported. The reporter assessed the event as non-serious. Follow-up report received on 27-Oct-2017: The patient's initials were updated. The patient's period was late by 14 days. It was reported that, the patient underwent a pregnancy test which was negative. Amended narrative accordingly.
Information regarding PREVNAR 13 was received from a consumer regarding a 75-year-old male patient who experienced listlessness, off balance, fatigue/tired, upset stomach, lack of energy, body aches, no appetite and tenderness/soreness at injection site. At 75 year of age, the patient received a dose on 23-Jun-2010. The patient experienced listlessness and off balance in 2010, fatigue/tired, upset stomach, lack of energy, body aches and no appetite in Jun-2010 and tenderness/soreness at injection site on 24-Jun-2010. The patient was recovering from all the events except injection site tenderness which was reported as recovered. No additional information was available at the time of this report.
Severe body aches. Chills and sweats. Fatigue. Fever 100.9.
vaccine induced inflammation; could barely move my arms or legs; This case was reported by a consumer via interactive digital media and described the occurrence of inflammation in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced inflammation and mobility decreased. On an unknown date, the outcome of the inflammation and mobility decreased were unknown.   The reporter considered the inflammation and mobility decreased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received first of the two doses of Shingles vaccines and within a month she could barely move arms or legs. The patient reported that after being told she just had to suck it up and wait it out, and her husband took her to a nearby city and the specialist said the patient had vaccine induced inflammation. The patient reported that no more vaccines period for her anymore. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Patient got vaccine Saturday 11/20/21. Patient had flu-like symptoms on Sunday 11/21/21. Patient went to dental cleaning on Monday 11/22/21. Patient had facial swelling (jaw) on 11/23/21. Patient said dentist did X-Rays and reported no infection or issues associated with dental cleaning.
Intense coughing for a couple of days, difficulty sleeping due to coughing, some mild fatigue, mild brain fog, feeling fine after 6 days.  High D-Dimer score (1316 ng/ml) July 14th, which was back to normal by (<.19) by July 19th.   Fatigue reappeared about three weeks after onset of COVID,  and has steadily improved, but still have a small amount of exercise related fatigue.
This event was a vaccine administration error.  No adverse reactions have been reported for this patient. The Pfizer pediatric Orange cap vial  ( ages 5-11) administered was not diluted. The vaccine should have been diluted with 1.3 mL sterile 0.9% Sodium Chloride. The amount of vaccine administered was  0.2mL of undiluted serum, resulting  in a dose 3 times more concentrated than the advised dose.  This patient was 1 of 6 individuals to have received improperly diluted vaccine.  Only one staff member that was responsible for the errors, but all staff were retrained on storage, dilution, and administration of the vaccine. Chart audits were preformed to identify affected patients.
This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 05-JAN-2016 the patient was vaccinated with a dose of improperly stored GARDASIL 9 (Lot # L017407, exp date: 15-AUG-2017) orally. The product was exposed to temperature of 50.2 F degrees for 1 hour 10 minutes. The temperature excursion was reported by a data logger. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Information has been received from a registered nurse who was also the patient's mother and a consumer who was also the patient's father concerning their son, a 6month old patient with no drug reaction or allergy who on 16-JUN-2009 was vaccinated with the first dose of ROTATEQ vaccine. On 21-AUG-2009 the patient was vaccinated with second dose of ROTATEQ vaccine. On 12-OCT-2009 the patient was vaccinated with the third dose of 2 ml ROTATEQ vaccine (lot # 660287/1887U) which was expired with an expiration date of September 2009 (the full expiration date was unknown). Other concomitant therapy included amoxicillin. The father reported that after received the vaccine, on 13-OCT-2009 the patient's "appetite dropped drastically". Father stated that is was possible that his son wasn't eating when he was around, or that it might be related to an ear infection that he got "around the same time the vaccine was given". Mother of the child also reported that her son had a slight rash on his face. Her son was also given diphtheria toxoid (+) Hib conj vaccine (unspecified carrier) (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid three in one vaccine, and a hepatitis B (manufacturer unknown) on the same date of 12-OCT-2009. It was reported that adverse event appeared after reintroduction. No laboratory diagnostics study was performed. Unspecified medical attention had been sought. The outcome of the adverse events was unknown. The mother wanted all the follow up information sent to the physician and her. Additional information has been requested.
Pt received 2nd dose earlier than recommended protocol - 2nd dose was only 21 days after 1st dose
I basically had a head cold, sinus drainage that led to a cough for a short period of time and I had pressure and an ear infection in my ear. And the head cold and sinus stuff was over maybe a week or two. And when I went to the doctor, the cough lasted for 3-4 weeks. The ear infection had pretty good ear pain in my Right ear primarily. The pain has gone away but at my last check up, there was still fluid in my ear. I actually had fluid in both ears but the right was worst. On the first visit they put me on amoxicillin for 7 days. And then I went back for a recheck and then we tried Augmentin for 10 days. When I went back for a recheck, this didn?t bother me but I still had fluid in my ears, and the right one was still fairly red. So she referred me to an ear, nose, and throat doctor that I?m going to see in about two weeks. Negative COVID test on the first visit.
2 hours after vaccination, severe headache, stiff neck, dizziness, fever. This continued until 9/17/10.
The patient describes immediate alopecia areata that began two days after the second vaccine and began in the crown area of the scalp. It quickly moved to multiple sites on the scalp within five days.   Patient was sent to Dermatology who  initiated injections of Triamcinolone into the areas of alopecia. Patient was seen today, which is 26 days later and the diffuse areas of alopecia are noted but with new small hair growth beginning in the sites  where the triamcinolone was administered.   There were no other abnormal labs to suggest other causes and the temporal relationship with the second Moderna vaccine coincides with the event. The first vaccine was administered on January 16, 2021 with no adverse events.
Fatigue began approximately 3 hours post injection. At 8pm, I began having severe body aches, chills, along with dizziness and a headache. Symptoms worsened with nausea and fever beginning at 9pm. Treated with Acetaminophen 1000mg every six hours and Zofran 4mg every six hours with rest.
Loss of taste; FEVER; HEADACHE; soreness in my arm (inj site); This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), PYREXIA (FEVER), HEADACHE (HEADACHE) and INJECTION SITE PAIN (soreness in my arm (inj site)) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (FEVER), HEADACHE (HEADACHE) and INJECTION SITE PAIN (soreness in my arm (inj site)). On 03-Feb-2021, the patient experienced AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste), PYREXIA (FEVER), HEADACHE (HEADACHE) and INJECTION SITE PAIN (soreness in my arm (inj site)) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information received on 24 Jun 2021contains non-significant information. Patient demographics updated.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
NECK PAIN; SHOULDER PAIN; ARM PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included guillain barre syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Magnetic resonance imaging (NR: not provided) Not Reported. On MAR-2021, the subject experienced neck pain. On MAR-2021, the subject experienced shoulder pain. On MAR-2021, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neck pain, shoulder pain and arm pain was not reported. This report was non-serious.
Uncontrollable elevation of Glucose - No change in diet, change in medications, use of corticosteroids, or illness.
Swollen, painful (L) upper arm w/limited ROM at elbow. Had full flexion but limited extension, also edematous forearm & upper arm. Tx'd w/Prenisone x 5 days, edema was almost gone but pt. c/o discomfort & only lacked 10-15 deg. extension.
Injection arm collapses; Injection arm pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Injection arm collapses) and VACCINATION SITE PAIN (Injection arm pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Injection arm collapses) and VACCINATION SITE PAIN (Injection arm pain). At the time of the report, MUSCULAR WEAKNESS (Injection arm collapses) and VACCINATION SITE PAIN (Injection arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
For the 4 weeks following the first COVID vaccine dose the patient had significant loss of taste and smell, mild nausea, mild aches and pains and increased anxiety. This resulted in an approximate 8 lbs weight loss, an acute drop in school performance & psychiatrist increased her SSRI medication dosage. She went to the doctor for blood work and a celiac disease panel, all of which were grossly normal. Unsure if she was tested for epstein-barr virus. Her escitalopram dose was increased.  After the second dose of the vaccine the patient became lethargic, lost interest in things she used to enjoy, had poor tolerance for conflict and activity. She began having panic attacks, severe abdominal pains with worse nausea and intermittent vomiting. Her menstrual periods were lasting twice as long (10 days) and she was fatigued to the point of exhaustion.  As the symptoms progressed the patient started having thoughts about hurting herself, definitively not suicidal, but so overwhelmed she felt the need to hurt herself.
Received VARIVAX #2 7/3/08.  Onset vesicle type blisters 7/27/08.  Itchy, afebrile.  Rx BENADRYL oral prn, calamine topical prn.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 07-SEP-2016, the patient was inadvertently administered an improperly stored dose of VARIVAX lot # M023384, expiration date 11-MAY-2018, subcutaneous. No adverse effects were reported. Additional information is not expected as no consent was given for further contact.
Distal to injection (influenza site) site is red/hot/itchy and hard to touch - baseball size per mother.