chrisvoncsefalvay/vaers-outcomes huggingface dataset:
EXPIRED VACCINE ADMINISTERED (3 DAYS PAST EXPIRATION DATE); This spontaneous report received from a consumer concerned a 32 year old of unspecified 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: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered (3 days past expiration date). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered (3 days past expiration date) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211132288, 20211132383, 20211132415 and 20211121650.
Severe stomach pains the first 4-5 days. I am still getting the sharp stomach pains on/off. They are in the upper abdomen. I had and continue to have a lot of nausea and vomiting. The day after the vaccine I vomited the most and could only keep water and milk down. I had and continue to have a lot of body aches and am very tired and cannot seem to get enough rest. I feel best if I lay down and curl up on my side. I have missed some work and am not sure if I will miss more. I feel about 80% better, but still am getting the abdominal pains, especially if I sit up for long periods of time (which I need to do to work). Last night I had extremely bad pains again.
HEART ATTACK; STROKE 2 WEEKS AFTER VACCINATION; This spontaneous report received from a consumer via a company representative via social media concerned a 40 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. Patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that "My best friend's fiance had a heart attack and a stroke 2 weeks after getting the Johnson and Johnson vaccine. He was 40 and healthy".. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack and stroke 2 weeks after vaccination was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211112281-COVID-19 VACCINE AD26.COV2.S-Heart attack, stroke 2 weeks after vaccination. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
iT triggers IT! / FKD me up!/ suspected vaccination failure; iT triggers IT! / FKD me up!; This case was reported by a consumer via(Facebook) 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 reporter was the patient. The age at vaccination was not reported. The reporter stated that, never had a flu one either and never needed that toxic stuff. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Intermittent blurry vision lasting seconds 10 minutes post vaccination.  First Response called, transported to ED
When mixing the vaccine with the diluent, I withdrew only 0.8 ml of the diluent instead of 1.8 ml. Thus only 0.8 ml of the 0.9% sodium chloride was mixed with the vaccine. I withdrew 0.3 ml of the gently inverted, not shaken vaccine, and injected into the left deltoid of the patient. The patient was watched for 20 minutes and left without incident or complaint. After my mistake was realized I called the patient and told him that he had received a more concentrated dose which may cause increased arm soreness. He was given my cell phone number and advised to call with any problems and to take ibuprofen at bedtime. This patient said he feels fine except for a mild sore arm similar to his first pfizer vaccine 3 weeks ago. I spoke with this patient the following morning; he again said that his arm was sore and that he felt sleepy but was doing well overall.
Redness, warm to touch, swollen very itchy left arm SQ area X this AM.
This spontaneous report as received from a registered pharmacist refers to a 62 years old male patient with no pertinent medical history and no drug reactions or allergies, who on 12-JAN-2013, was vaccinated with a dose of ZOSTAVAX (lot number H018093, Exp. Date: 04-JAN-2014) (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 13-JAN-2013, the patient developed redness and hardness at the injection site. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The relatedness for patient developed redness and hardness at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown) on or about 07-JAN-2013 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-NOV-2014, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 15-DEC-2014, the patient sought subsequent treatment for ongoing and worsening symptoms of shingles outbreak. On or about 09-MAR-2015, the patient was treated by a physician for unresolved and worsening painful symptoms of shingles, at which time she was diagnosed with post-herpetic neuralgia, a chronic condition of nerve damage and pain secondary to zoster infections. The patient was prescribed acyclovir, tramadol and hydrocodone for management of her continued and painful symptoms. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Headache, Myalgia, Fever, NauseaVomiting, chills, malaise, over all weakness Narrative: Employee states she was so weak she couldn't walk well, having trouble getting up. Went to the ER, given IV fluids, and steroids, then released. Has medical hx of Addisons and DM  Other Relevant History:
Patient administered with vaccine from vial exposed at room temp for more than 24 hours / vial punctured more than 12 hours; Patient administered with vaccine from vial exposed at room temp for more than 24 hours / vial punctured more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine from vial exposed at room temp for more than 24 hours / vial punctured more than 12 hours) and PRODUCT STORAGE ERROR (Patient administered with vaccine from vial exposed at room temp for more than 24 hours / vial punctured more than 12 hours) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 062G20A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022 at 2:02 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022 at 2:02 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine from vial exposed at room temp for more than 24 hours / vial punctured more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient administered with vaccine from vial exposed at room temp for more than 24 hours / vial punctured more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine from vial exposed at room temp for more than 24 hours / vial punctured more than 12 hours) and PRODUCT STORAGE ERROR (Patient administered with vaccine from vial exposed at room temp for more than 24 hours / vial punctured more than 12 hours) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was first punctured on 11-May-2022 at 9:30am and was left at room temperature from then on. The number of doses/vials was 1 dose. The date of vial was initially stored in the refrigerator was not reported. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 53 hours. The vial was stored post puncture at room temperature. The frequency was reported as times per.  No treatment medications were reported.
"Moderna COVID-19 Vaccine EUA"  Rash on face, swelling of my face and lips around 45 minutes after the vaccine was given.
Pt called complaining of shortness of breath and chest pain. Pt advised to proceed to Emergency department.
Noted an erythematous induration about 9.6 cm by 6.5 cm on the (R) thigh (anterior). Pt was not in pain, not bothered by it, kept walking across the room, opening doors, cabinets, very active and playful.
Doses received more than 6 months apart; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In January 2020, received first dose in left arm.).   On 09-JUN-2023, the patient received the 2nd dose of Shingrix (right arm). On 09-JUN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Doses received more than 6 months apart). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 09-JUN-2023 The reporter was a patient. The reporter reported that she received second dose of Shingrix more than 6 months apart from first dose. The reporter did consent to follow up. The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
I have had tinnitus for a very long time, but it became extremely loud the second day after vaccination.  I believe it has to do with the vaccine since I have never experienced tinnitus this severe before.  In addition, I started experiencing anxiety all during the day and had a severe panic attack before bedtime.  If it doesn't subside, I will need to find a doctor for this condition.  It is no better today, Jan. 31, 2021.
Member fell to floor after covid vaccine. Member alert and oriented to time and plce. member denies distress and brought to holding room. Member states had similar reaction when getting tattoo. Member observed x1hr and d/c'd by Dr.
expired Daptacel that was given to patient; Initial information received on 24-May-2019 regarding an unsolicited valid non-serious case received from other health care professional.   This case involves a female patient (age not reported) who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number, expiry date not reported via unknown route in unknown administration site.  It was an actual medication error due to expired vaccine used.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Patient has had continued bilateral shoulder, arm, and neck pain since receiving vaccines on 10/9/18. Pain significantly increased since 10/11/2018. She has tried massage, OTC TYLENOL/Ibuprofen/topicals without relief. She will be seeing a chiropractor next.
Extreme left upper arm and bicep pain, at times limited ROM and increased pain. Currently seeing an ART specialist on site Indicates the following issues: adhesion's in bicep and deltoid muscle tissues.
Information has been received from a nurse concerning a 3 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The "patient was given varicella virus vaccine live (Oka/Merck) vaccinations but got chickenpox from their Daycare facility this week". Unspecified medical attention was sought. At the time of the report the patient's status was recovering. A product quality complaint was not involved. Additional information has been requested.
Developed unusual high-pitched cry; Child's mom felt that the cry may have represented irritability; Subsequently the child experienced pain when the leg in which had been vaccinated was touched & tiredness;
Slight arm pain, A week after vac my teeth and sinuses hurt, regardless of heat or cold. Sat 4/27 I had a dentist appt scheduled. Teeth were cleaned day before injection, no cavities were found on X-rays. More X-rays were taken, no cavities were found the second time. Returned to dentist without taking Ibuprofin, still no problems were found with my teeth. More on the right side. More in back teeth. Went away after 2 weeks. Continued to take Ibuprofin.
Information has been requested from a physician concerning a patient who was vaccinated with a first oral 2 ml dose of Rotateq. Subsequently the patient developed intussusception. Medical attention was not sought. No product quality complaint was involved. No other information was provided. Upon internal review, the patient's intussusception was considered to be an other important medical event. Additional information has been requested.
back started itching; broke out in rash 3 1/2 hrs p/receiving vax; took DPH @ home;
Seen in ER @ 740PM on 18MAR91 w/red swollen tender thighs; mom states child cried constantly starting about 7 hrs p/inject;
pain at injection site, headache, body aches--neck, back, legs, chills and shivering. Treatment with Tylenol
JAN. 27, '21- NOTICED SHORTNESS OF BREATH DURING REGULAR EXERCISE ROUTINE FOR STRENGTH & FLEXIBILITY. JAN. 28, '21 WEAR A FITBIT ON WRIST- SAW READING OF REST. HEART DOCTOR. COULD NOT GET APPT. UNTIL FED. 2ND. WENT TO URGENT CARE- DIAGNOSIS OF SINUS BRADYCARDIA, DYSPNEA ELEVATED BP, CALF PAIN. REFERRED TO  ER DEPT. WAITED UNTIL NEXT MORN. TO GO TO HOSPITAL.
This spontaneous case reported by a consumer, describes the occurrence of nasopharyngitis (head cold) and illness (sickness) in a female 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), intramuscular; 1 dosage form. On Mar 19, 2021, patient experienced nasopharyngitis (head cold) and illness (sickness). At the time of the report, nasopharyngitis (head cold) and illness (sickness) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Patient was sick with a head cold for the last 8 days. Treatment information unknown.
I experienced heart palpitations and fever, contacted my PCP's office and was instructed to take Tylenol and rest. The heart palpitations went away but the fever remains for a few days before subsiding. I ended up going to see my PCP and was referred to a Cardiologist who performed a series of test to check for possible blockage of my arteries due to my elevated cholesterol early July to due the Echo Cardiogram, Nuclear Stress Test (06/22/2021), Halter Heart Monitor (07/01-07/02/2021). I returned to see the Cardiologist on 07/19/2021 Angiogram performed. He stated that my symptoms were common because of the vaccine lots of patients were experiencing the same symptoms; however, he wants to continue to monitor me since I still have the mild shortness of breath and my  MVP until further notice.
Large wheal (4-5" across) at injection site. Red, raised and itchy. Patient had gotten some relief by applying witch hazel to site.
Narrative:  Patient did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient past medical history include Obstructive sleep apnea of adults, Long term current use of anticoagulation, Transplanted liver present, Coronary Arteriosclerosis, Sleep Apnea, Hearing loss, COPD, A.Fib, Benign Prostate Hyperplasia. Patient had completed two series of covid vaccine back in Jan-Feb 2021. Recently patient was admitted to local ER on May 6th with covid diagnosis. Patient was transferred to Inpatient hospice on 5.15 and expired on 5.16 per very limited records received for hospital. No other detailed notes were found.
major arm pain; feels awful; flu-like symptoms; This spontaneous report was received from a consumer and refers to a 25-year-old female patient. The patient concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were ot provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23), intramuscularly, (dose, strength, lot # and expiration date were not provided) as a prophylaxis. On the same day the patient was vaccinated with unspecified influenza virus vaccine intramuscularly (dose, strength, lot # and expiration date were not provided) as a prophylaxis. The patient had" major arm pain in the arm in which pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23) injection was given (although which arm cannot be determined at this time). The patient felt awful, had flu-like symptoms since about 2 days then. The outcome of the events was reported as recovering.  The causal relationship between the adverse events and the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23) was not provided.
Pt recvd initial Hep B series 21OCT89, 20NOV89 & 21APR90 @ another institution 5JUN90 it was determined that pt had "no titer"; An Engerix-B booster was administered 9JUL90; a titer was taken 28AUG90 & it was neg;
Patient received 2nd PCV #13 on 4/20/15 patient immediately developed a (L) medial thigh puffiness which was about 4 cm diameter total 2 cm each side of shot site, pain. On 4/21/15, pt's swelling was down only 1 cm each side of shot site. Playful, active.
Information has been received from a physician concerning a female who on 05-SEP-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included atorvastatin calcium (LIPITOR). On 09-SEP-2007 the patient developed muscle pain and muscle spasm in her trapezius and thigh muscles. The patient went to the emergency room. The patient's muscle pain and muscle spasm persisted and was considered to be disabling. The patient's Creatine Kinase level was within normal limits. No further information was provided. There was no product quality complaint involved. Additional information has been requested. The reporter considered the patient's muscle spasms and pain to be disabling.
pt recv vax 24JUL98 & pt exp low grade fever, fatigue, soft stools, loose stools, mild nausea, bloating, weird muscle pain in arm of inj, mult episodes of muscle spasms deep @ site of inj;stomach did not feel right;nausea;did not want to ea
A report was received from a health care professional on 12/2/03 concerning 7 vaccinees under 4 years of age who inadvertently received Fluvirin on unspecified dates. On unspecified dates, the vaccinees inadvertently received Fluvirin. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
muscle aches; achy; a little tired, had a very slight fatigue/really fatigued, really really exhausted, extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), FATIGUE (a little tired, had a very slight fatigue/really fatigued, really really exhausted, extreme fatigue) and MYALGIA (muscle aches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (achy) and FATIGUE (a little tired, had a very slight fatigue/really fatigued, really really exhausted, extreme fatigue). On 18-Mar-2021, the patient experienced MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (achy) outcome was unknown and FATIGUE (a little tired, had a very slight fatigue/really fatigued, really really exhausted, extreme fatigue) and MYALGIA (muscle aches) had not resolved.            No relevant concomitant medications reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable     This case was linked to MOD-2021-049603 (Patient Link).
Patient was admitted to the hospital with complains of chest pain that was non-positional. He states it was a dull ache that was exacerbated by taking deep breath. Pro-BNP and troponin are elevated.. Echocardiogram  and EKG was normal for his age.