chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unresponsive; This is a spontaneous report from a contactable healthcare professional (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 13Apr2021 12:45 (Lot Number: EW0158) as SINGLE DOSE for COVID-19 immunization. Medical history included melanoma brain cancer from an unknown date and unknown if ongoing. Concomitant medications included hydrocortisone, calcium carbonate, colecalciferol and meso zeaxanthin, xantofyl, zeaxanthin (MACUHEALTH WITH LMZ3); all taken for an unspecified indication, start and stop date were not reported. The patient previously had first dose of BNT162B2 (lot number: ER2613) on 23Mar2021 12:15 PM in the right arm for COVID-19 immunisation at 66 years old. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient as not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The day following receiving the vaccination, the patient took her morning Hydrocortisone and fell asleep. Later that day, the patient became unresponsive on 14Apr2021 01:00 PM. The patient was admitted to the hospital and was released 2 days later. Many tests were performed including a Spinel Tap, MRI (brain - that is where my melanoma cancel was located), and a full panel of lab work on unspecified date. All tests responded normal. The patient was in the hospital for 2 days. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. Treatment was given to the patient such as fluids, hydrocortisone and antibiotics. The outcome of the event was recovering.   Information on about lot/batch number has been requested.; Sender's Comments: Based on the information provided, this patient with a medical history  relevant for melanoma brain cancer from an unknown date and  ongoing. It was noted that the day following receiving the vaccination, the patient took her morning Hydrocortisone and fell asleep. Later that day, the patient became unresponsive. Although the reported event could be possibly related to  intercurrent melanoma brain cancer, due to the plausible temporal association, a possible contributory role of the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Within 12 minutes patient developed palpitations and dizziness. Next day fever, joint pain, loss of taste, and brain fog.  She has continued to have joint pain and brain fog since that time. Palpitations at rest on occasion
pt recvd vax & father broke pt's fall-pt laid on floor elevated head & applied cool compress to forehead; pt's lt arm from the elbow to the shoulder was red & warm to touch & sl swollen;
2 days after Td, noted redness and swelling. Also pain of area under same arm on right.
Headache, Myalgia, body warmth without fever, left arm pain Narrative:  N/A
first dose: arm hurt, hurt to lift it up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07Aug2021 14:00 (Lot number: FC3181) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Digestive issues" (ongoing), notes: Verbatim: digestive issues; "Menopause" (ongoing), notes: in menopause, she has not had a period since she was, probably 3 years, 3.5 years; "Migraines" (ongoing), notes: she does migraines, she doesn't know if she is ever been technically diagnosed, but the first time she ever had one was after she had her 2nd child, so probably 29 years ago,. Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE MAGNESIUM] taken for dyspepsia (ongoing); ALKA-SELTZER HEARTBURN RELIEF taken for dyspepsia (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Aug2021, outcome "recovered" (09Aug2021), described as "first dose: arm hurt, hurt to lift it up".  Additional information: No vaccinations within four weeks prior to the first administration date of the suspect vaccine  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX for prophylaxis. On an unknown date the patient experienced incorrect product storage and poor quality drug administered. The outcome of poor quality drug administered is unknown. The reporter considered incorrect product storage and poor quality drug administered to be not related to VARIVAX.    ; Sender's Comments: US-009507513-1707USA001044: US-009507513-1707USA001045: US-009507513-1706USA007156:
Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date; No adverse event; Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date.), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date.), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date.) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date).    No concomitant medications were reported.  The patient received half dose of Moderna vaccine.  The vial had not undergone any temperature excursions.  The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected.  No treatment medications were reported.
dose received from vial opend> 12h; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose received from vial opend> 12h) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included COVID-19, Pulmonary embolism and Renal disease (Acute). Previously administered products included for Product used for unknown indication: Pfizer (Dose 1) on 23-Feb-2021 and Pfizer (Dose 2) on 18-Mar-2021; for Influenza: Fluzone (Route of administration of vaccine was IM ) on 01-Dec-2021; for Pneumonia: pneumonia (Route of administration of vaccine was IM ) on 01-Dec-2021. Past adverse reactions to the above products included No adverse event with Fluzone, Pfizer, Pfizer and pneumonia. Concurrent medical conditions included Hypertension and COPD. Concomitant products included ALBUTEROL [SALBUTAMOL], ALLOPURINOL, BACLOFEN and APIXABAN (ELIQUIS) for an unknown indication.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose received from vial opend> 12h). On 06-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose received from vial opend> 12h) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug Abnol Treatment information was not provided.   This case was linked to MOD-2021-416295 (Patient Link).
Patient developed documented endocarditis on day 7 post administration; This is a spontaneous report from a contactable pharmacist.  An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 intramuscular, administered in left arm on 13Sep2021 (Batch/Lot Number: EC0179) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on an unspecified date (Batch/Lot Number: EC0179) as dose 2, single for COVID-19 immunisation. The patient experienced patient developed documented endocarditis on day 7 post administration on 19Sep2021. The event led to hospitalization.  Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, it was unknown if the patient been tested for COVID-19. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of endocarditis cannot be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Vomiting, severe body aches, headache, chills, shaking, weakness of entire body, pain at injections site. Treatment was rest, water and lots of blankets
DOSE 1 ON MARCH 16, 2021; DOSE 2 ON APRIL 13, 2021; SEVERE PAIN STIFFNESS, TETANUS, ACHES, FATIGUE, MORE PAIN SAME DAY FOLLOWING FIRST INJECTION.... MUMPS-LIKE SYMPTOMS... PAIN FROM INJECTION SITE , UP NECK, BACK OF HEAD... TOTALLY DEBILITATING PAIN WORSE IN EVENINGS AND PAIN "MOVING" FROM ARM TO NECK TO HEAD AND BACK...WORSE AT NIGHT.... SAME SYMPTOMS WITH EACH DOSE... 2 MONTHS NOW! PAIN LASTED 4 WEEKS AND WAS REMITTING AT TIME OF SECOND INJECTION; SEVERE PAIN STIFFNESS, TETANUS, ACHES, FATIGUE, MORE PAIN SAME DAY FOLLOWING SECOND INJECTION (I WAS ALMOST BETTER AND THEN BACK TO WORSE THAN FIRST DOSE! WAY WORSE! PAIN LASTED 4 WEEKS AND IS CONTINUING NOW
Redness, swelling at injection site. See in local ER and diagnosed with cellulitis and prescribed oral antibiotics.
I experienced vertigo on 10/27/2022. I went to my doctor and was given a prescription to help me with my symptoms. I tested positive for COVID -19 on 12/12/2022. I had severe head congestion, cough, body aches and fatigue. I contacted my doctor and was given the prescription PAXLOVID. I tested negative for COVID-19 on 12/19/2022. I rebound and tested positive for COVID-19 again on 12/21/2022.
Moderate local rxn - hard nodule, rash, extreme itchness, local area. Chronic fatigue since July 1999. Weight gain. Joint sorness - minor.
High pitched crying, frantic lasted for 7-8hrs; Didn't stop crying to sleep or eat;
Left deltoid erythematous with increased warmth for 2 days. Left axillary node tenderness for two days. Treatment: Cephalexin 500mg PO BID for 10 days. Ibuprofen 800mg PO BID for 10 days.
0715: pt c/o dizziness, "can't see," "fuzzy" post 2nd dose of Pfizer COVID-19 vaccine. pt a&ox3, pale, and diaphoretic. VS 65/39, HR 51, RR 16, SPO2 99 on RA, T 98.4. laid patient on the ground with bilateral extremities above level of the heart. 0720: VS BP 97/53, HR 66, RR 16, SPO2 98 on RA. pt states she feels better. CODE BLUE team arrived at 0723. Blood glucose = 97. pt refused transfer to the ED for further evaluation.
Per Dad immunizations given on 03/15/2005 and redness occurred on 03/16/2005. Today (03/17/2005) pt presented with fever, Arm (rt) very red, swollen and hot to touch. Dr treated with Keflex 250mg/5ml 1 tsp TID x 10 days.
Information has been received from a nurse in a physician's office concerning an 8 year old white male, with no known medical history or allergies, who on 18-DEC-2007 was vaccinated with a second SC/LA dose of varicella virus vaccine live (Oka/Merck) (Lot #659533/15994U). Concomitant vaccine administered on the same day included a first IM/RA dose of hepatitis A vaccine (inactive) (MSD) (Lot# 657307/0442U). There was no illness at the time of vaccination and no adverse events following prior vaccination. On 19-DEC-2007 the patient returned to the physician's office and presented with an inflamed injection site, injection site swelling, and injection site itching. It was reported that the patient experienced pain with rings of erythema around the varicella virus vaccine live (Oka/Merck) injection site. The patient recovered on 22-DEC-2007. There was no product quality complaint. Additional information has been requested.
Injection site was sore, red,swollen. Lasted 4 days. Left a bruise. Another reaction at site one week later, redness, sore and a rash.
Patient describes adverse event as 2" long x 1" wide bump at site of injection. She states that the bump is red, hot, hard, & itchy (but not painful).
Rash was first noticed on 07-10-08. Raised, whelps and rash starting on trunk area spreading down bilateral arms and legs. Concentrated rash area noted on abdomen around waist band. Denies any other problems.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 1:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 1:09 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 72.41 for dose administered on 28-Apr-2021.  No concomitant medications were reported.  Batch number 007C21A underwent temperature excursion on 28-Apr-2021 with temperature 33 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 19-Apr-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 28-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (limited my mobility), VACCINATION SITE PAIN (injection site and surrounding muscle soreness), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (low grade fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (limited my mobility), VACCINATION SITE PAIN (injection site and surrounding muscle soreness), FATIGUE (fatigue), CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (injection site and surrounding muscle soreness). At the time of the report, MOBILITY DECREASED (limited my mobility), VACCINATION SITE PAIN (injection site and surrounding muscle soreness), FATIGUE (fatigue), CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (injection site and surrounding muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.; 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.
welt like raised area rt thigh; improved today; red, hard, bruised, raised welt 11AUG92;
Red and swollen at injection site, appearance of red rash that grew larger and larger around entire upper arm where injection was given.  Very painful.  All symptoms Last for about a week.
Information has been received from a physician concerning a 27 year old female with no known drug allergies and no pertinent medical history who on 26-JUL-2010 was vaccinated with the first dose of VARIVAX (Merck) (Lot# 666726/0028Z). There was no concomitant medication. On 28-JUL-2010 ("2 days after the vaccination") the patient experienced rash and hives. The patient did not seek medical attention. There was no lab or diagnostic test performed. On 02-AUG-2010 ("5 days after the appearance of hives"), the patient recovered from rash and hives. Additional information has been requested.
Pain in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 12:45 (Lot number: F1t8028) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Nov2021 13:30, outcome "recovered" (2021), described as "Pain in the arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.  Additional information: The patient did not receive any other vaccine in four weeks. The patient did have covid prior vaccination and was not tested for covid post vaccination. The patient did have known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID- 19. Since the vaccination, patient had not been tested for COVID-19.
This is in my vagina became very, very red a hole started in my vagina wall. I went to first doctor (nurse practitioner) at medical clinic stated might have herpes which I got further examination. I went to second (nurse practitioner) medical clinic that gave me a swab for herpes.Then I went back to 3rd doctor GYN Dr. at medical clinic I was diagnosed with Behcet?s syndrome prescribed with Lidocaine and Aquifer which didn't help. As of right now the hole is repairing (described as a dimple now at first it was deep deep open hole).Since March it caused me to have no intercourse scared of any infections.There is no cure this can be a ongoing disease my doctors are 99% sure that the vaccine is the cause.I want to inform the CDC I'm scared to take the booster.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (Lot#, dose and route not reported) on 13-SEP-2012 and was put on generic cefdinir (manufacturer unknown) on 21-SEP-2012 and experienced a rash (date not reported). The patient was switched to doxycycline (manufacturer unknown) on 24-SEP-2012. On 25-SEP-2012 the patient had a prescription for a steroid pack because the patient had hives all over. It was not reported if the patient sought for medical attention. The patient's status was unknown. Additional information has been requested.
103 FEVER; This spontaneous report received from a patient 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: Unknown) 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced 103 fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 103 fever was not reported. This report was non-serious.
New onset of seizures. Seen and treated in the emergency room and pediatric intensive care. 12/17/09 (01/04/2010-Dup. rec received) hospital records received for DOS 08/07/09-08/09/09 Dx: New onset seizures Patient presented in ER, screaming, combative, disorientated, tachycardic, hypotensive and bleeding from the nose. Patient received vaccination yesterday. Mother reported that patient called her today and complained of severe headache, not feeling well and was crying. Mother returned home and witnessed generalized tonic-clonic seizure. In ambulance, patient received valium for combativeness alternating with seizures. Admitted- one episode of sudden agitation during hospitalization. Patient treated with Torazepam, Haldol, saline bolus (3 liters). Discharged home.