chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The next day I started having pain in my right lung. On Wednesday 4/27/2021 I started having pain with breathing, and severe pain in my lung. I went to see my PCP. I was told it was just my fibromyalgia, and to take my medicine. On Thursday 4/29/2021 I was in so much pain, I went to the ER. I had a pulmonary embolism and infarction.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications reported. no treatment details reported.
2:30 PM - Dull soreness at injection site. 3:30 PM - increasing discomfort at injection site. 4:00 - 11:00 PM - discomfort continued to increase and noted with any movement, some shooting pains down arm from deltoid to elbow. 10/27/15 5:00 AM - mild discomfort more typical for flu shots of past years. 10/28/15 - am - Pain resolved.
Headache; Painful Arm (Injection Site); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and VACCINATION SITE PAIN (Painful Arm (Injection Site)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for an unknown indication.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (Painful Arm (Injection Site)). At the time of the report, HEADACHE (Headache) and VACCINATION SITE PAIN (Painful Arm (Injection Site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Headache, Myalgia, Fever, CHILLS, ALMOST SYNCOPE  Narrative:  Other Relevant History:
Site swelled and got red, site was hotter than surrounding arm area, site hurt with low pain, 9 days after injection.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree.  The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
fatigue; pain in her arm; pain in her bones; muscle pain; joint pain; pain in her tendons; pain in her legs so bad she was unable to sit or stand; nasal secretions; red eyes; flu; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fatigue, pain in her arm, pain in her bones, muscle pain, joint pain, pain in her tendons, pain in her legs so bad she was unable to sit or stand, nasal secretion, red eyes, flu. Therapeutic measures were taken as a result of all events and included treatment with took Tylenol and pills for Flu to treat the adverse effects of Pfizer's COVID-19 vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) outcome 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 assessments were provided for WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and UNDERDOSE (patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant medication details not reported by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details was not reported by the reporter. This case contains information about patient 7th out of 18 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Booster desired by way of consent signed on admission by resident representative.  Janssen booster 0.5 mL given as consented to stable resident by LPN on 12/29/21 at approx 11:00am.  On 12/30/21, resident status declined with rapid strep being done for fever, throat inflammation.  Later resident was found to have low B/P, diaphoretic, unresponsive.  Order received to send to local ER for eval.  Resident left our facility with tachypnea, tachycardia,  febrile and unresponsive and transported to local ER where he later was reported to have passed away in the ER.
onset of chest pain on April 30 with progressively worsening -dx with spontaneous pneumothorax
Intermittent blurry vision, dizziness, shakiness, chest tightness (mild); no shortness of breath, no rash, no edema, no nausea/vomiting, no palpitations.
Patient was to receive Pfizer Bival (12 yr & up) but gave Pfizer (12 yr & up ) instead. I mistakenly took the wrong bottle out - they look exactly the same with the difference of omicron coverage.
Headache; breathing is different; not feeling really bad; bloating in stomach; neck pain; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), DYSPNOEA (breathing is different), FEELING ABNORMAL (not feeling really bad), ABDOMINAL DISTENSION (bloating in stomach) and NECK PAIN (neck pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported.).    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced HEADACHE (Headache), DYSPNOEA (breathing is different), FEELING ABNORMAL (not feeling really bad), ABDOMINAL DISTENSION (bloating in stomach) and NECK PAIN (neck pain). At the time of the report, HEADACHE (Headache), DYSPNOEA (breathing is different), FEELING ABNORMAL (not feeling really bad), ABDOMINAL DISTENSION (bloating in stomach) and NECK PAIN (neck pain) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Significant Followup Appended
1st dose 10JUN2022, 2nd dose on 05JAN2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received on 10 June 2022).   On 05-JAN-2023, the patient received the 2nd dose of Shingrix. On 05-JAN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 10JUN2022, 2nd dose on 05JAN2023). The outcome of the drug dose administration interval too long was not reported.   Additional Information: GSK receipt date: 28-Feb-2023 Reporter comment: On 28th February 2023, a CPT called to report that the patient wanted to receive a dose of Shingrix.  According to the facility's registrations, the patient received two doses, meaning that the scheme was complete.  However, the patient stated that such first dose was never received (even though registered) and that another dose had to be administered.  Now, CPT had not administered the third dose.  The reporter did not consent to follow up. Additional Supportive Information: The patient received second dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
08/25/22 presents to ED for "leg pain, extremity weakness". PMHx of "hypertension, HLD, arthritis, obesity, and right lower extremity DVT status post IVC filter".
Information has been received from a doctor's staff concerning a 17 year old female patient who in 2007 was vaccinated intramuscular with the first dose of 0.5 ml GARDASIL. The patient never got her second or third dose. Subsequently a Pap smear done "within the past 2-3 weeks" came back positive for cervical cancer. It was unknown when the cancer started and whether or not it started after she got the first dose of GARDASIL. The outcome of the event was unknown at the time of reporting. The physician stated that the patient was vaccinated with the first dose of GARDASIL (Lot number 660557/0072X) on 11-SEP-2008. The patient did not receive any concomitant vaccinations. On 05-OCT-2009, the patient had a Pap smear which revealed low grade squamous intraepithelial lesion (LSIL). Additionally a medical assistant stated that the patient was seen by a OB/GYN physician on 19-OCT-2009 to discuss the patient's Pap smear results. The patient was scheduled for a colposcopy on 26-OCT-2009. Additional information has been requested.
Patient had second Pfizer vaccine on 5/22/21. She complains of sore arm and raised area like a bump. RN reviewed supportive measures, and to notify provider since area swollen with bump.
Throat closing in feeling ~24 hours after vaccine, lasting ~48 hours. Antihistamine needed.
Mildly elevated ALT of 40 (highest range is 32 for this particular lab that was run).; This is a spontaneous report from a contactable consumer (herself as patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 01May2021 10:00 22May2021 14:00 (Batch/Lot Number: EW0170), as single dose and then again the second dose via an unspecified route of administration, administered in Arm Left on 22May2021 14:00 (Batch/Lot Number: EW0187) as single dose; both for COVID-19 immunisation. Medical history included GERD, Anxiety, Allergies; all since from an unknown date and unknown if ongoing. Concomitant medications included famotidine, fexofenadine, paracetamol (TYLENOL) and ibuprofen. On 28May2021 16:15, the patient experienced mildly elevated alanine aminotransferase of 40 (highest range is 32 for this particular lab that was run). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included ALT (highest range is 32): 40 (increased) on 28May2021. The clinical outcome of the event was unknown.  Follow-up attempts are needed. Further information can be expected.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, there is a reasonable possibility that event alanine aminotransferase increased were related to suspect drug based on the temporal relation between the vaccination and onset of events. 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.
Child did not sleep for 3 days, ran fever, injection sites were red and inflamed. Site of Varicella had pass coming out for over a week. Child had aggressive behavior and beat his head on the floor and with his fists. His speech has been delayed. Child is now almost 3 and shows slow learning and verbal formation.  04/24/2007 Brief MR received from Ped for an ear re-check for OM on 04/14/2006.  Vax received. MD reports speech delays at this visit.   Assessment:  Otitis media.  Speech delay.  05/14/2007 MR from PCP received beginning 4/12/06 through 4/06/07. Exam 4/12/06 WNL except bulging erythematous TMs. DX:  Otitis Media. Next visit 5/08/06 with c/o agressive behavior following visit with dad. Behavioral rxn noted after 1st set of vax.  (+) head banging. Vocab is "coming along with good receptive skills". Assessment:  Well child 2 years. Visit 6/30/06 with mom's concern re: speech, with request for audiology consult.  MD notes speech is normal for a boy that age. Multiple visits for cold sx, OM, reported epistaxis,and cough.  04/17/2008 F/U report received with various attached medical records wit DX: ? regressive encephalopathy of toxic nature, functional diarrhea, delayed development, delayed speech, Adverse reaction to vaccines, yeast enteritis, and possible autism form eval of 10/29/07. Eval 1/22/08 with Assessment:Autistic Disorder.  Likely sensory dysfunction.  Sensory issues significant. Neuro eval 11/5/2007 with Assessment:  High functioning Autism. Night terrors. Autism/PDD see attached medical records faxed Faxing 15 additional pages lab report confirmation - mailed 4-17-08
Arm pain, headache, fever, chills, body aches, nausea, dizziness, sore throat
This case was reported by a pharmacist via call center representative and described the occurrence of flu-like aching in a adult patient who received SHINGRIX (batch number YS53Y, expiry date January 2020). On 22nd March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced flu-like aching. On an unknown date, the outcome of the flu-like aching was unknown. It was unknown if the reporter considered the flu-like aching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated that after receiving SHINGRIX, his employee who was the patient reported general flu-like achiness. The health care professional reported a total of 4 adverse events during call. Did not obtain patient-specific information. The health care professional mentioned this in passing during the course of conversation. This case is 1 of the 4 linked cases reported by the same reporter.
On 01/08/22, she developed a cough and fever then subsequently tested positive for COVID-19 on 01/10. She started improving and felt better until 01/13 at which time she developed high fevers 102-103F with Tmax 106F, nausea with multiple episodes of vomiting, diffuse myalgias with hand and foot edema, and malaise. Admitted on 01/16/22 for MIS-C, received 1 dose of IVIg on 01/17, and was discharged on Tuesday 01/18 on prednisone 40 mg PO and aspirin 81 mg. Readmitted on after resurgence of fever/102F, nausea, myalgias, and a mild headache. Mother noted she has been very fatigued. Likely secondary to refractory MIS-C, cannot rule out other source of infection. No fever since admission. Labs done on admission reassuring; showed continued downtrend of inflammatory markers. 1/20 Labs: WBC 12.8 (unchanged from 1/19) CK WLN, LD WLN, fibrinogen 618 (down from 782 on 1/18), D-dimer 2.38 WLN (slight increase from 1.69 on 1/16), CRP 30 (down from 56.1 on 1/19). Naproxen 375mg BID AMD Pepcid started on 1/21. Discharged 1/22 on prednisone 40 mg daily and ASA 81 mg ,
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter.  No treatment medications were provided by reporter.
Patient started to experience shortness of breath, swelling of the throat/tongue and gasping for air. Team members began to take vitals and once provider was called out, 0.3mg Epi pen was administered to patient with approval from patient and oxygen was started at 4 LPM.  Once oxygen was administered, patients O2 sats increased as well as her breathing. EMS was called after administration of Epi pen, once they arrived they began their own evaluation of patient and monitored for the next 20-30 minutes. Pt. denied transport to hospital and family stated that she would be fine with time as they have experienced this situation before.
This spontaneous report as received from a nurse refers to a 17 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 29-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
This spontaneous report as received from a pharmacist who was reporting on behalf of the patient's husband refers to an approximately 74 year old female patient with no pertinent medical history. On 12-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # I011533, expiration date: 20-JUL-2016, 0.65 ml, subcutaneously. The patient had no concomitant therapies. On an unknown date in 2015, the patient had a recent case of shingles. The patient sought medical attention, she called pharmacist and nurse practitioner. On 08-DEC-2015, nurse practitioner prescribed to the patient VALTREX 1 gram, three times a day for 7 days. No lab diagnostics studies were performed. Varicella zoster virus (VZV) packet was declined by pharmacist. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
hot cheeks; flushed body; Nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot cheeks), FLUSHING (flushed body) and NAUSEA (Nausea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001821A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (hot cheeks), FLUSHING (flushed body) and NAUSEA (Nausea). At the time of the report, FEELING HOT (hot cheeks), FLUSHING (flushed body) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
This spontaneous report was received from a nurse prescriber referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history or concurrent conditions were not reported. On 18-DEC-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R007693 (expiration date: 14-MAR-2020), subcutaneously for prophylaxis, which was reconstituted with a properly stored STERILE DILUENT. No adverse effects were reported. The vaccine was exposed to a temperature excursion of 21 Fahrenheit degrees (15 to 45 Fahrenheit degrees) for a timeframe of 8 hours. It was found because of a digital data logger and there were no previous excursions. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1812USA012971.
1/7/2021 Moderna lot 012L20A 2/5/2021 Moderna Lot 007M20A 10/05/2021 Moderna Lot 022C21A Arm cream: fluocinonide cream USP 0.1% after receiving rash on arm site, 46% inflammation due to immune system response. Immediately after an hour severe headache and, fever, sore arm. Could not get fever down below 101 for three days. Took Tylenol and liquid iv to combat fever and dehydration.
I had a cold that I contracted on 08MAR2023 as it was resolving I started to get a sinus infection 13MAR2023 that has lasted a couple weeks now and continuing.