chrisvoncsefalvay/vaers-outcomes huggingface dataset:
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medication information provided. It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment information provided.  This case is for 26th patient out of 77 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Received AVA #1, #2, and #3 in country. Received #4. She reports that since her 1st AVA immunization she has experienced joint pain throughout her body, most notable when she doesn't exercise.  Positive for morning stiffness, treats self with Aleve or Advil, and working out helps. She also notes memory impairment; requiring 3-4 tries to remember what she is looking for.  18 Oct 2002  Received AVA #1, and then, as she was walking out of the clinic she felt numbness and tingling with "lots of burning" at the injection site on her R arm on the lateral arm. Within a couple of hours she felt tingling cold feeling travel down her R arm and leg to her fingertips and toes. This symptom lasted 2-3 days. She was able to walk, but with a numb feeling. The injection site remained painful, swelling to a red welt the size of a tennis ball, with that lasting about 1 week. The first night after the immunization she kept waking up with muscles contracting. Did not see MD, wrote up symptoms on AOR on deployment  refused MD at that time. The knot on her R arm lasted months and then resolved. She had a headache, bad feeling "flu-like" all over for about 5 days. Fever on the second day, but did not miss work, and did not go to sick call. 1 Nov 2002  Received AVA #2 and Influenza immunization together. Reaction same as AVA#1 bu this time on her L side, the side with the immunization. 15 Nov 2002  Recorded AVA #3, felt no discomfort with injection, and no symptoms following. She questions actually receiving immunization because she didn't feel anything. 10 Sep 2003  Received AVA #4, developed bump and swelling, low fever, lethargy, nausea, burning down arm and tingling sensation. No muscle contractions this time. Notes that she has received typhoid, meningococcal vaccines without any problems.
PT VACCINATED WITH MMR DEVELOPED WELTS & FLUSHED SKIN ON ARM, FACE & EARS APPROX 1 HR AFTER VAX. MOM CALLED MD HE ORDER ANTIHISTAMINE; PT ALSO HAD DIFFICULTY BREATHING.
fever; sweating; I was itchy too right at the incision area; Fall asleep or unconscious at home; Fall asleep or unconscious at home; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jun2021 (Lot number: Ew0177) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cardiovascular" (unspecified if ongoing); "Inactive TB" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "Double joint" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing); "Muscle weakness" (unspecified if ongoing); "Mild hearing loss in my left ear" (unspecified if ongoing); "Severe ear infection in my left ear" (unspecified if ongoing); "Dermatitis" (unspecified if ongoing); "Otitis media" (unspecified if ongoing); "Sinus" (unspecified if ongoing); "Gait" (unspecified if ongoing); "Dry eye syndrome" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), SOMNOLENCE (non-serious) all with onset 14Jun2021, outcome "recovered" (2021) and all described as "Fall asleep or unconscious at home"; PYREXIA (non-serious) with onset 15Jun2021, outcome "recovered" (2021), described as "fever"; HYPERHIDROSIS (non-serious) with onset 15Jun2021, outcome "recovered" (2021), described as "sweating"; PRURITUS (non-serious) with onset 14Jun2021, outcome "recovered" (2021), described as "I was itchy too right at the incision area". Therapeutic measures were not taken as a result of loss of consciousness, somnolence, pyrexia, hyperhidrosis, pruritus.  Clinical Course: Patient have not received any other vaccine in four weeks, neither tested positive for COVID prior vaccination nor post vaccination.  No follow-up attempts are possible. No further information is expected  Follow-Up (14Feb2022): Follow-up attempts are completed. No further information is expected.
No adverse effects; administered an improperly stored dose of PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical condition and drug reactions/allergies were not reported.   On 12-NOV-2019, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot # S012470, expiration date 20-OCT-2020; strength, dose, frequency and route were not reported) for prophylaxis (Product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored sterile diluent.  The administered dose of the vaccine experienced a temperature excursion at -9 degree Celsius to 8 degree Celsius (0.9C) for 6 hours and 1 min; No previous temperature excursions. The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA005701:
Injection site pain; injection site redness; injection site swelling; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (injection site swelling) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (injection site swelling). At the time of the report, INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication history not provided by reporter.   Treatment information is not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: The follow up received on 24-May-2021 contain no new information.
This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, patients were vaccinated orally with improperly stored doses of ROTATEQ (lot number K009900 and expiration date 04-MAY-2016, dose was not reported). The temperature and the time frame of the excursion were 12.3 Celsius degrees for 83 hours and 40 minutes and -3.4 Celsius degrees for 105 hours and 50 minutes. There was no previous temperature excursion and it was stated it was a data logger. No adverse events were reported No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Approx. 8 hours after vaccines (and nonstop crying since 2 hours after vaccines), he had his first episode of head tremors. It lasted about 10 seconds and was a very mild shaking/vibration. Since then, he has had about 50 episodes of these tremors, occasionally involving his entire body but usually just his head, shoulders and arms. They have lasted as few as 5 seconds and as long as 60 seconds. Sometimes they are more severe than others, more vibration/shaking; sometimes it is a gentle tremor. Talking to him doesn't stop them. They are occurring less often and are less severe as time passes.
Nausea; Vomiting; Unable to tolerate food; Lack of appetite; The recipient was "down & out" for a week after receiving 1st dose.; diarrhea; This is a spontaneous report from a contactable Consumer. An unspecified age male patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: not provided), via an Intramuscular route of administration on an unspecified date Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. It was unknown whether the patient received any other vaccine within 2 weeks. It was unknown if Prior to the vaccination, the patient was diagnosed with COVID-19. It was unknown if Since the vaccination, the patient had been tested for COVID-19. On an unspecified date Apr2021, the patient had "down & out" for a week after receiving 1st dose. Nausea, vomiting, diarrhea, unable to tolerate food (including PediLyte), lack of appetite. It was unknown whether the patient received any other treatment medication. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
My face has become like a moon face.  I have done massage and drank water but it doesn?t go away.  It happened right after my shot.  I ate nothing  nor did anything different.
This spontaneous report as received from a pharmacist refers to a 67 year old female patient. Concurrent condition included CIPRO allergy, KEFLEX allergy, LEVAQUIN allergy, penicillin allergy and sulfonamide (unknown reaction). Concomitant medication was not provided. On 10-FEB-2014 the patient was vaccinated with ZOSTAVAX lot # J007858, 1 DF, subcutaneous. Frequency was not provided. In February 2014, after the administration, the patient developed a large, hard, red spot at the injection site. The area of the reaction was enlarging. The patient did not receive any treatment. The outcome of the developed a large, hard, red spot at the injection site was reported as not recovered/not resolved. The reporter causality was unknown. Additional information has been reported.
Fainting spell; Loss of feeling in hands and feet; Dangerously low blood pressure; Sweating profusely; Chills; Overall weakness; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 14May2021 08:00 (at the age of 29 years) (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included penicillin allergy. The patient previously received the 1ST DOSE of BNT162B2 administered on the left arm on 16Apr2021 at 08:00 (at the age of 29 years) for COVID-19 immunization. On 14May2021 08:00, the patient experienced fainting spell, loss of feeling in hands and feet, dangerously low blood pressure, sweating profusely, chills, overall weakness and "nautilus". The event fainting was assessed as serious (medically significant). Therapeutic measures were taken as a result of all the events. The outcome of the events was recovering.  No follow-up attempts are possible, information about the batch number cannot be obtained.
Pt recvd 1st dose of Hep B vax on 5JAN92; On 27JAN92 devel a generalized intense pruritus especially @ noc w/occasional hives; pt later recovered; no further details were provided;
This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB (lot #N024570, with expiration date 01-MAY-2020), for prophylaxis (dose number, frequency, route and anatomical location were not provided).The administered dose of the vaccine experienced a temperature excursion in the range between 47 degrees F to 77 degrees F (52.7 degrees F) during 2 hours and 15 minutes. The vaccine had not had any previous temperature excursions. There were no adverse effects reported. This is one of eleven reports received from the same reporter. Sender's Comments: US-009507513-1808USA011005; US-009507513-1808USA011006; US-009507513-1808USA011007; US-009507513-1808USA011008; US-009507513-1808USA011009; US-009507513-1808USA011010; US-009507513-1808USA011012; US-009507513-1808USA011013; US-009507513-1808USA011014; US-009507513-1808USA006003.
5 1/2hr p/vax pt had a sz;parents advised to bring child to ER;pt did not return to clinic;mom stated child had sz & staring spells in the past. Information received from follow-up states mom reports he continues with seizure as he had before the injections, but became ok from the seizure he had during the day of the injection.
After the vaccine was administered intradermally, the  patient had a syncopal episode where there was a brief loss of conciousness,  diaphoresis, tachycardia, and palor. The patient regained conciousness after about 10 seconds. Vital signs wer taken and improved over time. Please see the vitals listed below.   At 12:35pm: HR:103bpm SpO2: 98 BP: 100/60 At 12:40pm: HR: 87bpm SpO2:91 BP: 100/60 At: 12:45pm: HR: 96 bpm SpO2: 97 BP: 100/70   The patient drank 20oz of water, and was observed for 30 minutes, and felt well enough to leave the clinic.
Woke up @ 4:15 am to go to work, Right ear felt like it was stopped up, could not hear anything. Went to work, unable to be seen by primary office until Monday 01/18,2021, miss diagnosed with torn eardrum. Made ENT Appointment  for 01/26/2021, diagnosed Sudden onset neurosensory hearing loss,, put on high dose steroids., followed by hearing test,  MRI brain  2 steroid injections Right ear ,   No significant return of hearing to spoken word 30%.
Headache headache, sore thraot, body aches, nasal congestion and fever Narrative:  On day after vaccination patient experienced headache, sore throat, body aches, nasal congestion and fever of 101. Took OTC Ibuprofen
Pt received pneumonia vaccine on 11/01/2001. On 11/02/2001 arm hard, hot, painful, swollen and filled with fluid.
This spontaneous report was received from a pharmacist regarding 2 unspecified female patients (sisters) of unknown age. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported as unknown. On 18-NOV-2016, both the patients were vaccinated with GARDASIL 9 (lot # L001312 with expiration date 24-FEB-2017) (dose, frequency, route and anatomical location not reported). The patients' mother not pushed in all of the way. It was unknown whether these doses were the first doses of GARDASIL 9 for these patients. On the same day, the injection site for both patients was "hot to the touch". The outcome of injection site warmth was unknown. Causality assessment was not provided by the reporter. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about medical history and concurrent condition was not reported. On unknown dates the patients were vaccinated with doses of GARDASIL 9 (lot# reported as L007560 with expiration date of 15-JUN-2017; strength, dosage, frequency and route unspecified), which were exposed to temperature outside of the recommended storage range. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Injection site pain; Sore arm for 2 plus days; Tiredness for 3 days; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient experienced injection site pain, sore arm for 2 plus days and tiredness for 3 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events injection site pain, sore arm for 2 plus days and tiredness for 3 days was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
I had some nasal congestion and cough and called within 24 hours. I called my doctor and was given molnupiravir which helped, and I was recovered in two days with a cough that lingered 7-10 days.
PT. WAS GIVEN FLU VACCINE LEFT OFFICE- MOM CALLED APPROX. 15MIN LATER STATING PT WAS HAVING FACIAL SWELLING- MOM DENIED SOB, DROOLING, FEELING FEARFUL.  ADVISED MOM TO RTO UNLESS PT HAD SOB OR WORSENED THEN SHE WOULD GO TO ER.  PT RTO AND PRESENTED WITH FACIAL SWELLING MAINLY AROUND THE EYES.  DR. EXAMINED PT- THEN PT WAS GIVEN BENADRYL 15 MG IM.  PT WAITED IN OFFICE FOR 30 MIN AND THEN WAS ALLOWED TO LEAVE.
Pt. presented 9-16-12 with right side, hip, leg, spine, red blisters. Navel blister draining and yellow crusted. Severe itching, no pain yet. Phoning Dr. for direction 9-17-12. Instructed patient to go to ER if worsens. 9-18: Very tired-seeing MD Thursday 8-20-12. 9-17-12 -> Dr. wants to see pt. Left message.
Very sore arm from injection; headache; body aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 11:45 (Lot number: EL3247) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ALAVERT; ALEVE; MULTIVITAMIN & MINERAL. Vaccination history included: Bnt162b2 (dose number:1, administration time: 10:00AM, lot number: EL3247), administration date: 10Mar2021, when the patient was 43 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 31Mar2021 22:00, outcome "recovering", described as "Very sore arm from injection"; HEADACHE (non-serious) with onset 31Mar2021 22:00, outcome "recovering", described as "headache"; PAIN (non-serious) with onset 31Mar2021 22:00, outcome "recovering", described as "body aches"; FATIGUE (non-serious) with onset 31Mar2021 22:00, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of vaccination site pain, headache, pain, fatigue.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient had not been tested for COVID-19. Upon Follow-up on (PRD 05Apr2021) This 43-year-old female consumer (patient) responded for Query to confirm the PRD date that: this was her own adverse event to the Pfizer Covid-19 vaccine, so she is the patient. she had her second dose of the vaccine on Wed, 31Mar. she experienced these symptoms when woke up on 01Apr2021 and thats when she reported them. If they need anything else, please let her know.  No follow-up attempts are possible. No further information is expected.
Physician Discharge Summary   Patient ID: Age: 50 y.o. Admit Date: 7/14/2022  2:57 AM Discharge Date:  7/17/2022 Unit: 4A109/4A109A   Discharge Diagnosis: Principal Problem:   Pneumonia due to COVID-19 virus Active Problems:   Hypernatremia   Elevated troponin   Hyperlipidemia   AKI (acute kidney injury)   Hypothyroidism   Chronic respiratory failure with hypoxia     Hospital Course: 50yo female presented to ED from home with respiratory distress r/t COVID 19. Has significant past medical history, including L sided paralysis due to previous CVA. She has PEG tube and is on 4L NC PTA. Was also hypotensive and in renal failure w/hypernatremia  Continue to decompensate, was intubated and admitted to COVID ICU. Nephrology and Pulm/CCM consulted. Despite full care, she continue to have hemodynamic instability and decompensation. Also developed R UE and LLE loss of pulses and was started on Heparin gtt. Multiple discussions regarding goals of care initiated. Given her overall poor health/debility, family chose to purse comfort/withdrawal of care. This was initiated per protocol and patient expired at 06:42 today.      Consults:   IP CONSULT TO PULMONOLOGY IP CONSULT TO NEPHROLOGY IP CONSULT TO SOCIAL WORK IP CONSULT TO SEPSIS NURSE NAVIGATOR IP CONSULT TO DIETARY IP CONSULT TO DIETARY IP CONSULT TO SOCIAL WORK IP CONSULT TO WOUND CARE IP CONSULT TO SOCIAL WORK IP CONSULT TO VASCULAR SURGERY   Significant Diagnostic Studies:    COVID +, Na 156, Cr 2.1 at admission    Disposition:  Funeral home of family's choice   Discharge Condition:  deceased