chrisvoncsefalvay/vaers-outcomes huggingface dataset:
placed in refrigerator after the expire date; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (placed in refrigerator after the expire date) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (placed in refrigerator after the expire date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (placed in refrigerator after the expire date) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. There was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. Date place in refrigerator was 17Nov2021. Patient did not experience temperature excursion and any adverse event.  No treatment medication was provided by reporter.
Food began to taste funny.  My tongue felt like there was pepper on it or like I had bitten a jalapeño. But at the same time, there is a sort of numb feeling kind of like after taking a cough drop.  Food still does not taste right.
On 5/14 patient had partial seizure lasting 2-3 minutes during dialysis followed by fever.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Pt received first shot setting down.  When advised to move to obseration area and pharmacist walked back to pharmacy, pt fainted.  Pt was hot, sweaty, and has low BP.  EMT was called and pt was resolved and alert after several minutes.  Pt was evaluated by EMT and cleared and left on his own.
headache, left eye pain, chest pain located in his left upper chest, blood shot eyes, fatigue, bilateral leg and calf pain and the sensation as though blood was pulsing throughout his body.  Pt states that his symptoms continued for months and continue now.  He continues to have intermittent headaches located on the left front to side of his head described as a pulsatile sensation with an intermittent burning sensation.  He will also have bilateral flank pain described as an 8/10 hardening/vise  that occurs daily at random but does not wake him up at night.
Case number PHEH2012US010788 is an initial combined literature report received on 23 May 2012 with a follow up information received on 29 May 2012. The author presented a case of a young athlete who experienced exertional rhabdomyolysis following vaccination with S-OIV FLUVIRIN and FLUMIST. This report refers to a 29-years-old female patient. Her medical history included occasional use of alcohol and her family history included death of her elder sister due to H1N1 complication. Her concomitant medications were oral contraceptives. Her vaccination history included administration of FLUMIST (other manufacturer, batch number: 5005691P) on 01 Oct 2009. Following FLUMIST vaccination she was admitted in hospital due to exertional rhabdomyolysis (without renal complications) with the symptoms of diffuse muscle pain associated with dark urine and severe upper arm and leg pain exacerbated by movement following a workout consisting of squats, push-ups, sit-ups and shoulder press. Lab tests results were as follow: Creatinine kinase (CK): 66,000; Blood urea nitrogen (BUN): 8; creatinine: 0.8; Aspartate aminotransferase (AST): 441; Alanine aminotransferase (ALT): 220 and Urinalysis: 1.006, small blood and no RBCs. On an unspecified date she was discharged home with aggressive oral rehydration and recommended physical rest. On 23 Nov 2009 she was vaccinated with S-OIV FLUVIRIN (batch number: 102126P1) through unspecified route and site. She had also resumed the low impact exercise again. It was reported that she developed the symptoms again. Due to the recurrence of symptoms, an exercise intolerance mutation panel was done. Physical examination was significant for diffusely tender muscles and pain on passive range of motion (ROM). She also had mild residual upper body weakness. The diagnosis was exertional rhabdomyolysis. She performed several laboratory tests and the results in the second episode were as follows: CK: 1300; BUN: 8; creatinine: 0.8; AST: 99; ALT: 40 and Urinalysis: 1.001, small blood and no RBCs. It was reported that the exercise intolerance mutation panel showed no mutations for myophosphorylase deficiency, carnitine palmitoyltransferase 2 deficiency or myoadenylate deaminase deficiency. Her muscle biopsy was negative. As per the reporter, the patient was used to eccentric exercise and it seemed rare that she would develop unprecipitated symptoms of rhabdomyolysis without a predisposing factor. The outcome of the event was reported as condition improving. The reporter assessed the event of exertional rhabdomyolysis as related to S-OIV FLUVIRIN and FLUMIST. The author concluded the article stating that given the timeline of live virus influenza vaccines 3 weeks prior to each episode of symptoms, as well as a negative genetic work up, it was hypothesized that the live influenza virus vaccine in combination with eccentric exercise caused rhabdomyolysis; however, further investigation revealed that the patient had received an inactivated parenterally administered H1N1 vaccination approximately three weeks after receiving FLUMIST, not a second live virus vaccine.
C/O pain and burning in left upper arm. Complaints of burning down arm to elbow and up through neck region including near breast. Complains that she cannot 'lean' on arm and has discomfort and difficultly lifting left arm.
Patient complained of left arm soreness initially at the vaccination site. On 6/30 she woke up from a nap and noticed her left arm was numb and she was unable to move.  Went to acute care facility where had acute onset quadriplegia. Was transferred to local hospital ED where CT scan  or cervical spine and MRI C spine were done with concern for acute spinal cord infarct. Patient was subsequently transferred to hospital for further care.  At hospital her BP was raised to increase blood flow to the spinal cord. Also lumbar drain was inserted for increased cord perfusion. Despite attempt to increase cord perfusion patients symptoms did not improve
Local inflammation reaction. Area of induration, redness, heat is about 3 inches diameter.
Patient had booster covid-19 vaccine moderna on 11/19/21. Husband reports that patient and himself had a cough for about 2 days during the month of November 2021, but doesn't recall when. Patient on 11/30/21 had severe clotting issues resulting in submassive to massive Pulmonary embolism as well as substantial ischemic stroke resulting in right sided hemiparalysis and mixed aphasia (expressive>receptive). So far no other etiology or major risk factors have been discovered that explain events that occurred.
weak; lightheaded; no taste sensation; This case was reported by a consumer via interactive digital media and described the occurrence of weakness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2022, the patient received Shingrix. On 2nd November 2022, 1 days after receiving Shingrix, the patient experienced weakness, light headedness and taste absent. On an unknown date, the outcome of the weakness, light headedness and taste absent were not recovered/not resolved.   It was unknown if the reporter considered the weakness, light headedness and taste absent to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a Shingrix shot the day prior reporting and on the reporting day patient was weak, lightheaded and had no taste sensation. The reporter wanted to know was this normal.  Additional supportive information: The follow-up could not be possible as no contact details were available.
Shingles outbreak.  Rash started to appear on 4/4/21.   Patient has had shingles one time in the past. The rash appeared in that same location.
blood pressure which is usual 110/70 is now 106/60; swollen lymph glands in both arms; inflammation and pain and tenderness in the lymph nodes; swollen lymph glands in both arms; inflammation and pain and tenderness in the lymph nodes; swollen lymph glands in both arms; inflammation and pain and tenderness in the lymph nodes; back issues really acting up and lot of back pain now; very achy; back issues really acting up and lot of back pain now; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 16Mar2021 at 16:30 (at the age of 35 years old) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included allergic to bee stings and insect bites. There were no concomitant medications (reported as other products: No). The patient did not have prior vaccinations within 4 weeks. On an unspecified date, the patient experienced blood pressure which is usual 110/70 is now 106/60. On 18Mar2021, the patient experienced swollen lymph glands in both arms; inflammation and pain and tenderness in the lymph nodes, back issues really acting up and lot of back pain now, and very achy. Event resulted in physician office (OBGYN) visit on 01Apr2021. The outcome of the event 'blood pressure decreased' was unknown and outcome of other events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I still feel little bit fatigue during the day but nothing compared to the evening hours; Joint pain; Muscle pain; Fever only last about only 2 hours and then it goes away; This is a spontaneous report from a contactable consumer (patient).  A 38-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient reported that: "during the day I feel almost like 80%, I still feel little bit fatigue during the day but nothing compared to the evening hours, in the evening hours and in the early morning, I am getting like severe joint pain, muscle pain and I also come down with fever from last two nights but the fever only last about only 2 hours and then it goes away". The patient outcome of fever was recovered, the outcome of the other events was unknown.  Information on Lot/Batch number has been requested.
Chills, fever, headache, body aches, A couple of nosebleeds, and my arm hurt from the injection site down to the end of my fingers. Headache continued for  four days and fever would come and go but usually at night. I did not receive treatment but I did let my cardiologist office know what was going on. When I continued with the headache, I contacted the internist?s office and I only had a TelMed visit with them. My nostrils had something like cold sores but then I started sneezing and realize there was infection also. Had a second TelMed visit with the PA who started me on an anabiotic Amoxicillian. The infection is clearing up in my sinuses but I am coughing a lot. Overall continue to feel very tired and weary
Sore arm on 2nd day lasting one more day.  On day 8 post injection, arm hurting and sore with itchy red rash approximately 2-3 inches in diameter..  Low-grade fever, some chilling and heat at site.. on-going.
On Saturday patient's (r) arm was red and inflamed, called on call who stated if it gets worse to go to ER. Foster mom brought patient to ER on Sunday. b/c swelling and redness was past the elbow.-Given Benadryl and Motrin in ER.
This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (I have had my period for 14 days so far with COVID-19 shot) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Keflex) and Drug allergy (phenergan). On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (I have had my period for 14 days so far with COVID-19 shot). At the time of the report, HEAVY MENSTRUAL BLEEDING (I have had my period for 14 days so far with COVID-19 shot) outcome was unknown. No concomitant medications were provided by the reporter. No treatment details were provided by the reporter.
A non-serious event of flu symptoms has been received from a company from a physician concerning a male adult. No medical or drug history was provided for this patient.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 13-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N023828 and expiration date 25-JUN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
2/28 6pm face flushed and puffy              10pm anxiety on guard, trouble sleeping 3/1     6am heart rate 108, no temp scratchy throat               10am diarrhea ; unease and rapid heart rate continue              5pm read about adverse events, called doctor, took     Benadryl and began to feel better.  3/2 am communicated with doctor and she advised holding off on second shot, next steps tbd
Information has been received from a physician concerning a female patient who was vaccinated on an unspecified date with her second dose of Gardasil. Approximately a week later, the patient developed herpetic appearing lesions located on the perivulva and/or gynecological area. The patient was diagnosed with type 1 herpes simplex. The patient's outcome was known. No further information is available.
Second dose: May 7th 2021. Next morning side effects: very tired/run down, body aches, headache all  lasted less than 24 hours. Left arm: (arm of the injection) entire left arm sore but the worst was  VERY sore SWOLLEN under arm/arm pit felt like a lump but I think it was the gland swollen. Took about 5/6 days before the swelling and pain diminished.
"Tennis ball" sized area around injection site. Dr believes it is a shingles lesion. Being treated with Acyclovir.
Patient received the Pfizer vaccine as first dose and Moderna as second dose; Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Pfizer vaccine as first dose and moderna as second dose) and EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 39-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 007J21-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (first primary series vaccine dose) on 12-Feb-2022. Past adverse reactions to the above products included No adverse event with Pfizer vaccine. On 18-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Pfizer vaccine as first dose and Moderna as second dose) and EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Pfizer vaccine as first dose and moderna as second dose) and EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter No other adverse reactions or side effects were reported on 18 APR 2022. Treatment information was not provided.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. There was reported none concomitant medications, pertinent medical history, drug reactions or allergies. On 28-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot # J000432, exp. date 28-JUN-2014) (dose and route were not reported). Concomitant medications were not reported. The pharmacist reported that on 28-JUN-2013, a patient had a small black dot at the ZOSTAVAX injection site (no rash). The pharmacist reported that the small black dot appeared shortly after vaccination with the ZOSTAVAX and it has not changed or gone away. Patient was not treated for small black dot. No lab diagnostics studies were performed. Patient seek unspecified medical attention. The outcome of black dot at the ZOSTAVAX injection site was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the small black dot was not reported. Additional information is not expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 27-FEB-2015 the patient was vaccinated with expired dose of ZOSTAVAX (lot # J014567 and expiry date: 18-FEB-2015) 0.65 ml subcutaneously. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
PATIENT BROUGHT WITH RAPID RESPONSE TO ED FROM VACCINATION ROOM; SYNCOPE IMMEDIATELY AFTER VACCINE SHOT; PATIENT FELL FROM STANDING AND HIT HEAD ON TABLE; C-COLLAR IN PLACE; PATIENT REPORTS LOSS OF CONSCIENTIOUSNESS; PATIENT STATES HE HAD PAIN TO LEFT SIDE OF HIS ARM; NO SIGNS OF SOFT TISSUE INJURY
This spontaneous report was received from a registered nurse refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose (Oka/Merck) VARIVAX immunization series (lot # L002869, expiry date: 27-JAN-2017). The temperature excursion details were reported as follows: temperature 8 degree F, for a time frame of 10 hours. There were no other temperature excursions. No adverse effects were reported. Additional information has been requested.
Pt was given a dose of unreconstituted vaccine.  Pt informed of error. Medical Director contacted immediately who then contacted patient and counseled regarding sign and symptoms to watch for. At time of report filing, no adverse reaction noted.
Starting about 8 hours after the shot I began having chills; within 3 hours after the chills started, I felt feverish and fatigued; the chills and fever continued through the night and into the next morning (about 15 hours after chills began); for  the next  3 hours, I was fatigued and slept.  After then taking a generic acetaminophen, the symptoms lessened.  Occasional chills continued through the next night.  Once symptoms started, it was about 34 hours before they were gone.  I did not seek medical attention.
Varicella given on 7/30/14, the next day had an area of erythema 1 1/2 X 1 1/2 inches and fever of 99.4.  Area of redness enlarged to 3 inches overnight on 8/1/2014.
This spontaneous report as received from a pharmacist (who was also the patient's husband) refers to a 73 year old female patient. The patient's pertinent medical history was not provided. On an unspecified date in 2008, the patient was vaccinated with PNEUMOVAX 23 (Manufacturer unspecified) (dose, route of administration, lot # and expiration date were not reported). Concomitant therapies included ALLEGRA. On an unspecified date in June 2014, the patient was diagnosed with pneumonia by an unspecified physician. On an unspecified date in June 2014 a chest x-ray was completed and it had shown 25% of one lobe was affected. The patient was treated with an unspecified medication for 2 weeks following diagnosis and did recover on an unspecified date in approximately 2014. Then, on an unspecified date in September 2014, the patient fell and fractured her right wrist. At the time of the report (also reported as currently), the patient not recovered from the injury. The patient took acetaminophen as a treatment for adverse event. The patient sought medical attention. Additional information has been requested.
Little to moderate numbness from injection site on my left arm, up the shoulder, up the left side of my face, and up to my left eye. No weakness in muscles or drooping face. Came and went. Physical activity such as lifting heavy objects and sleeping on my left side made the symptoms worse.  Numbness lasted for about 2 weeks then went away. I can't remember exactly when it started, but it was shortly after the first shot. I received the second shot on my right arm from a different pharmacist and didn't have numbness. The pharmacists believed that the first shot was given too high and may have hit a nerve. Could the vaccine be injected too close to a nerve which could result in aggravated nerves?
This spontaneous report was received from a licensed practical nurse, referring to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L013428, expiration date 03-FEB-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient had a small rash after vaccination with Shingrix. The reporter declined to provide contact information. The reporter had no other information to provide. The reporter stated that the adverse event was reported to VAERS two months ago.