chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna vaccine viability per vial is 6 hours once the cap is popped off and the rubber seal is punctured. This was misunderstood by the staff providing the vaccine; this patient was provided the vaccine injection from this same vial the next day, well over the 6 hour limit.   No significant adverse signs or symptoms noted from the patient following vaccination.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program. A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient's platelet count decreased (platelet count is 17/1000), with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
1/5/21-Soreness initially started at 3:00 and progressed with increased pain and able to only lift to 80 degrees of shoulder flexion. Increased pain through the night and in morning of 1/6/21 only able to raise arm to 30 degrees with significant pain and had to help with my right arm to raise the left and to dress myself. The pain woke me up at night. I could not go to work for 3 days because of limited active movement to 45 degrees and significant pain and weakness. I am  taking 600-800mg Advil every 6 hours, icing and performing range of motion and massage and kinesiotaping my shoulder. 1/11/21 to present, pain has decreased but soreness still present with internal rotation of my arm and muscle weakness in shoulder muscles and occasionally discomfort with arm positioning at night wakes me up still.
Myalgia chills arm swelling and redness Narrative:  Other Relevant History:
Blood sugar went up to 596; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar went up to 596) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN HUMAN (NOVOLIN R) and INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN N) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar went up to 596). The patient was treated with INSULIN for Hyperglycemia, at an unspecified dose and frequency. On 11-Feb-2021, BLOOD GLUCOSE INCREASED (Blood sugar went up to 596) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Blood glucose: 596 (High) Blood sugar went up to 596.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication also included fluids to decrease blood sugar. .   This case was linked to MOD-2021-069678 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-MAY-2021 contains significant information: Treatment medications added. The outcome of the event changed from unknown to resolved.
COVID arm; Area below the injection site hard; Area below the injection site raspberry red; Area below the injection site hot; Left arm itching, area below the injection site itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Area below the injection site hot), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (Left arm itching, area below the injection site itchy), VACCINATION SITE INDURATION (Area below the injection site hard) and VACCINATION SITE ERYTHEMA (Area below the injection site raspberry red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included GERD. Concomitant products included PANTOPRAZOLE for GERD, VITAMIN D2, ESCITALOPRAM and SIMVASTATIN (STATIN [SIMVASTATIN]) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Left arm itching, area below the injection site itchy). On 10-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Area below the injection site hot), VACCINATION SITE INDURATION (Area below the injection site hard) and VACCINATION SITE ERYTHEMA (Area below the injection site raspberry red). On 11-Feb-2021, the patient experienced VACCINATION SITE REACTION (COVID arm). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pruritus, Vaccination site induration, Vaccination site erythema, Vaccination site warmth and Vaccination site reaction, at an unspecified dose and frequency and NONOXINOL, SODIUM LAURYL SULFATE (POISON IVY [NONOXINOL;SODIUM LAURYL SULFATE]) for Vaccination site pruritus, Vaccination site induration, Vaccination site erythema, Vaccination site reaction and Vaccination site warmth, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Area below the injection site hot), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (Left arm itching, area below the injection site itchy), VACCINATION SITE INDURATION (Area below the injection site hard) and VACCINATION SITE ERYTHEMA (Area below the injection site raspberry red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
Fever of 100.7, moderate body aches, chills and a headache for approx 24 hours post 2nd Moderna vaccine; sore muscle at injection site
pt recvd Typhoid vax & devel hives, which lasted for 24 hrs;
Patient received a double dose of flu vaccine. Should have been given 0.25 mL and was given 0.5 mL dose. No adverse reaction noted. Doctor and parent notified.
Narrative:  patient had his first covid vaccine 2/10, second yesterday (had Moderna vaccine). A week after the first shot, he developed a pruritic rash on his arms, feet, neck. He did not take any medication such as benadryl for it.
Per patient she states after receiving her first vaccine she began to have itching all over especially around eyes, scalp, and arms. Pt states currently may be an autoimmune disorder but is certain began after receiving vaccination and itching especially on scalp was significantly worse after booster.
Vaccine was given to an under age patient. Patient does turn the age of 16 till 12/05/2021. Patient has not developed any symptoms/signs after vaccine admin as at 3/31/21.
Pt was given 3 vaccines, pt turned pale, pt set in chair had fell back, eyes rolled back into head and looked like having seizure. Went and got Dr to evaluate and within 2 minutes pt was alert and was made to lay down for 20 minutes and given water. Dr re-evaluated and pt was released.
Spoke with pt via phone.  She received vaccine Thursday and began feeling ill on Friday - c/o vomiting, chills, headache, and diarrhea that persist to today (Monday 3/29).  Also notes that the site where immunization was given is red, warm to touch, itching at site, and swollen with a lump approximately the size of a grapefruit.  Has tried cool compresses and taking Benadryl without much change.   She also sounded a little out of breath on the phone though denies any SOB or difficulty breathing.  She does not currently have a PCP - I suggested she go to the walk in clinic for further evaluation.  She is in agreement with that and will have her husband drive her.
HCP has no further AE information; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; This spontaneous report was received from a medical assistant concerning to an approximately 4-month-old (also reported as 5-month-old) female patient.  Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 19-SEP-2023, according to a digital data logger, there was a temperature excursion in clinical practice at 9:28, temperature was 8.3 Celsius degree and at 10:02 the temperature was 7.5 (units not provided) for a total excursion time of 34 minutes for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number reported as 1933911 (expiration date 18-APR-2024) and with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot  number reported as W001598 (expiration date 14-JAN-2024), albumin status was not provided, however, upon internal validation it was stablished as rHA. On 20-SEP-2023, the patient received the improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, and route of administration were not provided) and the improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, and route of administration were not provided) (product administered to patient of inappropriate age) (product storage error) both of them administered as prophylaxis. It was reported that the patient received the vaccination in a private doctor's office.  No adverse effect was observed (no adverse event). On 25-SEP-2023 at 11:08 temperature was at 9 Celsius degree and at 15:01 it was at 8.0 Celsius degree, for a total excursion time of 4 hours.     This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA002926: US-009507513-2310USA010775: US-009507513-2311USA003147: US-009507513-2311USA002932: US-009507513-2311USA002930: US-009507513-2311USA002929: US-009507513-2311USA002928: US-009507513-2311USA002927:
This spontaneous report as received from a nurse refers to a 84 year old patient. Medical history and concurrent conditions were not reported. On 05-FEB-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
My body/blood became anemic, crash my red blood cell counts.  Cause me to have to sleep over 12 hours a day, miss and delay work.
site of inj rt deltoid site began to swell 12-24hr p/vax;fever @ home up to 101, large lump 7x9cm w/erythema & tenderness;tx w/heat, APAP #3, zyrtec;
This spontaneous report was received from a medical assistant referring to 4 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # M002419, expiry date 12-JAN-2018) (dose and route not reported). The vaccine was exposed to temperature of 61 Fahrenheit for 3 hours. No previous temperature excursion was reported. No adverse effects and no product quality complaints (PQC) were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
antibody test  negative; This spontaneous report was received from a registered nurse and male patient "in 60's years of age" who is also a physician, . Infoamtaion regarding the patient's medical history, concurrent conditions and cocnomitant medications was not provided.  On 11-NON-2019, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) 10/1.0 mcrg/ml (dose, route, lot # and expiration date were not provided) for prophylaxis. Nurse reported that the patient was tested non immune and not reactive for antibody testing(hepatitis b surface antibody negative ) on an unknown date after was administered hepatitis b vaccine (recombinant)(RECOMBIVAX HB) ;no clarifying information provided.   The outcome of hepatitis b surface antibody negative was unknown.    Causality assessment was not provided.
This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included: lost part of the thyroid (taking thyroid medication a little over weight), and concurrent conditions included: hay fever, shellfish allergy, alcohol use (very rarely), and non-smoker. The patient previously received with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 for covid-19 prophylaxis. The patient did not experienced any negative effects with the first shot and handled the Janssen vaccine well. No fever no tiredness (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, administered on 15-NOV-2021 for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced slightly sore arm that lasted for 24 hours. There was no other symptoms with both vaccination. No fever no tiredness (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slightly sore arm. This report was non-serious.
PT OBSERVED FOR 40 MINUTES STATES FEELS LIKE A PANIC ATTACK BP 137/80 PULSE 122 SAT 98  DENIES ANY SOB OR   CHEST PAIN PULSE REMAINES 110-131; MD IN TO SEE PATIENT DISCHARGED
At 23:15 (7 hours after the dose) I started to get cold while under my blankets trying to sleep. My teeth began chattering as I started to shiver. I got up out of bed to put on a sweater. With each step I took towards the sweater my body started to fully shiver and contract. After about 4 or 5 steps I could no longer move and I fell over. I started having full body spasms and full contractions. I felt like I pulled every muscle in my body trying to relax and fight the contractions. It felt like I was being tasered for about 10-15 minutes. Once I had the strength to grab my sweater I slipped it on. As my body warmed up these contraction subsided.  By 01:00 (9 hours after dose) my body temperature had spiked. I didn't have a thermometer to check my temperature but I wouldn't be surprised if I spiked a fever. I placed a wet cloth on the back of my neck, forehead and chest to cool down.   At 06:00 (14 hours after dose) I took a cold shower to further drop my body's temperature. It felt like a full body sun burn where you just radiate heat. I was hot everywhere.  At 08:00 (16 hours after dose) I took three (3) 500mg ibuprofen to help fight a nagging headache. I did not have much appetite for food. I regularly eat breakfast in the morning (bowl of cereal).   From 09:00 to 12:00 (17-20 hours after dose) I felt groggy. Did not seem or act like myself. Was very tired from the lack of sleep the night prior. Seemed very fatigued.  Around 13:00 (21 hours after dose) I took a 45-60 minute nap. Woke up feeling much better. I would say most / if not all symptoms subsided after 22-24 hours.
9hr p/vax pt went limp, stopped breathing, had sz;treated @ ER;fever followed diarrhea & vomiting 2x/day for 5-6 days p/fever;2nd sz 27JUL;
Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; Vaccines administered after being in stored in fridge past 30 days; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event) in a 67-year-old 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. AS7185B) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) 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 EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days).    No concomitant medication was reported. No treatment medication was reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:same reporter
I experienced swollen painful lymph nodes, fatigue, trouble sleeping, congestion, slight cough, and headache. I was examined and prescribed a Z-pack on 06/29/2022 where I was diagnosed with an upper respiratory infection. I was beginning to feel better today 7/1/2022, but the congestion has improved greatly. Around my nostrils on top of my skin I have bumps, but they are also improving.
Strong pain in the left arm with limited movement Arm's  muscle has been paralyzed (No medication cures the pain) Brain fog  Lack of energy Raised body temperature at night - difficult to sleep  hot flashes at day time
contracted Covid; contracted Covid; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient wanted to know how to reschedule her second dose. The patient stated that after she got her first dose, she and her husband contracted Covid on an unknown date. The outcome of the events was unknown.   Information about batch/Lot number has been requested.
I had 2 Pfizer vaccines and the booster was Moderna. My fingertips started turning gray. There was still blood flow. Nothing helped. Cold water and hot water made it worse. There was nothing to release the pain. That lasted for about 3 days. That same day I went to the doctor and they ran a special test. I have not heard anything form the results because the insurance was trying to get it approved. I had a positive antibody cardiolipin test, which means I had blood clots. We do not know if it was because of the vaccine or my Lupus or both. I was diagnosed with Covid on 01/10/2022. I had an extremely sore throat, I lost my smell and taste, I had headaches, body aches. I took some over the counter medications.
This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of DRY MOUTH (excessively dry mouth) in 79-year-old male patient who received apixaban (Eliquis) tablet for an unknown indication. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for COVID-19 immunization. On an unknown date, the patient started Eliquis (Oral), 5 milligram twice a day and Covid-19 Vaccine (unknown route) had second Covid vaccine. On 12-Mar-2021, the patient experienced DRY MOUTH (excessively dry mouth). The action taken with Eliquis(Oral) was unknown. At the time of the report, DRY MOUTH outcome was unknown. For Eliquis(Oral), the reporter did not provide any causality assessments.
patient was diagnosed with COVID-19; patient was diagnosed with COVID-19; This is a spontaneous report from a contactable consumer (patient's mother).   A 23-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on an unspecified date for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was diagnosed with COVID-19 on an unspecified date with outcome of unknown (as reported).  The event was described by reporter as follows: her son who received the first dose of the Pfizer vaccine, and is due for the second dose this weekend. Between the two doses the son was diagnosed with Covid, but currently is already doing fine according to the caller. She wanted to know if her son can take the second dose of the Covid vaccine as intended.  The information on the Lot/Batch number has been requested.
Patient complained of numbness in right arm, light headed and headache after receiving the second dose. History of Diabetes and Hypertension.  Vitals  were BP 191/97, Pulse 77 Respiration 21, SPO2 100% RA Patient was released to seek medical care, after driver arrived.
Right arm swelled up - began 2/3/07 - 25-35% larger from shoulder to hand "feels tight" started Keflex no erythematous. On Sunday began to itch (2/4/07) - Gave Benadryl 50 TID. 2/5/07- symptoms subsiding. Denies pain, no hot to touch.