chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine went under temperature excursion; No adverse event; Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023) 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. 066H22A) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023).    No concomitant medications were provided. It was reported that due to lost power in the middle of the day at 12:00 PM, had to place all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. No symptoms were reported. No treatment medication was provided. This case contains information for the 3rd of 26 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:master case
Swollen lymph node under the collarbone on the left side. It was small (dime-sized) and noticed a few days after the vaccine. It did not resolve for more than 2 weeks, so I saw my doctor who confirmed that it was not concerning. It took another 2 weeks (so a total of 4 fours) to resolve.
Immediate pain and arm soreness, injection site hot to the touch Arm soreness and cramping of feet, calf muscles, lower left arm until 5am despite adequate hydration Shivering, slight fever, flushing of face, general discomfort until 5am ( 500mg acetaminophen at 3am) Tiredness on waking, very sore arm Not feeling like usual self
mom reports about 20 mins after leaving the facility he was very itchy all over.  and very red all over, small  hives...  No lip and tongue swelling, no coughing, no wheezing.
Sept 2022 ER visit, presented as inability to move right arm. Believed to be AE from flu vaccine earlier that week, noted.
Bruise; Symptoms worsening; Redness at injection site; Swelling at injection site; Pain at injection site; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 Vaccine, and experienced bruise/ contusion, symptoms worsening/ condition aggravated, redness at injection site/ vaccination site erythema, swelling at injection site/ vaccination site swelling, pain at injection site/ vaccination site pain.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (LOT# 011J20A) on an undisclosed date intramuscularly for prophylaxis of COVID-19 infection.   A pharmacist called to report that 70 patients received their Moderna vaccine.  He stated that the patients reported redness, swelling and pain at the injection site and bruising Additionally, pharmacist said that some of the patients have stated that their symptoms have worsened. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the events, bruise, symptoms worsening, redness at injection site, swelling at injection site, pain at injection site were unknown.; Reporter'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.
Myocarditis  Observation and anti-inflammatories Two weeks later patient still having fatigue, dizziness, chest pain
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies. The reporter stated that, since 09-MAR-2017, the patients received an improperly stored dose of VARIVAX lot number M040137, expiration date 28-SEP-2018, and lot number M037643 with an expiration date 01-SEP-2018 (strength, dose, frequency, route of administration, and anatomical location were not provided) for prophylaxis. The nurse did not have access to the lot numbers and expiration dates for the diluent that was used. The vaccine was exposed to a temperature between 15 and 46 Fahrenheit (F) for 15 hours. The call was not because of a data logger, and there was no previous temperature excursion. No adverse effects had been reported. There was no product quality complaint involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA013127.
raised lump formed at the injection site/ is sore and slightly itchy; raised lump formed at the injection site/ is sore and slightly itchy; raised lump formed at the injection site/ is sore and slightly itchy; This is a spontaneous report received from 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 20Apr2021 12:00 (Lot number: EN0172) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 30Mar2021, when the patient was 43 years old, for Covid-19 Immunization.The following information was reported: VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious), INJECTION SITE PRURITUS (non-serious) all with onset 04May2021 12:00, outcome "not recovered" and all described as "raised lump formed at the injection site/ is sore and slightly itchy". The event "raised lump formed at the injection site/ is sore and slightly itchy", "raised lump formed at the injection site/ is sore and slightly itchy" and "raised lump formed at the injection site/ is sore and slightly itchy" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site mass, vaccination site pain, injection site pruritus.  Additional Information: It was reported that About 2 weeks after the 2nd vaccine, patient experienced a raised lump formed at the injection site. It's about 5mm and was sore and slightly itchy. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, the patient has been tested for COVID-19, had no known allergies.  No follow-up attempts are possible. No further information is expected.
pt recv vax 10AM 245Pm crying & screaming unconsolable since shot; 416PM doing a little better not screaming as much; 9AM cries when leg is moved or touched; 2JUN95 better slept w/t101;
pain and muscle stiffness in arm after Trumenba injection; pain and muscle stiffness in arm after Trumenba injection; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration at the arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain and muscle stiffness in arm after Trumenba injection. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Swelling of arm and sore muscle, red, and hot. Hives, rash, fever in arm heart race dizziness 5/14/13 7:30PM.
This spontaneous report was received from a licensed practical nurse refers to an approximately 35-year-old female patient. On 25-APR-2013 the patient was vaccinated with dose 2, 0.5 milliliter (ml) M-M-R II (lot # H011889, expiration date 25-JUN-20134) subcutaneously which was improperly stored. The M-M-R II was exposed to 48 Farenheit (F) for 9 hours and had a previous excursion at 48F for 16.5 hours. On 31-JAN-2013, patient was vaccinated with dose 1, M-M-R II (lot#, expiration date and route not reported) at an unspecified facility. No adverse effect reported. Nurse was unaware if any additional patients received improperly stored M-M-R II. Additional information has been requested.
I got a headache about noon on 4/9. I started shivering at 9 pm. I woke at 11 pm shivering uncontrollably. I took my temperature at 1 am and it was 102 degrees F.  My temp dropped gradually and returned to normal by 12 noon on 4/10. I also had a bad headache. On 4/11 I felt fine but was weak.
Blood clot  in left calf; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 03May2021 10:00 (Lot Number: EW0173) as dose 2, single at the age of 36-year-old for covid-19 immunization. No known allergies. No other medical history. No concomitant medications. No other medications in two weeks. No other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other vaccine in four weeks. Historic vaccine was bnt162b2 received via an unspecified route of administration, administered in left arm on 12Apr2021 11:00 (Lot Number: ER8731) as dose 1, single at the age of 36-year-old for covid-19 immunization. The patient experienced blood clot in left calf on 14Aug2021 08:00 and diagnosed on 16Aug2021. The aeriousness of event was hospitalized for 2 days (no hospitalization prolonged) and life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included PCR -Nasal Swab: unknown results on 18Aug2021. Therapeutic measures were taken as a result of blood clot in left calf which included blood thinner. This event resulted in emergency room visit and physician office visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination,  the patient had been tested for COVID-19. The outcome of event was recovering.  No follow-up attempts are needed. No further information is expected.
Patient presents today to be seen by Dr. Complaining of low back pain on left side. Rash consistent with shingles.
This spontaneous report was received from a physician via a field employee refers to a 14-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, units, frequency, lot # and expiration date unknown) for prevention HPV. On an unknown date the patient experienced severe fatigue. On an unknown date the patient was tested for everything and all results came back negative. The outcome of fatigue was unknown. The causality of the event fatigue was not reported. No PQC (product quality complaint) was involved.
1 day p/vax pt devel generalized rash & hives; had no resp Sx.MD tx w/Benadryl. This is 1 of 2 pts from this site to have adverse rxn p/vax w/lot #4968281
sore arm; tenderness; Injection site had a little red small spot; little lump under skin; Red like 3 inches around little spot; little warm area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore arm), TENDERNESS (tenderness), ERYTHEMA (Injection site had a little red small spot ), INJECTION SITE MASS (little lump under skin) and RASH MACULAR (Red like 3 inches around little spot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (sore arm), TENDERNESS (tenderness), ERYTHEMA (Injection site had a little red small spot ), INJECTION SITE MASS (little lump under skin), RASH MACULAR (Red like 3 inches around little spot) and VACCINATION SITE WARMTH (little warm area). At the time of the report, PAIN (sore arm), TENDERNESS (tenderness), ERYTHEMA (Injection site had a little red small spot ), INJECTION SITE MASS (little lump under skin), RASH MACULAR (Red like 3 inches around little spot) and VACCINATION SITE WARMTH (little warm area) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient put ice and week after the lump dissipated and red gone away.
The patient suffered from a brainstem hemorrhagic stroke on November 25th, 2021 about 4 weeks after receiving the 2nd dose of the Pfizer vaccine. The patient starting having bad headaches and heart palpitations immediately after the second dose. The brain stem bleed occurred in the pons and affected the right side of the pons causing facial paralysis on the right side and left side body paralysis. Since it affected cranial nuclei and nerves of cranial nerves 5, 6, 7, 8 and 9, she lost sensation on the right side of her face and had trouble swallowing and at this point cannot speak. She was on a ventilator for 10 days, then a trach tube for 3 weeks. She is now at the rehab center, where she is receiving physical therapy, OT and Speech therapy.  She remains paralyzed on the left side of her body and right face and still cannot vocalize. The relationship between the Pfizer vaccine and brain bleeds and stroke have been documented in a study of (privacy) women and with a (Privacy study showing that there were 60 cases of hemorrhagic stroke (brain bleed) for every 10 million adults receiving the Pfizer/BioNTech vaccine (published in 2021).
My left tonsil swelled, increased salivation, trouble with breathing.  Pfizer
pt recvd 3 doses of Engerix-B 9JAN91; 14FEB91 & 29JUL91; 2OCT91 it was determined that pt did not respond; 4th dose of Engerix-B was administered 30OCT91;
6 days after she had eye numbness , had to wear a patch , headaches, body spasms, needed rehab for a couple of months , currently using a walker.
pt c/o tingling in legs on 9SEP93; felt dizziness & funny;  10SEP93 some swelling in legs; BP110/70 P60; MD notified; tingling persists; to see neurologist 18SEP93 w/dx of GBS;
This spontaneous report as received from a pharmacist refers to a patiens of unknown age. On an unknown date, the patients were vaccinated with several unspecified number of doses of improperly stored ZOSTAVAX, (lot number K009770 expiry date 09-OCT-2015) 0.65 ml, subcutaneous. No adverse effects reported. Additional information has been requested.
fainted; aches; headache; fever; nauseous; excessively sweating; heartrate was elevated to about 90 bpm vs resting heartrate of 60 and remained elevated for the next 12 hours; This is a spontaneous report from a contactable consumer reporting for himself. A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number ER8735/expiration date: not provided), via an unspecified route of administration, on 20Apr2021 at 08:30 (at the age of 29 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: not provided), via an unspecified route of administration, on 04Jan2021 at 12:00 (at the age of 29 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included was not provided. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included melatonin, fish oil, calcium.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Apr2021 at 02:00, the patient fainted, experienced aches, headache, fever, nauseous, excessively sweating, and heartrate was elevated to about 90 bpm vs resting heartrate of 60 and remained elevated for the next 12 hours. The patient went to the emergency room due to the events and received treatment for these events which included fluids. The clinical course was as follows: after experiencing expected side effects (aches, headache, fever), the patient got up to use the restroom in the middle of the night. About 1-2 minutes after getting up, he fainted. The patient awoke shortly after on the floor and felt nauseous and was excessively sweating. His heartrate was elevated to about 90 bpm vs resting heartrate of 60 and remained elevated for the next 12 hours. The outcome of the events was recovering. Since the vaccination, the patient had been tested for COVID-19 (saliva test) on 20Apr2021, and the result was negative.
At approximately 3am woke to bad chills, terrible body aches in neck, back and arm and leg joints, terrible headache. Took temperature/ 101.02.  Woke again at approx. 6:30am, all symptoms above were still ongoing except when I awoke at 6:30 was very nauseous and began vomiting. The vomit was a bright yellow bile  type substance, no food particles.  These symptoms persisted throughout the day of Feb. 10th. After awaking on Feb. 11, 2021, I was feeling better, the chills, fever, aches had stopped. I felt tired and fatigue for another 24 hours.
Patient is a 75 years Old male patient of, DO with history of AML, RUE DVT, recent COVID diagnosis on 12/28 presented to Hospital with progressive shortness of breath and feeling of throat swelling,admitted with Acute COVID-19 pneumonia,Suspected HAP And Acute Laryngitis/pharyngitis.   CT chest Interval development of sequela of infectious/inflammatory bronchiolitis involving superior segments of both lower lobes and basilar segments of the right lower lobe.  Bronchopneumonia involving basilar segments of the left lower lobe now identified as well. CT Soft tissue Neck;Mild mucosal thickening of the supraglottic larynx, which may represent laryngitis.  No fluid collection or discrete mass.  No foreign body Echocardiogram;Left ventricular systolic function is hyperdynamic with an estimated ejection fraction of >70%. Patient responded to treatment intravenous Decadron, cefepime and supplemental oxygen.  Patient was successfully weaned off supplemental oxygen. However hospital course complicated by progressively worsening white cell counts, differentials 11% blasts.  Case was discussed with University hematologist who recommended that patient be transferred to facility, and initiation of hydroxyurea 2 g every 8 hourly, with labs. Hematology was consulted to assist with orders of hydroxyurea per policy.   Discharge Diagnoses: Acute COVID-19 pneumonia. Suspected HAP Acute Laryngitis,pharyngitis.   AML. RUE DVT,
Right arm and muscle pain with headache the evening of shot date, 3/27/21 fever of 100.4 which lasted into 3/28/21. Very tired on 3/29/21 with what felt like lung pain. Today 3/30/21 woke up with bad sore throat headache high BP and high heart rate very tired.
This spontaneous case reported by a healthcare professional, describes the occurrence of product administered to patient of inappropriate age (13-year-old girl given Moderna vaccine not approved by the FDA) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 003C21A and 014C21A) for COVID-19 immunization. Concurrent medical conditions included prediabetes since Jan 28, 2021. Concomitant products included Zyrtec (cetirizine hydrochloride) for allergy. On Aug 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 9, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Aug 12, 2021, product administered to patient of inappropriate age (13-year-old girl given Moderna vaccine not approved by the FDA). On Sep 10, 2021, product administered to patient of inappropriate age (13-year-old girl given Moderna vaccine not approved by the FDA) resolved. The reporter did not provide any causality assessments or treatment information. This case linked to MOD-2021-284575 (patient link).
Site of the shot in the left arm has developed swelling, red, itching 10 days after the vaccine injection. Have not visited the doctor yet.
Pt was in the clinic for a yearly family planning visit and was offered updated vaccines as indicated on her forecaster for her age.  Pt accepted vaccinations.  Pt had last received a Menactra vaccination in November of 2017 and had not received her second dose within 8 weeks. Pt. is in a population susceptible  to meningococcal disease exposure.  After checking dose and CDC requirement administration of vaccination was given without reaction or incident. After speaking to pt. today pt. states no adverse reaction noted. " Feeling fine, just have a little bruise from where I got the other shot." No rejection due to age or otherwise noted when giving pt vaccination. Rejection was noted at time of billing.   Pt. was given Menactra dose 45 days prior to her 16th birthday.  Dose should not have been treated as initial dose and should have been treated as a booster and should not have been given until pt. 16 years of age.  Pt is within guidelines for Menactra dosing schedule (A single booster dose may be given to individuals 15 through 55 years of age at continued risk for meningococcal disease, if at least 4 years have elapsed since the prior dose.)however not correct based on the 16 year old  guideline.
She was given Covid vaccines for ages 5-11yrs. I called RN to see what to do. She said should be fine. Watch for side effects and notify mom which I did do.