chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 3:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 3:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 88.37.  Concomitant products were not provided.  On 07-Jan-2021, Temperature Excursion at 09:00 AM, temperature was 34, and Temperature Excursion at 10:00 AM, temperature was 34. total doses given for the day was 96, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 27-Jan-2021. 6 vials were sent to clinic. Vaccine BUD date was 27-Jan-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Throat tightness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 40-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: GW0170), via an unspecified route of administration (at the age of 40-years), administered in arm left on 28May2021 13:00 as dose 1, single for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccine in four weeks. The patient had no covid prior vaccination and has not been tested for covid post vaccination. The patient had no known allergies. On 28May2021, the patient stated that within 5 minutes of receiving the vaccine, I felt throat tightness which lasted 2-3 seconds. It occurred three times. It did not interrupt my breathing. The treatment was not received for the event. The facility type of vaccine reported as pharmacy or drug store. The clinical outcome for the events was reported as recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
fatigue; decreased appetite; possible reoccurance of jaundice; Decreased Milk Production; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A patient (no qualifiers provided) was exposed to bnt162b2 (BNT162B2), transmammary, administration date 22Sep2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The mother of the patient was 33 years old at the time of vaccination. The mother's relevant medical history included: "Heart murmur" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; IRON; PRENATAL [FOLIC ACID;IRON]. The following information was reported: FATIGUE (non-serious) with onset 22Sep2021, outcome "unknown", described as "fatigue"; DECREASED APPETITE (non-serious) with onset 22Sep2021, outcome "unknown", described as "decreased appetite"; JAUNDICE NEONATAL (non-serious) with onset 22Sep2021, outcome "unknown", described as "possible reoccurance of jaundice"; EXPOSURE VIA BREAST MILK (non-serious) with onset 22Sep2021, outcome "unknown", described as "Decreased Milk Production". Therapeutic measures were not taken as a result of fatigue, decreased appetite, jaundice neonatal, exposure via breast milk.  Additional information: The patient mother did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Prolonged Hospitalization. Since the vaccination, the patient mother had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101268502 mother/baby
I had to call in work sick  I had a fever  I felt nauseous  I was burning up but was shaking like I was cold I had a headache that made my head pound I felt like everything was spinning/ dizzy Had no energy  Laid on the couch all day
Pain in her arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her arm) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain in her arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
mild dizziness / got worse; nausea; diarrhea / got worse; Pain at injection site; Sore arm; Headache; Fatigue; Muscle Pain; Neck pain; General joint pain; This case was reported by a pharmacist and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 29A05, expiry date 4th February 2023) for prophylaxis.   Co-suspect products included ibuprofen for pain in arm and headache and paracetamol (Tylenol) for pain in arm and headache.   On 31st July 2021, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient started ibuprofen 200 mg at an unknown frequency and Tylenol 650 mg at an unknown frequency. On 31st July 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, pain in arm, headache, fatigue, muscle pain, neck pain and joint pain. On 2nd August 2021, the patient experienced dizziness, nausea and diarrhea. The action taken with ibuprofen was unknown. The action taken with Tylenol was unknown. On an unknown date, the outcome of the injection site pain, pain in arm, headache, fatigue, muscle pain, neck pain, joint pain and dizziness were not recovered/not resolved and the outcome of the nausea and diarrhea were unknown.   It was unknown if the reporter considered the injection site pain, pain in arm, headache, fatigue, muscle pain, neck pain, joint pain, dizziness, nausea and diarrhea to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The patient received Shingrix on the left arm. The patient reported headache, sore arm, pain at injection site, fatigue, muscle pain, neck pain and general joint pain. The patient took 2 tablets of Tylenol 650 mg and 4 tablets of Ibuprofen 200 mg. On 2nd August 2021 afternoon, 2 days after receiving Shingrix and less than week after receiving Tylenol and Ibuprofen, the patient experienced mild dizziness, nausea and diarrhea. Diarrhea got worse during the evening. On 3rd August 2021, dizziness got worse. It was unknown if the reporter considered the dizziness, nausea and diarrhea to be related to Tylenol and Ibuprofen. The reporter also provided consent to follow up with health care professional (HCP). The reporter consented to follow up.
Erythema with swelling on left arm. 17 x 13cm bruising on left deltoid area 6x 7cm around it.
Found by family in morning in crib deceased. Received ER medical records which revealed patient arrived in ER lifeless.  COD thought to be cardiac arrest likely caused by SIDS.
Within 24 hrs pt developed redness, tenderness, warmth and swelling of L shoulder with DTaP shot. No evidence of abscess Symptomatic test results.
felt dehydrated; a small case of food poisoning; dizziness; chills; tinnitus got really loud for 2 hours and then it went back down to normal.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus got really loud for 2 hours and then it went back down to normal.), DEHYDRATION (felt dehydrated), FOOD POISONING (a small case of food poisoning), DIZZINESS (dizziness) and CHILLS (chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced TINNITUS (tinnitus got really loud for 2 hours and then it went back down to normal.). On 12-Apr-2021, the patient experienced DEHYDRATION (felt dehydrated), FOOD POISONING (a small case of food poisoning), DIZZINESS (dizziness) and CHILLS (chills). At the time of the report, TINNITUS (tinnitus got really loud for 2 hours and then it went back down to normal.), DEHYDRATION (felt dehydrated), FOOD POISONING (a small case of food poisoning), DIZZINESS (dizziness) and CHILLS (chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal normal. On an unknown date, SARS-CoV-2 test: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment medication has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Updated patient demographics, lab data and added vaccine facility details.
Daughter tested positive for influenza A and B today.  She was administered vaccine 10/21/21 at clinic.  1st time ever receiving FluMist.  She tested positive for both A and B 4/18/22 at Urgent Care.  Symptoms include sore throat, ear pain and headache.  She was prescribed liquid tamiflu.
redness, itching swelling, warmth at site, muscle aches, fatigue evaluated by MD, tx with pepcid, Tylenol, Claritin,Zyrtec began 01/19/2021 with mild relief
Flu-like symptoms; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Bexsero.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced extreme flu-like symptoms. Additional information was unknown at the time of reporting.  Due to this adverse event the patient was not given the 2nd dose.  The site and route of injection were unknown.  No additional information available at this point. The reporter did not consent to follow up.
Red, swollen, painful reaction to the site. Temp 98.3 11/12/04.
On 03/11/2021 I started having a rapid heartbeat, racing heart rate at 171, blood pressure increased to 161/100. Which lead to two ER visits. I was prescribed metoprolol.
Mild headache x 8 hrs Malaise, myalgias x 48 hrs
Bright red rash on every knuckle of hands and feet; bright red rash on both elbows
loss of appetite; tiredness; stiffness in the neck; painful HSV spread to her flank and eyes; painful HSV spread to her flank and eyes; itching; This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC HERPES SIMPLEX (painful HSV spread to her flank and eyes) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PRURITUS (itching). On 13-Apr-2021, the patient experienced OPHTHALMIC HERPES SIMPLEX (painful HSV spread to her flank and eyes) (seriousness criterion medically significant) and HERPES SIMPLEX (painful HSV spread to her flank and eyes). On 22-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in the neck) and FATIGUE (tiredness). On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite). At the time of the report, OPHTHALMIC HERPES SIMPLEX (painful HSV spread to her flank and eyes), PRURITUS (itching), HERPES SIMPLEX (painful HSV spread to her flank and eyes), MUSCULOSKELETAL STIFFNESS (stiffness in the neck), DECREASED APPETITE (loss of appetite) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
approx 30min p/vax pt c/o tightness in throat & chest & upper chest pain;tx w/ epi & solumedrol & albuterol by nebulizer & got relief about 1hr p/tx;
No adverse event. Patient was given a Tdap on 4/2/19  and then again  on 5/9/19.  Tdap on 5/9/19 was given IM in left arm. Same lot and manufacturer as previously stated
Within 15-minutes of vaccination, the patient reported feeling flushed with tingling in their fingertips. Denied CP, SOB, or difficulty swallowing. EMS evaluated patient on-site. Patient was hypertensive (172/92) with all other vitals WNL. Physical exam was unremarkable. Patient refused transport to ED for further evaluation.
48 hours after shot developed high fever, dizziness, chills, sweats, body aches,
The night following the vaccine pt broke out in welts (nickel to quarter size), itching, relieved with Benadryl.
Patient had no adverse effects or symptoms from this dose; Caller is a medical assistant who reports six expired doses of VAQTA were administered; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 21-JUN-2022, the patient was vaccinated with an expired vaccine of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter (lot# T031201, has been verified to be a valid lot number for hepatitis a vaccine, inactivated (VAQTA), expiration date not reported, but upon internal validation established as 14-JUN-2022) (dose, anatomical location, and route of administration were not reported) (Expired product administered).  The vaccine did not have any prior temperature excursions and the patient had no adverse effects or symptoms from this dose.  This is one of several reports received from the same reporter.
Patient was supposed to recieve Hep B vaccine. Medic grabbed Hep A instead of grabbing Hep B and administered the wrong vaccine to patient. When medic was documenting after administration he noticed he had given the wrong vaccine.
terrible soreness after vaccine; A spontaneous report was received from a consumer concerning a 65-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pain (terrible soreness after vaccine).  The patient's medical history included arthritis. No relevant concomitant medications were reported.  On 1 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 1 Feb 2021, the patient experienced terrible soreness after vaccine and on the day of reporting it was still there.  Treatment details included tylenol, ibuprofen and heating pad.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event  was reported to be unknown.
acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling of first 3 fingers in left hand (median nerve distribution); tingling of first 3 fingers in left hand (median nerve distribution).; significant cervical lymphadenopathy; painful neck; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old adult female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number: EJ1686, via an unspecified route of administration, in left arm, on 06Jan2021 at 9:52 am, at 42-years of age, at single dose for COVID-19 immunization. The patient was vaccinated in Hospital. Medical history included overweight and no known allergies. Concomitant medications included the second dose of HPV VLP vaccine rL1 4v (yeast) (GARDASIL) received in left arm on 18Dec2020 and ergocalciferol (Vitamin D). On 06Jan2021 by 10:05 the patient experienced acute onset nausea, diaphoresis, presyncope and concomitant left arm weakness/flaccid arm with numbness and tingling of first 3 fingers in left hand (median nerve distribution). The patient informed vaccine staff of symptoms and advised ongoing observation. Flaccid arm/weakness/numbness continued for more than 24 hours, although at the time of the report it was slowly improving. At the time of the report the patient further reported significant cervical lymphadenopathy and painful neck (specific onset date not provided - captured as Jan2021). The events were reported as non-serious. The reporter specified that the injection was not given anywhere near brachial plexus. At the time of the report the events "Left arm weakness" and "Left arm numbness" were resolving, the outcome of the events "Nausea", "Diaphoresis", "Presyncope", "Tingling of first 3 fingers in left hand", "Cervical lymphadenopathy" and "Painful neck" was unknown.
itchy bumps; very tired.; chills; extreamly weak/ feeling weak; couldn't get out of bed; every joint in her body was in pain; This case was reported by a consumer via other manufacturer and described the occurrence of itchy rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2021, the patient received Shingrix. On 14th September 2021, 1 days after receiving Shingrix, the patient experienced chills, weakness, activities of daily living impaired and generalized joint pain. On 15th September 2021, the patient experienced itchy rash and tiredness. On an unknown date, the outcome of the itchy rash, chills, weakness, activities of daily living impaired, generalized joint pain and tiredness were unknown.   It was unknown if the reporter considered the itchy rash, chills, weakness, activities of daily living impaired, generalized joint pain and tiredness to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient herself. The patient received a dose of Shingrix at pharmacy and had chills, extremely weak, could not get out of bed, total every joint in her body was in pain. On 15th September 2021, in morning patient woke up with woke up feeling weak and very tired, had 3 bumps in her left temple near her hairline. The patient stated that those bumps were not blisters which she knew that usually shingles presents with a blister type thing but the bumps were a bit itchy, but not painful which were also not typical to shingles. The patient was concerned about what she should do, if she should be seen by her doctor as she did not know how to proceed.  The patient stated about a scary arrangement with the pharmacist, who did not even do proper hygiene with hand washing, it was scary. The reporter consented to follow-up.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 22 months old patient of unknown gender. On 12-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J015437, expiration date: 09-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Extreme itching over entire body. No visible rashes, or lumps on skin. Slight redness on skin in some places.
ADMINISTRATION OF EXPIRED VACCINE WHOSE EXPIRATION DATE WAS 24-AUG-2021; This spontaneous report received from a health care professional concerned a 25 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 24-AUG-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced administration of expired vaccine whose expiration date was 24-aug-2021. The action taken with covid-19 vaccine was not applicable. The outcome of administration of expired vaccine whose expiration date was 24-aug-2021 was not reported. This report was non-serious.