chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have administered past 30 days from being thawed / The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and POOR QUALITY PRODUCT ADMINISTERED (Some doses that may have administered past 30 days from being thawed / The vaccines were applied to patients after being refrozen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and POOR QUALITY PRODUCT ADMINISTERED (Some doses that may have administered past 30 days from being thawed / The vaccines were applied to patients after being refrozen). At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and POOR QUALITY PRODUCT ADMINISTERED (Some doses that may have administered past 30 days from being thawed / The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment information was provided by the reporter
she had chills after second booster; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (she had chills after second booster) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 939904, 016B21A and 012A21A) for COVID-19 vaccination.     Patient had no history of Pericarditis or myocarditis Patient not diagnosed with COVID positive test  .  Concurrent medical conditions included Penicillin allergy and Sarcoidosis. Concomitant products included ROSUVASTATIN for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (she had chills after second booster). At the time of the report, CHILLS (she had chills after second booster) had resolved.            The patient had not received other vaccine within 1 month prior to Moderna COVID-19 vaccine.  It was reported that, the patient had chills which went away the next day.   No treatment medications were reported.   This case was linked to MOD-2022-647514, MOD-2022-647505 (Patient Link).
This patient had an extensive past medical history including breast cancer, lymphoma, CAD s/p stents. Patient was vaccinated with Pfizer vaccine x3. She presented to the hospital with shortness of breath, hypoxia after being evaluated at urgent care. Patient had tested positive for COVID-19 approximately 3 weeks prior to Hospital on 5/15/2022. The patient had a prolonged and complex hospitalization, with numerous consultants during her stay including infectious disease, intensivist/pulmonology, nephrology, gastroenterology, palliative care teams. She was treated for COVID-19 pneumonia with steroids, duo nebs at the at the direction of infectious disease. This patient  was also thought to have superimposed bacterial pneumonia and completed a course of ceftriaxone and doxycycline. She was suspected to have post COVID pneumonitis/pulmonary fibrosis as well contributing to worsening shortness of breath and respiratory decline. Patient was DNR. She was initially hesitant to be intubated but did elect intubation. Patient did not improve, and her respiratory status continued to decline. Hospitalization was complicated by acute on chronic normocytic anemia. She also had melena and underwent EGD with findings of slow oozing blood likely from NG tube gastric erosions. She was treated with APC. Of note, patient would not accept blood products. Nephrology followed closely and assisted with volume management during her stay.  Patient had aggressive treatment by pulmonologist/intensivist, multiple consultants input, but patient respiratory continued to decline. Palliative care followed and family elected to transition the patient to comfort measures. Family was able to visit and she was compassionately extubated at 11 AM and given IV morphine for comfort. Time of death was 11:14.
Vaccine administered at 4pm and approximately two hours post vaccination, pt experienced "generalized warmth". Next morning, experienced "generalized muscle weakness, fatigue and chest soreness." "It was hard to breathe." No site reaction. Went to MD who referred her to vaccine administrator. Dx'd with strept, 2 days later, on 10/5/01.
Experienced a heart attack on the evening of March 23, 2021 quickly followed by cardiac arrest.  Was resuscitated during transport to the hospital. The hospital discovered a coronary artery embolism with myocardial infarction.  I was taking a blood thinner at the time so the blood clout should not have formed to begin with.   No heart disease was found and once clout was removed by heart function returned.  I had had my first COVID-19 shot the Thursday before the event so I thought I should report the event in case there's a connection.
This spontaneous case was reported by a non-health professional and describes the occurrence of DIZZINESS (lightheaded with some dizziness), MYALGIA (sore arm) and FATIGUE (Felt tired, fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.  No Medical History information was reported. On 17-Mar-2021 at 3:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MYALGIA (sore arm). On 20-Mar-2021, the patient experienced DIZZINESS (lightheaded with some dizziness) and FATIGUE (Felt tired, fatigue). The patient was treated with PREDNISONE from 21-Apr-2021 to 01-May-2021 at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (TORADOL) on 21-Apr-2021 at an unspecified dose and frequency. On 23-Mar-2021, DIZZINESS (lightheaded with some dizziness) and FATIGUE (Felt tired, fatigue) had resolved. At the time of the report, MYALGIA (sore arm) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Blood pressure measurement: 151/94 mmHg (Inconclusive) 151/94. On 21-Apr-2021, Body temperature: 98.1 Farad (Inconclusive) 98.1. On 21-Apr-2021, Heart rate: 86 mmHg (Inconclusive) 86. On 21-Apr-2021, Respiratory rate: 18 (Inconclusive) 18. On 26-Apr-2021, Blood pressure measurement: 144/91 mmHg (Inconclusive) 144/91. On 26-Apr-2021, Body temperature: 98.2 Farad (Inconclusive) 98.2. On 26-Apr-2021, Heart rate: mmHg. On 26-Apr-2021, Respiratory rate: 16 (Inconclusive) 16. On 03-May-2021, Blood pressure measurement: 121/79 mmHg (Inconclusive) 121/79. On 03-May-2021, Body temperature: 97.3 Farad (Inconclusive) 97.3. On 03-May-2021, Heart rate: 79 mmHg (Inconclusive) 79. On 03-May-2021, Respiratory rate: 18 (Inconclusive) 18. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided by the reporter. This case was linked to MOD-2021-101780. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Non-Significant follow-up appended.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 08-MAR-2016"), the patient was vaccinated with an improperly stored adult dose of VAQTA 50/1.0 U/ml injection (lot # L004745 with expiry date: 28-APR-2017; exact dose, route and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. Data logger was involved. No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Very sore arm; Swollen lymph nodes; Felt sick; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ej1685), intramuscularly in left arm on 29Dec2021 (at the age of 34-years-old), 1st dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at a workplace clinic. On 19Jan2021, the patient had a very sore arm, swollen lymph nodes and felt sick for weeks. The events resulted in doctor or other healthcare professional office/clinic visit. After the first dose the patient was put in medications (unspecified) to help to prevent the same symptoms with second dose. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was unknown.  Information on Lot/batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021570459 same reporter/patient/vaccine, different dose
The patient called with-in 1 hour of receiving these vaccinations to report jaw tingling/pain/swelling that started on the right side of jaw, but spread to both sides of the faces. No itching or hive or difficulty with breathing. Took a Benadryl tablet (not sure what strength) while on the phone with me. There was a family member with the patient at the time.I called back to check around 2:45 PM and the patient said that they were doing ok, a little headache, but the swelling was better. Left v/m on 8-3-21 to follow up as well, no response as yet. Patient called back and said doing fine. Arm never hurt, started with tingling in jaw and both sides of face swollen. Benadryl took care of swelling.
On May 3rd I started with a chest cough with sinus congestion with a minor headache and fatigue. It was not major symptoms but like a bad cold, I occasionally had a low grade fever of 99.3. I am still having the cough still and I just tested on the 11th and it was negative still had the cough then but the sinus congestion went away.
Developed erythema, induration, and pruritis around vaccination area (Tdap) on left upper anterior arm, 72 hours after vaccination.  No treatment, symptoms have begun to resolve now (one week later) though some redness, induration, and pruritis remain.  No other effect on left upper extremity.
Approximately 4 months post my second vaccine of Moderna I began to see significant joint swelling and pain. It progressed and went from discomfort to then waking up in pain. Over the counter medications were not effective against the pain and swelling. Around mid-July, I began to be unable to flex my feet to walk up and down staircases, and I really could not do anything due to the swelling and pain. I was then given a high dose of prednisone and after about ten days my symptoms began to slowly resolve and this brought back my range of motion and function back slowly. I stayed on prednisone until the end of September beginning of October. Symptoms were completely gone by that point once finishing last of prednisone. Sometime in October 26th 2021 I saw a physician in regards to a new onset symptom of neuropathy. I am still experiencing the neuropathy since. Post 24 hours of booster shot, I slept the entire day, and then woke up 48 hours after and felt fine.
patient was given the moderna half dose booster instead of the pfizer booster.  Patient was notified and made aware of the vaccine given. She has not yet reported any adverse symptoms.
This spontaneous report as received from a physician refers to a female patient of unknown age with skin papilloma. On an unknown date the patient was vaccinated with GARDASIL 9 for skin papilloma. On an unknown date the patient experienced product use in unapproved indication, therapeutic response unexpected and no adverse event. Additional information has been requested.
The pt has continual pain in the arm where the shot was given. The pt has had numerous tetanus shots and never had this problem. It is like someone hit him with a "sledge hammer". The pain is always there.
18JAN91 tc from mom reporting lump on lt upper arm @ inject site & fever; Did not take temp; pt felt warm; no change in behavior only c/o soreness @ site of inject; Pt active, playing as usual;
Small lump and mild soreness at injection site proceeded to larger lump at site and moderate full upper arm soreness for 3 days, then fully resolved. Itching and circular scaly patch approx. 1 inch diameter at injection site started on 03/01/2021 and continued to 03/14/2021 when fully resolved.
right hand swelling; blisters or vesicles on right forearm down from injection site; Pain right arm; 2 patches of Rash right forearm & antecubital / abrasion; feeling bad; tingling right arm; Suspects Shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2021, the patient received Shingrix. On 5th October 2021, less than a day after receiving Shingrix, the patient experienced shingles, feeling bad and tingling of extremity. On 6th October 2021, the patient experienced patchy rash. On 7th October 2021, the patient experienced hand swelling, blister and pain in arm. On 8th October 2021, the outcome of the shingles, patchy rash, feeling bad, tingling of extremity, hand swelling, blister and pain in arm were recovered/resolved.   It was unknown if the reporter considered the shingles, patchy rash, feeling bad, tingling of extremity, hand swelling, blister and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a very unusual rash following Shingrix vaccination on the right deltoid.  Patient experienced general feeling bad and tingling right arm on evening. The patient experienced 2 patches of rash on right forearm and antecubital similar to an abrasion.  Patient had seen in office with right hand swelling, blisters or vesicles on right forearm down from injection site and pain. Reporter suspected Shingles. The reporter consented to follow up.
brought by EMS to ED; seizures at home in bed; 6 Epi and 1 bicarb; no hx of seizure
Pt was completely irritable, crying (screaming) for about 10 hrs, ran 106 temp, lt leg was all swollen;
This female subject was enrolled in a study. On 09 July 2014, she received a dose of INFANRIX HEXA, Pfizer's PREVENAR 13 and ROTARIX. On 09 July 2014, on the same day after the 1st dose of INFANRIX HEXA, on the same day after the 1st dose of PREVNAR 13, on the same day after the 1st dose of ROTARIX, this two-month-old subject developed an apparent life threatening event with leukocytosis. The subject was hospitalised. The event resolved on 09 July 2014. The investigator considered that there was a reasonable possibility that the apparent life threatening event with leukocytosis may have been caused by INFANRIX HEXA, PREVNAR 13 and ROTARIX. Investigator Comments: On the evening of the 09 July 2014 baby was very irritable then finally went to sleep. Mom went to check on the baby and the skin was pale and the lips were pale, breathing was noted to be very shallow and baby tried to go back to sleep. Lips were not blue at all. Mom states that the baby acts like she is trying to let out a big cry and can't quite get it out. Was instructed by the after hours nurse on call to take baby to the ER to be evaluated. Baby was taken in and from there admitted to the hospital. Baby did well with some mild fussiness and decreased stooling. Was discharged from the hospital on 10 July 2014. Baby is to return to the clinic for a check up on 11 July 2014. Mom also reported limp floppy extremities.
Dose 2 of Pfizer Covid vaccine on 1/12/2021 4:53 pm 1/13/2021 827 am Temp 99.3 , pulse 82/min sitting. Feeling tired and very sleepy. Left work to go home 1/13/2021 350 pm temp 100.2 pulse 81 supine  headache, tired, myalgias, run down 1/13/2021 554 pm 101.6 f 1/13/2021 815 pm 102.1. F chills after dinner. 1/13/2021 830 pm diaphoresis starts intermittently. Chills and sweating. 1/14/2021 temp at 8 am 99.7 F 1/14/21 11 pm 97.1 F, symptoms resolved. Missed two days of work
Chills; Fever; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 25Mar2021, as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got chills and fever in the middle of night on Mar2021. The patient underwent lab tests and procedures which included body temperature: 102   on Mar2021 and body temperature: 101   on 26Mar2021. The outcome of the events was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
immediately after pt recv vax, pt seemed dazed, not responsive, this lasted 10-20 min; two hr later pt vomited once, became very limp, very pale, unresponsive, rapid respirations;hypotonic/ hydroresponsive rxn to dtp
Headache, lymph node swollen and painful on left side , dizziness off and on, (muscle ache  and nausea two  days)   After 3 days still have sore lymph nodes and headache and was dizzy and sent home from work today. Off and on feeling of  fatigue. Will feel wide awake and then overwhelmed with sleepiness for a bit then feel awake  again for a bit.  Weird.
Administered improperly stored MMR II.; This spontaneous report was received from a registered nurse, referring to a 14-months-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 13-OCT-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), administered at a dose of 0.5 milliliters (ml), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number 029454, which has been verified to be valid, expiration date reported and validated as 19-SEP-2021). The vaccine administered experienced a temperature excursion of -50 degrees Celsius (C) to +8C (14.58C), for a time frame of 11 hours and 45 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA004818:
This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 75-year-old male patient received BNT162b2 (BNT162B2), on 07Feb2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "RECURRENT IDIOPATHIC PERICARDITIS" (unspecified if ongoing). Concomitant medication(s) included: COLCHICINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". Anti viral details: product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date: 06Apr2022, Treatment stop date: 10Apr2022, Indication: Treatment of COVID-19. Covid vaccine details: vaccine brand=Pfizer/BioNTech, Vaccine lot unknown reason=Misplaced/discarded. Adverse event: return of Covid symptoms 9 days after finishing full Paxlovid doses. Abbott rapid test done at urgent care site 17 days post finishing Paxlovid was negative. AE treatment: antibiotic (Doxycycline) and Advair inhaler. Known allergies: No. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Negative, notes: Abbott rapid test done at urgent care site 17 days post finishing Paxlovid was negative. Therapeutic measures were taken as a result of drug ineffective, Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available.
When given shot it hurt that night arm was sore next morning it became swollen, hot, and red. 3 days later area is still swollen and red and the bruising has spread down the arm.
This patient is a 39 year old lab tech employed at the local hospital.  He is previously healthy but smokes about 3/4 pack of cigarettes a day.  He has no heart or pulmonary problems.  He was vaccinated on 4-8-03 and several days later began having throat discomfort and vague URI symptoms.  On 4-18-03 he became very short of breath and went to the ER at the local hospital, where he was noted to be extremely dyspneic, with O2 saturations in the high 70's to low 80's.  His respiratory rate was around 40.  A chest x-ray was essentially unremarkable but a neck x-ray showed a prominent epiglottis.  However, he had little or no stridor clinically.  He was afebrile.  He was admitted to the ICU where he was observed carefully for deterioration.  He was treated with racemic epinephrine, inhaled bronchodilators and high-dose IV steroids (methylprednisolone 125 mg Q6h) and over the next few days he improved dramatically.  He did not require intubation or any other respiratory assist except supplemental oxygen.  His vaccination site did well, he had no satellite lesions or other obvious vaccine complications.  He was in the hospital about 5 days, and continues to do well, as per a follow-up phone call to his treating physicians today.
Headache Narrative: PATEINT REPORTED MILD ACHES WITH VACCINE #1. DEVELOPED HEADACHE 45 MINUTES AFTER SECOND COVID VACCINE