chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival). At the time of the report, PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.
This case was reported by a other health professional via sales rep and described the occurrence of neuropathy in a 35-year-old female patient who received FLUARIX QUADRIVALENT. On 24th September 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On 24th September 2015, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced neuropathy. On an unknown date, the outcome of the neuropathy was recovering/resolving. The reporter considered the neuropathy to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by a healthcare professional, who herself was the patient. The reporter had extremely limited information. After 2 hours of the vaccination, the patient developed neuropathy of the right arm (injection site). The patient went to the Employee health clinic, but they did not do anything for her. The patient then went to her own physician who sent her to a neurologist. The neurologist completed an Electromyogram (EMG) for the patient but did not follow through with any recommendations. The patient then submitted a workman's complaint case to her employer. They sent her to another neurologist and he did another Electromyogram (EMG). The neurologist stated that the nerves were not damaged just inflamed. He also said that the patient had post viral neuropathy. The reporter stated that the symptoms were reoccurring which has not totally resolved till the time of reporting. The reporter did not have lot number and expiry date of the vaccine.
Became short of breath a few days later, diagnosed with bilateral pulmonary embolism on 3/10/21 at Medical Center
Nausea; Headache; Chills; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 4th February 2023, the patient received the 2nd dose of Shingrix. On 4th February 2023, less than a day after receiving Shingrix, the patient experienced nausea, headache, chills and tiredness. On an unknown date, the outcome of the nausea, chills and tiredness were recovered/resolved and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the nausea, headache, chills and tiredness to be related to Shingrix.     Additional Information: GSK Receipt date: 07-Feb-2023. Reporter's Comment: The patient received Shingrix on left arm. The patient received 1st dose of Shingrix about 2.5 months prior to the reporting. The reporter stated that she felt fine after the first vaccine, but following the second vaccine, she had nausea, headache, chills, and tiredness. She is still having headaches, but her other symptoms have resolved The reporter consented to follow-up.
10 days after receive ing the booster shot of Moderna, I became very itchy seemingly out of nowhere. I have no prior  food allergies and did not eat anything out of the ordinary that day either. The next day I was still itching and developed welts and then hives. Went to urgent care and they prescribed me prednisone and over the counter allergy medicine. The hives as progressively gotten better, but are now at a stand still at week 10, and have now taken the form of positive dermatographia.
Started having nasal congestion and sneezing 3/28, sore throat started on 4/3, got tested 4/3 and came back positive.
tested positive about 4 days later/got sick; This is a spontaneous report received from a non-contactable consumer (Patient) via medical information team. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and lot number: unknown) via an unspecified route of administration on 10Jan2021 as a single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Patient tested positive about 4 days later, on 18Jan2021. patient stated she "got sick" on an unspecified date in 2021. she said she received a "monoclonal antibody transfusion on 22Jan2021". Outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Varicella vaccine given 09/20/2002, 10/02/02 -sore/hot red arm 10/13/02 -fever  by hx, Office visit on 10/09/02, T 100.0 F, arm red swollen warm, Called CDC Hotline for instructions Re: Flu injection, Told no counterindications.
Patient reported having hives in two places (left thigh and left flank), hot face (not noticeably red), shortness of breath, pulse 68, BP 118/76; occurred within 15 mins of immunization, Benadryl 50 mg PO capsule x1 dose was administered and all symptoms resolved (per patient report) within 10 minutes. She reported a history of similar reactions, resolved using Benadryl. She also carries an epi pen and has one at home if needed.
This is a spontaneous case, initially received on 07-Nov-2018 from other health professional (nurse), concerning a 43-year-old, adult, male patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 252227, expiry date: 31-May-2019, route of administration: intramuscular and anatomical location: left deltoid) which underwent temperature excursion. At the time of this report, no adverse events were reported. This case is linked to case 201805327 owing to same reporter. The reporter assessed this case as non-serious. Follow up report received from the reporter on 28-Nov-2018: Age, route of administration and anatomical location was updated. The reporter confirmed that no adverse events were reported after vaccination. The narrative and the case comment were amended accordingly.
Terrible headache all day; Fever; Chills; Vomiting; diarrhea; Tummy aches; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (BNT162b2; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Sep2021 at 18:00(at the age of 31-year-old) as a single dose for COVID-19 immunisation. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (BNT162b2; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Aug2021 at 16:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Sep2021 at 08:00 the patient experienced terrible headache all day, fever, chills, vomiting, diarrhea and tummy aches. The patient did not receive any treatment for the events. No therapeutic measures were taken as a result of the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events terrible headache all day, fever, chills, vomiting, diarrhea and tummy aches was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient woke up with face redness, swelling, and rash on her chest. She had headache, body aches, and nausea. Patient took Benadryl, Tylenol, and 2 Ibuprofen. Most of patient's symptoms have resolved by today, except the rash on her chest.
received Shingrix stored in the freezer. Pt is immunocompromised; This case was reported by a nurse via call center representative and described the occurrence of product storage error in a adult female patient who received Herpes zoster (Shingrix) (batch number XX474, expiry date 26th June 2023) for prophylaxis.   Concurrent medical conditions included immunocompromised (patient was immunocompromised).   On 17th March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product storage error. On an unknown date, the outcome of the product storage error was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccination which was accidentally stored in the freezer for 4 to 5 hours at negative 19.3 Degree F, which led to product storage error. The reporter gave consent to follow up.
No additional AE / the patient had no reaction; Patient was administered expired MMRII; This spontaneous report was received from a nurse practitioner referring to a 4-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 08-MAR-2022, the patient was vaccinated with an expired measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection, administered in the right arm subcutaneously as prophylaxis (lot number T000892 which has been verified to be valid, expiration date reported and validated as 08-JAN-2022) (dose was not reported) (expired product administered). In addition, the patient had no reaction and left the clinic in a stable condition.
Extreme breathing difficulty,  veey bad cough.m, heavy mucous severe headache, blured vision.  Had to have albuteral treatments in nebulizer every 4 hours, started on Adair inhaler and Augmentin 875 mg 2 times daily.
Soreness in left upper arm; This is a spontaneous report from a non-contactable consumer. A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 20Dec2020 at a single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced soreness in left upper arm starting several hours after administration on 20Dec2020. Soreness was worst the next morning. No treatment was received for the adverse event. However, the outcome of the event was recovering. The event was considered non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recvd vax; onset of local swelling, redness, warmth & itching; apap & ice packs used
immediately after receiving his vaccine, he swelled at the injections site. His arm was red. After 10 minutes, he had a red rash around the injection site. After 10 more minutes, injection site was red and rashy, after 10 more minutes, his injection site reaction was mellowing out-no additional redness or swelling. He felt fine each time I asked him-no itching or trouble breathing. After 30 minutes, he left with his mother. I called him at 2:45 pm and he was feeling fine. he said that the rash and swelling were going down but his arm did hurt.
Approximately 30 minutes after the Yellow Fever vaccine was administered, the patient noted itching on his scalp, felt his throat was closing up and his tongue was itching.  He also noted that his face appeared red and he felt hot.
Developed excessive bruising around march/april with office on 04/06 for evaluation of increase bruising and fatigue.   CBC was check with platlet count of 7.  CBC was repeated on 04/08 with platlet count of 13.  She was referred to hematology for possible evaluation of acute ITP
Received PEDIARIX, Merck HIB, PCV13, ROTARIX - began constant high pitched scream, cat scream, struggling to cry.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial was pulled from the freezer on 13-Oct-2021 with a use by date of 12-Nov-2021 (30 days storage viability in the fridge).  No concomitant medications and no treatment medications were reported.   This case was linked to MOD-2021-364614 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow received contains no new information.
Room was spinning after laying down; Dizzy, couldn't get up at times; Got Sick; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Room was spinning after laying down), DIZZINESS (Dizzy, couldn't get up at times), ILLNESS (Got Sick) and PYREXIA (Fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028LR0A and 028120A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VERTIGO (Room was spinning after laying down), DIZZINESS (Dizzy, couldn't get up at times), ILLNESS (Got Sick) and PYREXIA (Fever). At the time of the report, VERTIGO (Room was spinning after laying down), DIZZINESS (Dizzy, couldn't get up at times), ILLNESS (Got Sick) and PYREXIA (Fever) had resolved.            No concomitant medications was not reported. Treatment medications was not reported.   This case was linked to MOD-2021-154316 (Patient Link).
Burning sensation in my heart area for about 24 hours; My resting heart rate increased to 107 beats per minute; My blood pressure  wich was elevated vs my normal level; This is a spontaneous report from a contactable healthcare professional (patient herself). A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 09Mar2021 at 11:00 (Batch/Lot Number: EN6208) (at the age of 62-years-old) as first dose, single dose for COVID-19 immunisation. Medical history included penicillin allergy, pollen allergy and allergic to cats. The patient's concomitant medications were not reported. Patient previously took codeine and experienced drug allergy. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 09Mar2021 at 11:15 (about 15 minutes after receiving the vaccine), the patient's resting heart rate increased to 107 beats per minute. The patient alerted the medical personnel. They took her blood pressure which was elevated vs normal level, but oxygenation was normal. Heart rate returned to normal in about 5 minutes, but the patient experienced a burning sensation in her heart area for about 24 hours. Events resulted in doctor or other healthcare professional office/clinic visit. No treatment was given to the patient. Reporter assessed the events as non-serious. Since the vaccination, patient had not been tested for COVID-19. Outcome of burning sensation in heart was recovered on 10Mar2021, heart rate increased was recovered on 09Mar2021 11:20 and remaining event was unknown.   Follow-up attempts are completed. No further information is expected.
Pt. developed erythema, st swelling and pain at injection site on day following injection. Noted pain with movement of (L) arm.
lightheaded; dizzy; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded), DIZZINESS (dizzy) and FATIGUE (fatigue) in a 29-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 LEVONORGESTREL (KYLEENA) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (lightheaded), DIZZINESS (dizzy) and FATIGUE (fatigue). At the time of the report, DIZZINESS (lightheaded), DIZZINESS (dizzy) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event and No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided by the reporter. Treatment provided include ibuprofen.
Full body aches and fever 12 hours after vaccine, lasted 2 hours, relieved by acetaminophen and ibuprofen. Daily headaches and nausea since second dose administration. Ibuprofen and acetaminophen PRN for headaches. No treatment for nausea. Headaches and nausea are still ongoing.
Burnt Taste/Smell. Everything smells and tastes the same. Going on 2 months now.
Patient received 2 doses of Moderna and came to facility and received 2 doses of Pfizer vaccination at our facility
felt like she had pneumonia; felt like panic attacks; heart would skip a beat; gasping for breath; low grade fever; chills; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (felt like she had pneumonia), PANIC ATTACK (felt like panic attacks), PALPITATIONS (heart would skip a beat), DYSPNOEA (gasping for breath) and PYREXIA (low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (felt like she had pneumonia), PANIC ATTACK (felt like panic attacks), PALPITATIONS (heart would skip a beat), DYSPNOEA (gasping for breath), PYREXIA (low grade fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, CHEST DISCOMFORT (felt like she had pneumonia), PANIC ATTACK (felt like panic attacks), PALPITATIONS (heart would skip a beat), DYSPNOEA (gasping for breath), PYREXIA (low grade fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood gases: low (Low) had low blood oxygen levels.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date, she went to a doctor, and started treatment with an antibiotic. On another future, unknown date, she went to different doctor, who confirmed that she had low blood oxygen levels that continued into Apr-2021.  Very limited information regarding this event/s has been provided at this time.  Further information is not expected as the patient has declined follow-up.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information is not expected as the patient has declined follow-up.