chrisvoncsefalvay/vaers-outcomes huggingface dataset:
There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. There was an excursion from the freezer on 01-Oct-2021 and the nurse used the excursion tool but there was no option for the excursion experienced. The only tool gave the options for excursion above one hour and not less than that so the nurse did not known about the analysis.The nurse stated that the team knew the recommended temperature and wanted to know whether the vials were still in a good condition to be used and were administered to 118 patients.The storage condition at the time of the excursion was frozen, vial size was 7.5 mL and maximum or minimum temperature mentioned as minimum minus 4.2 degree Fahrenheit and maximum 5.7 degree Fahrenheit. The excursion duration was 6 minutes.On visual inspection, the vials were thawed before administration and there were no color changes or anything abnormal. Total 10 vials or doses were impacted.No concomitant medications were reported.No treatment drugs were reported
Booster; Body ache and pain similar to the flu or even fibromyalgia; Body ache and pain similar to the flu or even fibromyalgia; Body ache and pain similar to the flu or even fibromyalgia; Low grade temperature 99.9. 100; This is a spontaneous report received from a contactable Consumer or other non HCP. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; FIBROMYALGIA (non-serious), PAIN (non-serious), INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered" and all described as "Body ache and pain similar to the flu or even fibromyalgia"; PYREXIA (non-serious), outcome "recovered", described as "Low grade temperature 99.9. 100". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Body ache and pain similar to the flu or even fibromyalgia. Low grade temperature 99.9. 100 This lasted for 3 days.Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
pt recv vax; felt n and devel fever;was quite achy;apap given;devel sore throat w/ cold sx;referred to md who said it was the flu;gave med to pt;still has fever
patient had a seizure 3 hours after getting the vaccine.seizure disorder was under control for 6 years as per patient.
Moderate arm muscle pain (4 days). Moderate swelling at the injection site (8 days). Redness at the injection site (4 days). Mild itching of the injected arm (8 days). Mild headache (day of vaccine), mild shivering (day of vaccine), mild fatigue (day of vaccine).
High fever of (102.8 degrees) head hurt, arm was red, hot, swollen, and could not lift, hurt underarm along the arm pit and left lung area, vomiting pain in stomach, sic for 4 days could not even stand. Head, arm and lung area hurts so bad! Sick for 4 days in bed, went to ER gave fluid 3 liters, 2 bags of antibiotics (IV), 2 days in a row. Hospital said I had (Cellulitis) given (Keflex antibiotics) due to shot. Arm where the vaccination was given still is tender at times-And he has lost 56 lbs. for what I don't know.
tingling sensation of the hands; Regular to Heavy menstrual flow; Feeling cold; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling sensation of the hands), HEAVY MENSTRUAL BLEEDING (Regular to Heavy menstrual flow) and FEELING COLD (Feeling cold) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Irregular periods (as reported by patient (she is irregular)) since an unknown date. Concomitant products included EMERGEN C for Prophylaxis.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PARAESTHESIA (tingling sensation of the hands), HEAVY MENSTRUAL BLEEDING (Regular to Heavy menstrual flow) and FEELING COLD (Feeling cold). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing from 31-Dec-2020 for Adverse event following immunisation, at a dose of UNK dosage form, bid. At the time of the report, PARAESTHESIA (tingling sensation of the hands) and FEELING COLD (Feeling cold) had not resolved and HEAVY MENSTRUAL BLEEDING (Regular to Heavy menstrual flow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received vaccine at approximately 8:05 am and had reported feeling well just prior. Patient stated that she did for sure want to get the vaccine but that she is nervous will needles. She did fine with the administration and for about 5 min. after.  At approximately 8:10, patient had left inj area and walked to a waiting area for  observation. At approximately 8:15 patient fell from the chair landing on side/face head area. No one witnessed the entire fall but I observed her immediately after. She immediately sat up and stated that she just felt like her head hurt. She was offered water, a granola bar and an  ice pack. Her significant other was at her side immediately after and reported to me that she was fine. She waited while her partner received his vaccination and they left (walking) the clinic at approximately 9:00 am
On 8/21, patient reported both arms are still red and tender. The right arm especially (pneumococcal was injected) is still hard to touch localized to the injection site, red, warm and painful. Per patient, the redness had spread out over the weekend to a larger portion of the upper arm over the weekend. Patient reports, it looks like that redness may be improving around the site but the redness local to the site is remaining.  Patient reported taking  Tylenol for pain. Noted patient went to urgent care the following day and was prescribed an antibiotic for right arm cellulitis.
Pt developed a fever to 104 and vomiting x 3 approximately 12 hours post vax.
Patient stated approximately 24 hours post-vaccination, he was at home in his garage and became extremely light headed and was unable to walk. He crawled into his house and called his wife to help him, and she immediately contacted 911.
Red, raised and swollen lump at the site of the injection.  Painful to the touch.
Elevated temperature, swelling of upper right arm into armpit & chest wall, two episodes of shortness of breath, extreme pain, redness spreading over entire upper arm & almost to wrist, extreme itching that lasted until 10/15/2012?
Started to become tired around 3:00 pm. The site of the injection was sore. At 8:00 pm I started feeling cold and that went right into the chills where I could not warm up. Went to bed at 10 pm with extra blankets. No fever. At 12:15 am I woke up very hot. I had a fever of 100.7. I researched online and took (3) 200 mg of ibuprofen at 12:45 am. Within 15 minutes I started feeling slightly better.  Went to bed and woke up at 7 am back to normal.
Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Hypertension-Medium, Additional Details: pt reported L arm pain and also some numbness in lower back right as well as some chest pain after shot. was not dizzy or nauseous. BP elevated at 191/116, then decreased to 180/109 but still elevated. initially offered to call 91 or an ambulance but pt refused. chest pain resolved within minutes as well as the arm and back pain. pt was feeling very anxious before the vaccine which may have precipitated the high bp and chest pain. pt felt fine,referred pt to urgent care for hypertensive urgency.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/29/2021 and 2/25/2021. Presented to ED on 7/19/2021 after a fall. For the past several days prior patient developed a dry cough and fever, pneumonia due to COVID-19 present on admission. Patient treated with remdesivir, dexamethasone, convalescent plasma, ceftriaxone, and azithromycin. Patient continued declining in mental status, renal function, and oxygenation. Patient expired on 7/29/2021.
PVC occurred 10 days after vaccination, lasted 5 days, decreasing in severity each day. Joint pain with swollen wrists 14 days after vaccination
Started with rash/welts all over fews days after no receiving vaccine on 10/17/14. Took Benadryl for few days until symptoms resolved.
Sweats; Night sweats; Something in lymph nodes; 57 days between first and second dose; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), NIGHT SWEATS (Night sweats), LYMPH NODE PAIN (Something in lymph nodes) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (57 days between first and second dose) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE), METFORMIN and GLIPIZIDE for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (57 days between first and second dose). On an unknown date, the patient experienced HYPERHIDROSIS (Sweats), NIGHT SWEATS (Night sweats) and LYMPH NODE PAIN (Something in lymph nodes). At the time of the report, HYPERHIDROSIS (Sweats), NIGHT SWEATS (Night sweats), LYMPH NODE PAIN (Something in lymph nodes) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (57 days between first and second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included unspecified antibiotics and pain medication.  Patient received both doses of Moderna COVID Vaccine, first dose on 3Mar2021 and second dose on 29Apr2021. First dose was administered on left non-dominant arm and second dose on right dominant arm. Patient said of being a little worried and alarmed. Patient went to see doctor last week because has something in lymph nodes.   Patient also had sweats and night sweats and these symptoms started approximately a week and a half ago.   Concomitant medication included Avipiline, lazole and medications for psychiatric disorders, blood pressure and diabetes.
Pt recvd series of 3 Engerix-B on 0,1,6 mo schedule.  Titers-neg.
Given 1st GARDASIL in (L) arm and within 10 mins c/o chest discomfort and feel jittery inside. Stayed with her and PA were with her. She calmed down some less discomfort but then started to itch all over PA gave her VISTARIL and CLARITIN - cont. to observe - 45-60 mins - the itching and sx relieved - Pt released to go home with father. Approx 5 pm.
A physician reported that a patient received an injection of Prevnar and diphtheria, tetanus  and acellular pertussis (manufacturer unk) vaccines and subsequently, developed an injection site reaction at the Prevnar administration site characterized by pronounced redness, raised skin and increased stinging and pain "than compared to DTaP injection." MANUFACTURER'S COMMENT: This is 1 of 2 patient's from this facility of adverse events who experienced an injection site reaction following Prevnar administration.
pt recvd vax & devel eye dermatitis & rash; was seen by MD;
patient received vaccine with no incident.  Upon finishing the vaccine, her sister, who was holding her opposite hand began to collapse which slightly pulled on the opposite arm (left arm, the arm receiving the vaccine).  the patient later complained of soreness/pain in her shoulder.
Pfizer monovalent was given instead of the pfizer bivalent due to look alike vials
body aches; chills; my back started aching; feeling feverish but no fever; felt like a headache was coming on/was going to get a headache; her arm hurt/arm pain/iced the injection site; never falling back asleep; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Feb2021 15:15 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 on 12Jan2021 for COVID-19 immunization. After 2nd vaccine. The patient felt fine most of the evening and through the night. The patient woke up in the middle of the night around 3/3:30 am (totally normal for her) and felt fine except for some arm pain on 05Feb2021. The patient iced the injection site, but by 4:30/5 the patient was still awake and now felt like she was going to get a headache (also common for patient). The patient took her temperature (was normal), took 2 Tylenol (5am), and went back to bed (but never falling back asleep). The patient left for work at 6:45am. The patient felt totally fine, even energetic, most of the morning. The following day at 10 am caller reported body aches and feeling feverish but no fever. At almost 10am exactly, her back started aching and by 10:30 the patient had full body aches and started getting chills. The patient left work at 11am, was home before 12pm with a temperature of 98.5, took 2 more Tylenol and napped. The patient had no symptoms the rest of the afternoon until 5pm when the back aches returned. Took 2 more Tylenol. The patient napped later in the evening, too, but took 2 more Tylenol at 10pm before going to sleep for the night. Woke up Saturday morning without symptoms. The outcome of events was recovered in Feb2021.  Information about Lot/batch number requested.
Feels overloaded; A Lot of red rash/ a lot of red rash from  increasing dose, the rash comes and goes but was really bad when it was 72 degrees. It was subsiding some; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (Feels overloaded) and RASH ERYTHEMATOUS (A Lot of red rash/ a lot of red rash from  increasing dose, the rash comes and goes but was really bad when it was 72 degrees. It was subsiding some) in a 47-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product EPOPROSTENOL SODIUM for Primary pulmonary hypertension.    Concurrent medical conditions included Primary pulmonary hypertension.   On 29-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient started EPOPROSTENOL SODIUM (Intravenous) 1.5 milligram. On an unknown date, the patient experienced FEELING ABNORMAL (Feels overloaded) and RASH ERYTHEMATOUS (A Lot of red rash/ a lot of red rash from  increasing dose, the rash comes and goes but was really bad when it was 72 degrees. It was subsiding some). At the time of the report, FEELING ABNORMAL (Feels overloaded) outcome was unknown and RASH ERYTHEMATOUS (A Lot of red rash/ a lot of red rash from  increasing dose, the rash comes and goes but was really bad when it was 72 degrees. It was subsiding some) was resolving.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient received both PNEUMOVAX 23 and FLUZONE HD on 10-4. On 10/7 patient notified pharmacy that she had a reaction that involved a rash on her arm that extended to her armpit as well as having a headache and chills. She also stated that her arm was so sore that she couldn't lift it.
Received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised; Received booster shots of the Moderna COVID-19 vaccine; Pains/aches; Low grade Fever; Felt Like The Flu; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A, 037K20 and 0881021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BACLOFEN, SITAGLIPTIN PHOSPHATE (JANUVIA), METFORMIN HYDROCHLORIDE, VITAMIN D NOS, IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]), HYDROXYCHLOROQUINE, CYCLOBENZAPRINE, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), LOSARTAN, CHLORTALIDONE (CHLORTHALIDONE) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt Like The Flu) and PYREXIA (Low grade Fever). 21-Mar-2021, the patient experienced MYALGIA (Pains/aches). On an unknown date, the patient experienced IMMUNODEFICIENCY (Received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised) (seriousness criterion medically significant) and EXTRA DOSE ADMINISTERED (Received booster shots of the Moderna COVID-19 vaccine). At the time of the report, IMMUNODEFICIENCY (Received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised) outcome was unknown and INFLUENZA LIKE ILLNESS (Felt Like The Flu), EXTRA DOSE ADMINISTERED (Received booster shots of the Moderna COVID-19 vaccine), MYALGIA (Pains/aches) and PYREXIA (Low grade Fever) had resolved.            No treatment information was provided. The patient mentioned that he had not experienced any side effects from the booster at this point.  Company Comment:  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. Further information will be requested regarding Immunocompromise onset.   This case was linked to MOD-2021-018907 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information will be requested regarding Immunocompromise onset.
Hives all over body 8 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over body 8 days after 1st dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced URTICARIA (Hives all over body 8 days after 1st dose). The patient was treated with PREDNISONE for Hives, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over body 8 days after 1st dose) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient went to his doctor who said it was probably a delayed reaction to the vaccine.No concomitant medication were provided.
broke out in hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "primary immunization: Pfizer/ Booster: Moderna" (unspecified if ongoing), notes: primary immunization: Pfizer/ Booster: Moderna. The patient's concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "broke out in hives".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.