chrisvoncsefalvay/vaers-outcomes huggingface dataset:
102.7 degree fever; Chills; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (102.7 degree fever), CHILLS (Chills) and FATIGUE (Fatigue) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product BOSENTAN for Pulmonary hypertension.    Concurrent medical conditions included Pulmonary hypertension. Concomitant products included SILDENAFIL CITRATE for an unknown indication.   On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started BOSENTAN (unknown route) 125 milligram twice a day. On 07-May-2021, the patient experienced PYREXIA (102.7 degree fever), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, PYREXIA (102.7 degree fever), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        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 treatment information was provided by the reporter.   Reporter did not allow further contact
Skin sensitivity, burning/itching pain, mildly affecting chest for 1 day (then resolved), and more significantly affecting lower arms, and lower legs for 4 days (improving over time), and severely affecting hands/palms, and feet/soles for 5 days (very slowly resolving). These symptoms started 7-8 days after dosing, and were previously experienced (though then much more severely) starting 6-7 days after 2nd dose (and which was previously reported to VAERS).  Pain/burning somewhat responsive to neurontin/gabapentin.
The patient is experiencing extreme pain radiating down left arm into hand and general muscle aches. The discomfort started an hour after receiving the immunization. She reported the issue to our pharmacy at 10:00 AM the next day after vaccination. She was unable to sleep due to the pain.
The day after receiving my third "full" dose, I noticed swelling and a rash. After a course of a couple days, there was a range growth of 2x4x1/2 inches. It was red, itchy, stinging and burning and continued to grow. I went to the doctor right away this time. The day after my vaccine, I could barely walk because of the pain. There was pain if anything touched my legs. I had a headache and was pretty nauseous as well. I took Benadryl immediately when I got home so it made the rash not as bad as the second dose, but it did not help with the swelling. Dr. gave me more Keflexan, since that worked after the second dose. I am mildly immunocompromised.
No other issues or concerns noted.; VARIVAX and MMR II were administered to a patient past expiration date; This spontaneous report has been received from an office manager, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.   On 18-OCT-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S028925 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 16-SEP-2021, dose, route and strength were unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot # S032825 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 16-OCT-2021, route and strength were unknown), both for prophylaxis (expired product administered). No other issues or concerns noted.
Welt almost like hives; Red welt; Itchy welt; Arm was sore; Arm was warm to the touch; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), SKIN WARM (Arm was warm to the touch), URTICARIA (Welt almost like hives), ERYTHEMA (Red welt) and PRURITUS (Itchy welt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 30-Dec-2020 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm was sore) and SKIN WARM (Arm was warm to the touch). In January 2021, the patient experienced URTICARIA (Welt almost like hives), ERYTHEMA (Red welt) and PRURITUS (Itchy welt). In January 2021, URTICARIA (Welt almost like hives), ERYTHEMA (Red welt) and PRURITUS (Itchy welt) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore) and SKIN WARM (Arm was warm to the touch) outcome was unknown.        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. Treatment for the events included Benadryl.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
SICKEST; CHILLS ALL NIGHT; TERRIBLE HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sickest, chills all night, and terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sickest, chills all night and terrible headache was not reported. This report was non-serious.
Seizure, respiratory arrest approximately 45 minutes after. Transported by ambulance to hospital. 2 night observation and testing. 10/19/05 Review of d/c summary indicates final diagnosis was 'ALTE vaccine with possible reaction'. Diagnostic code for 'apnea' appeared on cover sheet.
Child developed hives 10 minutes after vaccination. He has hx of eggs & nuts allergy & was sent to ER.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, rash, teeth chattering and pain in arm. On an unknown date, the outcome of the fever, rash, teeth chattering and pain in arm were recovered/resolved. The reporter considered the fever, rash, teeth chattering and pain in arm to be probably related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX vaccine between the end of February and 1st March. The patient had a fever of 103 degrees F which lasted for 24 hours. The effects lasted for 3 days. This case was linked with case US2018124952, reported by the same reporter.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 24-JAN-2011, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 06-FEB-2014, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster. The patient was prescribed VALTREX and betamethasone dipropionate for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
T101 Thursday 2JAN92 PM-temp controlled w/Tempra; pts death was a result of SIDS;
Massive Hemorrhagic stroke 24 hours after receiving first Pfizer vaccination. Suffered bleeding of kidney 6 days later, followed more brain bleeds and blood in stomach area.  Vessels are leaking blood, Dr's were could find no reason for the bleedings, have not seen this before.
1st shot was Thursday night. Started getting a stomach ache before dinner Friday, didn't get better after eating, felt very nauseous the remaining of the evening. About an hour or two after nausea started, felt very tired. Slept fine Friday night, woke up Saturday and stomach ache was gone, but tired all day Saturday. Sunday I felt normal.  I also had a sore right arm Friday and Saturday.
Left Arm is swollen around and below injection sites. Patient feels pain and itiching and has had trouble lifting the arm. This began 1 day after the vaccinations. Patient has been using homeopathic therapy at home. The condition it seems to be improving.
Patient reported that he was administered the first dose of the Moderna vaccine on13Mar2021. Patient reported 2-3 after the vaccination he began to experience floaters and flashes before his eyes for 2 days. He then stated that after that he has been seeing a black dot to the right of his lateral periphery. Patient did see the optometrist on the same day.   Optometrist noted: No tears or detachments noted today, with extensive    (extended) BIO + peripheral 90D. Pt states floater remains since Saturday    (though not present per pt during exam) but denies flashes or curtain veiling.     Query if complete PVD though difficult to appreciate on exam. Strict RD     precautions given, STAT if symptoms arise. Pt expressed understanding.     Will repeat DFE at scheduled f/u 5/4/21 @ 13:40, or sooner PRN.
Patient received vaccine in left arm and during waiting/observation period a few minutes later (while sitting), he told the person near him he felt dizzy, and he fainted. He soon regained consciousness (within about a minute) and was observed/attended to. 911 was called immediately as a precaution, and paramedics monitored his vital signs slowly helped him into a chair. He drank some water and a little electrolyte drink. He did not want to seek hospital treatment, and paramedics left.  He stated he was experiencing nausea while sitting in the chair, and said he started to feel like he was going to faint again.  Again 911 was called and paramedics attended to him, but he did not faint again. After resting in a chair and drinking some more water and some electrolyte drink, as well as cold compresses on his forehead and the back of the neck, he was eventually escorted by two store employees on a motorized scooter cart to his parent's car and went with his parent home (he did not want to seek hospital treatment).
This spontaneous report has been received from an office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions and allergies were not provided. The office manager reported that, on 22-AUG-2018, the patient received a dose of improperly stored VARIVAX, subcutaneously, for prophylaxis (dose number, frequency and anatomical location of vaccination were not provided; lot number R008394, expiration date 20-MAR-2020). The reporter also mentioned that the vaccine was reconstituted with a properly stored sterile diluent. No adverse effects were reported. The VARIVAX dose was exposed to a temperature excursion of 15 degrees Fahrenheit (°F) to 46 °F (22.1 F) for a time frame of 2 hours and 30 minutes, which was detected by the Digital Data Logger. No previous temperature excursion was reported.
Very bad vertigo early morning lasting into the next day.  Worse while changing sleep positions at night.
Swelling on rt arm @ site of inject noted 23AUG91 more swollen & discomfort since that time; no fever;
pain & swelling in injection site same day, pain & swelling on left underarm on 1/6/21 Narrative:
Employee reports onset of fever, chills, and dizziness following second dose of vaccine. Employee has taken Motrin and Tylenol and reports mild improvement. Symptoms have not interfered with ADL's.
No adverse event; patient who received the bivalent booster of the Moderna Covid-19 vaccine for the second dose of her Moderna Primary Series.; Patient received First Primary Series dose of the Moderna vaccine on 22-FEB-2022 and Second primary series dose on 18-OCT-2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient who received the bivalent booster of the Moderna Covid-19 vaccine for the second dose of her Moderna Primary Series.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First Primary Series dose of the Moderna vaccine on 22-FEB-2022 and Second primary series dose on 18-OCT-2022.) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient who received the bivalent booster of the Moderna Covid-19 vaccine for the second dose of her Moderna Primary Series.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First Primary Series dose of the Moderna vaccine on 22-FEB-2022 and Second primary series dose on 18-OCT-2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient who received the bivalent booster of the Moderna Covid-19 vaccine for the second dose of her Moderna Primary Series.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First Primary Series dose of the Moderna vaccine on 22-FEB-2022 and Second primary series dose on 18-OCT-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (patient who received the bivalent booster of the Moderna Covid-19 vaccine for the second dose of her Moderna Primary Series.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First Primary Series dose of the Moderna vaccine on 22-FEB-2022 and Second primary series dose on 18-OCT-2022.).    Concomitant medications details were not reported by the reporter. Patient received first Primary Series dose of the Moderna vaccine on 22-FEB-2022,  lot number 083521A  expiration date 2-MAY-2022. Patient received the vaccine in left arm,  no adverse events were reported. Treatment details was not reported by the reporter.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 02-MAY-2016, the patient was vaccinated with a dose of improperly stored of unspecified HPV vaccine (unknown if it was GARDASIL or GARDASIL 9) "SDV; 10 pack" with lot number K010215 with expiration date of 05-MAY-2017 (dose, route of administration and anatomical location were unknown), which was stored at the lowest temperature of 34 (1.111111111 Celsius degrees) for 48 hours. The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
JOINT PAIN BEGINNING 09JUN95; JOINT PAIN CONT; DX OF RHEUMATOID ARTHRITIS ON NOV95;
pt recvd vax; w/in 12-24 hrs, devel inflam at inject site, and a knot below inject site;
nodule; This spontaneous case was reported by an other health care professional and describes the occurrence of NODULE (nodule) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dental cleaning (Patient had dental cleaning within the last 6-12 months.). Previously administered products included for an unreported indication: INFLUENZA VACCINE (She had the flu shot in the fall of 2020.) in 2020. Concurrent medical conditions included Notalgia paresthetica. Concomitant products included TRAZODONE for Insomnia, GABAPENTIN for Notalgia paresthetica, POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) from 07-Jun-2021 to an unknown date, HYALURONIC ACID (JUVEDERM), BOTULINUM TOXIN TYPE A (BOTOX), HYALURONIC ACID (RESTYLANE), HYALURONIC ACID, LIDOCAINE (RESTYLANE L) and BOTULINUM TOXIN TYPE A HAEMAGGLUTININ COMPLEX (DYSPORT) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced NODULE (nodule). At the time of the report, NODULE (nodule) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The HCP said to massage nodule 2x a day for 2 minutes for 2 weeks but the patient had been told by previous providers to do it 5 minutes a day 5 x for 5 weeks. Her husband who is a retired physician thinks it's about a 2-3 mm nodule. Patient has had Voluma, Vollure, in past. Treatment information was not provided.
Around 9am recieved the vaccine  930 am extreme neck pain traveling to fingers  8pm slight confusion, body pain, eye pain 11pm chills, nausea 2/20/2021 1am shakes, chills, body aches, temp of 102, back pain pressure in head, extreme head ache (never had one so bad). Skin pain when touched by anything including blankets,  7am - until extreme fatigue hard to get out of bed. Eye pain jaw pain,  lymp nodes pain throughout my body head ache at a 10, both arms hurt. Cough
Moderna COVID19 vaccine for Age 6m-5y was ordered and given to a 12yo. No reported adverse events.
CHILLS; JOINT PAIN; FATIGUE; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was on cholesterol medication and had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced chills. On 04-MAY-2021, the subject experienced joint pain. On 04-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from chills, joint pain, and fatigue. This report was non-serious.
Gradually worsening tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm left on 07Apr2021 at 19:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), tadalafil (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), aluminium hydroxide, magnesium hydroxide (MAGNESIUM), colecalciferol (VITAMIN D3) and ascorbic acid (VITAMIN C) for unknown indication from an unknown date. The patient previously received amoxillin (MANUFACTURER UNKNOWN) and bactrim (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. 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 08Apr2021 at 12:00, the patient experienced gradually worsening tinnitus. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event worsening tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
On 7/2019 woke with a red itchy rash on the left arm (where the vaccine was given.  Pain started in shoulder and went into the palm of the hand and the left thumb was numb.  Nurse practioner gave me a steroid shot and a muscle relaxer. I have been using cortisone cream,  but the symptoms are still there. Cannot see my dermatologist until the end of August
Lt deltoid and mid region with hot and were swelling and erythema tender on palpation 24 hrs post vaccines.
Swollen Lymph nodes, body aces, fatigue, headache breast pain. Lymph nodes began 2-3 days after 2nd vaccine. Swelling in breast began on 2/12/21 increased on the 13th to feeling of infection in left breast (heat, pain, extreme swelling) visited medical on the 13 and started antibiotics Keflex that day
sore arm; sick; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and sickness. On an unknown date, the outcome of the pain in arm and sickness were unknown.   It was unknown if the reporter considered the pain in arm and sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as an adult as per the vaccine indication. The reporter states that she works in a pharmacy and had heard a lot of people had sore arms and were sick after 2nd dose of Shingrix. The reporter states she was not sure if any these were reported, declined to provide further details. This case has been linked with the cases US2019GSK103032 and US2019098035, reported by same reporter.
pt recv vax & 1wk post vax MD devel pain in deltoid that hurts to even raise arm over head;pain is worse in the morning & the evening;It was also reported that the pain lasted for approx 2wk;
She has a 2x2 inches rash about 3 inches from the injection site. It is red and warm to touch. Pt also said it itches.