chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 0100 on 07/20/16, developed hot flashes and nausea, vomiting, and dizziness. Unable to keep fluids down. Diarrhea started at 0900 7/20/16. Symptoms still occurring.
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 24-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
my bones get cool; I get cold; severe pain in my neck; tired body and I have to lie down; I fall asleep/Sleeping is almost like being unconscious; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 09Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing), notes: I have depression, and if I don't take the Clono Pill, I don't sleep for even a minute. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Unknown manufacturer), for COVID-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset Jun2022, outcome "recovered" (2022), described as "I fall asleep/Sleeping is almost like being unconscious"; FEELING COLD (non-serious) with onset Jun2022, outcome "recovered" (2022), described as "I get cold"; BONE DISORDER (non-serious) with onset Jun2022, outcome "recovered" (2022), described as "my bones get cool"; NECK PAIN (non-serious) with onset Jun2022, outcome "recovered" (2022), described as "severe pain in my neck"; FATIGUE (non-serious) with onset Jun2022, outcome "recovered" (2022), described as "tired body and I have to lie down". The events "my bones get cool", "i get cold", "severe pain in my neck", "tired body and i have to lie down" and "i fall asleep/sleeping is almost like being unconscious" required physician office visit. Therapeutic measures were taken as a result of bone disorder, feeling cold, neck pain, fatigue, somnolence. Additional information: On 09Jun2022, patient got the COVID vaccine number 4. About 2 weeks later, she started to have strange and strong symptoms. She needed to resolve some of the adverse effects. Right now, she's fine, her bones get cool, she gets cold, gets severe pain in her neck, tired body and have to lie down, fall asleep. Sleeping was almost like being unconscious, because the alarm on the phone sounds, people call her and don't hear anything. Her body wakes up when it feel like it. She has a lot of problems because of the situation, and claims her doctor was crazy, all she knows to tell her was to take acetaminophen. Doctor tells her that these were the normal side effects of the pills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1. Complete Lethargy 2. DiaRRhea for 3 wks.  3. Nausea 4. Fever / sweats 5. Rash Body Wide 6. Flu like symptoms Stomach is still Nauseated
During routine lab tests drawn on 10/22/2021 I was found to have a platelet count of 139x10E3/ul (Normal being 150-450 x10E3/ul.)  One year earlier they were 162 x 10E3 within normal range.  I have never had a low platelet count previously.  I am wondering if thrombocytopenia might be a possible side effect of  an mRNA Covid Vaccine?
After about 3 weeks before it was time to get my 2nd dose   i have been having arthritis like discomfort in left and right hand ( cramping) and discomfort  my lower neck and discomfort left arm.  It is a on going issue and the only i can conclude is its from the vaccine.   I had severe pelvic area cramps and severe tenderness of the pelvic area prior to everything else happening. This only lasted 2-3 days.
No adverse effects; the patient was inadvertently administered a dose of Rotateq; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.  On 18-JUL-2019, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R012957 with expiration date of 11-JUN-2019, orally (strength, frequency, dose, lot # and expiration date were not provided) for prophylaxis.  No adverse effects were reported.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored GARDASIL (strength, dose, frequency, lot # and route were not reported). No concomitant medications were reported. No adverse effects were reported. This healthcare worker was inquired about the stability of M-M-R II, however, M-M-R II did not undergo a temperature excursion and is not included in this adverse event (AE). There was no product quality complaint involved. This is one of the several reports received from same reporter. Additional information has been requested.
Cough; head was killing her; Fever (101); Muscle pain; Chilled; Joint pain, knees hurt; A spontaneous report was received from a healthcare professional, a female patient,  who experienced fever (pyrexia), muscle pain (myalgia), cough, headache, chills, and joint pain in knees (arthralgia).  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient, a medical researcher, reported that she received the Moderna Covid-19 vaccine on 23 Dec 2020. She did not experience any side effects until 02 Jan 2021. The patient experienced a fever of 101.7, muscle pain, cough, headache, chills, and joint pain and knees hurt.   Treatment for the event included paracetamol and dextromethorphan hydrobromide for pain and cough.    Action taken with mRNA-1273 in response to the events was not provided/unknown.   The outcome of the events, fever, muscle pain, cough, headache, chills, and joint pain in knees were unknown/not reported.; Reporter'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.
Tachycardia, shortness of breath, right heart strain evident on EKG.  Follow-up tests showed no blockages or anatomical abnormalities. Symptoms are resolving.
Patient received 2nd dose of Pfizer. Afterwards she felt nauseated and vomited x1. Vital signs were taken by paramedic at 11:40: BP 104/68, P74, resp 18, O2 saturation 98%.  states she felt better after few sips of  water. She was able to walk to observation area from vaccination area with supervision.  She was given soda which helped with her nausea. Her VS was taken at 1200: BP 94/64, P69, Resp 18, O2 Sat 100%. All symptom subsided at this time. Patient left with her mother at 12:10pm.
12/25 experienced dizziness, small chest discomfort, and vertigo. Went directly to ER and there they gave me a few tests: Blood, Chest X-ray, CT scan (head). Was given Antivert for dizziness and was kept overnight for observation. 12/26 after a night of observation everything came back OK and was ordered an EKG. On 12/27 EKG was done and no issues detected. Was discharged and given Antivert and Lexapro for the duration. 12/29 ENT after exam was referred to audiologist. No appointment yet set. 01/06 Follow up with PCP.
Hives and dermatographia developed for the first time approximately a week and a half after booster dose.
GI UPSET THAT LASTED A WEEK, EMPLOYEE CALLED OFF SEVERAL DAYS POST VACCINE.
Dose was administered after more than allowed time after first vial puncture; vial was punctured 8/19/21 at 4:35pm and administered 8/20/21 at 2:35 pm
Patient passed out.  Witness (girlfriend) reports patient's eyes rolled to the back of his head and his foot hit the gas when waiting in observation area.  Symptoms started about 5 minutes after vaccination. Patient reports mild lightheadedness and has history of passing out with needles (panic attack).  Patient was observed by EMS and was cleared after 20 minutes.
Beginning today (1/19/2021) reports of abdominal pain, nausea, chills, tinnitus both ears.  Tinnitus has resolved.  Other symptoms remain.  No home remedies taken.
chilled; lack of energy; low grade fever for 5 days; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2, via an unspecified route of administration, administered in left arm on 25Feb2021 16:00 (Batch/Lot Number: EL9266) at the age of 68 years old as dose 1, single for covid-19 immunisation. Medical history included blood pressure, cholesterol, anemia, arthritis, all from unknown dates and unknown if ongoing. Patient was not pregnant. There were other (concomitant) medications in two weeks. The patient previously took phenobarbital (known allergies). No other vaccine in four weeks. The patient was chilled, experienced lack of energy and had low grade fever for 5 days (as reported) on 26Feb2021 19:00. No treatment for adverse events. No COVID prior vaccination and not COVID tested post vaccination. Outcome of events were recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
The pharmacy received Moderna vaccine (lot number 069H21A, expiration 4/6/22) from on 12/6/21 at 3:23 PM. The pharmacy miscalculated the beyond use date as 1/6/22, when it should have been 1/5/22 (30 days from the date received). It appears the pharmacy did not account for December having 31 days, which lead to the miscalculation. Patients administered vaccine after 3:23 PM on 1/5/22 received product that was past its beyond use date.
Patient reported  on 11/01/2017, that he had blisters on his wrist, hands and legs 2 weeks after getting the shots. He saw Dr on 08/10/2017 and prescribed Triamcinolone.
01Oct, 10pm--vomiting.  Restless night 02Oct, attended online school, no energy, slept most of the afternoon, ate only dry toast ~3pm.  7pm temp of 99.5.  10pm temp of 99.1, gave 2 tylenol. 03Oct, slept better, ate some breakfast, temp 97.2 @11.30am.   no further issues
Started running fever of 101 with chills. Body aches, nausea, headache. Blood pressure raised to 148/101 with dizziness
Narrative:  No documentation found on chart review indicating that death was due to COVID-19 vaccine administration.
Swollen Lymph Node in the Left Arm Armpit beginning about one week after the vaccine was administered through injection in the Left Arm. Injection site became sore at the same time. The symptoms have lasted over 24 hours with an increase in pain and a decrease in arm mobility without pain.
FEVER; CHILLS; HEADACHE; MUSCLE PAIN; JOINT PAIN; NAUSEA; roof of mouth raw; left side throat swollen; This spontaneous case was reported by a consumer and describes the occurrence of PALATAL SWELLING (roof of mouth raw), PHARYNGEAL SWELLING (left side throat swollen), PYREXIA (FEVER), CHILLS (CHILLS) and HEADACHE (HEADACHE) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PALATAL SWELLING (roof of mouth raw) and PHARYNGEAL SWELLING (left side throat swollen). On an unknown date, the patient experienced PYREXIA (FEVER), CHILLS (CHILLS), HEADACHE (HEADACHE), MYALGIA (MUSCLE PAIN), ARTHRALGIA (JOINT PAIN) and NAUSEA (NAUSEA). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, PYREXIA (FEVER), CHILLS (CHILLS), MYALGIA (MUSCLE PAIN), ARTHRALGIA (JOINT PAIN) and NAUSEA (NAUSEA) had resolved. At the time of the report, PALATAL SWELLING (roof of mouth raw), PHARYNGEAL SWELLING (left side throat swollen) and HEADACHE (HEADACHE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.
Day of, severe arm pain which was gone the next day. However,  on 3/11/2021 woke with headache, nausea, all over muscle and joint pain, weakness. By mid day, eyes were irritated and sensitive to light.  By 5:00, fever, chills, muscle aches, headache, joint pain, nausea, rapid pulse rate when walking.  Symptoms lasted 3 days.  On 4th day, no fever or chills but still painful headache and some muscle/joint pain and weakness.
Patient presented to pharmacy roughly 48 hours after receiving Fluzone HD and Moderna Spikevax in the Left deltoid. On the same arm about 6 inches down from the injection sites the arm was red, warm, and itchy. The size of the rash was about 5 inches in diameter. Patient stated she woke up with it this morning (10/5/23) and it was that size and has not changed since.
Redness all over the body, including flaky scalp and skin, inflammation, cracked skin on hands and feet, itchy body.
This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 10-JAN-2017, the patient was vaccinated with an improperly stored doses of M-M-R II, lot # M015931, expiration date 30-MAR-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
pt recvd vax & had very sore arm; was red; swollen 2 days after inject; advised to take po antihistamine for rxn; pt stated antihistamine worked;
Severe headache; Jaw pain; Swollen lymph node left armpit; chest pain; Left pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 12Feb2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EZ9262) via an unspecified route of administration in the left arm on 25Jan2021 at 15:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 02:30, the patient experienced severe headache, jaw pain, swollen lymph node left armpit, chest pain and left pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19.  On an unknown date in 2021, the patient underwent COVID-19 virus test and the result was negative. The clinical outcome of the events severe headache, jaw pain, swollen lymph node left armpit, chest pain and left pain was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
PFIZER vaccine that was stored in pharmacy refrigerator given outside of 31 day expiration. Vaccine received at hospital on 11/19/2021. Expiration date on vial 02/2022. NDC# 5926710000
Employee received vaccine on 12/17/20 on 12/18/20 employee noted red rash to abdominal area. Raised no drainage
Healthcare worker describes bruising at injection site on 2/26/2019 that then developed into localized redness with swelling. Healthcare worker states swelling in right arm has continued into 2/27/2019 - AM on 2/27/2019 she took Benadryl and used ice pack on area.
Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016522203) on 05-Dec-2016. This case involves a 65-year-old female patient who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, unspecified timeframe following vaccination, the patient experienced allergy to Tetanus Vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by the sender: None.
They were achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (They were achy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced PAIN (They were achy). At the time of the report, PAIN (They were achy) outcome was unknown.            No concomitant medication was provided.  No treatment medication was provided.  The patient was achy at the night after receiving the booster.
This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 673029/0616AE, expiration date not listed, dose not reported) on 13-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a physician via other company, Pfizer- 2018377136 on 18-Mar-2019. This case involves a patient of unknown demographics who experienced headache/migraine, body ache and labored breathing, while he/she received vaccines TRUMENBA and MENACTRA. The patient had no past medical history and concomitant therapy was unknown. On an unknown date, the patient received a single dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5984AC via intramuscular route in the left deltoid. On 06-Sep-2018 at 13:30, the patient received a single injection of suspect TRUMENBA not produced by Sanofi Pasteur lot T52806 via intramuscular route in the right arm. On 06-Sep-2018, The patient developed a non-serious headache/migraine, body ache, labored breathing same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. Lab test not reported. Final diagnosis was labored breathing, body ache and headache/migraine.   The patient was treated with IBUPROFEN for Pyrexia and Pain, ZOFRAN for Nausea and SUMATRIPTAN for Migraine. (started from 06-Sep-2018, every 8 hours for Zofran and Ibuprofen). The patient outcome is reported as Recovered / Resolved on an unknown date for headache/migraine, as Recovered / Resolved on an unknown date for body ache and as Recovered / Resolved on an unknown date for labored breathing. The reporter assessed the causal relationship to Trumenba.
Left arm red, swollen, warm, itchy. Treated with OTC Benadryl.
Information has been received from a pharmacist (R. Ph.) concerning an approximately 66 year old male with allergy to contrast media dye who on 24-JAN-2011 was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (Merck) (lot # 669191/1456Z, exp: 28-JAN-2012). The reporter stated that the patient phoned her to report that he developed shingles on the left side of his face in February 2011. The patient mentioned he had no rash or facial pain. LST lab work was performed with no results provided. On 04-APR-2011 the patient had recovered from shingles on the left side of his face. The reporter also mentioned that the patient developed nausea and vomiting while using the pravastatin sodium (manufacturer unspecified). Additional information has been requested.
Discomfort; This case was reported by a consumer and described the occurrence of discomfort in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced discomfort. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Shingrix.  Additional case details were reported as follows: The patient asked could she take Tylenol for the discomfort of the Shingrix vaccine she received on day before reporting. The reporter gave permission to follow up.
Patient stated flu shot was administered too high on right arm - feels it went into joint - right after shot he had tingling in right hand and has had persistent nerve pain since then.
Patient states on morning of 1/11/2021 she noted the L deltoid injection site was red, warm  to touch and swollen.  By 1/12/20201 she  also noted fatigue.  She states it does not itch. The patient took Tylenol, benadryl and ice since noting the erythema on 1/11/2021.