chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Improper storage of product; No adverse event; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were unknown. On 06-FEB-2020, the patient received a dose of improperly stored (product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose with lot # 1660112, expiration date 18-OCT-2020 (anatomical location was unknown) via oral route for prophylaxis. The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at multiple temperature excursions of below 2 degrees Celsius (1.28 degree Celsius) for a time frame of 2 hours and 30 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Tender two nights after vaccine admin that self resolved. 21 days after, the arm started throbbing and having deltoid spasms. Pain radiated from elbow to skull up To ears. Spasm would come and go. Tingling in forearm also reported. Lasted three or four days and then went away the day before the second shot.
20 mins p/vax pt exp red, raised rash; rash on neck, underchin, chest, shoulders, exp itching all over including eyes, felt nervous, inject site remained reddened for 2 wks;
Patient had chills the night after the vaccine and throughout the night pulse ox dropped to 88, given 3L O2. Pt  had little sleep and the next day had no appetite pulse ox between 88-90. After dinner had severe chills, no fever ,extreme SOB , pulse ox down to 79, coughing up blood tinged sputum, fluid in lungs, anxious. EMT called sent to hospital confirmed to have had an MI and new onset CHF, enzymes elevated, creat 1.8. Transferred to hospital and was stable. The next day still SOB, enzymes lessening, trying to wean from O2. The nurse attempted to get the pt to the bathroom he became extremely SOB and became unresponsive. They attempted CPR and the pt expired shortly thereafter due to another MI.
12/6 at 3p pneumococcal adm. (L) deltoid, 3-11 no adverse RXN., 12/7 5A pt c/o left arm pain, area is hard left mid upper arm (below the injection site 2-3" no redness warmth at this time 7:15A nurse noted moderate amt swelling (R) elbow --> (R) mid arm (below inj. site) redness MD notified ordered KEFLEX 250mg po qID x 7 days, CBC and cold compresses. Stable - cond. Better later during day trans to ER ? R/T vaccine. dev. rash BLE and back with (L) sided weakness.
Large swollen area above left clavical bone.   3mm round hard area.  Tender to touch.  Warm and Red. 7-21-2012 she reported lymph node under right arm swollen.  Referred to Primary MD.
CAN'T WALK WITH OUT GETTING EXHAUSTED, CAN'T DO MY 20 MIN YOGA WORKOUT,
I?m addition to the heart pain, respiratory issues, rashes, nerve issues, sharp back pain for over a months and other issues I previously reported, I started noticing hair loss at my scalp a few months later. I thought maybe it?s because of stress from the pandemic, but it hasn?t been growing back, I?m only 32 experience female pattern hair loss, and I started looking online and others reported the same after their mRNA vaccine so I?m wondering if my hair loss could be due to my vaccine considering it didn?t start happening till after I was vaccinated.
Initial and follow up information has been received for a Merck Pregnancy Registry via a health professional concerning a female who on 06-SEP-2006 was vaccinated with the first dose of Gardasil (lot not reported). On 08-NOV-2006, the patient was vaccinated with the second dose of Gardasil (lot reported as "9725101"). The patient was found to be pregnant after receiving her second dose, and it was noted as "second trimester". Routine vital signs were noted to be performed. The patient sought unspecified medical attention. Additional information has been received concerning the 24 year old female who had her last menstrual period on 27-FEB-2007 (estimated date of delivery, 04-NOV-2007). From 23-MAR-2007 to 03-MAY-2007 the patient was treated with PROMETRIUM, 200 mg BID, for low progesterone. From 23-MAR-2007 to the present she was treated with PHENERGAN, 25 mg PRN for nausea. On 26-MAR-2007 an ultrasound was performed due to "spotting". The results of test were "Early IOP". Additional information has been requested.
1-2min post vax -lacy roseola rash on trunk, upper/lower extremities;also causing obvious trouble breathing, crying & anxiety (turned blue w/central cyanosis-did not lose consciousness for approx 15min rash & some crying cont for 30min;
pt given vax & devel urticarial rash on face;arms & itching all over & did not feel good;
13-year-old 1 Dose of Engerix-B Peds, Received HEPLISAV-B Instead of Dose 2 of Engerix-B Peds; 13-year-old 1 Dose of Engerix-B Peds, Received HEPLISAV-B Instead of Dose 2 of Engerix-B Peds; Initial Report Received on 09-Jun-2023.  Additional information was received on 16-Jun2023.  A physician reported that a 13-year-old (gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization instead of a second dose of Engerix-B Peds.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unknown date, the patient received a dose of Engerix-B Peds.  On an unspecified date, the patient received a dose of HEPLISAV-B (route, lot #, expiration date and NDC # not reported) instead of the second scheduled dose of Engerix-B Peds.  The reporter advised to count this as a valid dose and to proceed with the 6-month dose of Engerix-B Peds.  No additional information was reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
At 3:35 PM on 12/01/21 (1 1/2 hours after vaccination), patient had a massive breakout of hives. A large patch on her right side torso 14" long and 10" wide; patches of hives on her forehead, nape of neck, right forearm, belly button area and back of left leg. NO hives around injection site. NO breathing issues. Contacted doctor, gave OTC doses of Benadryl, Zyrtec and covered affected areas with Hydrocortisone cream. Within 45 minutes, the hives were 75% resolved. By bedtime, 100% resolved.  On 12/02/21, patient noticed that the big toes on both feet were swollen. They were a bit uncomfortable for her but tolerable. Gave her another dose of of Benadryl and Zyrtec. NO breathing issues, NO itching. This resolved after 3 days.  On 12/03/21, patient woke at 7AM and her cheeks and forehead were extremely swollen. She could barely open her eyes and complained about being sleepy. NO breathing issues, NO itching. This continued for several hours. At 10AM we gave her a dose of Benadryl and Zyrtec and applied ice packs to her forehead and cheeks. After 30 minutes, the swelling began to go down. We contacted her doctor, and went for an appointment at 4:30PM. At the doctor's office we saw a PA, who agreed that this was almost surely a reaction to the 2nd dose of the Pfizer MRna vaccine. The facial swelling took about a day to go down.
Patient had difficulty breathing, fainted, gasping for breath, given epinephrine injection in thigh, started to become conscious and breath more easily, then started vomiting. Called 911 in meantime. Patient taken to hospital.
Chest pain, palpitations, facial numbness, feeling of passing out, can't keep eyes open, hard to catch breath.
could not bend his foot; could barely walk; flu like symptoms; pain on the ball of his left foot; sesamoiditis of the 2 small bones of his left foot/tendonitis; headache; eye strains when looking at the computer; This spontaneous case was reported by a physician and describes the occurrence of METATARSALGIA (pain on the ball of his left foot), TENDONITIS (sesamoiditis of the 2 small bones of his left foot/tendonitis), LIMB DISCOMFORT (could not bend his foot), GAIT DISTURBANCE (could barely walk) and ASTHENOPIA (eye strains when looking at the computer) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 030M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Athletic pubalgia (12-11 years ago (2006 or 2007)).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced METATARSALGIA (pain on the ball of his left foot), TENDONITIS (sesamoiditis of the 2 small bones of his left foot/tendonitis), LIMB DISCOMFORT (could not bend his foot), GAIT DISTURBANCE (could barely walk) and INFLUENZA LIKE ILLNESS (flu like symptoms). In November 2021, the patient experienced ASTHENOPIA (eye strains when looking at the computer) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. In November 2021, LIMB DISCOMFORT (could not bend his foot), GAIT DISTURBANCE (could barely walk) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, METATARSALGIA (pain on the ball of his left foot) and TENDONITIS (sesamoiditis of the 2 small bones of his left foot/tendonitis) was resolving and ASTHENOPIA (eye strains when looking at the computer) and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported   This case was linked to MOD-2021-385888, MOD-2021-385871 (Patient Link).
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 16-FEB-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of RECOMBIVAX HB lot# K009953 and expiration date: 03-APR-2016, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Covid arm (Red itchy rash); Rash; Headache; Chills; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Covid arm (Red itchy rash)), RASH (Rash), HEADACHE (Headache), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Covid arm (Red itchy rash)), RASH (Rash), HEADACHE (Headache), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC R) at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form; TRIAMCINOLONE at a dose of 1 dosage form and ACETONIDE DE FLUCLOROLONE at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Covid arm (Red itchy rash)), RASH (Rash), HEADACHE (Headache), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's Concomitant Meds also include: Birth control pill and vitamins   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: No specific follow-up information recorded. This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Covid arm (Red itchy rash)), RASH (Rash), HEADACHE (Headache), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Covid arm (Red itchy rash)), RASH (Rash), HEADACHE (Headache), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC R) at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form; TRIAMCINOLONE at a dose of 1 dosage form and ACETONIDE DE FLUCLOROLONE at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Covid arm (Red itchy rash)), RASH (Rash), HEADACHE (Headache), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's Concomitant Meds also include: Birth control pill and vitamins
Muscle had severe burning sensation along with a peculiar feeling, like shards of glass embedded comes and goes but enough to interfere with daily living and movement
Patient developed headache and nausea on 1-11-2021. She was hospitalized on 1-14-2021 at Hospital. Found to have dural sinus thrombosis of the superior sagittal and right transverse/sigmoid sinus on MRV brain.  Currently admitted to ICU at Hospital, getting injectable blood thinners.  Neurology and hematology have been consulted.
According to patient, she received a COVID 19 vaccine in September, 2021. She reports immediately began to feel sick with multiple symptoms. Initially on 9/20/21, her symptoms  were reported via phone/ text communication. She reports that she was "pretty sick after second jab, in bed all week, dizzy, nausea, soreness, no appetite". Reported she had no symptoms from first vaccine, but symptoms began after second vaccine, in which symptoms started that night with no appetite, cough, weak, dizzy splitting headache, neck and arm numbness and pain, shortness of breath "feeling awful" and "almost passed out". Instructed patient flu like symptoms non uncommon following vaccine, rest at home.
The patient did not experience any symptoms; An adult patient received second dose of VAQTA one month after receiving their initial dose/ given 1 month after 1st one instead of 6-12 months; This spontaneous report was received from a registered nurse and refers to a 43 year old female patient. The patient concomitant therapies included benztropine mesylate, perphenazine, vitamin d (unspecified), lithium and the first dose of hepatitis b virus vaccine.The patient's concurrent conditions included depression, dermatitis, vitamin D deficiency, lipids increased, hyperhidrosis, overweight, altered mental status, and allergy to sulfas, penicillins and nitrofurantoin. The patient was not ill at time of vaccination.  On 19-SEP-2019, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated(VAQTA) intramuscular lot # S012250, expiration date 07-JUL-2020 (dose and anatomical location were not provided); and the first dose of poliovirus vaccine inactivated (unspecified) intramuscularly, lot # PIA2420 expiration date 26-APR-2020, for prophylaxis. On 24-OCT-2019, the patient was vaccinated with a second dose of with hepatitis a vaccine, inactivated(VAQTA) (dose, route, anatomical location, lot # and expiration date were not provided). On the same date, the patient was additionally vaccinated with second dose of hepatitis b virus vaccine (unspecified) intramuscularly, lot #9N259 expiration date 04-DEC-2021 and second dose of poliovirus vaccine inactivated (unspecified) intramuscularly, lot # PIA25IM expiration date 22-MAY-2020.  It was reported that the person who applied the vaccines was a medical assistant, who was trained. No prescription drug treatment was required. No adverse effects were reported.
pt had a positive COVID test on 8/22/22; inpatient hospice; pt passed away in local Hospice; no other records
Child experienced knee joint pain in same leg where vaccine was administered.  Pain onset was 12 days post vaccination, and lasted for a week.  Child stopped walking for a week due to the joint pain.  No injury to affected joint was witnessed.
"her arm (at the injection site) had a red spot; her arm (at the injection site) had sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 67-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Feb2021 (Batch/Lot number: unknown) at the age of 67 years as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.   Vaccination history included: Bnt162b2 (Caller reported that his wife is 67 years old and she received her first dose of Pfizer-BioNTech COVID-19 Vaccine on 28Jan2021), administration date: 28Jan2021, when the patient was 67 years old, for COVID-19 immunization.  The following information was reported: INJECTION SITE ERYTHEMA (non-serious), outcome "recovered", described as ""her arm (at the injection site) had a red spot"; INJECTION SITE PAIN (non-serious), outcome "recovered", described as "her arm (at the injection site) had sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started with chills, felt like when my body was touched the pain radiated all over the area. That got worse turned into body aches headache and high fever.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On or about 09-DEC-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, they had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
Small hive-like bumps on abdomen, left and right shoulder and arms.  Bumps are generally about 1/4" i diameter.  No professional treatment.  Rubbed topical analgesic in bumps, took two benedryl tablets.  Bumps are mildly itchy.
(severe chills, 2 hrs) (aching shoulders and neck, 1 day) (fever, nausea, severe light and smell sensitivity, 2 days) (Severe headache, 3 days)
flu like symptoms; chills; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and chills. On an unknown date, the outcome of the influenza-like symptoms and chills were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and chills to be related to Shingrix.  Additional information was provided as follows: The case was reported by the wife of patient. The age at vaccination was not reported. In 2020, the patient received 1st dose of Shingrix on left arm. The patient experienced chills and flu like symptoms which were resolved in 1 day. The reporter mentioned that, her husband had received both the shots in 2020 but could not provide the specific dates. The reporter consented to follow up. For tolerance of 2nd dose, refer case- US2021AMR008973, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR008962:same reporter US-GLAXOSMITHKLINE-US2021008404:same reporter US-GLAXOSMITHKLINE-US2021AMR008973:same patient, 2nd dose
Moderna 3/25/21, 4/22/21. Positive on 9/6/22
Approximately 10 hours after 2nd Moderna vaccine shivers, fever and headache. Over the next 24 hours severe thirst, nausea, shivers, fever, body aches and headache.  Unable to drink anything due to severe nausea and vomiting for 48 hours. Extreme sensitivity to light for 4 days, unable to have any light, natural or other, in the room because of the headache and light sensitivity. Vomiting continued for 2 days.
Mom states child cried for 3 hours after vaccinations. Reports same thing with first round of shots at 2 mths.
Information has been received from a physician concerning 3-4 infants who in 2006 were vaccinated PO with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live. The physician reported that in 2006, the infants developed a fever after vaccination. Unspecified medical attention was sought. Subsequently, the fevers resolved. Additional information has been requested.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Patient inadvertently given the Moderna 6-11 year formulation instead of the bivalent booster.
After I gave the flu shot, I told the patient you are all set, but not responding to me so when I checked her she was not responding.Patient became unconscious for 5 seconds or less, had jerking movement like having a seizure. Eyes still open though. Then suddenly woke up did not recalled what happened so we told her she was unconscious for awhile then afterwards she cried realizing what happened to her. Called the Mom and I asked if she ate anything then told us nothing to eat did not even drink water that morning. We told the Mom will call 911 just to be sure although they said she was fine. After maybe 10 minutes or less the EMT arrived and checked her said she was fine but continue to observe her at home and will not go to work that day.
Tingling on arms,legs,face for 2 days after vax; 5 days later prickling, tingling in feet, numbness in lower legs & feet, slowly subsided. Dx:post-vax paresthesias/neuritis.
A localized rash with vesicles filled with fluid on the right arm. Paitent has reported that rash is not painful, and that she had it checked with her doctor, and they think it's a minor chickenpox or shingles rash.