chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced fever. It was reported that she had fever (probably around 99 F) a week after the first shot of the COVID-19 vaccine, she wanted to know if she should consult her physician about this, she was unsure if she should get tested for COVID-19 "again" or if that was a normal reaction. The patient underwent lab tests and procedures on an unspecified date, which included body temperature: 99 fahrenheit (probably around 99 F). The seriousness of the event was reported as non-serious. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
was administered after the excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA724Z, expiry date 30th September 2023) for prophylaxis.   On 5th October 2022, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.      Additional Information: GSK Receipt Date: 01-DEC-2022 Reporter's Comment: The reporter reported a clinic site recorded maximum temperature of 35 degree C for Menveo vaccines and that one dose of the Menveo was administered after the excursion. At the time of reporting, the patient had not been redosed. The reporter consented to follow up. Additional Supportive Information: The reporter stated that, one dose of the Menveo was administered after the excursion, which led to incorrect storage of drug. The case had been linked to US2022AMR180586,reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2022AMR180586:same reporter
Pt received #3 Gardasil on 2/22/07. L arm small red dot after shot. On 2/23/07 she started to get larger with raised area on 2/24/07. Size of (2) quarters, itching on/off with minimal pain. On 3/15/07 22mm bump felt under the skin but not raised.
I couldn't breath, my lungs felt full, small coughs, over the night a fever, so bad I was shaking cold, and later soaked in sweat, pounding headache, now just a small headache, and my lungs still feel like I can't get enough air.
Neck rash, face itchy and red. Peeling and skin and very dry. Started 4 days after vaccine approximately 9/8/14.
This case was reported by a consumer, via his father and described the occurrence of dizziness in an unknown number of subjects of  unspecified ages and gender who were vaccinated with Influenza vaccine, manufacturer unspecified. A physician or other health care professional has not verified this report. In 2007, the subjects received unspecified doses of Influenza vaccine (unknown0. The reporter stated his son "has known individuals who have experienced dizziness, inner ear problems, nausea and vomiting after receiving the flu shot this year". At the time of reporting the outcome of the events were unspecified.
Patient was given a booster of the monovalent Pfizer COVID vaccine instead of the bivalent booster
Vaccine H1N1 FLUMIST given 11/13. Pt developed fever and croupy cough 11/14. Symptoms worsened with severe croup and respiratory distress with cyanosis requiring emergency admission and treatment.  12/4/2009 ED/MR records for 11/15-16/2009 patient with c/o's fever, croupy cough, wheezing, poor appetite, runny nose, lethargy, respiratory distress with cyanosis. Tx: resp therapy with nebs, steroids, sx resolved. Dc Dx: Croup
Pt had a fever the night of vaccination. The following morning pt experienced vomiting  and fainted once while making coffee.
Upset Stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset Stomach) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset Stomach). At the time of the report, ABDOMINAL DISCOMFORT (Upset Stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported Treatment information was not provided.
12/25/20-12/26/20:  arm soreness,  extreme fatigue ~2 hours after vaccine. I slept for significant portions of the remainder of 12/25 through 12/26 and had no problems with sleep overnight.  12/27/20:  30% improvement of exhaustive fatigue, arm soreness, mental fog, headache, decreased appetite, low grade fever, chills  12/28/20-12/30/20:  fatigue, arm soreness, mental fog, headache, decreased appetite (+food aversion), nausea (not related to not eating), low grade fever, chills, body aches, joint pain, rhinnorhea, and laryngitis  12/30/20-1/1/21: fatigue, mental fog, headache, decreased appetite (general food aversion), nausea, low grade fever, chills
7OCT98 pt recv vax & 4hr later w/7cm welt, itching, redness, welt down in 24hr, redness remained x 2 days;
it bothered her where the shot was put in her arm.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received BNT162B2 (BNT162B2), administration date 17Mar2021 (Lot number: EN6208) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "it bothered her where the shot was put in her arm.".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021441732 same patient/product, different dose/event.
Mom states pt starting crying @ 8PM & cried till 3AM; Stated @ times, would stop crying & would whimper but majority of time, was loud crying-screaming;
Joint pain in legs; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain in legs) and HEADACHE (Headache) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced ARTHRALGIA (Joint pain in legs) and HEADACHE (Headache). At the time of the report, ARTHRALGIA (Joint pain in legs) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This spontaneous report was received from a Licensed Practical Nurse, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. On an unknown date, doses of RECOMBIVAX HB (lot # L025738, expiration date: 14-AUG-2017; L029631, expiration date: 14-AUG-2017, L038018, expiration date: 13-SEP-2017) (dose and route were not reported) which were exposed to temperatures outside of the recommended range were administered to the unspecified number of patients. It was unknown if the patients sought medical attention. No adverse effects have been reported. The reporter refers that there was not product quality complaint involved. This is one of several reports from the same source. Lot number L038018 has been verified to be a valid lot number for RECOMBIVAX HB. Additional information has been requested.
Around 20 min after receiving flu vaccine , patient complained of chest tightness. No SOB, hives, rash, wheezing. BP 120/80 HR 72 RR20. Undergoing chemotherapy. Oncologist notified, saw patient immediately at area hospital.
Pt fell on his head backwards.  upon regaining consciousness he said he felt dizzy and then collapsed.
SOME SPOTS; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (SOME SPOTS) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriasis.    No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (SOME SPOTS). At the time of the report, IMMUNISATION REACTION (SOME SPOTS) was resolving.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event SOME SPOTS was not provided. No treatment medications were reported.
4-10-21 Fever of 100.7 started at 1:00a.m. and ended in 12 hours.  On 4-11-21 had flashes in Right eye. Saw eye Dr. on 4-14, 5-4 and 5-11 with no determination what is pulling on retina. On 4-11-21 had tingling and loss of feeling in right thigh for approx. one month.  On 5-1 had rash on forehead, 5-3 lump on neck with swollen lymphs. 5-3 saw Dr. and given Valtrax for Shingles which delayed 2nd vaccine on 5-7.  On 5-19-21 given 2nd vaccine at 9:30a.m., took Alleve at 10:30a.m. and at 8:15p.m. after fever started which last 24 hours this time.  On 6-15-21 started having inflammation in legs mainly the knee area.  On 6-18 belly pain starts. 6-24 went to ER. Had CT scan and bloodwork with nothing found. On 6-24-21 went to ER with belly pain. CT scan and blood work done with nothing found except prior uterine fibroids that were no issue. On 6-25 saw GYN Dr. who found nothing and said I was an anomoly then referred me to Hospital same day for pelvic untrasound with no findings.  Also started vaginal bleeding.  On 7-19, 7-20 and 7-21 had severe belly pain again. Saw GI Dr. on 7-22 who found nothing specific but gave RX Dicyclomine for possible spastic colon to see if it would help. 7-29-21 stopped bleeding.  On 7-30-21 Dr. perfomed D & C with Hysteroscopy at hospital. On 8-19 Dr. said there are no issues and I am cleared.  In early August woke up one morning with severe soreness in arms and legs which continued thru Oct 12th when I met with RA Dr.  On Aug. 27th had blood work ordered by Dr. which showed elevated C Reactive Protein and elevated SED rate.  Dr. diagnosed me with PMR Poly Myalgia Rheumatica and started on 20mg Prednisone.  For over 2 months had limited range of motion.  Trouble walking, showering and getting dressed. Was becoming borderline disabled. Pain was worse at night. Hurt a lot just to just barely move.  A few days could not move right arm much at all. Prednisone eased the inflammation and pain starting in about 12 hours. Will follow up on Dec. 14th with Dr. after getting more blood work. Was told they had seen some of these cases since the COVID vaccines.   Also on 9-9-21 saw an Ortho Dr. who x-rayed knees. Said osteo-arthritis and can do physical therapy.  Over time had several visits to PCP and GYN Dr.  Incurred over $6500.00 in medical bills that is my portion to pay which I do not have.  ALSO HAD A LOT OF PAIN AND DISCOMFORT!!!!
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was unknown that the patient received any other medication within 2 weeks of vaccination. The patient received anti-viral drug (Paxlovid) from 20Jul2022 to 25Jul2022 for the treatment of COVID-19. Rebound infection with symptoms worse than initial symptoms. Congestion, headache, sinus drainage. Tested negative for two days prior to testing positive again. Still symptomatic a week after test positive again. No known allergies were reported. Report about covid treatment was yes. Adverse event start date reported as 30Jul2022 and patient recovered. Known allergies reported as no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patients were given shots during excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A and 065D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 28-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions). On 28-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.
INADVERTENTLY RECEIVED 2ND COVID-19 BOOSTER DOSE EARLY, WAS NOT ELIGIBLE FOR 2ND BOOSTER UNTIL 5/27/22.
All over body aches; severe headache; fever for 3 days so far; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0168) via an unspecified route of administration, administered in the left arm on 15May2021 17:00 (at the age of 52 year old) as dose number unknown, single for COVID-19 immunisation at pharmacy or drug store. Patient was not pregnant at the time of vaccination. Medical history included covid-19 (if covid prior vaccination: Yes). Patient had no known allergies. Concomitant medication(s) included bupropion, sertraline. No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. On 16May2021 02:00 the patient experienced all over body aches, severe headache, fever for 3 days so far. The patient underwent lab tests and procedures which included sars-cov-2 test resulted yes on an unknown date, body temperature: result: unknown on 16May2021. No treatment was received. Events were not assessed as serious. The clinical outcome of the events all over body aches, severe headache was reported as not recovered and fever for 3 days so far was reported as recovered on May2021.  Follow-up attempts completed. No further information expected.
Chills, fever, body aches, heart palpitations, back pain, heart burn, weak, and shortness of breath.
pt recv ax 2JUL97 & 6JUL97 pt devel a rash on rt arm;first they started like a pimple in clusters & then they had a thin scab on them but there were still new ones appearing;
Arm soreness due COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness due COVID-19 vaccine) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness due COVID-19 vaccine). At the time of the report, PAIN IN EXTREMITY (Arm soreness due COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
This case was reported by a lawyer via a statement of injuries and described the occurrence of neck pain in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced neck pain, back pain, stiff back, joint pain (knee, elbow, shoulder, and right ankle), scapula pain, thigh pain, severe headaches including migraines, leg heaviness, loss of balance, fatigue, "mottling in her eyes", and numbness/tingling in her toes, legs, back, arms, face, and fingers. The statement of injuries further alleged that the events "negatively impacted on her activities of daily living and enjoyment of life". At the time of reporting the outcome of the events were was unspecified. Follow-up information was received on 27 July 2009 via medical records. The subject was evaluated on 27 November 2001 for her headaches. She reportedly had a history of headaches for many years. Following exam, it was believed that the subject was suffering from either tension headaches versus migraines. She described a constant pulling feeling in the back of her head suggestive of a tension headache. However, migraine headaches can sometimes be associated with constant occipital pain. She has a family history of migraine. Her exam was unremarkable. The subject was seen again for headaches on 29 January 2002. It was remarked that it was not clear whether the subject suffered from tension headache versus atypical migraine. She was placed on Amitriptyline. The subject was evaluated for headache through 28 January 2003 and continued to do well on Amitriptyline. On 20 May 2003, it was reported that the subject was experiencing frequent headaches. The headaches were described as migraines. She was taking Amitriptyline, ACTONEL and ELAVIL. She was switched to TOPAMAX at this visit. In follow-up on 26 August 2003, it was reported that headaches were better and resolved after she stopped drinking coffee. At this visit, the subject reported right shoulder pain and pain at the tip of the right shoulder blade. She received chiropractic treatment and shortly afterwards started to experience numbness in the right second toe and occasional numbness in the left foot. Once she reported numbness in her fingertips bilaterally, but it resolved. Impression was believed to be cervical spondylosis. She was referred for physical therapy. The subject's second problem was numbness in the toes which was associated with decreased vibratory sensation on examination. This was suggestive of possible early polyneuropathy; the etiology was not clear. Additional testing was suggested. On 13 October 2003, the subject was seen in follow-up with new complaints of low back pain and spasms in the lower back. She was still having symptoms in both lower extremities. She had tightness in the calf muscles bilaterally and numbness in the toes. The
12 days post vaccine I had a red, blotchy, raised area around injection site. It extended for 4 inches down the arm, and was about 3 inches wide. Warm to touch, and slight discomfort but not painful. This is getting better but its still present, day 4.
35 Y O female presents with soreness and redness to left arm after receiving covid 19 vaccine on 1/6/2020. Does not hurt much but itches a little bit. It feels hard and very itchy. Applied ice with mild relief of symptoms. She has a hx of arthritis and psoriasis.
Glands still hurt; Lymph nodes in groin area between; Swollen Lymph odes in Armpit; Swollen Lymph nodes in Neck; Blisters on her Tongue; Swollen Tongue; Hard to Swallow; Diarrhea (a little); Stomach Upset (a little); Fatigue; Pain in Upper Arm Injection Area and 3" surrounding; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE BLISTERING (Blisters on her Tongue), SWOLLEN TONGUE (Swollen Tongue), DYSPHAGIA (Hard to Swallow), DIARRHOEA (Diarrhea (a little)) and ABDOMINAL DISCOMFORT (Stomach Upset (a little)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulfa).    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced TONGUE BLISTERING (Blisters on her Tongue), SWOLLEN TONGUE (Swollen Tongue), DYSPHAGIA (Hard to Swallow), DIARRHOEA (Diarrhea (a little)), ABDOMINAL DISCOMFORT (Stomach Upset (a little)), FATIGUE (Fatigue), INJECTION SITE PAIN (Pain in Upper Arm Injection Area and 3" surrounding), LYMPHADENOPATHY (Lymph nodes in groin area between), LYMPHADENOPATHY (Swollen Lymph odes in Armpit) and LYMPHADENOPATHY (Swollen Lymph nodes in Neck). On 17-Feb-2021, the patient experienced PAIN (Glands still hurt). On 16-Feb-2021, TONGUE BLISTERING (Blisters on her Tongue), SWOLLEN TONGUE (Swollen Tongue) and DYSPHAGIA (Hard to Swallow) had resolved. At the time of the report, DIARRHOEA (Diarrhea (a little)), ABDOMINAL DISCOMFORT (Stomach Upset (a little)), FATIGUE (Fatigue), INJECTION SITE PAIN (Pain in Upper Arm Injection Area and 3" surrounding), PAIN (Glands still hurt), LYMPHADENOPATHY (Lymph nodes in groin area between), LYMPHADENOPATHY (Swollen Lymph odes in Armpit) and LYMPHADENOPATHY (Swollen Lymph nodes in Neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Chills, malaise, loss of appetite, muscle aches, joint pain, red painful arm began approximate 18-24 hrs after vaccine and continued for 4 days. Missed 1 1/2 days work. Also vomiting.