chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient received a partial dose with no AE; entire hub of the syringe came off/ there was a leakage with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional (nurse) via Agency (Reference number- 00631232) and transmitted to Sanofi on 07-Jun-2021.  This case involves a 28 years old female patient who received an one mL dose (partial received) of suspect RABIES (HDC) VACCINE [IMOVAX RABIES] (lot T1B492M and expiry date: 07-Dec-2021) via intramuscular route in right deltoid (underdose) for prophylactic vaccination on 07-Jun-2021, as entire hub of the syringe came off and there was a leakage while administrating (syringe issue).  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  The nurse reports confirmed the product was not mishandled. The nurse added that they are not comfortable billing the consumer with the vaccine and was asking about how to process a reimbursement request.  It was an actual medication error case due vaccine underdose (latency: same day).  It was also a case of syringe leak as when reporter was mixing the medication, when she flipped the vial, the entire hub of the syringe came off. They were able to put it back in and administered the vaccine but there was a leakage. The consumer is estimated to have received half the dose.  At the time of reporting, the patient experienced no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
high fevers; A spontaneous report was received from a consumer concerning a 58-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high fevers.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced the event(s) high fevers.  Treatment details included Tylenol and Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  On 1 Mar 2021 the outcome of event(s), high fevers was resolved.
Case number PHEH2014US017394, is an initial spontaneous report received from a nurse on 27 Aug 2014. This report refers to a 20 year old male patient. Past medical history and concomitant medication were not reported. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X14022), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 22 Aug 2014. No adverse event was reported following this administration error.
This spontaneous report as received from a consumer refers to a patient of unknown gender aged 15 (details unspecified) (reported as family member of the reporter). No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with M-M-R II (dosing details, lot#, expiry date and route were not reported) for prophylaxis. On an unknown date, the patient experienced autism. The outcome of autism was unknown. The relatedness of the event to the therapy with M-M-R II was unknown. There were no product quality complaints (PQC) involved. Upon internal review autism was determined to be medically significant. This case is related to case number 1702USA011531 and 1702USA011534 via same reporter link. Additional information is not expected as the reporter did not wish further contact. Sender's Comments: US-009507513-1702USA011531: US-009507513-1702USA011534.
1. Nerve pain and tingling, and weakness in left arm and especially in left hand and fingers.  Generally burning pain and soreness throughout the entire left arm.  Lasted for around 12 hours and occurred ~12 hours after vaccine administration.  2. Significant flare up of muscle stiffness and dystonia, starting 2 days after vaccine.  It may be a myositis-like attack.  Facial muscles (scalp, tmj, forehead, sinuses) are tight, stiff, weak, and numb, and furthermore look swollen.   There was an MS-squeeze like sensation in abdominal muscles that became numb and perpetually contracted; have not had this reaction since removal from known autoimmune triggers (molds).  Skin above affected muscle groups is very hot, as well as numb and equally stiff.  Saw a mild malar rash.  Abdomen still feels stiff to the touch.  3. Significant swelling of abdomen and diarrhea 2 days after vaccine.  Swelling will not go down despite eating health and very little today.
Chicken Pox. First symptoms 5/6. Went to ER on 5/9, was given antibiotics/steroids. Kept spreading so went back to ER and saw a specialist on 5/11. Provided more medication.  I had the chicken pox as a child and haven?t been around large groups since vaccine. Only interacted with a total of 6 family members (all vaccinated/no chicken pox or shingles symptoms).
Development of a roughly circular spot 2 inches below the injection site - 2" diameter, warm to the touch, firm, and very tender. Developed less than 24 hours after injection. Appears to be getting bigger in diameter.
Baseball size, red, swollen bump at site of VARIVAX vaccine.  Parent called office to report these concerns on 3/27/08.  Appointment was made to see patient that day but "no-showed".  Message left to inquire of condition was not returned.
Rash developed on hands and feet. red, hot to touch.    Menstrual cycle disruption
deathly ill"; "could not get out of bed"; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (deathly ill") and GAIT INABILITY ("could not get out of bed") 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.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (deathly ill") and GAIT INABILITY ("could not get out of bed"). At the time of the report, ILLNESS (deathly ill") and GAIT INABILITY ("could not get out of bed") had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.
Acute Headaches (every day) Nerve pain, in different parts of  my body pain on my
fatigued; shooting pains under her armpit close to where she got the shot and the other side/shooting pains in her chest; shooting pains under her armpit close to where she got the shot and the other side/shooting pains in her chest; Chills; stated that she was cold; This is a spontaneous report from a contactable consumer (reporting for herself). A 83-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 28Jan2021 to 28Jan2021 at single dose for COVID-19 immunization. The patient's medical history included allergic mold, yeast and penicillin. Concomitant medications were not reported. On 30Jan2021, the patient experienced fatigued, shooting pains under her armpit close to where she got the shot and the other side, shooting pains in her chest, chills and stated that she was cold. The outcome of the events was unknown.  Information about batch/lot number has been requested.
severe constant dry mouth; mouth herpes/ a case of mouth herpes; numb; My lips were also swollen again, tender, cut; tender lips; upper and lower lips puffed up/ swollen lips; I got clear or white small bumps inside of my lower lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP DISORDER (I got clear or white small bumps inside of my lower lip), DRY MOUTH (severe constant dry mouth), ORAL HERPES (mouth herpes/ a case of mouth herpes), LIP SWELLING (upper and lower lips puffed up/ swollen lips) and HYPOAESTHESIA (numb) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History reported.  Concomitant products included BUPROPION for Depression and Anxiety, GABAPENTIN for Nerve pain, CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]) for Supplementation therapy, CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN for Vitamin supplementation, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced LIP DISORDER (I got clear or white small bumps inside of my lower lip), LIP SWELLING (upper and lower lips puffed up/ swollen lips) and LIP PAIN (tender lips). On 04-Jun-2021, the patient experienced LIP INJURY (My lips were also swollen again, tender, cut). On an unknown date, the patient experienced DRY MOUTH (severe constant dry mouth), ORAL HERPES (mouth herpes/ a case of mouth herpes) and HYPOAESTHESIA (numb). The patient was treated with BIOTIN at a dose of UNK dosage form and VALACYCLOVIR [VALACICLOVIR] from 04-May-2021 to 19-May-2021 at a dose of 1 gram 2/d. At the time of the report, LIP DISORDER (I got clear or white small bumps inside of my lower lip) and LIP PAIN (tender lips) had not resolved and DRY MOUTH (severe constant dry mouth), ORAL HERPES (mouth herpes/ a case of mouth herpes), LIP SWELLING (upper and lower lips puffed up/ swollen lips), HYPOAESTHESIA (numb) and LIP INJURY (My lips were also swollen again, tender, cut) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that she consulted two doctor's and a dentist for the white bumps inside her lower lip.  Treatment provided included hydration paste and blistex.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: ADR form appended. Added patient demographics, race, health care professional contact details, concomitant medications, start date of events, outcome, new events and treatment medications.
Vaccine was 10-1-22, event was 3-1-23, is this really relavent? 2 days dry annoying cough, day 3 added sore throat and cough is getting more frequent and wetter added mucinex cold and flu liquid, day 3-5 gradually more coughing and somewhat productive, throat more sore, feeling gradually worse like 75%, Day 5 really tired and not want to get out of bed and seek out doctor, day 5 given zpack and steroid for 7 days continued mucinex as needed.  after med dose over, continued mucinex and added Allegra 24 hour to handle allergy type symptoms, after 4 more days went back to urgent care with more sinusitis symptoms and given a bigger antibiotic for 7 days.  after med does much better.  after 5 weeks still drainage and some light cough, back to 99%
Patient slumped over in waiting chair shortly after vaccination. Felt like he was going to pass out he said, he got really sweaty and a little shaky. He slumped over twice for about 3 seconds each time, but he was easily woken up and was able to tell me his name. His  symptoms lasted about 15 minutes after his vaccination. He drank some water and had some candy. He felt much improved.
Aching feeling in left arm at the site, joints hurting, headache, blurred vision, and body aches. Symptoms occurred on 8-21-2023. He stayed out of school on 8-22-2023 and returned to school on 8-23-2023.  The parent stated her son was OK to return to school on 8-23-2023. The client's mother said she contacted office and was instructed to give her child Tylenol and Motrin and   alternate.
Patient has a sore arm that will not subside. Patient is treating the pain with Aleve.
The patient received her first covid vaccine on Friday, 2/19/21. The patient did not complain of any ADRs or fever immediately following the injection. However, the next day (Saturday morning) she had a temperature of 100.2 F. Patient received acetaminophen 650mg and fever subsided. 6 hours later, the repeat temperature was 100.4 F and acetaminophen 650mg was given again. When vitals were checked again, her temperature was 98.6 F and remained afebrile for the rest of the weekend. She was not in distress. She had no complaints otherwise.
Pt reports pain right above the elbow. It is affecting her range of motion. No swelling or redness. Arm looks totally normal.
Patient developed large red, swollen, hot area in upper arm of injection site. Redness covered outer arm from shoulder to elbow. On day 3 of event, center of area cleared but 1-2 inches of the edges formed angry, red blisters, which was very itchy. On day 4, patient saw PA, and began taking two OTC oral antihistamines, and applying prescription topical steroid cream to blisters. On day 5, patient developed id reaction on inner forearms. On day 8, patient saw PA again and bloodwork was ordered. By day 12, blisters had disappeared and skin was no longer swollen or itchy. On day 14, skin is still reddish in area of blisters but not hot or itchy. Pics available.
swollen arm, joint pain, breathing issues, elevated auto immune markers in blood test, sudden elevation in RA Factor.
Gilliam Barre and lost 50% of the nerves in legs; Gilliam Barre and lost 50% of the nerves in legs; Initial information was received on 12-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who experienced gilliam barre and lost 50% of the nerves in legs (guillain-barre syndrome) while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (formulation, strength, batch number and expiry date: unknown) via unknown route in an unknown administration site for immunization.  In 2015, the patient developed guillain-barre syndrome as event and 50% nerve damage in legs as a symptom of guillain-barre syndrome (unknown latency) following the administration of Influenza vaccine.   Seriousness criteria: guillain-barre syndrome as event and 50% nerve damage in legs as a symptom of Guillain-barre syndrome were assessed as medically significant.  Action Taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Gilliam Barre and lost 50% of the nerves in legs).  At time of reporting, the outcome was Unknown for the event gilliam barre and lost 50% of the nerves in legs.; Sender's Comments: Sanofi Company Comment dated 18-Feb-2022: This case involves a patient of unknown demographics who had guillain-barre syndrome, after he/she was treated with Influenza vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past medical history, medical treatment(s), vaccination(s) and family history precludes comprehensive case assessment.
A report was received from a health care professional on 12/8/03 concerning 5 children of unspecified sex and aged between 8 months and 3 years of age who inadvertently received Fluvirin on 12/6/03. On 12/6/03, five children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information received from a health care professional indicated that a 1.5 year old male vaccinee inadvertently received Fluvirin on 12/6/03. No adverse events have been reported to date. No follow up pending. All information received.
Oxygen level dropped; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733), via an unspecified route of administration in arm left on 28Mar2021 as a dose 1, single for COVID-19 immunization. It was reported that, other vaccine same date product included Pfizer (Lot number: ER8729), via an unspecified route of administration in arm left on 28Mar2021 as a dose 2, single. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. No covid prior vaccination and no covid tested post vaccination. On 21Apr2021, the patient experienced oxygen level dropped. The AE resulted in doctor or other healthcare professional office/clinic visit. Treatment included was breathing exercise. On 21Apr2021, the patient underwent lab tests and procedures which included oxygen level dropped (oxygen saturation), resulted as decreased. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Shingles rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rash (noted a rash prior to getting Shingrix).   On 14th August 2020, the patient received the 1st dose of Shingrix. On 15th August 2020, 1 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The GSK rep notes the patient was his wife and noted the patient noticed a rash prior to getting Shingrix.  The patient went to her primary care provider, but the provider did not look at the rash and administered dose one of Shingrix.  The patient went to Urgent Care and the rash was diagnosed as shingles. Since the rash began it had increased in size, no exact size provided.
Shingles on right side of face. Treated with Acyclovir for 7 days. Lingering hyperpigmentation typical of Shingles.
Sick as a dog!    Fever of 101.4 p.o., chills, vertigo, nausea,  Severe Malaise, weakness. THIS HAPPENNED AFTER M Y 1ST COVID INJECTION ON MARCH 19TH, 2021,  BOTH TIMES 24 HOURS POST-INJECTION. Injection site clear. I was NOT sick at all Prior to receiving Covid Injections BOTH times !!!!
Patient had several seizures lasting a few seconds each, the morning after being immunized.  He was taken to the Emergency room.
Red, macular line, circumferentially around right arm below smallpox immunization site. non-pruritic.  no lymphangitis, or local LAD.
Had vaccines 08/21/18. Today, 8/24/18, muscle on RT has a hard, pinkish lump about the size of half dollar. When mom rubs it she says "ouwy". She is happy, playful. Slightly feverish. She is sitting in warm bath currently which seems to give some relief.
Daily Migraine; joint pain; minor ache; pain in neck progress to migraine; armpits are tender under both arms; fatigue; Lymph node pain and enlargement; Migraine/Chronic migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine/Chronic migraine), NECK PAIN (pain in neck progress to migraine), AXILLARY PAIN (armpits are tender under both arms), MIGRAINE (Daily Migraine) and ARTHRALGIA (joint pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic migraine in 1956. Concomitant products included SUMATRIPTAN (IMITREX [SUMATRIPTAN]) and FLUOXETINE HYDROCHLORIDE (FLOXETINE) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced MIGRAINE (Migraine/Chronic migraine). On 15-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymph node pain and enlargement). On 18-Mar-2021, the patient experienced NECK PAIN (pain in neck progress to migraine), AXILLARY PAIN (armpits are tender under both arms), ARTHRALGIA (joint pain), MYALGIA (minor ache) and FATIGUE (fatigue). On 10-Apr-2021, the patient experienced MIGRAINE (Daily Migraine). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 27-Mar-2021, MIGRAINE (Migraine/Chronic migraine) had resolved. On 01-Apr-2021, LYMPHADENOPATHY (Lymph node pain and enlargement) had resolved. On 30-Apr-2021, MIGRAINE (Daily Migraine) had resolved. At the time of the report, NECK PAIN (pain in neck progress to migraine), AXILLARY PAIN (armpits are tender under both arms), ARTHRALGIA (joint pain), MYALGIA (minor ache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received first dose on 12 March 2021 in left upper arm (non-dominant) with lot #040A21A . Patient is prone to migraines. She had a migraine for 4 days in a row (March13-16). She did not have one yesterday. Today she woke up with pain starting in back of neck and progressed to a migraine. Today her armpits are tender under both arms. She is fatigued, has minor aches and joint pain. She is drinking lots of water and has taken Tylenol.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Patient demographics is updated, medical history is updated, vaccine information is updated, Events information is updated, concomitant product information is updated
Left side of face pain including eye inside mouth and throat. Felt like bad sinus infection. Still have some throat pain
C/o tightness in the right side of her jaw.no swelling,itchiness,shortness of breath. No history of an allergic reaction. History of diabetes,anemia.paramedics to evaluate