chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15 year old was accidentally given a Flublok vaccine, no AE; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 15 years old male patient who was vaccinated 0.5 ml of suspect with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number QFAA2014 Expiration date: 30-Jun-2021) accidentally via intramuscular route in the left arm for prophylactic vaccination on 25-Sep-2020 (PT:product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitants were given to patient.  It was an actual medication error case due to inappropriate age at vaccine administration (Same day latency).  Patient has not experienced any Adverse Events as a result of this  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 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.
Felt lightheaded. Began having trouble forming words around 3:15-3:30 close to 24 hrs after injection. Words began to slur and I got the chills and then my ears felt like they were on fire. I could feel the blood pumping in my head and I got a headache.
slight swelling of throat; dizziness; extremely fast heartbeat; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date were not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced slight swelling of throat , dizziness, shortly after getting vaccine and extremely fast heartbeat, 15 hrs after receiving the vaccine, on an unspecified date. The patient underwent lab tests and procedures which included heart rate: increased on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Stiffness and pain in shoulder, neck, arm and back. To Urgent Care, ER, and doctors office for unbearable pain. Treatment includes muscle relaxers, Vicodin and steroids.
received an expired dose of Twinrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 17th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-Aug-2022 Reporter's comment: The patient received an expired dose of Twinrix. The vaccine expired on 7 Aug 2022. The consent to follow up was granted. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
4/8/21 ? rapid heartbeat 5 minutes after injection, lasting several minutes, followed by chills for hours.  I woke that night with pain in my left wrist and right elbow.  I sweat at night and wake up sneezing, with itchy eyes, sore throat and sinus congestion.  Sneezing and congestion are less during the day.  The roof of my mouth was also itchy.  I had diarrhea for several days after the vaccination.  Tightness in my chest and shortness of breath throughout the day, lasting a week or more.  My arm was sore for a week.  4/16/21 ? a 4? red rash developed at the injection site and was very itchy.  It was gone by Monday.  4/23/21 ? a rash appeared at the injection site this morning.  It is mildly itchy and feels sore.  The size is 2-1/2? x 1-1/2?
ON 3/15/2021 I WOKE UP EVERY MORNING WITH HIP & LEG PAIN & THAT CONTINUED THRU MY BOOSTER WHICH 10/04/2021.
Fever 101, chills, severe body aches starting 6-8 hours after receiving the vaccine. So far it has lasted 1 day.
PAIN IN STOMACH; SWEATS; REDNESS ON BODY LOOKS LIKE SKIN IS DISCOLORED; CHILLS; FEVER; NAUSEA; BODY PAIN; MIGRAINE; EVERY BEAT OF HEART HURTS; HYPERVENTILATION; COULD NOT GET A FULL BREATH; PASSED OUT'; FINGERS WENT NUMB; GOT A CHARLIE HORSE ON LEG; EVERY SINGLE JOINT AND ANKLES HURTS FOR NO REASON; This spontaneous report received from a patient concerned a 43 year old  male. The patient's weight was 135 pounds, and height was 66 inches. No past medical history or concurrent conditions were reported. The patient's concurrent conditions included migraine The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered, 1 total to right deltoid on 19-MAY-2021 around 10 am for prophylactic vaccination. No concomitant medications were reported.  On 19-MAY-2021, around 7 pm patient started experiencing side effects. After 1 hour of shot patient had his heart hurt at every beats, hyperventilation. It lasted for 1 -2 hours. The patient also had fever, chills, nausea, sweats and had not taken any medication, as he was afraid of another side effects, had redness on his body which looked like skin was discolored and was like hives. The patient also had body pain appeared suddenly. The patient also had pain in stomach which felt like nastiest gas cramp patient had ever and it was continuous like a rock blocking in stomach, he did not know if it is pain or gas but was hurting. Patient had migraine which lasted long time and was continuous than he ever had. The patient was fine as he was speaking at the time of reporting. On MAY-2021 (dates unspecified) the patient experienced Charlie on his leg (muscle spasm) for which he stood up and didn't do anything on leg, he was passed out and fingers went numb, felt every single joint and ankle hurt with sharp pain like a stuffed knife (intermittent pain for 3-5 minutes).He could not get a full breath of air, and was breathing really fast. Then patient tried to slow down breathing as he didn't want to be hyperventilated but it happened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body pain, hyperventilation, migraine, pain in stomach, chills, fever, nausea, and sweats, and the outcome of passed out, could not get a full breath, redness on body looks like skin is discolored, got a charlie horse on leg, every single joint and ankles hurts for no reason, fingers went numb and every beat of heart hurts was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210540430-COVID-19 VACCINE AD26.COV2.S --Every beat of heart hurts, Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Loss of vision, experienced different colors, and gradual loss of vision.  Diagnosed by retinal specialist as an retinal occlusion, or blood clot in the vein feeding the retina.  Left eye is now legally blind.  Dr. gave me a shot in the eye at one appt. , and then laser treatment at 3rd appt.  No improvement noted.  He is still monitoring the eye.
Stiff and soreness in left shoulder (deltoid). Unable to raise arm above head with moderate weight, pain and difficulty with light or no weight.   Pain and difficulty fairly consistent from day 2 through day 8 (today) from injection date. Not getting better.
Patient's arm became very sore to the point of not being able to lift her arm.  sore from injection site, to underside of arm radiating down to elbow.  has been sleeping in recliner.  has not left the house since Monday following administration on Friday.  Doctor at Urgent Care suspects that the injection site was too high
Pt received vaccine at 1305, Pt awaiting husband in post vac area when she began feeling "dizzy" and "lightheaded". Pt state she was discharged from hospital approx 1 week ago for seizures. Patient encouraged to take slow deep breaths in through her nose and out of her mouth. Pt states relief of symptoms approx 1335. Husband at patient side. 1350 patient complains of "tingling". 1400 resolution of symptoms. Pt denied symptoms and further treatment at this time. Husband will drive patient home. Pt educated in the event symptoms should return to call 911 and to follow up with PCP as a standard to todays symptoms and complaints. Pt and husband verbalized understanding.  1325 - HR 87 BP 119/82 o2 98% 1355- HR 83 BP 135/79 o2 97%
I got "COVID Arm" starting the day after my second vaccine. It started in a circle just below my injection site and seemed to spread and get larger. By today (2/14) it has gotten less red and less hot. Also today is the first day it hasn't grown. It has been red, hot to the touch, hard and swollen. Also it's itchy but tolerable.
7/13: developed red, blotchy, rash on torso, back arms started itching on back of neck, face, upper lip swelled. No fever. 7/14: itching more sever, lower lip also swollen, Benadryl didn't help. Saw nurse practitioner at clinic. RX (unknown given: helped. 7/14: evening mostly gone. 7/15: gone/ recovered.
Progressive muscle weakness/Progressive lower extremity muscle weakness; muscle cramps; myalgias; amyotrophic lateral sclerosis (ALS); Moderate to severe neurogenic atrophy; peripheral neuropathy/neuropathy; drop foot on the L side; Limping; toe movement problem; numbness in left leg; Motor neuron disease; This case was reported by a lawyer and described the occurrence of amyotrophic lateral sclerosis in a 58-year-old male patient who received Herpes zoster (Shingrix) for product used for unknown indication.   The following information was received on 23 April 2020 via medical records (case is now medically confirmed). As per the pharmacy record, the patient had shingrix vial kit on 09 June 2018 and 14 August 2018. The patient's past medical history included Former smoker (0.50 pack per day for 10 years, ceased on 02 November 1995). The patient had a Family History of ALS (patient's paternal uncle had ALS) and guillain barre syndrome (The patient's mother had GBS). Concurrent medical conditions included alcohol use (occasional), hepatitis c and essential hypertension. The patient's mother had Guillian Barre Syndrome. As per the pharmacy record, the patient had shingrix vial kit on 09 June 2018 and 14 August 2018. As per medical record dated on 23 October 2018, the patient was present with numbness in left leg with limping. The patient had left toes movement problem. He had progressive muscle weakness in legs since 2018. He has had drop foot on the left side since December 2018. The patient was diagnosed with motor neuron disease in 2018. As per lab report dated on 22 March 2019, He was assess with Neuropathy. On 24 June 2019, he was diagnosed with amyotrophic lateral sclerosis (ALS). On 26 June 2019, during the review of the system, patient was positive for muscle cramps, muscle weakness and myalgias. Left tight muscle biopsy performed on June 2019, Moderate to severe neurogenic atrophy. As per Nerve conduction velocity study 2020, findings was indicative of a sensorimotor peripheral neuropathy in the nerves tested the bilateral lower extremities. It was unknown if the reporter considered the amyotrophic lateral sclerosis, motor neuron disease, neural atrophy, peripheral neuropathy, numbness in leg, foot drop, muscle weakness, muscle cramp and myalgia to be related to Shingrix.      Lab Comments: As per Nerve conduction velocity study 2020, findings was indicative of a sensorimotor peripheral neuropathy in the nerves tested the bilateral lower extremities
pt exp vomiting, t104.3, lethargy, sunken eyes, whimpering/crying constantly, excessive sleepiness, fever began 6hr p/vax peaked @ 11PM 104.3; remained for 40hr;vomiting for 36hr;
R65.10 - SIRS (systemic inflammatory response syndrome)  N17.9 - Acute kidney injury
positive for covid; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive for covid) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (positive for covid). At the time of the report, COVID-19 (positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Individuals tested positive for COVID-19 after receiving their first vaccine..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Day of Pfizer COVID-19 Vaccine, pt experienced fever, soreness under her arm, HA, chest and back aches and hand numbness. She took tylenol for relief--had chest pain(sometimes occurs with pain med usage). Did not reach out for medical advice. Symptoms resolved on their own.
Profound hair loss in clumps.  8/7/07 Received provider medical records which reveal patient experienced good health & developing as expected on day of vax.  On return vx 7/23 large sections of hair missing, scalp was clear w/scant amount of regrowth.  Advised no Pediarix at 6 mos, no third Hep B. FINAL DX: Hair loss, possibly secondary to Hep B vaccine.
Painful; Itchy; I still have it now from Aug have shingle shot/Suspected vaccination failure; I still have it now; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In August 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain and pruritus. The patient was treated with lidocaine. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient said still had it now, from August. The patient had shingle shot, taking pills for it also Ladocaine to rub on it still had it so painful and itchy. The patient give up on it, praying for his healing. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available. The case had been linked with US2021AMR257685, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR257685:pharma case (same patient)
I felt a pain in the lower quadrant of my right breast during the night and there was a hard nodule. It was sensitive to touch. Thursday evening I looked at the area in the mirror and realized that the area was red about 2 inches in circumference and the area was hard and appeared swollen. I saw the doctor the next morning and was put on antibiotics & anti-inflammatory medication. The redness has greatly reduced, but the hard nodule is still present. I have a follow up doctor's appointment this Thursday.
have a reaction after my second booster shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (have a reaction after my second booster shot) 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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IMMUNISATION REACTION (have a reaction after my second booster shot). At the time of the report, IMMUNISATION REACTION (have a reaction after my second booster shot) outcome was unknown.            No concomitant medication were provided No treatment details were provided
630PM pt began screaming rt upper thigh swollen warm to touch-appeared red-very small knot noted per parent;pt screamed constantly until about 10PM;t101;screamed again from 1230AM-130AM;fever of around 101 until about 1PM 17JAN96;
HbA1c level was one point higher; Stay home for 2 days, because of the shot; Sleeping for 2 days; Exhausted; This non-serious case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes, dietary control (the past 3 months or so  had been dieting because preparing for surgery so  expecting HbA1c to go down, not up) and drug allergy (had a allergy to several unspecified medications).   In MAY-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 07-JUN-2023, less than 2 weeks after receiving Shingrix, the patient experienced hba1c increased (Verbatim: HbA1c level was one point higher). On an unknown date, the patient experienced exhaustion (Verbatim: Exhausted), activities of daily living impaired (Verbatim: Stay home for 2 days, because of the shot) and sleep excessive (Verbatim: Sleeping for 2 days). The outcome of the exhaustion, activities of daily living impaired and sleep excessive were resolved (duration 2 days) and the outcome of the hba1c increased was unknown.   The reporter considered the exhaustion, activities of daily living impaired and sleep excessive to be related to Shingrix. It was unknown if the reporter considered the hba1c increased to be related to Shingrix.     The company considered the exhaustion, activities of daily living impaired and sleep excessive to be related to Shingrix. It was unknown if the company considered the hba1c increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JUN-2023 The reporter was a patient. The patient received Shingrix shot about 2 weeks ago from the date of reporting but she did not have the exact date of the shot or the lot number. She provided her pharmacy's name who would had that data on file. The patient reported that she had to stay home for 2 days, because of the shot, due to being exhausted and resting and sleeping for 2 days. The patient also reported that she had her blood drawn and the results show that her HbA1c level was one point higher than her previous score. The reporter did consent to follow up.
rash bilateral arms, shoulders, ankles (red and bumpy) severe diarrhea fatigue loss of appetite
Severe h/a, frontal area, onset 4hrs p/receiving vax & continuing 16 hrs later (now); +photophobia; Tx tylenol 2PO Q4-6hrs PRN HA
Five to six days after getting the vaccines, patient had rashes all over her body. The rashes are itchy and burning. Patient went see a doctor and got prescribed hydrocortisone cream and Benadryl.
Onset S/S 9/12/09 - Allergic reaction developed after receiving 2 vaccines on 9/10/09 - fever, behavior change (not herself) weakness, hoarseness, approx one wk later forehead pimples developed 9/16-9/17/09. Months later April 2010 body blisters arms, abd, back - develop.
Has had flu shots for many years. States arm with usual soreness for 2 days continued past that time. Limited range of motion. First reported to our office 10/31/17. Normal activity is okay but pain at muscle injection site persists when lifting to shoulder height.
Havrix: adult dose given to pediatric patient; 2 pediatric patient (siblings) receive an adult dose of Havrix yesterday on 8/21/2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 9-year-old male patient who received HAV (Havrix) (batch number 9SDB2, expiry date 13-DEC-2024) for prophylaxis.   On 21-AUG-2023, the patient received the 1st dose of Havrix. On 21-AUG-2023, an unknown time after receiving Havrix, the patient experienced overdose (Verbatim: Havrix: adult dose given to pediatric patient) and adult product administered to child (Verbatim: 2 pediatric patient (siblings) receive an adult dose of Havrix yesterday on 8/21/2023).  The outcome of the overdose and adult product administered to child were unknown.   Additional Information: Receipt Date: 22-AUG-2023 Nurse had a pediatric patient received an adult dose of Havrix, which led to overdose and adult product administered to child. The reporter asked what the next step. The reporter consented to follow up. This case had been linked with US2023114115, reported by same reporter.; Sender's Comments:  US-GSK-US2023114115:2 patient (siblings)
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "OCD (Obsessive-compulsive disorder)" (unspecified if ongoing); "high triglycerides" (unspecified if ongoing); "overweight" (unspecified if ongoing). The patient had no known allergies. Concomitant medications included: ATORVASTATIN, start date: 31May2022, stop date: 24Jun2022; FLOMAX [TAMSULOSIN HYDROCHLORIDE], start date: 31May2022, stop date: 24Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 for which included Pfizer PF-07321332, ritonavir (PAXLOVID) from 25Jun2022 to 26Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.