chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Double vision; Panic attack; Couldn't feel his body after 1st dose; Tongue and lips were numb after 1st dose; Pinched nerves; Did not get 2nd dose; He couldn't think well and went to bed/He says he woke up feeling worse; he couldn't think, couldn't think of words and didn't understand what he was reading; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision ), PANIC ATTACK (Panic attack ), SENSORY LOSS (Couldn't feel his body after 1st dose), HYPOAESTHESIA ORAL (Tongue and lips were numb after 1st dose) and NERVE COMPRESSION (Pinched nerves ) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIPLOPIA (Double vision ), PANIC ATTACK (Panic attack ), SENSORY LOSS (Couldn't feel his body after 1st dose), HYPOAESTHESIA ORAL (Tongue and lips were numb after 1st dose), NERVE COMPRESSION (Pinched nerves ), PRODUCT DOSE OMISSION ISSUE (Did not get 2nd dose), MALAISE (He couldn't think well and went to bed/He says he woke up feeling worse) and APHASIA (he couldn't think, couldn't think of words and didn't understand what he was reading). At the time of the report, DIPLOPIA (Double vision ), PANIC ATTACK (Panic attack ), SENSORY LOSS (Couldn't feel his body after 1st dose), HYPOAESTHESIA ORAL (Tongue and lips were numb after 1st dose), NERVE COMPRESSION (Pinched nerves ), MALAISE (He couldn't think well and went to bed/He says he woke up feeling worse) and APHASIA (he couldn't think, couldn't think of words and didn't understand what he was reading) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not get 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Computerised tomogram: nothing was found (Inconclusive) nothing was found. On 08-Feb-2021, Magnetic resonance imaging: (Inconclusive) didn't have MS. On 08-Feb-2021, Magnetic resonance imaging head: didn't have ms (Inconclusive) didn't have MS. On an unknown date, Blood pressure measurement: high (High) Blood pressures high. On an unknown date, Computerised tomogram: unremarkable (Inconclusive) CT scan of the eye which was unremarkable. On an unknown date, Electromyogram: he was found to had some pinched nerves (Inconclusive) He was found to had some pinched nerves. On an unknown date, Heart rate: high (High) heart rate was abnormally high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that  he was found to have no blockages. The neurologist of patient thinks his body's response to the vaccine fried patient's  nervous system.  Patient stated that he was going to get an EEG done on his brain. He was also going to get occupational therapy.
Patient received flu vaccine. Patient approached register to sign for vaccine received. Patient signed for vaccine, then fainted hitting his head on the floor. We then called 911 for assistance. Paramedic transported patient to hospital. After receiving vaccination and falling patient acknowledged that he had fainted before when receiving a vaccination.
PATIENT DEVELOPED FEVER, NAUSEA, SWELLING AROUND THE INJECTION SIDE FOR A FEW DAYS.  ALSO SHE LOST APPETITE FOR A FEW DAYS.  ON THE 3RD DAY SHE FELT "HER SKIN WAS ON FINE" AND IT LASTED FOR 1-2DAYS.
Pharmacist was supposed to give Fluarix, but accidentally grabbed and administered Fluzone High Dose Quadrivalent to a patient, No AE; a 52 years old patient was accidentally administered Fluzone High Dose Quadrivalent, No AE; a 52 years old patient was accidentally administered Fluzone High Dose Quadrivalent, No AE; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious case received from the other health care professional via agency (Reference number- 00358445.  This case involves a 52 years old male patient who was supposed to give INFLUENZA VACCINE INACT SPLIT 3V [FLUARIX], but the pharmacist accidentally grabbed and administered a 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] Prefilled Syringe lot UJ552AA, expiry date: 30-JUN-2021 via intramuscular route in the right arm on 05-Nov-2020 for prophylactic vaccination (Wrong product administered, product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No other vaccines given.  This was a case of an actual medication error case due to the event wrong vaccine administered and inappropriate age at vaccine administration  (latency: same day).  It was also a case of overdose. (latency: same day).  At the time of reporting, no adverse event was reported.  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.
Veins was outside and sore; really big and sore red area; really big and sore red area; all the veins in his R leg was protuberate; two blood clot; DGThrombosis; Felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (two blood clot) and THROMBOSIS (DGThrombosis) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leg injury (severe damage to right leg, hit by "protellier" small airplane.) in 1977, Surgery ("many surgeries") and Clot blood.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced MALAISE (Felt terrible). On 13-Mar-2021, the patient experienced THROMBOSIS (two blood clot) (seriousness criterion medically significant), THROMBOSIS (DGThrombosis) (seriousness criterion medically significant), VASCULAR PAIN (Veins was outside and sore), ERYTHEMA (really big and sore red area), PAIN IN EXTREMITY (really big and sore red area) and VEIN DISORDER (all the veins in his R leg was protuberate). At the time of the report, THROMBOSIS (two blood clot), THROMBOSIS (DGThrombosis), MALAISE (Felt terrible), VASCULAR PAIN (Veins was outside and sore), ERYTHEMA (really big and sore red area), PAIN IN EXTREMITY (really big and sore red area) and VEIN DISORDER (all the veins in his R leg was protuberate) outcome was unknown. Not Provided          Concomitant medication included unspecified statin for high cholesterol.  The patient reported that he is retired. He reported that his leg is functioning well, he has only one of the three arteries in the legs and many damaged veins.  Treatment  medication included Seroto to treat the blood clots.  Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-077978 (E2B Linked Report).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-077978:
arm was really sore; felt tired; passed away / she was dead; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (passed away / she was dead) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   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 VACCINATION SITE PAIN (arm was really sore) and FATIGUE (felt tired). The patient died on 13-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, VACCINATION SITE PAIN (arm was really sore) and FATIGUE (felt tired) outcome was unknown.       No treatment information was provided. No concomitant medications was provided.    Reporter did not allow further contact; Reported Cause(s) of Death: unknown cause of death
Patient is only 16 and received two pfizer shots and came to our pharmacy for her booster and was given Moderna as the booster at age 16 should have been pfizer. Moderna is not approved on protocol yet for 16 yo. no issues reported pharmacy concern wanted to report .
Severe fatigue,  couldn?t draw a deep breath, had pain in my right groin, belching and reflux.  But this all occurred 12 days after my second shot.  I am wondering if this was a delayed immune response.
One month later I had a bad sinus infection. Went on antibiotics, was ok for awhile, The infection came back, went on a different antibiotic, the infection part went away, but left with bad nasal problems. Little by little, has let up some, but still going on as of 9-25-2021. I do have one or two sinus infections a year.
ITCHING STARTING UNDER ARMS AND MOVED OUT TO THE REST OF BODY.  HAS GRADUALLY INCREASED IN SEVERITY TO WHERE PATIENT NOW ITCHES PROFUSLY FROM HEAD TO TOE.
I got Corona virus disease; I got Corona virus disease; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "I got Corona virus disease over the holidays". The patient wanted to know when he can get his booster dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Bilateral numbness and tingling on entire body; Bilateral numbness and tingling on entire body; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection in the left arm on 30Dec2020 at 17:30 (at the age of 34-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included multiple sclerosis. Concomitant medications included fingolimod hydrochloride (GILENYA) and vitamin D3. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Dec2020 at 18:00, the patient experienced bilateral numbness and tingling on entire body. It was unknown if treatment was provided for events bilateral numbness and tingling on entire body. The outcome of the events bilateral numbness and tingling on entire body was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
On November 6, 2017, a woman, age unknown, incorrectly received a 0.1mL injection of MassBiologics' Td vaccine (Lot # A087A2) in her arm instead of Tuberculin Purified Protein Derivative (PPD); the patient was reported to be an employee for the health care provider. The administration of the wrong drug was made apparent when the patient went to have the results of the tuberculosis skin test read and it was reported that the patient experienced redness (10mm) and bruising at the site of injection, however no induration was observed as typically seen with a tuberculosis skin test. A review of the medical records confirmed that the patient had received the Td vaccine by identification of the lot number. MassBiologics queried the reporter for a root cause for the medication error and the reporter indicated that the patient reported that the nurse who administered the Td was having difficulty finding the "needles and the vial for injection". Furthermore, the patient felt that the injection was administered intramuscularly instead of intradermally but was not confirmed. Multiple attempts at follow up with the patient and the facility where Td was administered were made with no response. The patient's recovery status is unknown. Sender's Comments: MassBiologics assessed this adverse event as non-serious and contained both labeled reactions and unexpected reactions.
Panic attack like symptoms.  Tightness in chest.  Wheezing, dizziness, nausea.
On March 3, 2022 I suffered a stress-induced heart attack, while exercising. Ambulance to hospital. EKGs, O2 checks, Heart catheter; bloodwork; ultrasound. Meds.
mom reports 1 hr p/vax administered that pt had swelling of face, tongue & some stridor; denies any other side effects; pt taken to hosp given Epi, decadron & DPH; mom said pt recovered completely;
No addittional adverse events reported; Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.       On 05-FEB-2022, both rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1741817, expiration date 30-JUL-2022) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) (lot #U7124AA, expiration date 13-JUL-2024) had occurred a temperature excursion in 0.8 degree Celsius for 35 minutes. And on 09-FEB-2022, the patient was vaccinated with both improperly stored vaccines (strength, dose and route of administration were not provided) for prophylaxis (product storage error). There was no previous temperature excursion. No additional adverse event (AE) reported.   This is one of multiple cases received from the same reporter.; Sender's Comments:  USA-009507513-2203USA003814: USA-009507513-2203USA003938: USA-009507513-2203USA003853: USA-009507513-2203USA003841: USA-009507513-2203USA003951: USA-009507513-2203USA003955:
Infant received PENTACEL, PREVNAR, and rotavirus vaccine on 11/19/14 and mother noted bright red blood and mucous in stool on 11/20/14. She had been taking rectal temps on infant but this never happened before or since, with temp. taking. Lasted only that day. Resolved simultaneously.
A non-serious spontaneous report of viral syndrome, flu symptoms, gastroenteritis, myalgias, and neck pain has been received from a nurse in a physician's assistant office and the patient, a 27-year-old female. Concomitant medications included lamotrigine, buspirone hydrochloride, venlafaxine, and duloxetine hydrochloride.  The patient had an allergy to aspirin. The patient received FLUMIST, intranasal administration for flu immunization on 19-AUG-2008. The patient had never received FLUMIST before. Since receiving FLUMIST, the patient was having viral syndrome that started to improve. On 26-Aug-2008, the patient thought she may have had gastroenteritis or food poisoning. She developed severe diarrhea. The patient also reported her experience as flu symptoms described as headache, fever, chills, sever aches, and dehydration. She had no abdominal pain, nausea or vomiting, just decreased appetite. She had no blood or mucous in her stools. On 27-Aug-2008, the patient experienced myalgias and neck pain (reported by the patient as a neck strain that stretched from the back of the lower neck over the head and to the eyes). The patient saw her physician's assistant on 28-Aug-2008 and was diagnosed with gastroenteritis with viral syndrome, currently improving. The patient reported her diagnosis as "a virus that attacks the neck muscles." The PA recommended pushing plenty of fluids and gastrointestinal rest. The patient recovered from the events of Viral syndrome, gastroenteritis, flu symptoms, myalgias, and neck pain. The PA's nurse did not feel the patient's illness was secondary to FLUMIST.
Fever, chills, achiness, muscle pain, joint pain, sore arm at injection site
The cases were received on 21 March 2014 at GPV. Initial misuse report received from a healthcare professional on 21 January 2014. A patient whose age was less than 35 months (No information was provided regarding the patient) had received dose of FLUZONE 0.5 ml on an unspecified date i.e. overdose. No adverse event was reported. List of documents held by sender: none.
Patient seen in the emergency department after receiving a pneumonia vaccine that was injected above the muscle into the subacromial bursa, likely causing a traumatic bursitis.
Anaphylactic shock. High fever. Swollen breast. Swollen arm. Swollen throat. Unable to swallow. Dizzy. Nauseous. Insomnia.  Flu like symptoms. Sore throat.
Customer had a flu shot 9/26/2020 and had bruising and still has soreness in the arm. She reported this to the pharmacy 11/7/2020.
Pt's mother called to report that patient's left leg at injection became progressively red, itchy, painful, and warm to touch shortly after injection of Kinrix and Proquad. Also the size of redness continued to increase in size. Pt's mother took pt to hospital where pt was diagnosed with suspected injection site reaction on left leg and suspicion for early cellulitis. At the hospital, patient was prescribed Benadryl and Keflex.
Patient received a second booster (Moderna) outside the CDC guidelines as she was 37 years old and not immunocompromised.  She had received Janssen as her primary series and already received an mRNA booster.
Persistant unconsolable crying from afternoon 12-16-03 to this am 12-18-03 - mother voices temp range from 99.1 to 102 - tylenol given every 4 to 6 hours. To doctor on 12-17-03 Dx DTP reaction
Initial report received from a consumer (a healthcare professional) on 28 May 2014. A female patient whose age is above 65 units not reported, had received a dose of FLUZONE HD (lot number, dose number, route and site of vaccination was not reported), on an unspecified date. It was reported that after vaccination, the patient developed fever, aches and pains and feeling dizzy for 4 hours. Laboratory details and corrective treatment was not reported. On an unspecified date the patient was recovered. Documents held by sender: none.
Had a Dtap/Hib vaccine on 4-30-07 at 1100am. On 5-1-07 700AM developed hives on face only - at 415P hives on arms, face, legs back - Benadryl given resolved. Hives again in AM only X 2 days - resolved with one dose Benadryl. At PE on 4-30-07 mom discussed adding milk into diet - had ice cream that night (beast fed) questionable milk allergy. Since 5-1 had had milk products and has not developed hives.
Patient complained of severe arm pain starting the evening of 11/8/21. 5" x 4" area of redness and swelling on the back of the arm and 4.5" x 3.75" area of redness and swelling on the right bicep started the next day. Patient took Benadryl 50 mg at bedtime on 11/09/21 and 25 mg in the am on 11/10/21 and started Cortisone cream on the evening of 11/09/21. Patient presented to the office on 11/10/21 to have the area looked at. Redness and swelling has improved to 4" x 3.5" on the back of the arm and 3.5" x3.25" on the bicep. Patient is to continue Benadryl 25 mg tonight and Cortisone cream.
First vaccine 31Dec, tested positive for covid 01Jan; First vaccine 31Dec, tested positive for covid 01Jan; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for self that the 21-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19, Pfizer), via an unspecified route of administration on 31Dec2020 02:30 PM on Right arm at single dose for covid-19 immunisation. Medical history included known allergies: Cefdinir, asthma, anxiety, and depression. Concomitant medications included Duloxetine, lamotrigine, buspirone hydrochloride (BUSPAR), etonogestrel (NEXPLANON), ethinylestradiol/ norethisterone acetate (JUNEL). First vaccine 31Dec2020, tested positive for covid 01Jan2021, had second dose 21Jan2021. The outcome of the events was unknown.   Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Information has been received from a registered nurse concerning a female between the ages of 9-years-old and 12-years-old who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the child developed a severe case of varicella, and was "covered" with lesions. The child was treated with calamine (+) camphor (+) pramoxine hydrochloride (AVEENO), diphenhydramine hydrochloride (Benadryl(, and acetaminophen (Tylenol) prn. Unspecified medical attention was sought. Additional information is not available at this time. The reporter indicated that 4 other females (2 of which are the child's sisters) were not vaccinated with a dose of varicella virus vaccine live from different lot numbers and experienced varicella (WAES #0304USA00358, WAES #0304USA00480, WAES #0304USA00481, WAES #0304USA00483). Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 29-DEC-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Information has been received from a grandmother concerning her 21 month old grandson with eczema who was vaccinated with a second dose of VARIVAX (Merck). The grandmother reported that on 10-MAY-2008, her grandson had developed a fever and a few red spots and the child's mother thought it was rosiola. The grandmother reported that on 11-MAY-2008 the patient had developed big red spots. The child was taken to his physician's office on 12-MAY-2008 and was diagnosed with chicken pox, which had not scabbed over. At the time of the report the patient had not recovered. No further information is available.