chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FROM 8/31 UNTIL 9/4/2019 HE EXPERIENCED PAIN IN HIS LEFT ARM AND HE COULDNT PUT HIS ARM OVER HIS HEAD THE ENTIRE TIME. HE SAID " IT HURT LIKE THE DICKENS" BUT IT CLEARED UP ON THE DAY HE REPORTED ON 09/04/2019 AT 11:44AM
Sore spot on my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR123588   Additional Information: GSK Receipt Date: 23-Aug-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the first dose and was fine, just had a sore spot on his/her arm. Additional Supportive Information: Follow-up would not be possible, as no contact details were available. For tolerance to the 2nd dose refer case US2022AMR123588.; Sender's Comments:  US-GSK-US2022AMR123588:Same reporter.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:47 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 30.20 years old. Concomitant products were not provided. On 03-Apr-2021, Excursion time was 09 AM, temperature were 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40and 5 PM: 41. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
07/09/2015 mild other Patient had fever of 101, nausea, fatigue and pain in upper right arm. Patient started on KEFLEX to provide coverage if infection present.
Pt called office on  1/14/2021 and reported that she had her second Pfizer Covid 19 immunization.  she reported having some periorbital edema, facial rash (located underneath her protective face mask) and tingling around her lips.  She had self medicated with some cetirizine . we provided her an injection of solumedrol IM. Symptoms resolved.
an expired dose of Ipol was inadvertently administered/NO AE; Initial information was received on 05-May-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a four years old male patient who received expired dose of IPV (VERO) [IPOL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for prophylactic vaccination.  On 05-May-2020, the patient received a 0.5 mL dose of suspect IPV (VERO) (lot P1A46, expiry date- 03-May-2020) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  At the time of report there was 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.
Tinnitus began the morning after the first dose and after 3 months these symptoms have continued. It doesn't stop and at times is louder than others.
Severe fatigue; Myalgia; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 at 17:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO), both taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received nystatin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 13Apr2021 at 05:00, the patient experienced severe fatigue, myalgia and diarrhea. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe fatigue, myalgia and diarrhea were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
My left are fell asleep and numb, decreased motor functions and then the tingling sensation moved to my left eye, lips and whole face, left lower leg and right hand. It progressed for an hour or two and then went away. Employee health sent me to the ED for observation. I am  due 08/01/2021.
On May 20, 1999 the pt broke out in a case of full blown chickenpox with greater than 75 lesions and a fever.
This spontaneous report was received from a registered nurse referring to a 7 month old male patient (also reported as "14 month"). There were no concurrent conditions and illnesses at the time of vaccination. Concomitant therapies included FLUZONE, PENTACEL and PREVNAR 13. The reported stated that on 11-DEC-2017, the patient was vaccinated with the third dose of, ROTATEQ liquid, orally, lot # M025568, expiration date 07-NOV-2017, for prophylaxis. This was an already expired dose.
The patient passed out and fell on the floor. He woke up. He laid down. He drank some water. The nurse took his vitals BP 128/80, P:82, SPOZ: 99%. He stated that he was ok. EMS checked him out. He stated that he was ok and refused transport.
Patient became hot with injection.  Patient fainted and seizure (20 sec). BP 80/40 directly with seizure. Patient awoke aware of seizure. BP at discharge 98/62.  Patient states "She used to faint with shots".
Moderate swelling and erythema down arm and into shoulder. Warm and hard to the touch.
On December 16, 2022, I had a sore throat and fever.  It developed into severe body aches and headache.  I called the doctor and had a video chat.  He listened to my symptoms and prescribed Paxlovid.  I did not take it because by Sunday I began to feel better.  By the following Tuesday the body aches were mostly gone, and my sore throat was better.  The rest of the week I was feeling mostly weak and had low energy.  I continued to test positive until December 23, 2022.  By that following weekend I was feeling normal.
On the morning of 8/2/03, patient became blue, fell over onto floor with her arms and legs twitching, became unconscious and eyes rolled back into head. Fell asleep for a few hours. At 5PM that evening, the same scenario occurred and patient taken to ER where she was observed overnight without further incidences. The discharge summary states new onset seizures.
it becomes hard to breather much quicker and lasts much longer. Patient can almost feel it in throat and chest that it's harder to breathe, and toward the end of a long exhale, it sounds as though wheezing.; it becomes hard to breather much quicker and lasts much longer. Patient can almost feel it in throat and chest that it's harder to breathe, and toward the end of a long exhale, it sounds as though wheezing.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 03Apr2021 at 16:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy, penicillin allergy. Concomitant medications included melatonin (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took amoxicillin (MANAFACTURER UNKNOWN), E-mycin (MANAFACTURER UNKNOWN), cefaclor (CECLOR), amoxicillin; potassium clavulanate (AUGMENTIN) all from an unknown date for an unspecified indication and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 08:00 the patient experienced whenever exerting himself, such as lifting weights or doing cardio, it becomes hard to breather much quicker and lasts much longer. Can almost feel it in throat and chest that was harder to breathe, and toward the end of a long exhale, it sounded as though he was wheezing. It was beyond normal exertion. The patient did not receive treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events breathing difficult, wheezing was recovered with sequelae on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
PATIENT REPORTS SINCE VACCINATION TIREDNESS, JOINT PAIN AND BREST PAIN
Narrative:  75 yo M with a history of dysphagia, cardiac dysrhythmia, stasis ulcer due to T2DM, hypothyroid, peripheral vascular disease due to secondary DM, HLD, BCC of face, peripheral neuropathy, legal blindness, HTN, renal impairment. Patient received covid vaccination on 6/10/21. Patient was admitted to hospital on 6/14/21 due to reported symptoms after receiving covid vaccination. Complaints included fatigued, fever, and cough. Patient tested positive for covid on 6/14/21. Patient passed away on 6/30/21 in hospice with reported cause of death as SARS PNA. Covid vaccination could possibly be related to patients death.
Hives and itching all over for the past month.; Hives and itching all over for the past month.; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in left arm on 11Apr2021 at 15:45 (at the age of 54-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included montelukast (MANUFACTURER UNKNOWN) and latanoprost (MANUFACTURER UNKNOWN) taken for an unspecified indication received within 2 weeks of vaccination. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 02Mar2021 (at the age of 54-years-old) as dose 1, single for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnancy at time of vaccination. Patient had no known allergies. On 26Apr2021, the patient reported hives and itching all over for the past month. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the event. The clinical outcome not recovered for the events.  Follow-up attempts completed. No further information expected.
Pt received Moderna vaccine, dose 1 in right deltoid IM. After approximately 10 min, pt reported that her tongue felt tingling. Pt was able to swallow her saliva, no difficulty breathing, and able to speak clearly.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced an earache for 3 days and mild symptoms for 8 days. A physician reported that the mild symptoms were a mild breakthrough case of chickenpox.
I have lost all smell and taste. The taste is slowly coming back but it is very slowly. As far as the smell goes, I cannot smell the scents from the candles, food, or anything else.
SCIATIC NERVE FLARE UPS; FLU LIKE SYMPTOMS; DIARRHEA; JUMPING NUMBNESS; FEVER; CHILLS; FATIGUE; 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 SCIATIC NERVE PALSY (SCIATIC NERVE FLARE UPS), INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), DIARRHOEA (DIARRHEA), HYPOAESTHESIA (JUMPING NUMBNESS) and PYREXIA (FEVER) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SCIATIC NERVE PALSY (SCIATIC NERVE FLARE UPS), INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), DIARRHOEA (DIARRHEA), HYPOAESTHESIA (JUMPING NUMBNESS), PYREXIA (FEVER), CHILLS (CHILLS) and FATIGUE (FATIGUE). At the time of the report, SCIATIC NERVE PALSY (SCIATIC NERVE FLARE UPS), INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), DIARRHOEA (DIARRHEA), HYPOAESTHESIA (JUMPING NUMBNESS), PYREXIA (FEVER), CHILLS (CHILLS) and FATIGUE (FATIGUE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were provided. No treatment medications were provided.
The patient was administered improperly stored PROQUAD; Information has been received from a medical assistant and refers to a 4 year old female patient. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  03-SEP-2020, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T005406 with expiration date of 12-AUG-2021, subcutaneous for well check (route of administration and anatomical location were not reported), which were stored in the range of -14 Celsius degrees to -10 Celsius degrees for 116 hours and -9 Celsius degrees to 8 Celsius degrees (-6.1 Celsius degrees) for 13 hours (multiple excursions) with a time frame of 129 hours. No previous temperature excursion was reported. Measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was reconstituted with properly stored sterile diluent (MRK STERILE DILUENT).  Digital data logger was involved.
7 days, post vax, child experienced red, vesicular rash on his torso. No SOB. No hives. No allergic reaction.
severe edema-nephrotic synd-lasted 2 months;dx FSGS form of glomerulonephritis;had 2 more episodes of nephrotic synd MAR98 & AUG98;controlled w/meds;Annual follow-up received on 9/29/00 states that the pt still is losing 2 grams of protein through kidneys per day. Will likely need dialysis or kidney transplant in future.
headache; arm pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN IN EXTREMITY (arm pain) and FATIGUE (fatigue) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HEADACHE (headache), PAIN IN EXTREMITY (arm pain) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency; HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), PAIN IN EXTREMITY (arm pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Improperly stored ROTATEQ was administered to a patient; No additional adverse effects were reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.    On 12-MAR-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # S017642 (also reported as A017642, conflicting information) and expiration date 28-FEB-2021, 1 dosage form, oral (dose was not reported) for prophylaxis.   Temperature: 11.4 °C (Celsius degrees); Timeframe: 1 hour; no previous temperature excursions with digital data logger involved. No adverse events were reported.
pt became ashen, bradycardic, & hypoventilated; blood tinged vomitus was noted; pt was intubated & given CPR; pt did not respond to resuscitation & died; temporally related to vax administration (2hrs);
pt recv vax & w/in 24hr pt devel an inj site rxn characterized by redness & swelling;pt also devel a low grade fever & gen aching;pt was seen by MD & treated w/APAP & applications of ice;
I received the vaccine ZOSTAVAX. I had all the side effects listed, except I had an outbreak on my arms like chickenpox. Was this normal
7 days after shots, had running nose and fever for 72 hours. After 72 hours fever went down but sore throat and cough started. 1 day after fever went down, broke out in Measels-like rash
pain at the site of injection. Headache, shivering, severe muscle pain and tenderness to touch all over the body. My symptoms started same day night 1/15/21 and continued through out the next day 1/16/21, I completely recovered on 1/17/21 morning. I did take Advil and Tylenol continuously.
Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided. No treatment information was provided.
itchiness on the BCG/TB vaccination scar; Small pustules; Scratching it made it worse; Redness; This spontaneous case was reported by a patient and describes the occurrence of ITCHING SCAR (itchiness on the BCG/TB vaccination scar), PUSTULE (Small pustules), SCRATCH (Scratching it made it worse) and ERYTHEMA (Redness) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Concomitant products included LEVOTHYROXINE, FLUVASTATIN, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), ATENOLOL, PAROXETINE, VITAMIN D NOS and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 15-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient started INFLUENZA VACCINE (unknown route) at an unspecified dose. In October 2022, the patient experienced ITCHING SCAR (itchiness on the BCG/TB vaccination scar), PUSTULE (Small pustules), SCRATCH (Scratching it made it worse) and ERYTHEMA (Redness). At the time of the report, ITCHING SCAR (itchiness on the BCG/TB vaccination scar), PUSTULE (Small pustules), SCRATCH (Scratching it made it worse) and ERYTHEMA (Redness) had not resolved.            The patient received moderna dose 1 on apr-2021, dose 2 was received 6 weeks after dose 1, first booster dose and second booster dose on apr-2022. The patient had never tested COVID positive or diagnosis. Patient had no allergies. The adverse event did not cause patient to seek medical care. The patient never had  experienced a similar event in the past. It was reported that symptoms were improved. Treatment medication included topical cream.   This case was linked to MOD-2022-660219, MOD-2022-660211 (Patient Link).
Patient received shot and approx 23 hours later she lost strength in her legs and was unable to walk on her own with the use of her walker.  Patient has since been required to be transported in her house with the use of a wheelchair and helped off/on toilet.  Patient developed a low grade fever (99-100.3)  approx 27 hours after her shot which was controlled with acetaminophen.  Patient has had a significant decline in cognitive ability since receiving vaccine and now needs 24 hour care and has been placed on hospice approx one week after vaccine.