chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Patient received eceived Monovalent booster instead of Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received eceived Monovalent booster instead of Bivalent) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received eceived Monovalent booster instead of Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received eceived Monovalent booster instead of Bivalent) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received eceived Monovalent booster instead of Bivalent).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-672524, US-MODERNATX, INC.-MOD-2022-672557 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672524:1st Elderly patient US-MODERNATX, INC.-MOD-2022-672557:2nd Elderly patient
Vaccination given in error. Pt was not 18 years old at the time of administration.
fever started 6/18/99 @ 7PM rash started 6/19/99 fever 104-105;
On December 9, 2022, two days after my dose 5, I began coughing heavily. I have not been feeling well and I am sleeping more. I would wake up coughing and I be awake for an hour because of my coughing. The cough has been affecting my breathing. I took some TYLENOL and ROBITUSSIN. On Saturday I went to the walk-in-clinic. I took benzonatate for a few days and that relieved my cough a bit. I am still not sleeping well due to waking up with my cough. I have had Asthma cough for so many years, but this cough is different.
chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (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: CHILLS (non-serious), outcome "unknown", described as "chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
p/vax pt devel hives approx 1hr p/vax;when examined 2hr p/vax had 2 1/2cm papules on neck;exp dyspnea or dysphagia;
Hive like rash on face x 45 minutes noted by mother. Resolved with no treatment. She also had congestion, cough, conjunctivitis prior and during administration of vaccine. No fever.
Pt.'s wife states pt. experiencing shortness of breath, fatigued, arm soreness, headache, nauseous, left neck pain moving to the right side, 2nd shot muscle pain in the back continuing to move down towards buttock. Suffered a stroke 05/10/2021, shortly recovered with semi-weakness still on/off. PT recommended and home-health required. Stroke (right-side of brain) Did not preform an ultra-sound to locate potential of future clots.
Seizure lasting from injec to hosp/5min. pale dazed. C/O stomach pain, extreme tiredness before losing consciousness.
administration of expired acthib and daptacel with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Healthcare professional).  This case is linked to case 2022SA391400.  This case involves a 2 years old male patient who was administration expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past 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 (daptacel) for Immunisation.  On 20-Sep-2022, the patient received 0.5 ml dose of suspect HIB (PRP/T) vaccine (formulation, strength, expiry date : unknown) lot UJ583ABA via intramuscular route in the left deltoid for immunization.  On 20-Sep-2022 the patient administered of expired ACT-HIB and Daptacel with no reported adverse event (expired product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
Acute onset of urticaria rash at site of injection-becoming generalized with scanty developed expiration. Received SQ Epinephrine.
Pfizer-BioNTech COVID-19 Vaccine EUA Received Pfizer-BioNTech COVID Vaccines on 1/31/2021 and 3/18/2021. Arrived to ED acutely ill and was found to be very lethargic and barely able to open eyes. COVID+ x1 week. Placed on non-rebreather mask and O2 sat remained in low 80s. Pt was transitioned to DNR/DNI and comfort care. Pt expired 7/10/22. Given cefepime and vancomycin.
Client received injection and immediately stated she felt numb, and wanted to vomit. Client was pale and clammy, and kept feeling as though she wanted to vomit. After client was placed in anti-gravity chair she began to feel better.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the second dose of GARDASIL (lot # not reported). Subsequently the patient had fainted, became pale, has spasms, tachycardia and was hyperventilating. The patient was monitored more than 30 minutes after the adverse event occurred. On an unspecified date the patient recovered. the physician would not be giving the third dose to the patient. Additional information has been requested.
Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    196 patients received 0.25ml of Moderna Covid-19 Vaccine, Bivalent. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Dosage text was reported as Additional Booster.   No concomitant medications was provided. No treatment medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live non-significant follow up appended
Information has been received from a RN concerning a 12 week old male pt who on 3/5/03 was vaccinated with a dose of hep B vaccine (643641/0894M). "Three days ago," on 3/30/03, the child developed a "papular, acrodermatitis rash," on the extensor surface of the legs and arms and presented to the office on 4/2/03. Unspecified medical attention was sought.
A physician reported the occurrence of an injection site reaction in a 2-year-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt had no known allergies or other medical history, concurrent medical conditions, or concurrent medications. The pt experienced no adverse events following previous immunizations. On 07/31/2002, the pt received her 4th injection of Infanrix (lot DTPA526A9) into the right leg. On the same day, she also received injections of hepatitis B vaccine (manufacturer unknown) and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). One day later, on 08/01/2002 the pt developed an injection site reaction characterized by redness measuring 1.5" by 2.5", warmth and hardness at the site of Infanrix administration. The pt was treated with diphenhydramine (Benadryl). The reporter considered the injection site reaction to be probably related to Infanrix administration. Comment: This report has been linked to reports A0376898A and A0376899A due to same reporter.
Chills for several hours, nauseous, cold. The next day I was tired and had a headache.
The patient fainted approximately 3 minutes after receiving the vaccine. I caught him before he fell out of his chair, and he regained consciousness within about 5 seconds of me tapping on his shoulder. We got him some water immediately and he was able to speak to me, but he continued to nod off in his chair over the next couple minutes. We got him to lay on the floor with his legs elevated and a damp cloth across his face.  As soon as he made it safely to the floor he had fully regained consciousness and held a conversation with me. I had him stay on the floor in that position for about 10 minutes. When he felt like he had his full strength back he went back to his chair and sat there for another approximately 10 minutes and continued to drink his water. At that point I let him walk around the area with my supervision and he still felt strong so he left the pharmacy.
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, lot number M031802, expiration date 09-NOV-2017, lot number M032636, expiration date 06-APR-2018, (strength, dose, dose number, route and anatomical location were not reported), for prophylaxis. The temperature was between 32 and 36 Fahrenheit degrees during 7 hours, and, below 32 Fahrenheit degrees (the lowest temperature was 29 Fahrenheit degrees), during a time frame of 6 hours. The vaccines did not experience any previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA008038: US-009507513-1702USA008037: US-009507513-1702USA005634: US-009507513-1702USA008036:
high fever (101-104 F) vomiting headache muscle aches fatigue fogginess * Lasted 2 full days
Says she believes she is having allergic reaction to Shingrix. Says that on 09/16/2019 she received the Shingrix  in her left arm and flu shot in her right arm at pharmacy. She said that the next day the area where she had this Shingrix injected became red, warm, and swollen. She was seen for this at urgent care on 09/18/2019. She was diagnosed with irritation of injection site. Shortly after that, she developed generalized itching with a rash on her trunk and extremities. She said that the redness in local reaction at the injection site has improved but the rash has worsened. She said she can think of nothing else new that she has come into contact with. She has had flu shots many times without problems. She denies any new foods, beverages, soaps, shampoos, laundry detergents, or dryer sheets. She denies any difficulty breathing or swallowing. No wheezing.
chill, mild fever, body ache, fatigue, headache for 24 hours.
Started getting chronic hives daily all over body in different areas each day starting almost 24 hours after receiving first dose
This spontaneous report as received from a nurse referring on herself a female patient of currently 61 year old with urine uric acid, herpes simplex from some time ago and about 44 years ago had small pox injection as treatment for herpes outbreak, sensitivity to HALCION and PERCOCET. On 26-AUG-2013, the patient was vaccinated with ZOSTAVAX, vial 19400 PFU for prevention of shingles, lot number, dose and route were not reported. Concomitant therapies included allopurinol (manufacturer unknown), vitamin d (manufacturer unknown), ESTRACE, and omeprazole (manufacturer unknown). Approximately in August 2013, the patient experienced symptoms after receiving the ZOSTAVAX vaccination including vesicles on her left foot that reminded her of past Herpes Simplex outbreaks, two painful areas on her back near the armpit that ware red and itchy. Since the reporter had VALTREX in her home, she decided to take it to arrest any further outbreak. The patient reported that she developed cold symptoms after being on ZOSTATAV. The patient did not seek medical attention and did not plan to. None diagnostic studies were performed. The outcome of the events was reported as not recovered. The relation between ZOSTAVAX and the events was not reported. Additional information has been requested.
Temp 99.4 site of inject red mod. swelling (not unusal 22FEB91 temp to 102 at 42PM when sz occured. Known to have febrile sz; developed cough & loose stools;
Heptavax inadvertantly given SC rt arm; pt fine p/12, 24 hrs;
Upset stomach; chest started getting tight; throat started closing up; breaking out in rash all over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), CHEST DISCOMFORT (chest started getting tight), THROAT TIGHTNESS (throat started closing up) and RASH (breaking out in rash all over) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021 at 4:00 PM, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), CHEST DISCOMFORT (chest started getting tight), THROAT TIGHTNESS (throat started closing up) and RASH (breaking out in rash all over). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 19-Mar-2021 at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) on 19-Mar-2021 at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), CHEST DISCOMFORT (chest started getting tight), THROAT TIGHTNESS (throat started closing up) and RASH (breaking out in rash all over) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided.  The patient was treated in the emergency room  for 4 hours on 19MAR2021.  The patient  stated he would not be getting the second dose of the vaccine because he doesn't want to "go through this again". The patient reported consulting with his HCP.
Narrative: 81yo male patient in home based primary care - geriatrics died at home of unknown cause on 4/16/2022. Pt had the following problem list in his chart: Hyperlipidemia 12/17/2021 Anxiety 12/17/2021 Benign prostatic hypertrophy without outflow 12/17/2021 obstruction GERD - Gastro-esophageal reflux disease (12/17/2021), HTN - Hypertension (12/17/2021) OA - Osteoarthritis (12/17/2021) Obesity 12/17/2021 Sleep Apnea 12/17/2021, Pulmonary hypertension (12/17/2021) Venous statis 12/17/2021 Lymphedema 12/17/2021 Chronic back pain 12/17/2021, Lumbar spondylosis (12/17/2021) Glaucoma 12/17/2021 Insomnia 12/17/2021 Restless Legs 12/17/2021 Seen by palliative care medicine service Gout 02/24/2016 Depression 08/20/2021 Brief history and current status: Patient dependent on continuous O2 and co-morbidities including Pulmonary HTN, Obesity, Lymphedema, Venus Stasis. Last hospital discharge 1/18/22. DISCHARGE DIAGNOSIS was - Acute on Chronic Hypoxic/hypercapnic Respiratory failure due to COPD. Pt received a covid vaccine (J&J) on 6/10/2021. This death likely is not related to the covid vaccine given the pt's advanced age, long length of time between death and date he received the vaccine and the pt's comorbidities.
brief period of chills; tired all day; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CHILLS (brief period of chills) and FATIGUE (tired all day) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced DIARRHOEA (diarrhea). On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (brief period of chills) and FATIGUE (tired all day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Jan-2021, DIARRHOEA (diarrhea) had resolved. On 11-Feb-2021, CHILLS (brief period of chills) and FATIGUE (tired all day) had resolved.            No concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
hair loss, tongue swollen, rt side of tongue had lumps on the next day;really losing a lot of hair;
DELAYED SKIN REACTION. LARGE RASH MADE OF SMALL RED BUMPS ON ARM.
This spontaneous report as received from a nurse refers to a 19 years old female patient without drug allergies and medical history. The patient did not develop any immunity after having 3 dose series of some unspecified hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route, lot# and expiration date were unspecified). The therapy started on 27-NOV-1992. The lab diagnostics studies blood titer has been performed. The patient sought medical attention via coming into office for a titer. No other co-suspects were reported. No concomitant medications were reported. The outcome of did not develop any immunity after have 3 doses series is unknown. Additional information has been requested.
Fast heart rate, resting heart rate 104; Her arm hurt extremely badly; Body aches; Headache; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Fast heart rate, resting heart rate 104), PAIN IN EXTREMITY (Her arm hurt extremely badly), MYALGIA (Body aches), HEADACHE (Headache) and CHILLS (Chills) in a 24-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.     Concurrent medical conditions included Asthma. Concomitant products included Asthma medication for Asthma, Birth control for Birth control.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her arm hurt extremely badly), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Tired). On 10-Feb-2021, the patient experienced TACHYCARDIA (Fast heart rate, resting heart rate 104). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Ache, at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Fast heart rate, resting heart rate 104) had not resolved and PAIN IN EXTREMITY (Her arm hurt extremely badly), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Heart rate: 104 (High) 104.
I contracted COVID during the holidays. I had a severe cough and a runny nose. I took an inhaler which I have for emergencies. A few days later I did develop a fever. I took my first COVID test and took a saliva antigen test while overseas on holidays. I came back positive. About 3 days later symptoms eased a bit but still had them, I did not bother to retest. By January 6th my symptoms were fairly gone. I tested again and came back positive. The 7th and 8th also showed positive. By the 10th and 11th it still showed positive and strong positive. By the 15th, it still showing positive even though the symptoms are basically resolved already.
This spontaneous report as received from a nurse refers to a 14 year old patient of an unknown gender. On 03-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
p/vax pt devel chills x20 min; had dizziness; malaise; felt feverish; devel vomiting & loose BM x1 w/local soreness; erythema/tenderness at inj site;
I experienced a mild headache for 2-3 days; runny nose; mild fever; sinus congestion.
Pt reported a 4 inch x 2 inch injection site reaction that was hot, itchy and inflamed for about 4-5 days after the injection. Pt still has red spot at injection site about the size of a quarter but has no pain at this site. Patient wanted pharmacy & manufacturer know. Pt said "it is not a big deal" and will not see doctor despite our recommendations.
Began feeling fatigue by 2:00pm, in the evening reports chills with fever over 102.0 F, throat felt "swollen" and sore, felt fatigue and tiredness. Felt fine before the shot and feels fine by the next morning.
Around 6 pm on 12/30/20 I began to have a visual aura to both eyes, though it seemed to be primarily to the left.  It lasted about 20 minutes.  About 30 minutes later it started again, this time primarily to the R eye.  This again lasted about 20 minutes and was followed by a mild-moderate frontal headache.  It seemed to be an ocular migraine, but I have never had them before.  It resolved while I was sleeping and I did well today.
Numbness down left arm and leg making it unable to get out of bed. Managed to get to the floor and after > 30 minutes, was able to get sat up and eventually struggled/climbed up and onto feet to get dressed. Eldest son was in contact and came to deliver for an  ER visit, ND on or around 08/20/21. Subsequent incident 09/05/2021 including a fall after dizziness and numbness experienced throughout the whole body and predominantly below the knees. Daughter delivered to ER. Held in observation for three days running multiple tests including EKG, Blood tests, Xrays, CT scans, MRI of brain, Neurology report, etc. Suspicion of mini stroke. MRI not conclusive. Again, no conclusive findings. Zio Patch  recommended for heart rhythm monitoring. Zio Patch placed on patient 09/11/2021 to remain for two weeks until 09/25/2021.