chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from the medical assistant refers to a 4 year old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to the patient included DILUENT MRK INJ used to reconstitute the (Oka-Merck) PROQUAD was properly stored. On 01-JUN-2018, the patient was vaccinated with improperly stored doses of (Oka-Merck) PROQUAD recombinant Human albumin (rHA) (lot number R001541, expiration date 15-JUL-2019), subcutaneously. The doses of (Oka-Merck) PROQUAD were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1806USA001756.
Pt lightheaded, running nose after being vaccinated.  BP 115/60, HR 61, OxSat 98%, gave water and 2 mints.  After resting 15 min. able to leave.
I had a bad cold, sore throat and I got tested for COVID-19 on 10/06/2022 and it was positive. I consulted with my doctor and I was prescribed PAXLOVID (low renal dose), cough medicine (benzonatate) for my symptoms. I also did not have much energy after testing positive for COVID-19. My symptoms started on 10/04/2022, I was coughing, sore throat and sniffles. We had not been around people and we caught COVID-19 and I had not had a cold or flu for years, this was very odd. I have my first doctor's appointment with my doctor coming up due to changing doctors on 11/04/2022. I have recovered from my symptoms and have been fine for over one week.
Nausea; Diarrhea; Myalgia; Influenza-like symptoms; Upper respiratory infection; Difficulty lifting right arm; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included osteoporosis. Previously administered products included flu vaccine (in the past and did not experience these side effects). Concomitant products included denosumab (Prolia).   On 26th September 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced nausea, diarrhea, myalgia, influenza-like symptoms, upper respiratory tract infection and injected limb mobility decreased. On an unknown date, the outcome of the nausea, diarrhea, myalgia, influenza-like symptoms and injected limb mobility decreased were recovered/resolved and the outcome of the upper respiratory tract infection was not recovered/not resolved.   The reporter considered the nausea, diarrhea, myalgia, influenza-like symptoms and injected limb mobility decreased to be related to Shingrix. It was unknown if the reporter considered the upper respiratory tract infection to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. It was unknown if the reporter considered the nausea, diarrhea, myalgia and influenza-like symptoms to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient Shingrix vaccine and a flu vaccine and says within 24 to 36 received Shingrix in her right deltoid and flu vaccine in her hours after receiving both vaccines, she experienced difficulty lifting up her right arm, nausea, diarrhea, myalgia, and flu-like symptoms. She cannot recall specific dates but said all these side effects resolved about two weeks later. She believes these side effects were caused by Shingrix because she said she has received flu vaccines in the past and did not experience these side effects.  The reporter consented to follow up. The patient was due for my 2nd Shringrix vaccine at the time of reporting which has been held pending my recovering from an upper respiratory infection that was still resolving.  The patient received Prolia injections every 6 months for osteoporosis with my next Prolia to be given. The reporter asked was there potential for interaction, decreased efficacy, or any contraindications to administering the Prolia and Shingrix in close proximity to each other.
Pt received vax and went to observation area. W/in 10 min, pt reported to observation nurse she felt lightheaded & nauseous. Pt was transported via w/c to EMT triage/observation area outside ballroom. VS assessed: BP 139/84, HR 103, Sp02 99, T 97.8F.  Pt rested, was given water. After 5 min, VS were reassessed and WNL. Pt was observed for an add'l 20 min, over which time VS remained WNL. Pt refused additional assessment, stated she was feeling well, and left w/ partner, who she stated would be driving. At 11 pm, pt returned to EMT triage area reporting renewed symptoms of dizziness and nausea. Pt agreed to transport to ED for add'l assessment via ambulance. Transported on stretcher to ambulance w/ assistance/monitoring by EMTs.
11 days post vaccination, warmth, erythema diffusely over R arm 10 x 4 cm, diffuse margins c/w cellulitis, no f/c . presented b/c palpitations
Fever, anorexia and pain at injection site on left thigh. Left thigh has a 3-4cm area of erythema, induration and increased heat of overlying skin. No evidence of infection. Vaccine reaction. Recommend that Prevnar vaccine not be repeated in this pt. On 4/2/01, 09:45, pt has vomiting and diarrhea, no fever per parent. Will give Pedialyte, Gatorade, 7-up, jello, popcicle in small amounts, Tylenol/ibuprofen if fever. Call if symptoms persist. Injection site has redness.
Patient got vaccine at around 9:40 am and returned to the pharmacy about 10 minutes latter saying he felt strange. Upon checking vitals, his BP was 196/99 and his pulse was 146.
15OCT96 10PM very warm-achy w/chills-1wk t101;16OCT95 530AM in bathroom, passed out, spouse found pt unconscious-eye opened;appeared gasping for air;pt recovered but felt hot & nauseous all day;
01/07/07-Parents noted red rash on upper torso-front and back. <50 lesions. Afebrile.
Patient called to report severe arm pain lasting to day 4 after vaccine; cannot lift arm. No signs or symptoms of allergic reaction reported; pain described sounds exclusively musculoskeletal.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
The vaccine dose was given to patient approximately 2 hours after its beyond use time. The manufacturer was contacted to seek best practice protocols. Patient was informed of the situation and options to get a replacement dose were discussed as per Pfizer's literature. For now, patient declined another dose but will let us know if she changes her mind.
pt exp erythema, induration, inflammation, & swelling @ the inject site p/recvd flu vax;
Six days after I received the vaccine, a large area on my arm near the injection site became red, somewhat swollen and itched a great deal.  It is now 10 days post-injection and the area is still red but the itching has decreased.
Between 10 and 12 minutes statutes to get tightness in head. Asked if normal- told to sit bp was 110/68 15 minutes headache 7/10. 16 mins headache 10/10 pain. Took bp again bp was 238/100 - ice packs on neck. Sent over medic. 3rd bp 240/100.  Ice pack on left shoulder. Sat and breathed deeply. No loss of vision - no faintness. Staff wanted to call 911 - I refused ambulance. I was told I could leave when my bp went down to 186/90. Was escorted out to my husband,took bp every 2hrs. Went to bed 9hrs later and bp was 124/70. Upon waking it was 105/49(normal morning low bp). Did not take any blood pressure meds. Bp is usually low.
Pt vaccinated with DTP/MMR/OPV and developed a fever of 104.2; Temp decreased with tylenol and ice pack; Pain and swelling of leg site
Patient complained of headache and the "sweats" Assisted to lay down for awhile and offered water. After about 30 minutes, the patient stated that he felt better. Advised to go home and rest, work note given. Vitals were stable
L arm swollen and warm; from fingers up into L shoulder. No SOB. States started after injection on 10/19/09. Reported on 10/20/09. Sent to work comp MD. Dx: local vaccine reaction.
body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) and PYREXIA (fever) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYALGIA (body ache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, MYALGIA (body ache) outcome was unknown and PYREXIA (fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient was not taking any chronic condition medications/vitamin/supplement. The patient had no pre-existing medical condition.   This case was linked to MOD-2021-410117 (Patient Link).
BODY SHAKES, COUGH, FEVER, HA, FACIAL SWELLING, NUMB LIPS.
Patient presented to the ED for tachycardia within 6 weeks of receiving covid booster. he died on 12/22/21.
Very Flush; hot/cold flashes; hot/cold flashes; mild headache; sore at injection site; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, lot number=EL9261), via an unspecified route of administration on 23Jan2021 14:45 at single dose at left arm for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included allergies to sulfa, mold, asthma, multiple sclerosis, anemia. Concomitant medication included dimethyl fumarate, chorionic gonadotrophin (PROVIGIL), clonazepam, modafinil and Fl. The patient previously took Wellbutrin and experienced allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient experienced very flush, hot/cold flashes, mild headache, sore at injection site on 23Jan2021 17:00. The outcome of the events was recovered in Jan2021. No treatment received for the adverse events.
Arm pain; Joint pain; Muscle pain; Sore throat; Headache is so bad; I don't feel good; I am not ready and even I can't  stand up; Body aches; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 20Apr2021 (Lot Number: EW0162) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication was not reported. The patient experienced arm pain, joint pain, muscle pain, sore throat, headache is so bad, he/she didn't feel good; he/she was not ready and even he/she can't stand up, body aches on an unspecified date with outcome of unknown. Clinical course: the patient calling because he/she took the Pfizer (vaccine) yesterday and not only his/her arm (pain) but do you supposed to have side effects like you have the Covid (vaccine) like in the joint (pain), in the muscles (pain), sore throat and headache. The patient wondered if they supposed to have these symptoms. When paraphrased the concern with Covid-19 vaccine, consumer added, "Yes because I don't feel good at all, I can't even stand up." Consumer stated, "What do you want to ask, I am not ready, I can't even stand up, my headache is so bad." When probed for any treatment for event, consumer stated he/she took Ibuprofen 100mg, 2 tablet.  No follow-up attempts are needed. No further information is expected.
parent stated pt had fever on 13AUG for 2 days & broke out in rash on 15AUG;parents stated rash lasted 3 days;no tx given;fever inc to 101 13AUG97;
Newly occurring arm pain and redness at the injection site, 6 weeks after the injection.
Vaccine given around 5:30PM. Pt wife states, severe cough, tightening of throat by 8:30PM Benadryl taken Sx resolved.
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 06-AUG-2014, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to two temperature excursions, one for a sum of 24 hours with a lowest temperature recorded as 33 degree F (0.555555556 degree C); and other for a sum of 136 hours with a lowest temperature recorded as 34 degree F (1.111111111). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
All over Body aches/soreness, muscles and joints.  Major fatigue,  intermittent low grade fever and chills.  Lasting 24 to 36 hours.
Per Employee: "My left arm started hurting & during the night I started feeling real weak & fatigued." Narrative:
Prickly pains through her whole body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Prickly pains through her whole body) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Tested positive) on 01-Dec-2020 and Loss of smell (at the time of the report, "a couple weeks ago she lost her smell"). Concurrent medical conditions included Cramps in legs and Sleep difficult. Concomitant products included HYDROCODONE for Cramps in legs, ZOLPIDEM for Sleep difficult, GABAPENTIN, DIAZEPAM, LISINOPRIL and DICLOFENAC SODIUM (DICLOFENAC NA) for an unknown indication.    On 02-Mar-2021 at 10:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Prickly pains through her whole body). The patient was treated with PARACETAMOL (TYLENOL ARTHRITIS) for Myalgia, at an unspecified dose and frequency. On 03-Mar-2021, MYALGIA (Prickly pains through her whole body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2020, SARS-CoV-2 test: other (Positive) Tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Bivalent vaccines have undergone several temperature excursions and have been administered to patient; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No medical History was reported.  It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.     On 24-Sep-2022 at 1:46 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 24-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    No concomitant medicine were reported. No treatment medicine were reported.
Received Pfizer vaccine on 1/29/21 and 2/18/21. Presented to ER on  1/19/22 and was COVID positive on 1/17/22. presented with a chief complaint of shortness  of breath and chest pain that has been going on for approximately the past  week.  Accompanied by a cough with productive sputum.  Cough is greenish in  color.  She is found to have a COVID positive tested a couple of days ago,  found to be positive, called the Urgent Care.  Oxygenation does drop down in  the emergency room tonight.  She was 97% on room air, but does drop down with  small amounts of movement.  She had an ABG, which showed a pH of 7.4,  oxygenation was 65%, pO2 of 32.  Likely this is a venous sample.  Also has  lactic acidosis likely from hypoxia.  She had a CT angio of her chest, which  did show a small pulmonary emboli in the right lower lobe pulmonary artery  along with mild bilateral ground-glass opacities significant for COVID  pneumonia.  She is agreeable to hospitalization at this time for acute hypoxic  respiratory failure secondary to COVID pneumonia and pulmonary emboli.  She  received a dose of Lovenox at therapeutic dose. Received remdesivir and dexamethasone. Based on 6 minutes walk test, patient need 1 L oxygen with exertion. Discharged on 1/24/22
From faxed correspondence received on 08/01/2002, it was reported that a 4 month old female received a dose of ACTHIB, Tripedia, IPOL and Prevnar on 07/11/2002.  Patient developed two hard areas with redness at the right leg injection site and one area on left leg injection site on 07/12/2002.  No fever noted.  Patient was fussy and sleeping a lot.  This reporter has two more patient's experienced same reactions after receiving these vaccines.  Linked with cases U2002-00607 & U2002-00608.  From additional information received at AP, Inc on 11/26/2002, it was reported that the patient was a 3 month old infant, who received ACTHIB, Lot # UB246AA, in the left leg as dose #2.  IPOL, Lot # U04252, in the right leg as dose #2, TRIPEDIA, Lot # U0544CA, in the left leg as dose #2, and PREVNAR (manufactured by Lederle), Lot # 484210, in the right leg as dose #2.  The patient had no illnesses at time of vaccination.  The patient recovered. Case is closed.
Information has been received from a physician's assistant concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route, and lot# not reported). "The physician's assistant heard from another healthcare worker that a patient had reported hair loss after a GARDASIL injection (which dose in the series was unknown)." The patient's outcome was not reported. No further information is available.
1 week post 1/2 booster dose of moderna I developed a full body rash. Initially focused in ?hot areas? of the body (thighs, underarms, scalp, neck) In the acute phase this was extremely itchy and anywhere I scratched would develop raised welts. Treated myself with Benadryl and hydrocortisone crème with little improvement.  I also developed esophageal tightness and a feeling like food is stuck. This is not heartburn. I have difficulty swallowing at times including liquids.  Approx 1/7 I had a virtual urgent care visit and was prescribed prednisone 20mg BID x 5 days with non improvement and no worsening.  1/12 I had an in person visit, UA with culture, and was prescribed macrobid for UTI and another 7 days of prednisone. I finished the antibiotics but the prednisone made me very nauseous. I did not complete the course of prednisone.   12/9 I returned for another in person visit. Itchiness has improved however I am still experiencing redness and dermatographia. Started OTC fexofenadine and referral made to dermatologist.  At the time of this report 1/8/22, nearly 10 weeks after onset, the esophageal tightness (?stuck food?) and difficulty swallowing persists as well as the dermatographia
Fever, chills. Swelling/inflammation/pain. Hallucinated. Symptoms for 3 days, then resolved except for swelling/pain/inflammation (right deltoid).
Hello, After recieving the first vaccine, I had headaches, body aches, confusion, lack of energy, rash, diarrhea. Its been six months and I still have lack of energy and confusion. Regards
This spontaneous report was received from a pharmacist concerning to a 25 year old female patient. Prior medical history, relevant drug history, drug or alcohol abuse, drug allergies, family history and concomitant therapies were not reported. On two unknown dates, the patient was vaccinated with two separated doses of VARIVAX for prophylaxis, dose, route, frequency, anatomic location, lot/batch number and expiration date were not reported. On an unknown date, after the second dose of VARIVAX the patient "failed to seroconvert" (seroconversion test negative).  The outcome of the patient's seroconversion was unknown. The relationship of "failed to seroconvert"(seroconversion test negative) and VARIVAX was not provided. There was no Product Quality Complain (PQC). Additional information has been requested.