chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got the shot and the Flu too; Initial information received on 20-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/ non-health care professional via Digital Media..  This case involves a patient of unknown gender and age who experienced got the shot and the flu too while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (dose, route, strength, formulation, frequency, batch lot number and expiry date: unknown) in unknown administration site for immunization. Information on batch lot number is requested.  On an unknown date, the patient developed a non-serious event got the shot and the flu too (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza).  At time of reporting, the outcome was Unknown for the event influenza.
pt recv vax & 10mins later looking pale, c/o not feeling well;pt started to slip from chair & lose consciousness;pt began to have sz w/profuse sweating, skin cold & clammy, diff breathing;pt c/o h/a & exhausted;t100.4; tingling rt arm;
Pt. tol vaccine well and was moved to observation room. He was given water and apple juice--both of which he quickly finished. Appx. 3 minutes after vaccination, pt reported feeling dizzy. 1 minute later, became diaphoretic and reported losing his vision. CNP was called in and pt. was moved to a lying position in our recuperation area. As he was being lowered, pt fainted. After 5 seconds, he became cogent and said he felt fine. Cool cloths were applied. He remained lying for about 20 minutes before sitting in a chair for another 10-15 minutes. He finished 2 bottles of water and 2 boxes of juice in this time period. Pt. left with friend feeling better. He was instructed to continue drinking water.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 06-JUL-2018 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # N030965, exp date 25-AUG-2019) (dose not reported) orally. There was a data logger issue reported. The temperature of excursion was 32 degrees F up to 35 degrees F (multiple excursions) for a time frame of 13 hours. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1807USA004813; US-009507513-1807USA010173; US-009507513-1807USA010174; US-009507513-1807USA010175; US-009507513-1807USA010177; US-009507513-1807USA010178; US-009507513-1807USA010214.
Syncope 18 hours post injection, Feb 13 left eye irritation with tearing, Feb 14 mild case of Bell's Palsey right side of face, along with headache, herpes on left corner of mouth, fatigue and ?Epstein-Barr. I was exposed to  the virus by my hairdresser on 2-11-21 and she developed symptoms and tested positive 4 days later
Left arm is numb from shoulder to palm and there is an aching in the arm. Has full motor ability. 12/11/03 called, arm better a little, sore but no numbness left.
Severe cough, dyspnea, nausea, pains, chills, weakness, dizziness onset within 2 hours of vaccine.  Cough, vomiting, low appetite, fatigue, metal taste, wheezing, burning in chest.
pt came in for 2nd dose and reported pain/soreness of his nose for almost 1 month after 1st dose. Pt reports history of nasal cancer. Contacted Dr. (PCP) for a recommendation on how to proceed after this reaction and whether to give 2nd dose. Spoke with nurse and Dr. himself - PCP has ok'd second dose of Shingrix as he does not believe it is due to the vaccine. He advised patient to call office immediately if any reaction occurs after 2nd dose.
This spontaneous report was received from a physician and refers to an unspecified number of female patients of unknown age. No medical history, current conditions and concomitant therapies were reported. On an unknown date, the patients were vaccinated with M-M-R II. Lot #, expiration date, dose and route of administration were not reported. On an unknown date, the patients were tested for rubella immunity as a routine part of pre-pregnancy testing and their titers came back showing that they had no immunity to rubella. On an unknown date, the patients were revaccinated with unspecified rubella vaccine. The patients outcome was not reported. The relatedness between the event and M-M-R II was not reported. Additional information is not expected because the physician retired from her practice and had no longer records for these patients therefore she had no specified details regarding the patients involved.
They have tried to administered it was damaged, when they trying to put cap or something on it, it would not lock; part of the securing mechanism broke off; They have tried to administered it was damaged, when they trying to put cap or something on it, it would not lock; part of the securing mechanism broke off; When we tried to secure, when we had to push down and then turn, part of the securing mechanism broke off; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 27Oct2023, this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF3020, Expiration Date: Feb2025, NDC number: 0069034405) and as dose number unknown, single (Lot number: PAA209777, Expiration Date: Feb2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE PHYSICAL PROPERTY ISSUE (non-serious), DEVICE MECHANICAL ISSUE (non-serious), outcome "unknown" and all described as "They have tried to administered it was damaged, when they trying to put cap or something on it, it would not lock; part of the securing mechanism broke off"; DEVICE BREAKAGE (non-serious), outcome "unknown", described as "When we tried to secure, when we had to push down and then turn, part of the securing mechanism broke off".  Additional information: It was reported the Abrysvo was defective and a piece of glass broke off it. When they have tried to administered it was damaged. The product was damaged, when they she said when they trying to put cap or something on it, it would not lock." When they tried to push down and then turn, part of the securing mechanism broke off. So it would not secure a lock so, it had sharp edge so we have to put it on our sharp box. It was reported that a sample of the product available to be returned. Reporter stated, "It is in our sharp container, I can dig it up, I guess; "I do have piece of glass that broke of it, if you need that."  Causality for "they have tried to administered it was damaged, when they trying to put cap or something on it, it would not lock; part of the securing mechanism broke off" and "when we tried to secure, when we had to push down and then turn, part of the securing mechanism broke off" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Developed "red spots" on his arm approximately 2 weeks post vaccination. Approximately 1 week subsequently ~ 24 Jan 2022, developed painless "red splotches" on his back. Evaluated by a dermatologist who diagnosed pityriasis rosea  No systemic symptoms Lesions resolved by evaluation 28 Feb 2022
Janssen COVID-19 Vaccine EUA.  constant stabbing/poking pain on my left hand side chest. I feel that there is a sharp foreign object inside my left chest in which a needle or nail-cross pokes my heart or internal muscle something.
Dizzy after 2nd dose; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was allergic to peanuts, shellfish, methimazole, proparacaine and onion. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient was not tested positive for COVID-19 since vaccination. On an unknown date, the patient experienced dizzy after the second dose. The clinical outcome of the event dizzy was unknown at the time of report.   Information about lot/batch number cannot be obtained. No further information is expected.
pT ARRIVES TO BE SEEN FOR Short of Breath. pT IS BREATHING HARD Pt is here to be seen with husband. They believe they caught covid from their daughter who drove them to the HCF for pt. to be seen for follow up on esophageal cancer. Pt has had covid vaccine. pt has dementia and her husband is responsible for remembering things. Pt does not have a history of MI, cardiac stent or bypass. She is a diabetic. She is currently taking cipro for uti. Pt arives with a low sat at 85%.  Associated Symptoms: cough, shortness of breath, sputum, wheezing
experienced dizziness like he was going to fall/the dizziness "felt like a stroke"; nausea; vomiting; diarrhea; soreness; didn't want to eat; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting), DIARRHOEA (diarrhea), PAIN (soreness) and DECREASED APPETITE (didn't want to eat) in a 70-year-old male 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 COVID-19 (in November 2020. He stated that he was sick from COVID-19 for 2.5 weeks.) in November 2020. Concurrent medical conditions included Renal disease (Moderate renal disease), Drug allergy (Sulfa) and Drug allergy (Flexeril). Concomitant products included POTASSIUM CITRATE, SODIUM BICARBONATE, CALCIUM and VITAMIN D NOS for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting), DIARRHOEA (diarrhea), PAIN (soreness) and DECREASED APPETITE (didn't want to eat). On 02-Feb-2021, the patient experienced DIZZINESS (experienced dizziness like he was going to fall/the dizziness "felt like a stroke"). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea) had not resolved and VOMITING (vomiting), DIARRHOEA (diarrhea), PAIN (soreness), DECREASED APPETITE (didn't want to eat) and DIZZINESS (experienced dizziness like he was going to fall/the dizziness "felt like a stroke") was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 2 Feb 2021, the patient reported that he feels better but still feels queasy and is not working today.   Reporter did not allow further contact
Swelling at injection site; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2019, the patient received the 1st dose of Shingrix. On 1st September 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On 3rd September 2019, the outcome of the injection site swelling and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: After administration of 1st dose of Shingrix patient experienced injection site swelling and injection site pain. The follow up consent was granted. This case has been linked with case US2019222789, reported by same reporter.
a significant thrombosed external hemorrhoid; Chest pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 03:30 (Lot number: 8W 0158) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme's disease" (unspecified if ongoing); "myocarditis" (unspecified if ongoing), notes: mirroring a severe case of myocarditis suffered 20 years ago. The patient's concomitant medications were not reported. The following information was reported: HAEMORRHOIDS THROMBOSED (non-serious) with onset 10Apr2021 12:00, outcome "recovered with sequelae", described as "a significant thrombosed external hemorrhoid"; CHEST PAIN (non-serious) with onset 10Apr2021 12:00, outcome "recovered with sequelae", described as "Chest pains". Therapeutic measures were not taken as a result of haemorrhoids thrombosed, chest pain.  Clinical course: Chest pains...mirroring a severe case of myocarditis suffered 20 years ago. Chest pains started 2 days after vaccine date and persisted for 2 weeks. Also, a significant thrombosed external hemorrhoid appeared 3 days after vaccine date.  Follow-Up (01Dec2021): Follow-up attempts are completed. No further information is expected.
No appointment found in scheduling system, but paper copy of administration record of a third dose of Pfizer vaccine found for this client.
fatigue; nausea; Did not eat and drink; Diarrhea; Joints Pain; Muscle Pain; Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Did not eat and drink), DIARRHOEA (Diarrhea), ARTHRALGIA (Joints Pain), MYALGIA (Muscle Pain) and HEADACHE (Headache) in a 69-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.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FEEDING DISORDER (Did not eat and drink), DIARRHOEA (Diarrhea), ARTHRALGIA (Joints Pain), MYALGIA (Muscle Pain), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced FATIGUE (fatigue) and NAUSEA (nausea). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 12-Apr-2021, FEEDING DISORDER (Did not eat and drink), DIARRHOEA (Diarrhea), ARTHRALGIA (Joints Pain), MYALGIA (Muscle Pain), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) was resolving. At the time of the report, FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Non-significant follow-up appended.NNI
Patient said her arm was sore and she had difficulty raising it after a few days.   After 11 days she went to an urgent care and was prescibed meloxicam for inflammation.  Over time she said it is feeling better, but not 100 %.
After vaccination, I have been with issues with my lungs (short breathing) and bronquiatis/Neumonia  Medication relives but my lungs are not getting better.
This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ROTATEQ (dose, frequency, strength and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that an unspecified number of patients (no patient information was known) were administered ROTATEQ, was improperly stored outside the temperature storage range listed in the product inserts, on an unknown date. No adverse effects reported. Additional information has been requested. These case is one (1) of four (4) reports from the same source.
Patient was vaccinated per standing orders. Patient called the office approximately 4 hours later reporting "worst pounding headache i've ever had" and nausea. Denied any other symptoms at that time. Denied fever, site swelling drainage warmth. Denied shortness of breath and chest pain. Instructed to go to the ED immediately.
sore throat; mild chest pressure; neck feels puffy; sore in eye; sore in tongue; swollen glands; body ache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), CHEST DISCOMFORT (mild chest pressure), SWELLING (neck feels puffy), EYE PAIN (sore in eye ) and GLOSSODYNIA (sore in tongue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052FZ119) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Endocrine disorder. Concomitant products included HYDROCORTISONE for Endocrine disorder.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), CHEST DISCOMFORT (mild chest pressure), SWELLING (neck feels puffy), EYE PAIN (sore in eye ), GLOSSODYNIA (sore in tongue), LYMPHADENOPATHY (swollen glands), MYALGIA (body ache) and FATIGUE (fatigue). The patient was treated with ZINC for Adverse event, at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Ache, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), CHEST DISCOMFORT (mild chest pressure), SWELLING (neck feels puffy), EYE PAIN (sore in eye ), GLOSSODYNIA (sore in tongue), LYMPHADENOPATHY (swollen glands), MYALGIA (body ache) and FATIGUE (fatigue) had not resolved.       The patient got booster dose and 5 days after that, she started with (and are still ongoing): sore throat, swollen glands, neck feels puffy, mild chest pressure, body ache, fatigue, sore in tongue, sore in eye; everything is mild to moderate.  Company comment: This case concerns a 71-year-old, female patient with medical history of endocrine disorder, who experienced the unexpected non serious events of oropharyngeal pain, chest discomfort, swelling, myalgia, eye pain, glossodynia, lymphadenopathy and fatigue. The events occurred approximately 5 days after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-403251, MOD-2021-403248 (Patient Link).; Sender's Comments: This case concerns a 71-year-old, female patient with medical history of endocrine disorder, who experienced the unexpected non serious events of oropharyngeal pain, chest discomfort, swelling, myalgia, eye pain, glossodynia, lymphadenopathy and fatigue. The events occurred approximately 5 days after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Severe allergic reaction after 1 hour of administration (throat swelling and difficulty swallowing-911 activated-to local ER for epinephrine and Benadryl-client recovered fully.
No adverse event. The patient was given .3 mL of purple cap Pfizer on 11/29/22 and 0.2mL of the purple cap Pfizer lot # FJ8757
This spontaneous report as received from a consumer refers to himself, a 67-year-old male patient with allergy to sulfa drugs. The patient's medical history included an open heart surgery in 2008 (reported as 11 years ago). The patient's concomitant therapies included SYNTHROID, "alapuridol" and ibuprofen. In approximately 2017 (reported as about a year and a half ago), the patient was vaccinated with the first dose of PNEUMOVAX 23 (strength, dose, frequency, route, anatomical site, lot # and expiration date were unknown) for prophylaxis. On 11-DEC-2018 (reported as four months ago), the patient experienced pneumonia, and his doctor recommended a second PNEUMOVAX 23 because of this, which was administered on 05-APR-2019 around 2:00 PM. The patient described that, at 7:00 PM he noticed severe stiffness in his neck, and by 8:00 PM he had a horrible, monumental headache. He stated that he took ibuprofen and went to sleep, but, on 06-APR-2019 at 4:00 AM he was up with uncontrollable diarrhoea. The patient also reported that musculoskeletal stiffness and headache came and went, but nothing helped, and he had taken diarrhoea medication. However, the patient had had no fever and no soreness at the shot site. The patient did not see for medical attention, but a blood work panel was done "for physical"; however the results were not provided. The patient did not received any treatment. At the reporting time, the outcome of pneumonia was reported as recovered on an unknown date. Nevertheless, the outcome of musculoskeletal stiffness, headache and diarrhoea were reported as not recovered. The causality between PNEUMOVAX 23 and the reported events was unknown. Upon internal review, pneumonia was considered to be medically significant.
(L) deltoid muscle warm, mild edema 15 in length by 14 in width. Cellulitis vs reaction / antibiotic given.
Received vaccine at 2:50 on 4/22. Within a couple of hours was feeling a bit dizzy and light headed.  And very tired and fatigued. Vomited at 2:15am, low grade fever at 8am, body was sore and aching- felt like I was hit by a truck, limbs felt very heavy, extremely fatigued, headache.  The next day, 4/24, fever was gone, but still very fatigued and limbs still felt heavy, mild headache. By day 3 was just a bit tired, but overall had recovered.
pt recvd vax; after 4 hrs pt exp hot & cold sensations; pt exep nausea;
SYRINGE WAS KEPT AT ROOM TEMPERATURE FOR THREE HOURS AND ADMINISTERED TODAY; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUL-2021, the subject experienced syringe was kept at room temperature for three hours and administered today. On 15-JUL-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the syringe was kept at room temperature for three hours and administered today and poor quality vaccine administered was not reported. This report was non-serious.