chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediate sever pain at injection site, immediately followed by flushed face, racing heartbeat, tingling and inching of face, watering eyes, itchy throat that felt like it was closing in, lump in throat, difficulty breathing, unable to speak. Was able to speak after a couple minutes and the other symptoms started to gradually improve at that point. Most of the above symptoms subsided within around forty minutes. The lump in the throat remained for weeks eventually coming and going.
While still in bed, the room started to spin; This case was reported by a consumer via call center representative and described the occurrence of spinning sensation in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2020, the patient received the 2nd dose of Shingrix. On 2nd December 2020, 2 days after receiving Shingrix, the patient experienced spinning sensation. On 2nd December 2020, the outcome of the spinning sensation was recovered/resolved.   It was unknown if the reporter considered the spinning sensation to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself/herself. On 2nd December 2020 morning, while patient was still in bed, the room started to spin.  The patient felt ok at the time of reporting.
missed his second Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed his second Moderna vaccine) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed his second Moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed his second Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.   The reporter stated that the patient was sick and was in and out of hospital, not due to the Moderna vaccine.  Treatment information not reported.
Reddish rash below injection site on left arm, approximately 3 inches x 2 inches. I first discovered rash on left upper arm on morning of March 9.  I called primary doctor. At advice of primary doctor, I took Benadryl beginning night of March 9 . No apparent change as of morning of March 10.    Took photos at various times.
1/7/2021 vaccination 1/9 abcess on tooth; dental pain Following Tuesday, root canal 1/11/2021. Dentist suspected that the vaccine opened avenue of abscess; triggered.  1/10 Saw PCP and following week EKG, Stress test and appt with cardiologist. Cardiologist suspects inflammation to the valve symptoms.
Developed hives to legs immediately after immunizations given. Monitored for 15 mins; Hives resolved. No other symptoms. Advised to call if hives returned.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Right knee pain, that began 2 days after the vaccine, that is still sore; Right knee pain causing him to limp.; Fatigue the day after the vaccine; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2022, the patient received the 1st dose of Shingrix (intramuscular). On 27th May 2022, 1 days after receiving Shingrix, the patient experienced fatigue. On 28th May 2022, the patient experienced knee pain and limping. On an unknown date, the outcome of the fatigue was recovered/resolved and the outcome of the knee pain and limping were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, knee pain and limping to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's Comments:  The patient received his first Shingrix vaccine in the left arm.  General fatigue the day after the Shingrix vaccine, that resolved. The patient was reported right knee pain, that began 2 days after the Shingrix vaccine, that was still sore and causing him to limp. The reporter did not consent to follow-up. The reporter did not give permission to contact health care professional.
I got hives on my neck and on the top of my chest; Itching; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200, Expiry Date: Jun2021) via unknown route of administration on 13Feb2021 at single dose for COVID-19 immunisation. Medical history and Concomitant medication were not reported. Patient stated, "I recently had my shot (clarified as Covid 19 vaccine Pfizer) yesterday, my first one where I go to the site. On the way home I got hives on my neck and on the top of my chest, that was the only place on 13Feb2021. I had no trouble breathing but I was itching on 13Feb2021. Anyway, my concern now was I was trying to find out if I should even think about getting the second shot of the possible, more severe side effects? Treatment was reported as No. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse practitioner (N.P.), for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female with herpes simplex virus and no drug reactions or allergies who on 12-SEP-2011 was vaccinated with the first dose of GARDASIL (lot #, dose and route not reported). There was no concomitant medication. The N.P. reported that the patient had positive pregnancy test (by urine) on 04-OCT-2011. The N.P. stated that the patient was a few days pregnant when she received the vaccine. No adverse effects to report. The Last menstrual period (LMP) was 25-AUG-2011 and the Estimated Delivery Date (EDD) was 31-MAY-2012. The patient sought unspecified medical attention. At the time of the report, the outcome of the pregnancy was unknown. Follow up information has been received from the nurse practitioner concerning the 24 year old female patient. A girl baby was born via C-section on 29-MAY-2012 at 39 weeks and 5 days. The gestational blood sugar (GBS) performed positive (+) (also reported as "GBS+"). The patient had a complicated antepartum course with hemorrhage and decreased haemoglobin (HB) to 9.2 but was discharged in good condition on post-partum day 4. As far as she knew the baby was normal and healthy. There were no congenital anomalies or problems with the baby mentioned in the chart. The infant was a baby girl and weighed 4.425 kg. Apgar scores were 8 and 9. The outcome of the C-section was unknown. Upon internal review, C-section was considered as medically significant. Additional information is not expected.
Pt rec'd immunizations 12/10/01, same day (evening) had onset of fever, chills, weakness. Symptoms resolved by next morning.
This spontaneous report as received from a pharmacist via company representative refers to a 80 year old male patient. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque forming units (PFU) (Lot number, dose and route were not reported). Concomitant therapy was not reported. On an unknown date, the patient received ZOSTAVAX, and then fell into a coma (medically significant). The patient sought unspecified medical attention. The primary reporter stated that he was unsure if the patient had died. The outcome of the event was unknown. Relatedness between the event and ZOSTAVAX was not reported. Upon internal review the event was considered medically significant. Additional information has been requested.
Local irritation, swelling, redness in right arm. Itching subsided - irritation has not progressed in day since first noticed. Reported to pharmacy 11/7/09 at 14:00
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID19 INFECTION; This spontaneous report received from a health care professional concerned a 61 year and 8 months old white female of unknown ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and other pre-existing medical conditions included no drug abuse or illicit use, no recent history of exposure to a person with Covid infection. The patient did not have past history of similar event. The patient did not had adverse event after any previous vaccination. The patient did not had any history of allergy to vaccine, drug, or food. The patient did not had any pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, with cause, no family history of any disease (relevant to vaccination) or allergy. The patient was not breastfeeding at the time of report. On 25-Mar-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020 and expiry: Unknown) frequency 1 total, 0.5 ml, administered on left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-Aug-2021, the patient experienced cold, with running nose and felt tired. On 07-Aug-2021, Laboratory data included: Covid-19 PCR test, was tested Positive on 9-Aug-2021 (confirmed clinical vaccination failure and confirmed covid19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210846649 and 20210846822.  Additional information was received from health care professional on 26-Aug-2021. The following information was updated and incorporated into the case narrative:  Multiple patient changed to Single patient case, Patient information (age, gender, name, race) Past medical history, Event onset date, Lab test, product Dose, route of admin, site of vaccination, RRT of event suspected clinical vaccination failure changed to confirmed clinical vaccination failure. Events cold, with running nose and felt tired subsumed under confirmed covid19 infection.; Sender's Comments: V2: This follow-up adds: Multiple patient changed to Single patient case, Patient information, past medical history, Event onset date, Lab test, product Dose, route of admin, site of vaccination, RRT of event suspected clinical vaccination failure changed to confirmed clinical vaccination failure.   20210846435-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure . Follow-up received regarding Clinical Details. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
I am reporting as the mother of my daughter, who began suffering severe cyclic vomiting, sometime after receiving the HPV (GARDASIL) vaccine. She has episodes of bi-weekly to monthly, and she vomits all day; it subsides by early evening: They last from days to beyond a week. I am at a loss at this time because there has been NO diagnosis to date. She has been to the ER >25 times since c.2011 and her health as well as her ability to earn a living has been seriously, adversely affected. I was responsible for my daughter at the time she received the vaccine and I placed my trust in doctors as well as the drugs that are released/approved for use on patients. My daughter has lost too much weight and there is no way to know what damage she has sustained internally. Please contact her going forward as she is an adult and I have no authority beyond expressing my deep concern for her health.
The patient recieved her second dose of Moderna and was sitting in observation when staff told us that  the pt was falling asleep and was near syncopal.  The patient was assessed by and the patients Power of Attorney was called to ask if they wanted the pt transported. who makes decisions for the patient did not want the patient transported and we advised him that it was against our medical advise and he still refused transport. He stated that he wanted staff to observe the patient.
Patient stated on 4/17 (approximately 4 days after receiving shot) she got a rash on her left arm.  The rash started  in the same area as the shot and continued over time   almost to her elbow.  She reported this to the pharmacy on 04/23/2021 and at that time the rash was improving. Patient stated the rash itched but did not indicate any other symptoms.
Stated to have redness, warmth, swelling, around the site of administration of her Moderna Booster on 11/6/21. SHe stated to have had same reaction to the Moderna vaccine prior. Symptoms improving but not resolved at the time of the form being completed on 11/9/21.
A 95-year-old gentleman with significant Medical history for dementia/hypertension/hyperlipidemia, who presents from nursing home after being found on the ground, unable to get up; the patient was evaluated in the ED, patient is hard of hearing, does not have a hearing aid, is alert, able to communicate. Patient subsequently tested positive for COVID on 4/10/2021 and placed on 5L nasal cannula. Patient was previously diagnosed with COVID on 12/07/2021, so this could represent a persistent positive.
Achy legs from previous dose; Headache from her previous two doses; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Achy legs from previous dose) and HEADACHE (Headache from her previous two doses) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Migraine and Headache. Concomitant products included GABAPENTIN for an unknown indication.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Achy legs from previous dose) and HEADACHE (Headache from her previous two doses). At the time of the report, PAIN IN EXTREMITY (Achy legs from previous dose) and HEADACHE (Headache from her previous two doses) outcome was unknown.      Concomitant medication also include blood pressure medication. No treatment information were given.   This case was linked to MOD-2021-406263 (Patient Link).
Pt developed swelling and pain at injection site. Pt's Dr initiated treatment for bacterial infection (prednisone and cephalexin).
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 left, administration date 07May2021 15:30 (Lot number: EW0182) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; LISINOPRIL; ASPRIN; GINKO BILOBA [GINKGO BILOBA LEAF]; FISH OIL. Vaccination history included: Bnt162b2 (dose 1, lot number: EW0162, administration time: 03:30 PM,, vaccine location: Left arm), administration date: 16Apr2021, when the patient was 61 years old, for COVID-19 immunization.The following information was reported: BACK PAIN (non-serious) with onset 07May2021 19:00, outcome "recovered" (2021), described as "Severe Lower Back Pain"; GAIT DISTURBANCE (non-serious) with onset 07May2021 19:00, outcome "recovered" (2021), described as "could barely walk.". Therapeutic measures were not taken as a result of back pain, gait disturbance. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Follow-up attempts are completed. No further information is expected.
Started developing left arm pain at the injection site. Later that evening started developing severe chills and shaking, fever and a Migraine. 2 hours later started developing jaw pain, fatigue and a fever. Next day had 102 fever and severe migraine headache, and took Sumatriptan. Started having chest pain and pressure 2 days after vaccine, and took Tylenol with Codeine with Sumatriptan. Called RN on COVID-19 Hotline and was told that deep chest pain was a symptom of COVID-19 vaccine, however if the pain changes to sharp go to the ER, never needed to because pain wasn't sharp. Next day had a 101.4 fever with chills with headache, fatigue, pain in jaw, teeth and chest pain with shortness of breath. Shortness of breath was steadily getting stronger.  One month later went to ER was having severe chest pain on my right side and was admitted to the hospital for 11 days. Was given Heparin, then changed to Eliquis and put on oxygen. Given a CT Scan, Chest X-ray and bloodwork. CT scan showed that I had Pulmonary Blood clots in both lungs.  When discharged was Oxygen, using 5 liters per minute. Home health was provided for 2 weeks. Had Occupational Therapy and Physical Therapy. Went back to my doctor and had a Pulmonary Function test and was able to decrease Oxygen intake to 2 liters per minute. Currently taking Eliquis and smaller amounts of Oxygen.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer also received additional information on 05 Oct 2018. This case involves Adult female patient who experienced i feel funny and am sick to my stomach, feel shaky like i've had too much caffeine, my muscles are tense, i am nauseated and i have a lump in my throat, while she received vaccine FLUBLOK QIV. It was reported that, patient's had an Alpha Gal allergy. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported in the right arm. On an unknown date, 15 min post vaccination patient developed a non-serious i feel funny and am sick to my stomach (feeling abnormal), i feel funny and am sick to my stomach (abdominal discomfort), feel shaky like i've had too much caffeine (nervousness), muscles are tense (muscle tightness), i am nauseated (nausea), i have a lump in my throat (sensation of foreign body). Final diagnosis was i have a lump in my throat, i am nauseated, my muscles are tense, feel shaky like i've had too much caffeine, i feel funny and am sick to my stomach and i feel funny and am sick to my stomach. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for i feel funny and am sick to my stomach, as Unknown for i feel funny and am sick to my stomach, as Unknown for feel shaky like i've had too much caffeine, as Unknown for my muscles are tense, as Unknown for i am nauseated and as Unknown for i have a lump in my throat.
Restless leg syndrome, muscle pain, joint pain, chills/fever, cold/numb hands and feet, tingling arms and fingers, dizzy, nausea, head pressure, headache, brain fog,/slow  sensitive to cold/heat/body temperature fluctuations, heart palpitations,  Acetaminophen, Ibuprofen, Naproxen -- > no relief from even the higher doses
Almost exactly one day later, I had chill and started to shake rather violently....I failed to realize that it was a reaction to the booster shot I received one day ago....I lied down on a couch with a blanket over me, still shaking a lot....I stayed like that for about 2 and a half hours, and the symptom went away, and it never came back.  I did not take any medication to treat this symptom.
Vertigo; dizziness when they if looked down; achy; pretty good headache; Body Ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (pretty good headache), PAIN (Body Ache), VERTIGO (Vertigo), DIZZINESS (dizziness when they if looked down) and PAIN (achy) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis since an unknown date. Concomitant products included LOSARTAN, LEVOTHYROXINE SODIUM (SYNTHROID) and OMEPRAZOLE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (pretty good headache), PAIN (Body Ache) and PAIN (achy). On 25-Mar-2021, the patient experienced VERTIGO (Vertigo) and DIZZINESS (dizziness when they if looked down). On 19-Mar-2021, HEADACHE (pretty good headache), PAIN (Body Ache) and PAIN (achy) had resolved. At the time of the report, VERTIGO (Vertigo) and DIZZINESS (dizziness when they if looked down) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included multiple sclerosis medication and muscle relaxer Treatment for the event, headache included ibuprofen
Caller reports an expired dose of VAQTA was administered. No temperature excursion on the vaccine. No additional information. No PQC reported.; This spontaneous report was received from a nurse prescriber refers to a patient of unknown age and gender.There was no information about the patient's medical history, concurrent conditions or concomitant medication.   On 08-APR-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA), prefilled syringe,dose: 0.5 milliliter, lot # T023913, expiration date: 31-MAR-2022 for prophylaxis (route, and dose number were not reported) (expired product administered). No temperature excursion on the vaccine. No additional information. No product quality comaplint reported.
Patient received his vaccine and immediately sat down in the observation chair. About 3-4 minutes after his vaccine, he slumped over in the chair and was unresponsive. The pharmacist and store manager stayed with him as a technician called 911. He was unresponsive for about 30 seconds before he came to but then continued to go in and out of consciousness for the next couple of minutes. He said he had a history of dizziness after vaccines. When he was finally able to hold a conversation with us, he said he felt hot and we gave him a cold bottle to put on his head until the paramedics arrived. His blood pressure was 100/50 when the paramedics arrived about 7-10 minutes after we called and patient was fully responsive then. Paramedics continued to monitor him and followed him home to make sure he was okay.