chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt felt dizzy, lightheaded after administration, pallor skin, reported throat was sore, felt tight lung wheezing, pt was diaphoretic. Gave .3 epi, pulse ox 89 prior, 98 post treatment. resp status improved, transferred to Emergency Dept via ambulance
pt. c/o headache, dizziness after Pfizer vaccine was given.  pt. symptoms was resolved and patient went home
HAS ADVERSE REACTION HE THOUGHT HE MIGHT LOSE HIS LEGS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced an adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of an adverse reaction was not reported. This report was non-serious.
When I got up the next morning, I had hives going up my neck and my neck was swollen. I called doctor he had me double up on my Claritin and take Benadryl every 4 hours and Tylenol. About 4 days I was completely better except my neck is numb on my collarbone.
Persistent low grade fever over 7 days. On and off dizziness, which is still occuring 10 days after being vaccinated. Also persistent headaches for 10 days varying from mild to migraine. Persistent fatigue.
4 hours after the vaccine the patient called and reported that she had shortness of breath and throat swelling which resolved after taking diphenhydramine.
general flu like; loss of appetite; shaking on and off; tingling in arms; muscle weakness; general malaise; nausea; muscles aching of left arm left leg; feeling cold then hot; weight loss; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a 66-years-old female patient who experienced feeling cold then hot (Feeling of body temperature change), weight loss (weight decreased), general flu like symptoms (influenza like illness), loss of appetite (decreased appetite), shaking on and off (tremor), tingling in arms (paraesthesia), muscle weakness (muscular weakness), general malaise (malaise), nausea, muscles aching of left arm left leg (myalgia), while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  The patient had a bat in her room and woke up with a scratch on her neck. She was unsure if she was bitten by the bat.  Concomitant medication included HyperRab.   The patient received first, second, third and fourth dose of suspect RABIES (HDC) VACCINE (lot number and expiry date not reported) via an intramuscular route in an arm NOS (not otherwise specified) for prophylactic vaccination on 24-Aug-2020, 27-Aug-2020, 31-Aug-2020 and 07-Sep-2020 respectively.   In Aug-2020, the patient developed a non-serious feeling cold then hot (Feeling of body temperature change), weight loss (weight decreased), general flu like symptoms (influenza like illness), loss of appetite (decreased appetite), shaking on and off (tremor), tingling in arms (paraesthesia), muscle weakness (muscular weakness), general malaise (malaise), nausea, muscles aching of left arm and left leg (myalgia) 3 days after each of the 1st, 2nd and 3rd dose of RABIES (HDC) VACCINE.  The patient experienced the symptoms again 10 days after her 4th vaccine that lasted for 7 days.  Relevant laboratory test: blood work and X-rays results came back normal.  The patient had to go to the emergency room (ER) twice due to these symptoms.  The ER gave her fluids.  At the time of this report, the patient had not recovered from events.  There will be no information available on the batch number for this case.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Nurse manager reporting that Bivalent Vaccine underwent temperature excursion started on 21-Feb-2023), POOR QUALITY PRODUCT ADMINISTERED (Bivalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023, They were to be used within 24 hours but administered to 17 patients on unknown dates.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.
Pimples; It is itching so much like the bleedings; It is itching so much like the bleedings; All sores on my arm, on my legs; Bumps that itch/Little bumps all over my legs, all over my arms and itching like hell; Bumps that itch/Little bumps all over my legs, all over my arms and itching like hell; Scab on my arms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 85-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: 100-012-1721), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 13:15 as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism, hypersensitivity. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); hydrochlorothiazide (HYDROCHLOROTHIAZIDE). The patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, administered in Arm left on 18Feb2021 13:30 as SINGLE DOSE for covid-19 immunization. No other vaccine in four weeks. The patient experienced bumps that itch/little bumps all over my legs, all over my arms and itching like hell, scab on my arms on 28Jan2021 13:15 with outcome of not recovered, pimples, it is itching so much like the bleedings, all sores on my arm, on my legs on an unspecified date with outcome of unknown. Patient stated that she had the shot 2 times and the 2nd time that she had the shot she was all broken up with little bumps all over my legs, all over my arms and itching like hell. Now the doctor gave her prednisone 2 times that didn't help and it helped me itching (Not cleared since there was distortion on line hence captured suspect conservatively). patient asked the pharmacist, what she could give her. She didn't know. So she don't know what to do. It is itching terrible. Patient stated that It is driving her crazy. Her legs, her arms and this happened right after she had the shot. Patient stated Yes. That would be wonderful because this itch is driving me nuts. Itching all the time. Patient stated never had this in her life. Patient stated that he told me to take prednisone, but he only put like 6 pills and she had to take 2 a day. So it is 3 days. When probed as, improved, worsened or persisting, Consumer stated that it was the same way like it was when it started but now that she got more sores. She even asked the pharmacist yesterday and she can't tell me anything she could take and she said No. She didn't know. No covid prior vaccination and no covid tested post vaccination. Therapeutic measures were taken as a result of events with prednisone and Benadryl. The outcome of the events the patient experienced bumps that itch/little bumps all over my legs, all over my arms and itching like hell, scab on my arms was not recovered and for rest all events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (a breakthrough COVID-19 infection) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced COVID-19 (a breakthrough COVID-19 infection). The patient was treated with DAYQUIL AND NYQUIL SEVERE+ VICKS VAPOCOOL COLD AND FLU at an unspecified dose and frequency. At the time of the report, COVID-19 (a breakthrough COVID-19 infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive. No concomitant medications were reported Symptoms: It was reported that the patient had experienced a breakthrough COVID-19 infection, and was diagnosed on 01-Nov-2021, while the symptoms were began on 29-Oct-2021, there were no side effects from Moderna COVID-19 vaccine reported, and the symptoms were ongoing. Patient wanted to knowif he could get a booster dose of vaccine following a breakthrough infection. Company comment: This spontaneous case concerns a 22-year-old male patient with no medical history reported, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 9 months after the initial schedule of mRNA- 1273 vaccine, schedule of vaccination unknown. Clinical manifestations included fatigue, oropharyngeal pain, rhinorrhoea and dizziness. At the time of the report, the symptoms were ongoing. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.  Vaccination failure/ Drug ineffective is not assessable since the actual schedule of vaccination is unknown. Sender's Comments: This spontaneous case concerns a 22-year-old male patient with no medical history reported, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 9 months after the initial schedule of mRNA- 1273 vaccine, schedule of vaccination unknown. Clinical manifestations included fatigue, oropharyngeal pain, rhinorrhoea and dizziness. At the time of the report, the symptoms were ongoing. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.  Vaccination failure/ Drug ineffective is not assessable since the actual schedule of vaccination is unknown.
Fever, chills, chest pain, shortness of breath, tachycardia, fainted once morning after vaccine. It?s been 2 weeks and still have chest pain, tachycardia, and shortness of breath. Had ekg, prescribed propranolol and anti inflammatory and bed rest.
This is a spontaneous report from a contactable consumer (patient's mother/reported for her son). A 14-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EW0169, expiration date: unknown), at the vaccination age of 14, via an unspecified route of administration, in left arm, on May 14, 2021, at 11:00, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. Since Saturday, May 15, 2021, at 00:00 am, patient could not taste anything. No treatment received for the adverse event. The device date reported as May 17, 2021. The outcome of the event: not resolved. Follow-up attempts completed. No further information expected.
Initials and follow up information has been received from a licensed practical nurse and a physician concerning a 78 year old male patient with hypertension and a history of prostate cancer, colon cancer, colectomy and bone spur who on 04-Dec-1998 was vaccinated with the first dose of PNEUMOVAX 23 (lot number not reported). On 13-March-2008, the patient was vaccinated intramuscularly in the deltoid with a second 0.5ml dose of PNEUMOVAX 23 (lot number 659486/1539U). Concomitant medications included Atenolol, Lisinopril, Casodex and Lupron. There was no illness at the time of vaccination. The physician reported that on 13-May-2008 the patient experienced a swollen red area over the site of injection and that the patient had not experienced any adverse events following prior vaccination. The nurse reported that on 19-May-2008, the patient experienced reddened arms with small clear dots after receiving the second vaccination. The patient's arm was examined during a scheduled office blood pressure check on 19-May-2008 and no treatment was rendered. The patient sought unspecified medical attention. No other symptoms reported. Subsequently, the patient recovered. No further information is expected.
Day 1&2 - sore arm at injection site 5-7 days after injection - fever, nausea, diarrhea, achiness, exhaustion 19 days after injection - shortness of breath and tightness in chest 20 days after injection - extreme shortness of breath, tightness/pressure/pain in chest - mimicking heart attack; went to ER 21 days after injection - diagnosed with atrial fibrillation **Had recently been to annual physical and check-up with PCP, no concerns from PCP or patient; had also recently been through LifeLine Screening, no concerns seen with any of the tests/ultrasounds/etc.** Still having issues with chest pain and shortness of breath
7 hours after injection I experienced full body muscle aches for approximately 18 hours.  I also experienced elevated heart rates 3 days after the injection, up to 101 bpm for up to 3 days
About 3 days after the 2nd vaccine, I started getting a number of itchy bumps on my left arm. Over the next few days, it started to spread to my other arm, torso and legs. They were very itchy. I consulted a doctor via telehealth and was prescribed a short course of prednisone, which did  not help. My rash continued to get worse and I made another appointment to see a dermatologist. The dermatologist commented that it looked like a viral rash. I was prescribed a course of 21 days of prednisone and a topical steroid cream. My rash did resolve after the 2nd round of medications.
She was so sick from the shingles vaccine; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a 48-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included dupilumab (Dupixent (Dupilumab)) for atopic dermatitis.   The patient's past medical history included anxiety disorder, gastroesophageal reflux disease, headache, insomnia, obstructive sleep apnea syndrome and unspecified nutritional deficiency. Concurrent medical conditions included autoimmune thyroiditis, celiac disease, essential hypertension, hepatic steatosis, fibromyalgia, generalized anxiety disorder, hypothyroidism, irritable bowel syndrome, major depression, migraine, amyloidosis, atopic dermatitis, hyperlipidemia, psoriasis vulgaris, supraventricular tachycardia, ulcerative colitis, drug hypersensitivity and primary hypertension. Concomitant products included amitriptyline, atorvastatin, azithromycin, buspirone, calcium, colecalciferol, diclofenac, linaclotide, lorazepam, levothyroxine, liothyronine, omeprazole, prednisone, topiramate, amitriptyline hydrochloride, calcium carbonate and dicycloverine.   On 22nd May 2020, the patient received the 1st dose of Shingrix and Dupixent (Dupilumab) (subcutaneous) 300 mg at an unknown frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. The action taken with Dupixent (Dupilumab) was unknown. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comment: This case involved a patient who was sick from the shingles vaccine while being treated with Dupilumab (Dupixent) via prefilled pen and varicella zoster vaccine. The patient's past medical treatment and family history were not provided. The patient concomitant medication included Vitamin B complex, Linaclotide (Linzess), Liothyronine (NP thyroid), Vitamin D Nos, Colecalciferol (Vitamin D3 ) and Dicycloverine (Dicyclomine). The patient started taking Dupixent (Dupilumab) solution for injection on 300 mg QOV (every other week) subcutaneously via prefilled pen (strength 300 mg/2m), batch number and expiration date were unknown for other atopic dermatitis and Shingrix (varicella zoster vaccine, dosage, frequency, route device , strength, batch number and expiration date were unknown for prophylactic vaccination. The patient was so sick from the shingles vaccine( illness) unknown latency following the first dose of Dupilumab and varicella zoster vaccine. The action taken was unknown with Dupilumab and varicella zoster vaccine. The information on the batch number was requested. It was not reported that if patient received a corrective treatment for the event (she was so sick from the shingles vaccine). It was unknown if reporter considered sickness to be related to Dupixent (Dupilumab). Additional Supportive Information: The follow up would not possible as no contact details were available.
After the first vaccination, about 3-4 days I started feeling some tingly in my hands and feet. I had more of it in my feet. An then the second vaccination it came back about 3-4 days later. An it got worse in my feet and I felt it more on the left side of my body. I couldn't feel anything on my bottom, I could walk and hold my balance but I stepped on a lock and didn't feel it all. The tingly progressed up the left side of my thigh and my left calf. My left hand was partially numb and it was up to my wrist. On my right side, I had some numbness in my right foot and hand right hand. My right foot continue to get worse and that was up to 3 weeks ago. It has gradually started to get a little better. My toes on both feet are still numb. My left hand is still numb as well and it is getting better. My thigh and calf is also getting better.
Blacked out; This is a spontaneous report from a contactable consumer (who is also the patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 26Mar2021 10:30 (lot number: ER8730); then the second dose via an unspecified route of administration, administered in the right arm, on 16Apr2021 10:30, both as single dose, for COVID-19 immunisation. Medical history included colon cancer from 2016 (5 years ago). The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient has no known allergies. There were no concomitant medications (no other medications in two weeks. The patient did not receive other vaccines in four weeks. On 26Mar2021 at 10:30, almost immediately after the first vaccination, the patient blacked out twice. On 16Apr2021, after the second vaccination, the patient blacked out four or more times. The event resulted to emergency room visit. The patient underwent EKG and blood work on an unspecified date with unknown results. The patient recovered from the event on an unspecified date.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium
This spontaneous report as received from a physician refers an unknown number of patients of unknown age. The physician reported that the unknown number of patients might have received improperly stored MMR II from 21-JAN-2011 to present. No adverse event reported. This is one of several reports from the same reporter (Other MARRS# 1305USA009039, 1305USA010280, 1305USA010281, 1305USA010282). Additional information has been requested.
Pain and swelling and redness and right upper arm, then fever 102 and body aches.
This serious case was received on 01 April 2009 from a health care professional. A 5 month old male patient received PENTACEL (lot number C3188AA), ROTARIX (manufacturer GSK, lot number A41DA693A), and PREVNAR (manufacturer Wyeth, lot number D37016) on 01 April 2009 at 10:45 AM. On 29 January 2009 the patient received a first dose of PENTACEL and on 23 January 2009 first dose of ROTARIX, PREVNAR, and Hep B (lot numbers were not reported). Concomitant therapy included PREVACID. On 01 April 2009 at 1:30 PM the patient developed a big red area on the neck with white blisters and both knees and thighs were bright red with purple blisters and peeling skin. He went to the physician's office and the patient was subsequently admitted to the hospital. The reporter stated that the patient had "JOHNSON syndrome". The recovery status was not reported. List of Documents held by Sender: None.
Extreme join pain, shortness of breath, water retention, sleeplessness, decrease urine output, urine odor, fatigue, weakness, lack of appetite (all came on suddenly about three weeks after 2nd dose of Pfizer COVID vaccine).
Fatigue and weakness of both shoulders and hips worse in the mornings. Later diagnosed as Poly Myalgia Rheumatica (PMR) and treated with Prednisone 5mgs BID with significant improvement.
This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received HAVRIX (batch number 7YA99, expiry date 30th September 2022) for prophylaxis. On 25th January 2023, the patient received HAVRIX. On 25th January 2023, unknown after receiving HAVRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional Information: GSK Receipt Date: 26-JAN-2023. Reporter's Comment: The reporter reported the administration of an expired dose of HAVRIX. The reporter stated that HAVRIX was administered. The reporter consented to follow up. Additional Supportive Information: The reporter reported the administration of an expired dose of HAVRIX, which led to expired vaccine used.