chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sweating; weakness; Chills; Low blood pressure of 100/51; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Low blood pressure of 100/51), HYPERHIDROSIS (Sweating), ASTHENIA (weakness) and CHILLS (Chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Hyperlipidemia in 1995 and Stroke (2 strokes) in 2010. Concurrent medical conditions included Blood pressure high since 1998, Diabetes since 2008, Benign prostatic hyperplasia (chronic condition worsening) since 1990 and Neuropathy (chronic condition worsening) since 2008. Concomitant products included TAMSULOSIN from 1990 to an unknown date, LISINOPRIL from 1998 to an unknown date, PRAVASTATIN SODIUM, GLIPIZIDE from 2008 to an unknown date, CARVEDILOL from 1998 to an unknown date, METFORMIN, CLOPIDOGREL, AMLODIPINE BESYLATE and CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced HYPOTENSION (Low blood pressure of 100/51). On 30-Jan-2021, the patient experienced HYPERHIDROSIS (Sweating), ASTHENIA (weakness) and CHILLS (Chills). On 01-Feb-2021, HYPOTENSION (Low blood pressure of 100/51) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), ASTHENIA (weakness) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Blood glucose: 188 (Inconclusive) 188. On 29-Jan-2021, Blood pressure measurement: 100/51 (Low) 100/51 blood pressure has been going high and low and has not taken his BP medicines..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication was taken. Patient stated that she didn't take blood pressure medication at that night.   This case was linked to MOD-2021-082574 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow-up received on 19-Apr-2021. The patient provided his Race as White and Ethnicity as Not Hispanic or Latino. The patient provided Medical history details  with High blood pressure and Diabetes as ongoing, Hyperlipidemia as no recent change in status of chronic condition, Benign Prostatic hyperplasia and Neuropathy as in worsening  status of chronic condition and the patient also had 2 strokes in the past. The patient provided the second dose details. The patient also provided several concomitant medication details. The adverse event outcome of Low BP after first dose and second dose was recovered.
covid vaccine breakthrough case  dose 1 1/29/21 Pfizer  EL9265 dose 2 2/19/21 Pfizer  EM9810
This spontaneous case reported by a patient, describes the occurrence of vaccination site pruritus (itchy sensation - near injection site), vaccination site erythema (redness - near injection site) and vaccination site swelling (swelling - near injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 004M20A) for COVID-19 immunization. Concurrent medical conditions included Parkinson's disease. On Jan 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 28, 2021, patient experienced vaccination site pruritus (itchy sensation - near injection site), vaccination site erythema (redness - near injection site) and vaccination site swelling (swelling - near injection site). At the time of the report, vaccination site pruritus (itchy sensation - near injection site), vaccination site erythema (redness - near injection site) and vaccination site swelling (swelling - near injection site) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. Concomitant medications included a lot of different unspecified medications for Parkinson's disease. Treatment information not provided.
Patient was fine, about 10 minutes after vaccine, went to stand up to leave. Patient passed out very slowly, to the point the father and I thought he was joking. He came to about 1 second later saying he didn't know what happened. Patient was very pale and started vomiting. He was minimally responsive. Paramedics were called and he was taken via ambulance.
Saturday beginning at 11:00 AM - Severe headache over entire head and neck, extreme joint and bone pain especially through my back, hips, pubic bone, and knees. The pain reminded me of pre-labor. By the time I reached the urgent care facility around 1:30PM, I was experiencing weakness, dizziness, and fainting, and fever around 102. I was also having trouble breathing but that was due to my anxiety and fear from pain. Urgent care sent me directly to the ER. I arrived at the ER around 2:30 PM. I feel like I waited in the waiting room forever crying out for help because "help me" was all that I could utter. I was finally treated with IV fluids, a few rounds of toradol, Phenergan, benedryl, steroid, morphine. I was also given a spinal tap and kept over night for pain management and observation.
Shingles; get a rash on my left thigh and waist; extrem body aches; had side effects of chills; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, 14 days after receiving Shingrix, the patient experienced shingles, rash, general body pain and chills. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles and rash were not recovered/not resolved and the outcome of the general body pain and chills were unknown.   It was unknown if the reporter considered the shingles, rash, general body pain and chills to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. Less than 2 weeks after vaccination, the patient had side effects of chills and extreme body aches. The patien started to get a rash on left thigh and waist about 2 weeks later. The patient did not think it was Shingles but just a rash. The rash was on thigh but now was on waist . Reading the description of what shingles was, the patient believed it was Shingles.  The patient asked if an antiviral medication taken orally help at this time.
1/15/2021 and 1/16/2021 Extremely tired and fatigued and started having heavy night sweats, sleeping 10-11 hours on both nights. 1/17/2021 Chills and  temperatures between 99 and 101.2 degrees  1/18/2021 Temperature of 100.1 degrees in the morning with gradual decline to 98.9 degrees in the evening 1/19/2021 and 1/20/2021 Temperature normal  1/13/2021 to 1/15/2021 Injection site  "sore"  1/15/2021 Injection site became hard and painful to the point where I was not able to move the arm without pain at the level of 10 or above which of course limited my use of the arm 1/20/2021 Injection site still painful and difficult to lift or move the arm without pain at a level of 4-5.
Very high fever, aching, sore throat, wheezing, throwing up, stomach pain, cough, trouble breathing.
1 hr p/vax & immune globulin had itching all over body; called office & was prescribed DPH;
Red rash appeared at injection site. Rash was not painful, but very itchy. Four days post injection, rash started to disappear.
I awaken to go to work and experienced severe vertigo causing me to be unable to rise from the bed without assistance, experienced nystagmus, inability to walk independently,  nausea and was taken to the emergency room. They ran labs, Head CT, EKG, and neuro exams. I was administered Antivert and was also sent home with script for Antivert and Zofran. I was very fatigued without a fever and slept the rest of the day missing work. Vertigo happened 3 weeks and 1 day after second vaccine and 3 weeks exactly after the first vaccine.
NO immediate reaction during 30 min observation. No difficulty breathing. No welts RASH noticed the morning of 5/7, more than 4 hours but less than 24 hours after vaccination Red urticarial plaques with irregular margins on abdomen, back, and both thighs (have photos) About noon (~6 hours later) began to itch. Severe itching lasted 4 days. Controlled with Benadryl as needed. No clinical or ED visit, no blood work. Later resolved without recurrence. Came for follow-up vaccination on 6/3 and disclosed above history.  Vaccination was deferred pending discussion with me 6/4 and allergist evaluation.
Patient reported swelling at the injection site the next morning following the vaccine. She stated her arm was swollen 3 times its normal size around the site of the injection, and that she had difficulty moving it.  The patient spoke with her doctor and he advised her to go to the emergency room to be seen.
Nausea, Diarrhea, Pain in arm, Pain & Tenderness in armpit, swollen armpit, swollen & tender lymphnodes in armpit.
Patient had covid 7/22/21. Recovered and was encouraged by PCP to get vaccinated. Received first dose 8/6/21. 2nd dose 8/30/21 - both Pfizer. Onset of headache, cough, fatigue 10/8/21 - tested positive for covid 10/9/21.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age. On an unknown dates the patients were vaccinated with improperly stored GARDASIL (dose, frequency, route and lot# not reported). No adverse effects. Additional information has been requested.
Patient had  generalized anxiety disorder. Onsite EMS was called vitals BP 124/70  100% O2 HR 70.  Patient refused evaluation or care. Released to go home against medical advise.
Swelling in arms, eyes, throat, lightheadedness, coughing, soft pallet swelling.
pain, swelling, induration surrounding site approx 10cm x 7cm;MD @ clinic reports abscess;I&D done & drained purulent fluid;
"The second shot of Moderna in AM -2 days later had a Non- STEMI- Chest pressure in middle of night around midnight in 24 hours post  Second  Moderna  vaccine  Son took him to ER. 5/5- got the second  Moderna . 5/6 around Midnight had chest pressure that woke him up - he also had chest pressure .
Lot # exp had been extended and vaccine remained frozen until date of administration but was given 2 days past exp date.  Moderna consulted and deemed the vaccine viable so no revaccination was needed.  No adverse side effects were reported by patient.
Narrative: 64yr patient direct admit due COVID+ with requests for ongoing medical management of COVID given s/p lung transplant status. History of bilateral lung transplant 2016 on immunosuppressant therapy. Received Moderna x 2 (Jan/Feb). Hospitalized x 1 day (ICU) then discharged for ongoing /close management through agency Transplant team. Symptoms upon transfer cough, no SOB, or other complaints. Remained on RA with SpO2 at 95% during hospitalization (did not require Oxygen). did not receive dexamethasone or other inpatient COVID therapeutics. Was stable for discharge.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-AUG-2012, the patient was vaccinated at a clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-AUG-2012, only a few days after being vaccinated, the patient was treated by a physician for the onset of a painful vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed prednisone, acyclovir, NEURONTIN, and gabapentin for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Itching, injection site pain, tiredness, fever, injection redness and swelling, nausea, feeling unwell
1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt heart palpitations and a sensation that my heart was racing. I then became lightheaded and dizzy and my hands and lips/cheeks became numb and tingling and I got very shaky. I summoned paramedics who came and took vitals and my heart rate was in 130s with blood pressure of 200/110, I have no prior history of high blood pressure or high resting heart rate. Blood pressure came down to 160/92 within 30 minutes, other symptoms improved and I was cleared to leave vaccination site. Intermittent numbness in face and hands and general shakiness persisted through the next 12 hours and heart rate stayed 100-120 and blood pressure was elevated for 12 hours before returning to my usual results.
High Fever, Confusion, Fatigue, Stiffened muscles, forgetfulness, numbness at injection sites x4, inability to follow simple commands.  From 10/15/2003 to present has been diagnosed with depression, bi-polar disorder, and ADHD/ADD.  Ear Infections, Chronic Upper Respiratory infections, continued loss of sensation at vaccine sites x2.
Day 1 - arm soreness and fatigue Day 2 - arm soreness, major fatigue, fever, some cold type of symptoms, lymphatic pain (under left armpit, left breast, and down left side) Day 3-6 - arm soreness, decreasing lymphatic pain Day 7 - very limited soreness or pain
pt devel a large abscess on rt shoulder above breast p/recvd flu vax; pt was referred to a surgeon for tx; cult of the abscess showed salmonella & staph epidermidis;
At approximately 03:00 pm, patient had dizziness and it was notified to pharmacy staff by the patient?s brother.  Patient could laid down on a cot.  Patient was responsive and conscious and was able to recite her name and indicate that she was at the pharmacy for a covid 19 vaccine.  Vitals were taken at 3:07 pm and at 3:21 pm.  At approximately 3:25 pm she was able to leave the pharmacy on her own strength with her sister and brother.
headache since vaccine; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the right arm on 16Mar2021 at 09:00 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 16Mar2021, the patient experienced headache since the vaccination. The patient did not receive any treatment for the headache. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the headache was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Deep pain at time of injection. Mild to moderate pain for 3 days. 5-7 days developed shoulder pain (tendonitis) that has persisted. Consulted with med provider 10/16; CELEBREX and PT referral.
Patient complained of generalized pain in her arm. She stated it radiated from her upper arm to her elbow. It ached continually with no relief after many weeks.
expired vaccine given. patient reports no adverse effects. patient states he will get re-vaccinated on 2/8/22
Pt received Varicella in right deltoid/ .5ml/SC. 10 minutes later pt complained of swelling to lips eyelids. Had cough/gagging sensation. Brought to room, 911 called. Pt received .15mg Epipen Jr. and 25mg BENADRYL PO. Pulse ox 98%-100% entire time. Pt transported via ambulance to ER.
This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. On 03-JUL-2017, the patient was vaccinated with an improperly storage dose of PNEUMOVAX 23 lot number m042324 with expiration date on 10-JUN-2018; lot number reported as "m044564" with expiration date on 22-OCT-2018 or lot number n001007 with expiration date on 09-SEP-2018 for prophylaxis. No adverse effects were reported. The doses of PNEUMOVAX 23 were exposed to a temperature of 47 Fahrenheit degrees (F) to 77 F for time frame of 1 hour 20 minutes. There were no previous temperature excursions. Digital data logger was involved. No symptoms reported. This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1708USA002800:
fatigue Narrative: fluid left infra axillary region shrinking but pt has concern, chills and fatigue x24 hours
This spontaneous report was received from a pharmacist and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On multiple unspecified dates, the patients were administered improperly stored doses of GARDASIL 9 lot # L037339 with expiration date 09-FEB-2016 (dose and route of administration were not reported). The doses were exposed to 59 degrees Fahrenheit for 12 hours. The temperatures were not recorded with a data logger and there were no previous excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Toes turned purple; Large purple circle on my arm below the injection site; numbness in my lower left lip which spread to my chin and lower cheek the following day.; numbness in my lower left lip which spread to my chin and lower cheek; This is a spontaneous report from a contactable patient. A 58-year-old non-pregnant female patient received second single dose (Pfizer -BioNTech Covid-19 mRNA Vaccine,) via an unspecified route of administration on the right arm on 24Feb2021 for COVID-19 immunisation. Her medical history included hypothyroidism. She has no allergies to medications, food, or other products. Prior to vaccination, she was not diagnosed with COVID- 19 and has not tested for COVID-19, since the vaccination. Furthermore, she has not received other vaccines within 4 weeks prior to the COVID vaccine. She received concomitant medications within 2 weeks of vaccination were multivitamin, atorvastatin (LIPITOR 20mg) and levothyroxine (SYNTHROID 112 mg). Her past vaccination history included (Pfizer -BioNTech Covid-19 mRNA Vaccine) first single dose via unspecified route administered on right arm on 04Feb2021 for COVID-19 immunisation. On 24Feb2021 (the same day of vaccination), she had large purple circle on her arm below the injection site. On 25Feb2021, the patient toes turned purple but cleared quickly. On an unreported date (9 days post vaccination on an unknown date in 2021), she experienced some numbness in her lower left lip which spread to chin and lower cheek the following day. She felt better after a couple of days but still felt a slight numbness in her lower lip. It was reported that she did not receive any treatment for the events. At the time of the report, she has recovered from toes turned purple and was recovering from numbness in face and lips however the clinical outcome of large purple circle on my arm below the injection site was unknown. No follow-up attempts are needed. No further information is expected.
10 minutes after getting the first shot in upper left arm I felt dizzy, vision was getting blurry. The nurse put me on the bed and took blood pressure. It was 199/91.  I stayed on the bed for 20-30 minutes till the blood pressure went down to 136/75, then I felt well enough to sit up, and a little later my son took me home.
Pt started getting bruising on lower extremities, having 7/10 pain using the Numeric Pain Intensity Scale Method. Patient also stated getting a rash (red spots) on both hands front and back, causing burning  and itching.  She started experiencing shortness of breath, extreme tiredness and body ache. We did order an EKG on pt and sent her to the ER, we also prescribe medication to help relief most symptoms.
Within one week of the shot, episodes of weakness and unusual tiredness when walking.  Within two weeks, five emergency room visits, one hospitalization, MRIs, CTs and other exams.  Diagnosis of Myasthenia Gravis, Dr/Hospital.
This spontaneous report was received from a medical assistant referring to a 12 year old female patient. The patient had no medical history, concurrent conditions, drug reactions/allergies or concomitant medications. On 26-JUL-2018, the patient was vaccinated with the first dose of GARDASIL 9 lot # N028567 expiration date 17-MAY-2020 and on 11-OCT-2018, the patient received the second dose with the lot number N028567 and expiration date 17-MAY-2020, intramuscular indicated for human papillomavirus (HPV) vaccination (prophylaxis). On 12-OCT-2018, the patient's mother called to report that her daughter was admitted to a mental institute, as the mother explained that her daughter said that "she was going to kill herself this weekend" (suicidal behavior). The patient received treatment for the adverse event there was not laboratory diagnoses or studies performed. The outcome of suicidal intention was reported as not recovered. The causality between the event and the therapy with GARDASIL 9 was not reported. Upon internal review, suicidal intention was determined to be medically significant and life threatening.
Patient calls clinic 2 days following vaccine - symptoms noted in VIS Nausea, Weakness, Decreased appetite, Fatigue, Headache.
Slightly red and knotted the night vaccine given. Noticed last night reddness, warm to touch and "hurts". Today still red, warm and raised 2"x3" centering over where varicella vaccine given.
This case was reported by a physician via sales rep and described the occurrence of visual disturbance in a patient who received BEXSERO (batch number 146101, expiry date April 2016). On 9th April 2015, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced visual disturbance. On an unknown date, the outcome of the visual disturbance was unknown. It was unknown if the reporter considered the visual disturbance to be related to BEXSERO. Additional details were provided as follows: The patient was 11 or 15 years old. The patient's vision was adversely affected. This case was linked to case US2015GSK173014 (same reporter).
Site: Pain at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient experienced numbness on the left side of her face within an hour of receiving the Moderna vaccine in her left arm.