chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age and genders. The patients' medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (orally, lot # L037924, expiration date 22-JUN-2017). Concomitant medications were not provided. There were no adverse effects reported. Temperature and time were reported as 0 degrees C for 160 hours. Previous temperature excursion was reported as 9C for 10 hours and 30 minutes. This is one of several reports from the same source (MARRS #1604USA017912, 1604USA017913 and 1604USA017914). Additional information has been requested.
Client c/o swelling right after injection and it decreased the next day, however c/o increased pain at sight and stated sometime last week the pain went down her left arm and she had numbness in her fingers on her left hand occasionally. Client encouraged to call her PMD.Injection was given with a biojector.
Reported to pharmacist 04/14/2011 10am. Patient states muscle/tissue loss at site of injection which has caused indentation.  No infection or rash occured.
Tiredness, Chills, Fatigue, Coughing starting on Day 1. Loss of taste and smell on Day 3. Also tested positive on SARS-CoV-2 Antigen (rapid Covid-19 swab) on 1/6/2021, 2 days after administration of the Moderna vaccine. Question - Is taking the Moderna vaccine giving a positive test on the Covid Antigen test?
Chills; arm pain at site of inj; achy; nauseous; This case was reported by a consumer and described the occurrence of chills in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, pain in arm, pain and nausea. On an unknown date, the outcome of the chills, pain in arm, pain and nausea were unknown.   It was unknown if the reporter considered the chills, pain in arm, pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however it could be 63 or 64 years. The patient asked how long may typical non-dangerous side effect last from Shingrix vaccine. The patient had the first or 2nd Shingrix vaccine. The patient enquired how long might typical side effects last. The patient was experiencing side effects, was achy nauseous usually the side area from shots, chills and typical arm pain at site of injection.
pt recv vax 31JUL97 & 13AUG97 pt devel a varicella type rash described as not a standard presentation an eczema-type rash w/an erythematous base;pt had a fever on first day;
Patient received quadrivalent flu vaccine in L deltoid on 10/22/14.  He then received Pneumovax 23 in the same arm on 10/24/14.  He says he had no trouble with the flu shot but did feel his arm was painful with the Pneumovax 1 day after the vaccine.  He then developed a vesicular rash at the injection site that is 6.5cm wide x 7cm tall which he first noticed 10/31/14 but he says could have been there earlier and he just didn't notice.  He says he had this same reaction when he received the Pneumovax 10/2003.
Pain, paresthesias in limbs, weakness, areflexia.  Diagnosed as Guillain Barre syndrome. 1/28/08-records received for DOS 11/28-12/13/07-DC DX: Guillain-Barre syndrome. On 11/17/07 developed pain and numbness in both feet and pain in hands, pain and numbness persisted began to ascend to her legs. This is the second time the patient has experienced these symptoms. Eight years ago had similar symptoms of ascending numbness and weakness after receiving the flu vaccine but not as severe. Developed decreased muscle strength bilaterally in legs, unsteady gait.
Patient is COVID positive and fully vaccinated including a 3rd booster dose. 63-year-old female presents complaining of anxiety. Patient states that her husband recently died and she watched him die and she had driven about it and she woke up very anxious. She has known covert and tested positive on 11?11. She is supposed to have the infusion today in downtown, however she has not driven in 14 years and is nervous about going there.Patient was given a home dose of her Xanax. She was given a referral for Dr.  clinic for the infusion. Patient told to return to ED for new, worsening, changing or persistent symptoms.
Nurse administered IMOVAX vaccine but realized that it expired last month with no AE; Initial information was received on 28-Jun-2021 regarding an unsolicited valid non-serious case from a nurse and physician.  This case involves an 18-year-old male patient was administered 1 ml expired dose of RABIES (HDC) VACCINE [IMOVAX RABIES] but realized that it expired last month (lot number- R1D11, expiry date- 23-May-2021) via intramuscular route in left arm for prophylactic vaccination on 28-JUN-2021.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was a case of an actual medication error due to vaccine underdose.  It was reported that the patient received first dose of same vaccine on 25-Jun-2021 (lot number, expiry date, route site not reported) for prophylactic vaccination.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Unclear exact onset, approximately 2 weeks after first Covid vaccine or 1 week after 2nd Covid vaccine (2nd dose 1/17/21, Lot number EL3248) had sudden transient right leg weakness. Right leg gave out while walking, almost tripped. happed total of 3 times over course of 1 week, lasted approximately 10-30 seconds each time. about one week later began having severe paresthesias of bilateral upper extremities, worse on right arm. Would wake me up from sleep. Have had transient attacks of paresthesia in upper extremities since then. Pattern of paresthesia, burning, tingling sometimes numbness didn't follow a specific nerve distribution.
Onset of radiating pain occurred immediately from the vaccination shot site on my left arm.  It spread and enveloped the left chest, lungs, and heart area within minutes of the injection. A tingling sensation of the entire left chest area lasted for several hours.   Elevated heart rate, heart palpitations, and heart pain occurred within minutes of injection and lasted for several hours.   Fever of 99.6 degrees occurred approximately eight hours after injection and lasted for several hours.   Tiredness and fatigue occurred approximately eight hours after injection and lasted throughout the night.   Onset of extreme joint pain and stiffness occurred approximately eight hours after injection and lasted throughout the night.   At night I experienced chills, night sweats, and a headache that prevented sleep for most of the night.   Onset of tinnitus throughout the night. I could feel the pressure on my eardrums with every heartbeat.
Pharmacist administered the vaccine to age-contraindicated patient. Patient self-reported to be 18 years of age on vaccine consent form. Patient's actual age is 17 years old.
COVID-19 Vaccine EUA; 10 days after injection, my arm felt itchy.  Looked in the mirror and saw a red rectangular shape about 2x4 inches going diagonally down my arm.  Used Cortisone cream on the skin and itching went away.  It was rather red on first day, but redness is subsiding and itching is gone (only itched for 1 day, when it first showed up).
This spontaneous report was received from a 21 years old male patient regarding himself. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date the patient received first dose of GARDASIL, intramuscular injection (dosing details not reported). On 14-OCT-2016, after receiving GARDASIL the patient experienced pounding headaches, arm irritation and stomach pain. The patient sought medical attention by contacting the physician. No treatment was given for the events. Outcome of the events was reported as recovered. Causality of the events was not reported. No product quality complaint was involved. Additional information has been requested.
First 48 hrs 99 temp, muscular and joint pain  debilitating End of second day had to take prednisone for right knee, could not walk Knee was swollen intermittenty  until 19th Mar 19 th March knee very swollen, could not bend, back on 40g prednisone, Tylenol at night 9 days later cannot bend knee, cannot sit or get dressed knee very painful Walking makes my knee ache, but am massaging and forcing upright movement Doc says continue on pred, unable to begin tapering off I have had gout flareups since before vaccine, this is first time the pred has been unable to make it go down in 3-5 days Slight improvement on 27th can stand with help, walk slowly unaided with out crutches
Patient called complaining of red rash on arm at site of injection.  Patient said she did experience a little pain with the rash.
Possible myocarditis. Patient experiencing profound non-ischemic cardiomyopathy and acute CHF, without obvious other cause on preliminary investigation. Sx of fatigue, dyspnea, exercise intolerance, myalgia began 24 hours after vaccination. Myalgias resolved but CHF progressed until Dx 6/29/21. Previously an active runner.
Tetanus shot experienced arthritis, and lock jaw along with severe nasal congestion, inflammation, ear pain, throat tightness. Also had severe heartburn along with stomach pains, and a stabbing feeling in the chest area. I've been having problems breathing and swallowing it feels tight in the back of my throat along with swollen lymph nodes. Also experience burning in eyes, and tingling feeling in feet along with puffy hands and feet as well and severe muscle aches and pain.
Ran a fever of 102 degrees for 24 hours.  Had a large red rash (hot) at injection site for 6 days.
Shortness of breath leading to primary care physician clinic visit. Continued shortness of breath leading to ED visit. CT angiogram done shows bilateral pulmonary embolism. Patient is currently being treated with Eliquis.
8/19 2:30 noticed itching, 3:00 noticed hive, 4:30 hive bigger called dr, 6:00 seen and given Hydroxyzide       8/20 arm still swelling, 9:00 went to ER as elbow hot to touch, very swollen,  and red, a lot of pain in arm. Given Prednisone.  8/21 pain decreased but swelling lasted for several more days in arm, elbow and hand
Patient was slow to respond and appeared to be confused for approximately 15 minutes. All vital signs were WNL. Possible vasovagal reaction
I have a strange feeling that I am going to suffer a cardiac arrest; I never have felt so unwell; I have trouble to breathe; I feel that I have blood pressure high; hyperventilation; I have headache every night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 , MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I have a strange feeling that I am going to suffer a cardiac arrest"; MALAISE (non-serious), outcome "unknown", described as "I never have felt so unwell"; DYSPNOEA (non-serious), outcome "unknown", described as "I have trouble to breathe"; HYPERTENSION (non-serious), outcome "unknown", described as "I feel that I have blood pressure high"; HYPERVENTILATION (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "I have headache every night". Relevant laboratory tests and procedures are available in the appropriate section. The third dose, patient never have felt so unwell. This was the 18th day after vaccine, had trouble to breathe, felt that had blood pressure high. Sometimes, had a strange feeling that he was going to suffer a cardiac arrest, a really weird thing like some sort of hyperventilation. patient want to know if it was normal things happened or was vaccinated with a poor dose or your vaccines do not work, had headache every night. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Began getting a fever and congestion.  Had a Grand mal Seizure 5 days later
Patient was awoken about 6:25am with severe pain at injection site, sweating, shaking all over and nausea.   Patient took 4- 200mg ibuprofen at 6:30am.  Patient fell back asleep and awoke at 8:40am.  Patient stated that arm is still in pain, still sweating. Nausea and shaking has gone.
Strong pain in arm followed by unrelenting pain in armpit and left breast. MAssive pain surrounding heart like a squeezing sensation for the next 3 days that left me incredibly fatigued.
Tachycardia,  body aches,  headache, numbness in extremities
Associate states she was administered the Flu vaccine 10-25-10 about 3:30pm. That night she felt her "bronchioles" tight with SOB. Took some NYQUIL and went to sleep. In the am next day eyes were bloodshot and had hives to face and neck later that day developed hives to perineal area - Came to Occ Health to report and was referred to Employee Clinic, was Rx'd BENADRYL. Today 10/27/10 some itching no more hives - feels better.
Presented with chest pain, elevated troponin, and diffuse ST segment elevation. Found to have myocarditis with decreased LV function. Now status post IVIG and is receiving steroids.
Feb. 26, 2021; second day: pain at injection site in right arm. My upper right arm felt as if a heavy weight was inside it, under the skin, for several days afterward. Could not lift arm above shoulder without pain. Feb. 7, 2021: 14th day after shot: a round red rash appeared around the injection site, painful and very sensitive to touch, i.e., even any loose, lightweight sleeve was painful against the upper arm. Feb. 7 through Feb. 12: painful red rash increased in size to 3 inches in diameter. I have 3 separate photos, taken on 3 different days, of the red rash increasing in size. Feb. 13 through Feb. 20: rash lessened during these days, but had itching and discomfort that diminished nearly completely by Feb. 20.
Patient received moderna COVID19 vaccine on 03/18/21 and 04/15/21. Presented to ER on 1/4/22 and admitted. Positive for COVID 1/4/22. history of colon cancer with Mets to the lung and liver, not on chemotherapy, PE on Xarelto presented with shortness of breath.   she was vaccinated in April and had not received a booster.  Patient found to be in respiratory distress due to COVID and COPD exacerbation.  She was unable to tolerate BiPAP.  She was treated with remdesivir and Decadron.  Oncology was consulted and recommended hospice.  Patient decided on comfort measures.  She was pronounced dead at 1/10 at 5:55 a.m.
Right thigh 4x4.5 in, in diameter rash. Red and tender, warm to the touch.
Patient was administered vaccine 10/08/16, and came into pharmacy 11/10/16 complaining of pain at the injection site and throughout arm, despite it being over a month later.
In the last week of April, 1999, the pt received her first Lymerix vaccination and sometime, thereafter, she experienced muscle achiness which had a sudden onset on the left side, from her earlobe down to her waist. In late May, 1999, she received the second dose of Lymerix. Treatment included Tylenol and Vioxx and Lymerix was discontinued. The most recent information received on 11/1/99, reports the symptoms are ongoing.
Information has been received from a physician concerning a 12 week old male, with no medical history and no allergies, who on 31 Oct 2006 was vaccinated with a first oral 2 ml dose of Rotavirus vaccine (lot # 654970/0777F). Concomitant vaccines included "his other 2 month vaccines." On 01 Nov 2006 the patient developed diarrhea. It was noted that the patient had persistent diarrhea for 6 days. It was reported that the patient recovered on 08 Nov 2006. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Reddened, raised area at injection site, warm to the touch, measured 40 mm x 40 mm.  Plans to use over-the-counter medications and ICE as needed.
Patient comes to the office inquiring about 2nd dose of COVID-19 vaccine. Patient had received the 1st dose of COVID-19 vaccine on 7/14/2022. The date of previous dose was overlooked by the clinical staff. The second dose of Covid-19 (Pfizer) vaccine for ages >12 was administered to the patient one week before the recommended interval for his age group. The patient was observed for longer than 20 minutes in the office. No immediate reactions were present. The patient and guardian were counseled about the situation and plan by our Medical Director and Advanced Nurse Practitioner. The patient has not reported any adverse effects from the early administration of the COVID-19 vaccine at the time of this report. The Medical Director advise to patient is to repeat a second dose 3-8 weeks after 7/28/22, highly recommended to wait the 8weeks, for this age group. Booster will remain on the recommended schedule counting from the date the second dose is repeated. Patient was provided contact information to update if any questions and/or concerns.
metallic taste in  mouth; ache in  jaw; Pain side of the head; This is a spontaneous report from a contactable consumer, the patient. A 58 -years-old-non-pregnant- female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8732) via an unspecified route of administration in the arm left on 24Mar2021 at 15:30 (age at the vaccination was 58-years-old) as a single dose for COVID-19 Immunisation. Medical history was reported as Overweight, HBP and GERD. The patient did not report any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not tested for COVID-19. The patient had Allergies of avelox as a reaction of anaphylaxis, Flexeril, Z Pack and aloe as a reaction of itching. On 24Mar2021 at 15:30 the patient experienced metallic taste in mouth and a bit of an ache in jaw side of the head with it and the patient reported as it was similar to having received Novocain without the numbness associated. The clinical outcome of metallic taste in mouth and ache in jaw side of the head was ongoing.  No follow-up attempts are needed. No further information is expected.
Fatigue, headache, chills, fever, heartburn, body aches, joint pin
Day 10 post vaccine with second dose of moderna, severe shaking chills, lasting about 6 hours, no associated fever. (Normal reaction of sore arm, very mild chills day 2) My wife, (separate VAERS filed) also experienced severe shaking chills, onset about 2 hours after mine, and we received our vaccines about 2 hours apart...  the vaccine was the only thing we had in common in the interval between vaccination and symptoms.
Got first vaccine dose on the 18th and came out Covid test positive; Got first vaccine dose on the 18th and came out Covid test positive; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown) via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose on the 18th, and she came out Covid test positive yesterday (unspecified date in Dec2020). She wanted to know if she should get the second vaccine or what is the protocol into that. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) and RASH (Generalized rash) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Hypothyroidism ((years ago)) and Rheumatoid arthritis. Concomitant products included Levothyroxine; Methotrexate for an unknown indication. On 11-Apr-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jul-2022, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction) and RASH (Generalized rash). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) and RASH (Generalized rash) had not resolved. It was unknown whether patient was enrolled in a COVID-19 vaccine trial. No treatment medication was reported.
Rash: red, itchy, hot, raised, 3x5?; appeared 1 week post vaccine, lasted 3 days.
covid arm; Arm developed a red rash; arm developed a red rash and is extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (covid arm), RASH (Arm developed a red rash) and PRURITUS (arm developed a red rash and is extremely itchy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025AziA and 006MZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (covid arm), RASH (Arm developed a red rash) and PRURITUS (arm developed a red rash and is extremely itchy). At the time of the report, PAIN IN EXTREMITY (covid arm), RASH (Arm developed a red rash) and PRURITUS (arm developed a red rash and is extremely itchy) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment details included application of ice and anti-itch cream. Action taken with mRNA-1273 in response to events were not applicable.   Reporter did not allow further contact