chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving this first dose she experienced a tingling sensation and after receiving the second dose this sensation continued; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (After receiving this first dose she experienced a tingling sensation and after receiving the second dose this sensation continued) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PARAESTHESIA (After receiving this first dose she experienced a tingling sensation and after receiving the second dose this sensation continued). At the time of the report, PARAESTHESIA (After receiving this first dose she experienced a tingling sensation and after receiving the second dose this sensation continued) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2022-531656 (Patient Link).   Reporter did not allow further contact
After the injection, the following morning awoke with full body aches as though I hade the flu.  Running a temperature of 100.  Rest all the next day taking Tylenol to reduce fever.  The following day, systems seem to subside significantly.
Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The date of refrigeration was mentioned as 07-MAY-2021 . No concomitant medications was reported. No treatment drug details was reported.
Chronic Muscle Pain (arms, back). Extreme Chest Pain and Severe headache/ head throbbing. Is currently diagnosed with Pneumonia in the lower lobes. Felt chills. This lasted from the morning after the first dose, and has gotten better due to receiving medical attention in the emergency room, I needed two IV?s and Tylenol with codine. They did blood work and a CT scan on my head and chest, and I received Azithromycin to treat the chest pain. I am feeling slightly better, however there have been occasional pangs of pain on my head (right side), and a persistent dull chest pain that is on and off. I also had some break outs on my back, and my back still aches and my bones crack more often than usual. I am also dealing with drowsiness and some nausea. On 05/02/2021 they kept me in the emergency room until nearly 10pm.
Fever day after vaccine, several days later became suddenly confused, paranoid, having delusions, loss of appetite, personality change, not sleeping at night and had a fall - brought to emergency room on June 6, 2022
ulcerative colitis; They think it was because he was on that medication. The test didn't show any antibodies; They think it was because he was on that medication. The test didn't show any antibodies; This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first single dose of bnt162b2 on 04Feb2021 for covid-19 immunisation. He reported he received 2 doses of the Pfizer COVID vaccine. The first one on 04Feb2021, and the second one on 25Feb2021. He had physical and lab test done a few weeks ago in 2021. Lab results showed no protect/antibodies in the blood. He had ulcerative colitis in 2021 and take azathioprine (IMURAN) 150mg daily. It is an immunosuppressant medication. They think it was because he was on that medication. The test didn't show any antibodies in 2021.  He was going to take the booster dose. Patient wanted to know about time period he should stop or change the dose of azathioprine before he took the booster dose of Pfizer covid vaccine. The doctor's said that the test that was done at a local lab might not be accurate in judging what protection he did or didn't have. His doctor told him to call Pfizer to find a test that would be accurate. The previous agent said they have no information on what kind of test is accurate. That blows his mind. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test with negative in 2021. Outcome of events was unknown.  The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.
Worsening respiratory failure 1/20/2021 death 1/27/2021
On 07/31/2000 the patient experienced chickenpox, approximately 30 lesions. He also experienced a low grade fever. Medical attention was sought. Subsequently, the patient recovered. No further information is available.
fainted and continued to feel lost; hands and knee went numb; felt lost and disoriented; This case was reported by a consumer via call center representative and described the occurrence of faint in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), numbness in hand and disorientation. On an unknown date, the outcome of the faint, numbness in hand and disorientation were recovered/resolved.   It was unknown if the reporter considered the faint, numbness in hand and disorientation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. While driving, the patient felt lost and disoriented. When he arrived home his hands and knee went numb. He fainted and continued to feel lost. The reporter did not consent to follow up.
Small palpable lump on (L) upper arm. Dx with strep at todays visit.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 64-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020) for prophylaxis. Co-suspect products included dTpa vaccine for prophylaxis. The patient's past medical history included shingles (experienced in her 40's and again). Previously administered products included ZOSTAVAX (received on 16th October 2014). Concomitant products included ADACEL. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th July 2018, the patient received dTpa vaccine. On 31st July 2018, immediately after receiving SHINGRIX and 1 days after receiving SHINGRIX and dTpa vaccine, the patient experienced muscle pain and pain in arm. On 1st August 2018, the patient experienced feeling unwell, fever, stomach pain and headache. On 2nd August 2018, the patient experienced injection site erythema. The patient was treated with MOTRIN. SHINGRIX was continued with no change. DTpa vaccine was continued with no change. On an unknown date, the outcome of the muscle pain and pain in arm were unknown and the outcome of the injection site erythema, feeling unwell, fever, stomach pain and headache were not recovered/not resolved. It was unknown if the reporter considered the muscle pain, pain in arm, injection site erythema, feeling unwell, fever, stomach pain and headache to be related to SHINGRIX. The reporter considered the muscle pain, pain in arm and injection site erythema to be unrelated to dTpa vaccine. It was unknown if the reporter considered the feeling unwell, fever, stomach pain and headache to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received Tdap vaccine on the left deltoid. The patient received SHINGRIX on right deltoid. The caller stated that immediately after receiving SHINGRIX, the patient experienced the soreness and muscle pain of her arm. One day after receiving SHINGRIX and 2 days after receiving Tdap in the morning, the patient woke and experienced fever (the patient's body temperature was recorded as 99.4 degree F), stomach ache, really bad headache and not feeling well. Two day after receiving SHINGRIX, the patient experienced area of injection was red and a large area of 4 inches by 3 inches. The patient had been treated with MOTRIN. The caller noted that she received Tdap but did not contribute the issues to this product. The caller referred to health care provider for management of symptoms. This case has been linked with A0709984A (same patient).
Adverse Event: Lasting Shoulder and Upper Arm Pain. pain started at the upper arm near site of injection and radiated below elbow. Arm subsided after two and half weeks. Seen at an urgent care clinic on 10/26/2021  for acute pain to left arm and received a sport medicine recommendation, took x-ray and concluded no foreign body. Followed up with primary care on 11/03/2021. PMD recommended assessment by physical therapist. Current signs and symptoms after 4 weeks: Shoulder pain and limited full range of motion to the left arm.
Information has been received from a physician concerning a patient (age and gender unknown) who on 19-FEB-2007 was vaccinated with Gardasil (Lot number 654540/0800F). On 19-FEB-2007 the patient the received vaccine in the bottom. No further information is available.
That evening, right arm became hot, reddened, progressing to bluish the next day.  Went to doctor who advised against getting the H1N1.
mom reported that 3MA noc p/vax pt woke screaming;t103;mom gave APAP & put in tepid bath;pt had sz then shook;did not lose consciousness;mom did not seek medical attention & reports pt was fine next day;
Client states he received both Influenza vaccine (Left Deltoid) and Moderna Bivalent at the same time. Client states headache started at 10/14/2022 at 1945, temp of 100F, chills,  nausea, dry heaving, blood pressure of 191/79, heart rate 145, oxygen 93%. Client states all symptoms resolved within 6 hours. Client counseled to see physician for further follow up.
No adverse event; received improperly stored ROTATEQ; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.       On 14-JAN-2020, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # and expiry date was not reported) and subsequently on 10-MAR-2020, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # 1660942, expiry date : 06-FEB-2021) orally for prophylaxis.    It was reported that the vaccine experienced a temperature excursion below 2 degrees Celsius (C) (1.28C) for a duration of 2 hours and 30 hours (product storage error). It was reported that there was no previous temperature excursion and this call was due to a digital data logger. The patient had no adverse event. There was no product quality complaint reported.
36 days after the first dose and 2 weeks after second dose I began to feel a shock feeling from my fingers up my arms. I also had sore and weak legs shortly after that. Knees and ankles hurt after that and by May 3rd I was weak all over and then I started to have tingling feeling on my toes legs fingers and arms. I also have back and neck pain
Initially I had a fever of 104.5 for 24 hours. Fever gradually went down over a series of days to 102.5 for a week. Subsequently I had a fever of 101.5 for an additional 10 days. Total time febrile was 2 1/2 weeks. After fever lessened, I had profuse constant sweating both day and night for another two weeks. Other symptoms: severe body aches, headache, swollen lymph gland in elbow x 2 months,chest pain, extreme fatigue, ear pain
This spontaneous report as received from healthcare worker refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # L026551, expiry 16-JUL-2017 (dose and route not reported). No adverse effects reported. No additional information was provided. Temperature: 32 F. Time frame: 3 minutes and back in range. No previous temperature excursions reported. Data logger was used. Follow up information has been received from healthcare worker on 27-MAY-2016. It was confirmed that there was no previous temperature excursion. The call was made because of data logger. It was reported that temperature was 0,3C and time frame: 871 minutes. This case is one of the 4 reports from the same source. Additional information has been requested.
Minor stroke; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Minor stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Minor stroke) (seriousness criterion medically significant). an unknown date, the patient experienced HEADACHE (really bad headache). At the time of the report, CEREBROVASCULAR ACCIDENT (Minor stroke) and HEADACHE (really bad headache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. The patient stated that the side effect was not a really bad headache. She had a minor stroke 7 days after she received her second Moderna vaccination. She was not sure that if it was the vaccination or just coincidence. Company comment: This case concerns a female patient of unknown age with no reported medical history who experienced the unexpected serious adverse event of special interest of cerebrovascular accident. The event occurred approximately 7 days after the second dose of mRNA-1273. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-159768 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Case is upgraded to serious (Medically significant). Reporter added, patient initials added, dose number added (action taken with drug updated as per dose Number), event added: cerebrovascular accident.; Sender's Comments: This case concerns a female patient of unknown age with no reported medical history who experienced the unexpected serious adverse event of special interest of cerebrovascular accident. The event occurred approximately 7 days after the second dose of mRNA-1273. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.
on Monday morning i woke up with hives on the back of my neck and under my left armpit the area was swollen.
Severe pain upon raising arm laterally, warm compress felt better, ice did not, has since resolved--this was to PNEUMOVAX 23.
pt recv vax in 3/96 w/one dose of varicella then on 3/98 pt devel varicella.
On the night of the vaccine, patient developed fever (Tmax 104), chills, and myalgias. He had an outbreak of herpes on his shoulder.  Continued to feel very fatigued. Three days after the vaccine, he started having chest pain and shortness of breath with exertion. He continued to be fatigued. Chest pain was intermittent. Saw pediatric cardiologist at outpatient appointment on 6/15/21 where he had a normal EKG and ECHO.  High sensitivity troponin on 6/15/21 was 0.08. He had a Holter monitor placed. He was asked to do activity while wearing Holter monitor and self-limit based on symptoms. He played basketball that night and had to press the Holter button 8 times while playing when he was experiencing chest pain. When he got home from practice, he felt weak and dizzy with associated chest pain. Mom notes his nails were blue/purple, and he was "lethargic" . Symptoms improved with ibuprofen. Patient did not want to  do usual activity, mom called cardiology who recommended going to ED. Patient has not had chest pain since coming home from practice on 6/15/21.  He was admitted to hospital on 6/16/21. Repeat high sensitivity troponin was 0.82 on 6/16/21 and repeated on 6/17/21 was 0.41. Cardiology consulted. Cardiac MRI performed with normal results. He was dizzy on 6/17/21 when he got up to use the restroom, self-resolved. Cardiology evaluated him and cleared him for discharge with outpatient follow-up and self-limitation with activity.
Fever of 103, lethargy, severe fussiness, jerking and flailing in sleep (possible febrile seizure), not sleeping well and waking up screaming. Swollen legs, cough, runny nose, sore throat, possibly ear infection. Treating with antibiotics.
Red, itchy rash to left arm started today.  size approx 6-7 inches oval in shape to left arm (site of injection). No other associated sxs.
Local reaction on right arm where shot was administered.  Redness, swelling & heat.  Pt. denied pain, itching.
Pt presents with headache, fatigue and nasal congestion, left arm injection site pain. treatments increase fluids, motrin, sudafed  vitamin C and rest
significant fever (101+), major body aches and fatigue, chills for 2 days (still experiencing), extremely painful arm, slight swelling and redness
Raised welt, that is tender and warm to touch. Swollen with raised rough dots. Complains of pain/itching. Treatment included ibuprofen.
Vaccines were not given via recommended route. Kinrix was given subcutaneously instead of intramuscularly and Proquad was given intramuscularly instead of subcutaneously.
Complains of numbness tingling R arm, R side of face, down to fingertips. Denies SOB, dyspnea, CP, redness, swelling, rash. VS stable: 127/77, 77, 100% RA. A&O x4, able to speak full sentences. Refused transport.
Low grade fever, chills, flu-type aching, loss of appetite, extreme fatigue, pain at injection site, joint and muscle pain. The worst of it was the Wednesday after late Monday afternoon vaccination; ie on day two post-vax. Felt like a case of bad flu. Lasted about 2 to 3 days, with tapering severity. A week later, energy level is still down; sleeping more than usual.
they had injection site redness, with warmth to touch and one of them said that the redness; injection site warmth; injection site redness; hives spread down their arm; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case from a consumer (Office Staff).  This case is linked to cases 2019SA322706 and 2019SA327309.  This case involves female (age not reported) patient who had injection site redness, with warmth to touch and one of them said that the redness (vaccination site inflammation) with its symptoms injection site redness (vaccination site erythema), injection site warmth (vaccination site warmth) and hives spread down their arm (vaccination site urticaria), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6719KA and expiry date: 30-Jun-2020) via unknown route in unknown administration site.  On an unknown date, the patient who had injection site redness, with warmth to touch and one of them said that the redness (vaccination site inflammation) with its symptoms injection site redness (vaccination site erythema), injection site warmth (vaccination site warmth) and hives spread down their arm (vaccination site urticaria) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE..  (Other relevant tests included No lab data..)  Final diagnosis was vaccination site urticarial and vaccination site inflammation.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as Unknown for all events.
Pt devel a rash following 1st dose of Hep B vax; No further details were provided;
This spontaneous report was received from a 74 year old female patient regarding herself. The patient's concurrent conditions included diabetes mellitus, thyroid disorder and hypertension. She was allergic to an unspecified generic medication for high blood pressure. Approximately in 2013 (reported as about 2 years ago) the patient was vaccinated with ZOSTAVAX, subcutaneously. The patient was also on a lot of unspecified concomitant medications. On unspecified date in April 2015 the patient experienced herpes zoster. The patient sought medical attention for the same. No laboratory tests were conducted. No product quality complaint was involved. On unspecified date in May 2015 the patient recovered from the event. The causality assessment was not provided. Additional information has been requested.
Information has been received from a health professional concerning a 45 month old female who on 02/16/01 was vaccinated SC in the left thigh with a second dose of varicella virus vaccine live (Lot  # 636360/1334K).  On 12/02/03 the pt's symptoms began, she developed "20+ scattered papules and vesicles, itchy". It was reported that she was afebrile. Additional information has been requested.
Found bleeding from mouth; warm to touch, lethargic, not stiff, unresponsive, limp, poss sz activity;
pt found on floor waiting room p/falling from fainting p/vax; pt placed sitting in chair & aroused to consciousness; was assisted to exam table via chair w/wheels; VS BP 110/70, P100, RR22;
severe erythema multiforme required IV solumedrol to control the urticaria;pt has recovered;
Office drew up all doses for the day from vial w/o a double check. They then entered data into EMR from a sticky note with bivalent NDC, lot and expiration. At some point the realized that on some days they had pulled monovalent from the refrigerator and administered instead of the intended bivalent booster
Information has been received from a physician concerning now a 12 year old male who on 10/04/2000 was vaccinated with varicella vaccine. On approximately 08/02/2001, the pt developed a vesicular rash with some water filled lesions on the right side of the trunk and right arm. He was diagnosed with varicella. There was no evidence of shingles. He was prescribed topical treatment. Additional info has been requested.