chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient Received ADACEL vaccine on 11/20/2008 On 12/01/2008 he presented with leg numbness and tingling which was progressive.  Urgent referral to neurology for progressive Guillian Barre Syndrome, which eventually progressed to his head and mouth and upper body.  Hospitalized and received IV IG with improvement.  At present symptoms persist but are much less and seem to be resolving slowly. 2/6/09-records received for DOS 12/5-12/11/08-DC DX: Guilain-Barre. Hypertensive urgency. Sensory loss. One week after receiving tetanus shot developed left upper extremity pain, then tingling then numbness and decreased sensation. Difficulty wiht sensation of temperature of lower extremities, later all over his body. Pain in proximal muscles of upper extremities. Treated with IVIG. 5/11/10 Dysesthesias upper and lower extremity.
started having some sweats; started having diarrhea; feeling a little weak; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious), outcome "recovered", described as "started having some sweats"; DIARRHOEA (non-serious), outcome "unknown", described as "started having diarrhea"; ASTHENIA (non-serious), outcome "unknown", described as "feeling a little weak"; NAUSEA (non-serious), outcome "unknown", described as "nausea". Therapeutic measures were taken as a result of diarrhoea.  Additional Context: Caller states after the vaccine she started having some sweats and that was fine and after a while the sweats went away; states after she got the Pfizer vaccine she went to eat some chicken and started having diarrhea; states she has gone up to the bathroom today 10 times already and is feeling a little weak; states she is drinking Pedialyte to get better and is wanting to know if this is normal or is a regular that happens and she does not know what to do. States she ate an apple, some beef broth or soup and tried to do that and has not thrown up but started having some kind of nausea and has not eaten and has no temperature and no fever but does feel sort of weak. Caller states she was not specifically trying to do the medical part regarding the report and is taking Pepto Bismol trying to stop the diarrhea and is diabetic and states she has taken other things; no further details provided as caller then states she is feeling a little weak and is very weak and was thinking of telling her son to call an ambulance to take her somewhere and was thinking about getting some IV fluids and states she might faint out.  Caller verified she needs urgent medical attention at this point in the call. Caller asks if agent is unable to tell her if this is normal or if the diarrhea is a normal thing;   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a health professional concerning a 7 year old patient who on 11/12/1998 was vaccinated with a dose of varicella virus vaccine live.  On 03/03/2005 the patient presented with about 30 lesions attributed to breakthrough varicella.  Unspecified medical attention was sought.  No treatment was needed.  There was no product quality complaint involved.  Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (Irritating) and VACCINATION COMPLICATION (Side effect) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IRRITABILITY (Irritating) and VACCINATION COMPLICATION (Side effect). At the time of the report, IRRITABILITY (Irritating) and VACCINATION COMPLICATION (Side effect) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No Concomitant Medications were provided by the Reporter. Patient was due for booster shot. No Treatment Medications were provided by the Reporter.
Patient has a constant pain in arm where vaccine was given starting approx 3 days after administration. APAP lessens the pain but does not take it away completely. She states the pain affects her sleep and quality of life.
Immediately after receiving the vaccine injection I began experiencine acute pain at the vaccination site. After almost 4 months, the pain has persisted and gotten much worse. The pain now radiates down from the injection site in my upper right shoulder down to my right elbow.
This spontaneous report as received from a nurse refers to a 10 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with M-M-R II. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that the patients were administered improperly stored M-M-R II over the last three months (in 2014). No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
About 8-9 days after injection of Moderna  Coronvirus Vaccine on 2/4/2021, developed red swelling at injection site on left arm
Pt called the office & then was subsequently advised to come in & be seen after 1 week of headaches (worse than her usual migraine headaches & not responsive to ibuprofen); fatigue, eyes feeling "heavy" and she "doesn't feel right in her body". Denies dizziness, photo/phonophobia, visual changes, syncope, near-syncope, appetite changes, (+) nausea, no vomiting or diarrhea. No fevers/sweats/chills. I spoke with CDC & based on their protocols it was determined that this reaction, lasting 1 week in duration meets criteria for allergic reaction to vaccine and/or one of its components. Given that this was pts 1st time being vaccinated for both Hepatitis A and HPV; we can not isolate cause and will last as allergic to both; avoiding future vaccination to both in the future. Current treatment plan will include labs (done) prednisone x 7 days, Zantac 150mg BID for nausea + antihistamine; Benadryl or Atarax 25mg every 6hrs prn allergy & re-assess in 10-14 days. Pt and mother instructed to return for worsening of symptoms other concerns. Advised to increase fluid intake. Advised of drowsiness related to antihistamines. Questions/concerns addressed.
About 6 hrs after vaccines were administered child developed generalized rash and swelling of lips.
Transversal feeling; Lethargic; Exhausted; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Transversal feeling), LETHARGY (Lethargic) and FATIGUE (Exhausted) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 030L20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Iodine allergy (radioactive iodine contrast), Overweight and Fatty liver.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Transversal feeling), LETHARGY (Lethargic) and FATIGUE (Exhausted). At the time of the report, FEELING ABNORMAL (Transversal feeling), LETHARGY (Lethargic) and FATIGUE (Exhausted) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information was provided.   This case was linked to MOD-2022-555525 (Patient Link).
symptoms subsided after "a couple days" and then returned along with itching on the arm; chills; headache; arm pain; redness of the arm; arm was hot to the touch; small hard knot on arm; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (arm pain), VACCINATION SITE ERYTHEMA (redness of the arm) and VACCINATION SITE WARMTH (arm was hot to the touch) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included AMLODIPINE BESILATE (NORVASC), LISINOPRIL and IBUPROFEN for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (arm pain), VACCINATION SITE ERYTHEMA (redness of the arm), VACCINATION SITE WARMTH (arm was hot to the touch) and VACCINATION SITE INDURATION (small hard knot on arm). On 04-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (symptoms subsided after "a couple days" and then returned along with itching on the arm). On 28-Dec-2020, CHILLS (chills) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PAIN (arm pain), VACCINATION SITE ERYTHEMA (redness of the arm), VACCINATION SITE WARMTH (arm was hot to the touch), VACCINATION SITE INDURATION (small hard knot on arm) and VACCINATION SITE PRURITUS (symptoms subsided after "a couple days" and then returned along with itching on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient had high dose last year with no reaction. Patient had high dose flu shot and was ok for about 3 days, then started to show sign of bruises and then there was a bump around the area where the shot was administered. Patient patient to take Benadryl and Tylenol. Patient did not realize the bruise was there until she saw it in the mirror. It is not painful but if she presses it, the pain occurs. She was ok, just to let us know. We gave patient a box of #24 generic allergy relief Benadryl and a box of cold compresses. Told patient to come back to see us in a few days for us to follow up. She was fine with us handling the situation.
Headache within 15 min - 5 cm red spot painful - itchy- muscle weakness- slept 12hrs- went to urgent care on 12/28/08.  No infection at vaccine site- told to apply ice stopped at Walgreens on 12-27-08
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a 5 years old patient of unknown gender. Healthcare worker stated that on 02-MAY-2013, VARIVAX (Merck) (lot number, dose and route were not reported), that was stored improperly, was administered to the patient. Concomitant medications were not reported. Healthcare worker stated that VARIVAX (Merck) was storage with multiple temperature excursions up to 13F since February 2013 (vaccines were received in November 2012) exceeding one week (168 hours), then progressively up to 22F for an estimated 96 hours through June 2013. The healthcare worker did not believe overall temperature was maintained at 5F. No adverse effects reported. This case is linked to cases MARRS# 1307USA002435, 1307USA002437, 1307USA001233, 1307USA002436 via same reporter link. Additional information has been requested.
Flue like symptoms, cough, fever, headache, nose congestion, affecting vocal cords, blurred vision/tearing . All symptoms are of a low grade nature (not severe).
Left office - in car on way to school - felt hazy, nauseated and sweaty; passed out and had generalized shaking movements of extremities < 1 min.; sleepy - came around to full consciousness in 2 min. Returned to office; VSS/PE (-)/Pulse OX 95%.
20 minutes after administration patient had first episode of emesis. Sat for another ten minutes and then patient had several more episdoes of emesis. This went on for about an hour. Patient also reported a headache during this time. After an hour, patient stated she felt better.
Patient has red inflamed patch around the site of injection.  She says it is hot to the touch.  It measures 3.5 inches by 2.5 inches.
Diarrhea. 4/4/2021:More than 2 or more episodes daytime; 6 episodes at night, treat by eating only banana, applesauce, dry cracker, mashed sweet potato. Abdominal pain at times. Difficulty sleeping at night. 4/5/21: mostly watery stool, weakness. Eating beef broth, Pedialyte for liquid replenishment, dry toast, banana, applesauce. Better sleep at night. Improved diarrhea. 4/6/21: Only 2 diarrhea epsisodes until night time when 3 episodes and periodic abdominal pain. Ate small amounts of meat, sauerkraut and two eggs on dry cracker that may have brought diarrhea back. 4/7/2021: Slight but explosive diarrhea one time in AM. Returning strength in legs and walking though still weak. Pain and burning in thumb never experienced previously. Only moderate pain and only if I rub the thumb.
Resident started shaking approximately 7 minutes after the vaccine was given, diaphoretic, pale, HR 134, unable to obtain BP, O2 sat 95% on RA, good breath sounds, then she started to audibly wheeze approx 20 seconds, then no breath present, Pharmacist gave first dose of Epi in left thigh. Resident had a HR of 41 and O2 dropping in the low 80s high 70s. She remained there for approx 3-4 minutes then took a deep breath and O2 up to 90's. She was placed on oxygen and monitored closed for the enxt 4 hours
This spontaneous report was received from a nurse refers to 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 26-SEP-2017, the patient was vaccinated with improperly stored VAQTA lot # N017094, expiry date: 31-AUG-2018, and M-M-R II lot # M045401, expiry date: 14-NOV-2018; dosing details were not reported, both for prophylaxis (incorrect product storage). The lot# of M-M-R II was reconstituted with properly stored sterile diluent (STERILE DILUENT MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000054:
5 mo old baby girl admitted to PEDS ward for a complex febrile seizure. Patient was in her usual state of good health and received her 4 month vaccines at 11 am (9/13). She had a tactile fever at 5 am (9/14) and began seizing at 730 am. Seizure was tonic-clonic, lasting 20-30 min. Tx with ATIVAN 0.1mg/kg.
ARM STILL HURTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on JUN-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced arm still hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm still hurts. This report was non-serious.
24 hrs of continuous fever between 99.86 and 101.5 (aprox). Moderate to intense muscle / bone pain mostly in lower extremities (similar to the flu). Tiredness / inability to move (mostly due to muscle pain). Mild to moderate headache.
pt recv vax 21MAY97 & 3 days post vax pt exp an unusual, transient facial rash which was described as blotchy, erythematous/maculopapular lasting for about 1wk;approx 2.5 wk post vax pt also exp a rash @ inj site described as a wheal;
7"-8" wheal, redness, tender to touch per patient. Swelling and soreness.
Moderna COVID-19 vaccine booster dose 0.5 ml administered instead of 0.25ml.  Patient complained of body aches on 10/22/2021
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 11Oct2023 to 16Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
4MAY local rxn lt deltoid-swelling, pain, itching;5MAY macular rash abd, trunk (non-pruritic) HS chills, sore throat, low grade fever;6MAY knee swelling, joint pain esp knees & thumb lt, swollen occipital glands, stiff neck;7MAY gen mac ras
Rash, red itchy bumps starting within 24 hrs. Spreading from thorax area to entire body over 25 day period. 5 mg PREDNISONE twice daily started 12-28-09.
patient got herpes once from taking the flu shot; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social medias.  This case involves a patient of unknown age and gender who got Herpes (Herpes virus infection), after he/she received INFLUENZA VACCINE.  The patient's medical history, past medical treatments, concomitant therapy, vaccinations and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got Herpes (Herpes virus infection) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
This spontaneous prospective pregnancy report as received from a laboratory technician, for GARDASIL a pregnancy registry product, concerning an 18 years old female patient. The patient's history of previous pregnancies and live births is not known. The reporter stated that the patient received her GARDASIL intramuscular series doses on the following dates 19-JUN-2008, 11-SEP-2008 and 29-AUG-2012 (lot # 672652/0022AE, exp 30-SEP-20140). After the patient received her third dose of GARDASIL yesterday on 29-AUG-2012, the patient informed the physician that she was pregnant. The patients last menstrual period LMP was 15-JUN-2012 and EDD was 22-MAR-2013. The reporter stated that at the time of the administration of the third dose of GARDASIL (lot # 672652/0022AE, exp 30-SEP-2014). The practice's computer system was not functioning, so the fact that the patients pregnant was not considered prior to administration of the dose of GARDASIL. The dose of GARDASIL was administered concomitantly with MENACTRA and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufactures unspecified). The patient had consulted the physician because she was experiencing "stomach pain after eating spicy foods" (approximately in August 2012). The reporter was not aware if any treatment was given for the adverse experience. Initial exposure to GARDASIL was at 0 week. The patient was exposed to GARDASIL during trimester 1. The outcome was unknown. Additional information has been requested.
+ sx and covid test on 26Mar22.; + sx and covid test on 26Mar22.; congestion no loss of taste or smell; fever; body aches; cough; sweats; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality.  A 43 year-old female patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF2589) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Manufacturer: Pfizer, Batch/Lot No: EL3247), administration date: 16Feb2021, when the patient was 42 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Manufacturer: Pfizer, Batch/Lot No: EL3247), administration date: 26Jan2021, when the patient was 42 years old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Mar2022 22:00, outcome "unknown" and all described as "+ sx and covid test on 26Mar22."; NASAL CONGESTION (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "congestion no loss of taste or smell"; PYREXIA (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "fever"; PAIN (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "body aches"; COUGH (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "cough"; HYPERHIDROSIS (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "sweats"; HEADACHE (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "Headache". The events "+ sx and covid test on 26mar22.", "+ sx and covid test on 26mar22.", "congestion no loss of taste or smell", "fever", "body aches", "cough", "sweats" and "headache" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Mar2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, nasal congestion, pyrexia, pain, cough, hyperhidrosis, headache.  Clinical course: + sx and covid test on 26Mar2022. Some St late on 25Mar2022 then HA fever body aches cough sweats congestion no loss of taste or smell. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
12/27/2021-Event occurred after 2nd vaccine.   72-year-old female presenting due to hypoxia and Covid positive test from urgent care earlier today. Patient states 5 days ago she was around her Covid positive granddaughter and 3 days ago she started to notice cough, fatigue, nasal congestion, and shortness of breath.  Has had constant nonradiating chest pain that occurs predominantly when she coughs of 3 days duration.. Chest x-ray showed bilateral opacities consistent with Covid pneumonia.