chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 14 April 2008 from a health care professional. A 65-year-old male patient, with no concurrent illnesses, had received a second subcutaneous dose of Zostavax (manufacturer Merck, lot # and site not reported) on 05 February 2008; and the following day, on 06 February 2008 at 16:00 p.m., he received a left deltoid (route not reported) dose of Adacel (lot # C2889AA). Eleven days after receiving the Zostavax, which was 12 days after receiving the Adacel, the patient experienced pain down his left arm and weakness in the left hand that was diagnosed as brachial radiculopathy. The patient required medical evaluation; however it was not specified if the patient required emergency room visit or doctor visit. No relevant diagnostic test/laboratory data were completed. The patient did have a neurology consult; however the result of the consult was not provided. At the time of this report, the patient had not recovered.
Fever, repeated vomiting and febrile seizure leading to hospitalization.  High fever for 6 days.  Blood culture grew staph treated by antibiotic.  Blood culture negative on repeat.  08/13/2008 MR received for DOS 7/23-27/2008 with D/C DX: Febrile Seizure.  Pt presented to ER with 2 day hx of fever, several episodes of vomiting, and lethargy following recent vax. En route to hospital pt had seizure consisting of becoming still and stiff, head turned to the side and blank stare x 30 seconds. No further episodes of seizure even with fever.
This is a spontaneous report based on information received by Pfizer from company (manufacturer number: not available). A contactable consumer reported that a female patient of unspecified age and ethnicity received PREVNAR 13, (lot number: T78676, expiration date: not reported) via unspecified route of administration on 14May2018 at single dose for immunization. Patient had no known allergies and no medical conditions. Concomitant medications were not reported. On 14May2018, after administering the PREVNAR 13 vaccine, a large lump and redness was observed at the injection site. This was described as an unusual reaction for this patient. Swelling at vaccination site was also reported. After the other vials were observed, it was discovered that there were visible particles in the vials (pending clarification if vial received by the patient also had particles). No medical attention required for the events. Outcome of the events was unknown.
Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 2 months old female patient for whom gave only the liquid of the PENTACEL was reported, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 22-Oct-2018, the patient received a 0.5 ml dose 1 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via intramuscular route in unknown administration site. It was reported that nurse gave only the liquid portion of the PENTACEL to the patient. Final diagnosis was gave only the liquid of the PENTACEL. This case is actual medication error due to Inappropriate reconstitution technique. Outcome of the event was not applicable. 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. Documents held by sender: none.
2ND MODERNA VACCINE WAS ADMINSTERED. WITHIN SECONDS OF ADMINISTRATION PT BEGAN MOVING BACK AND FORTH, LOOKED FLUSHED AND I ASKED IF SHE WAS OK. PT RESPONSE WAS, ?YES, I DOWNED A BEER RIGHT BEFORE COMING IN TODAY!? (NO SMELL OF ETOH) I BEGAN TO EXPLAIN THAT ETOH BEFORE VACCINATIONS IS NOT A GOOD IDEA, WHEN THE PT BEGAN TO HAVE SUDDEN EYE TWITCHING AND SLUMPED OVER FOR SEVERAL SECONDS.  PT WAS RESPONSIVE TO QUESTIONS, COLOR WAS PALE AND CLAMMY. SHE SAID SHE LAST ATE AROUND 11AM. SHE ANSWERED QUESTIONS APPROPRIATELY. HER AND COMPANION STATED SHE HAD BEEN HAVING PAIN IN HER FEET FOR SOME TIME, ALONG WITH ANXIETY RELATED PAIN, (CHEST PAIN) THAT HER PCP HAD ORDERED STRESS TEST BUT SHE HAD NOT COMPLETED YET. PT BEGAN TO FEEL LIGHTHEADED AGAIN AND MENTIONED SEEING SOMETHING, THEN EYE TWITCHING OCCURRED FOR SEVERAL SECONDS. 911 WAS CALLED. VITAL SIGNS WERE TAKEN: 1ST SET SHOWED INCREASED HEART RATE OF 116 COUNTED, 147 (AUTOMATED DEVICE). 2ND SET OF VITALS ? BP: 101/60 HR79, EMTS WERE ON LOCATION THERE VITALS ? BP:102/71, HR 76, WITH REGULAR RHYTHM. THERE WAS NO APARENT PHYSICAL REACTION AT INJECTION SITE, NO REDNESS ON CHEST OR ABDOMEN, NO CHANGES IN VOCAL RESPONSE, PT WAS ABLE TO VERBALIZE NORMALLY, THE PT AT WAS RESPONSIVE, REFUSED TRANSFER TO HOSPITAL WITH EMT AND AGREED THAT IF SHE HAD ANY PROBLEMS OR CONCERNS SHE WOULD FOLLOW UP WITH PCP OR ED.
7 AM 01/06/2021: Soreness at injection site, fatigue 9 AM 01/06/2021: Soreness at injection site, fatigue, nausea
r. Sweating; Joint pain from head to toe; nausea; chills; body aches; Fever; Headache; Vomiting; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (Sweating), ARTHRALGIA (Joint pain from head to toe), NAUSEA (nausea), CHILLS (chills) and MYALGIA (body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy, Allergic reaction to analgesics (Naproxen) and Drug allergy (Ditropan). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety, LEVOTHYROXINE for Hypothyroidism, HYDROXYZINE for Itching.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced HYPERHIDROSIS (Sweating), ARTHRALGIA (Joint pain from head to toe), NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomiting). At the time of the report, HYPERHIDROSIS (Sweating), ARTHRALGIA (Joint pain from head to toe), NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPERHIDROSIS (Sweating), ARTHRALGIA (Joint pain from head to toe), NAUSEA (nausea), CHILLS (chills) and VOMITING (Vomiting) to be possibly related. No further causality assessments were provided for MYALGIA (body aches), PYREXIA (Fever) and HEADACHE (Headache).    Treatment medications were not provided by reporter.    This case was linked to MOD-2021-071072, MOD-2021-071082 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Patient's initials, details, medical history, concomitant drugs were updated. Patient's second and first dose of vaccine were updated. Vomiting added as event. Causality for chills, sweating, joint pain, nausea and vomiting was updated.; Sender's Comments:  MOD-2021-071072:Mother First dose of vaccine case MOD-2021-071082:Mother Second dose of vaccine case
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 15Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Obstructive sleep apnea" (unspecified if ongoing); "MRSA" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Atenolol, reaction(s): "Known allergies: Atenolol", notes: Known allergies: Atenolol, Vancomycin; Vancomycin, reaction(s): "Known allergies:Vancomycin", notes: Known allergies: Atenolol, Vancomycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 2 days after the suspect product(s) administration, outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Was given HPV, EIPV, MMR, Varicella and Hep A, a few minutes later client became pale, put her head down for a few minutes with cold compress to face and back of neck.  Complained of weakness, did not try to walk out, stepfather carried her out, was alert and able to hold conversation.
patient reported at 1525 with a hx of vagal rx to injections. NKA and mild COPD. 0 CP, 0 SOB, 0 N/V, 0 tightness. Patient diaphoretic, shaky, not answering questions, pale. HR 89, SP02 93%, 105/65. Patient felt better supine, color improved, drink and snack were offered but declined. patient was released to care of wife who was driving home with HR 73, and BP 145/67.
On Oct. 27, 2021,  I received my 2nd Covid-19 Pfizer shot and my flu shot (Fluarix Quad PF). This morning 10-28-21, I woke up with 2 very sore arms, nausea, body aches, and a headache. I've been taking Tylenol and drinking plenty fluids. I don't know if the symptoms are from both vaccines or one of them.....since I received both of them on the same day.
Breakthrough case admission after 2 vaccines Pfizer 4/13/21 lot# Ew0150;  Pfizer 5/4/21 lot# EW0179
approx 10min p/vax child c/o nausea, lightheadedness & chills;skin warm/dry;color pale;observed for 1hr;sx persisted;mom notified;child sent home w/mom;
Approximately 1/2 dose was wasted 2/2 accidental needle disconection. RN contacted pharmacy, and after discussion with the patient, determined that she would not like a secondary 1/2 dose to supplement what was lost.
PEOPLE HAVE SERIOUS SIDE EFFECTS; This spontaneous report received from a consumer via a company representative via social media concerned a multiple patients of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced people have serious side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of people have serious side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20211143081.
Flushed face; Hives; Numb and swelling tongue; Numb and swelling tongue; Numb and swelling tongue and lips; Numb and swelling tongue and lips; Residual tingling in hands and mouth; Residual tingling in hands and mouth; A fear of the allergic reaction rebounding; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 18:30 (at the age of 46 years-old) as a single dose for COVID-19 immunisation. Medical history included lupus, hypermobile and Ehlers-Danlos. The patient had known allergies to shellfish. Prior to the COVID vaccination, the patient did not received any other vaccines within four weeks. The patient did not received any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 17:45 (at the age of 46 years-old) as a single dose for COVID-19 immunisation and also received erythromycin (MANUFACTURER UNKNOWN) on an unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021 at 19:15, within 40 minutes of shot, the patient experienced flushed face, hives, numb and swelling tongue and lips. The patient had already left the hospital and was at home. Benadryl resolved the problem, but the patient needed a second dose due to residual tingling in hands and mouth, and a fear of the allergic reaction rebounding. Therapeutic measure were taken as a result of the events that included treatment with BENADRYL. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events flushed face, hives, numb and swelling tongue and lips, residual tingling in hands and mouth, and a fear of the allergic reaction rebounding was resolved on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Normal temp: 97.7 03/16/21 08:30pm - extreme fatigue, body aches and chills 10:00pm - temp 98.0 and mild headache 11:30pm - temp 101.3 and significant headache 03/17/21 12:50am -  temp 102.1, body ache and headache 03:45am - temp 101.9, body ache and headache 04:15am - temp 100.7, body ache and headache 06:30am - temp 99.3, headache 08:35am - temp 98.0, headache
Breakthrough case admission after 3 vaccines Moderna 1/21/21 Lot# 012L20A;  Moderna 2/18/21 Lot# 016M20A;  Moderna 11/12/21 Lot# 013F21A
This spontaneous report as received from a medical assistant refers to a 12 year old patient of unknown gender. The patients drug allergies and pertinent medical history was not reported. On 12-JUL-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA10956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908. 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946. 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954. 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959. 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013, 1407USA013014 (same reporter link). Additional information has been requested.
Arm at injection site is still sore after 2 months. Have tried warm compresses and nothing works. Talked with the pharmacist but they had no advice.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 9:13 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 9:13 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 54.81 for dose administered on 27-Apr-2021.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No concomitant medications were reported.  On 27-Apr-2021, Excursion time was 09 AM, temperature was 35 and total doses given for the day was 42, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 27-Apr-2021. 8 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  No treatment medications were reported.
Fever X 72 Hrs > 102 F at vaccine site -> 4-5 cm area of enthema, L thigh swelling, limp - lasting 12 hrs X lmp . 72 hrs
The next day (Friday),  I felt sluggish and slightly dizzy. That night (Friday) I awoke to a feeling of the room spinning.  On Saturday I was extremely dizzy and threw up. I felt like I had hot flushes, then I would have chills. The dizziness was the most uncomfortable side effect. I went to my local doctor twice- once that Monday, then on that Thursday.  The dizziness lasted until the following  Monday. I saw an ENT whose office performed a treatment for vertigo.
On 5/9/08, pt started feeling weakness and felt feverish but no temperature was taken. Hives started on 5/10/08. Patient was examined on 5/12/08 and had welts on trunk and extremities, along with swollen lips.
5 minutes after administration of vaccine patient developed numbness to left side of tongue. No tongue swelling, SOB or difficulty swallowing and talking. She was monitored for 35 minutes at that time she reported the symptoms have almost completely resolved.
Prickly feeling on skin started after about 3 days, mostly on legs but traveling around the body, went away after about 4 days, then came back around day 12 with chills and feeling run down/sick, but as more of a pins and needles/cold burn feeling, again mostly around legs,  went away after a few days, came back again 4/26 as pins and needles and cold burning feeling  with chills every now then, also experiencing off and on vertigo since vaccine and tinnitus, as well as painful lymph nodes in chest mostly on vaccine side starting in day 12ish post vaccine.
FEELS LIKE SICKNESS; HEADACHE FOR ONE HOUR; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JUL-2021, the subject experienced headache for one hour. On 21-JUL-2021, the subject experienced feels like sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache for one hour on 20-JUL-2021, and the outcome of feels like sickness was not reported. This report was non-serious.
Swelling; Itching; Erythema; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Erythema), VACCINATION SITE SWELLING (Swelling) and PRURITUS (Itching) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Erythema) and PRURITUS (Itching). On 15-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE ERYTHEMA (Erythema), VACCINATION SITE SWELLING (Swelling) and PRURITUS (Itching) 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.   Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow-up received on 13-Apr-2021 included no new information.
Swelling, redness, warmth to immunization sites on both legs (DTaP, Prevnar, and HIB).