chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT BECAME ILL AFTER VACCINATION, DID NOT LOSE CONSCIOUSNESS BUT FELT VERY FAINT, BROKE OUT IN SWEAT, COLOR WAS POOR, NAUSEATED/VOMITED. MOTHER STATED THAT CHILD ALWAYS FAINTS AFTER INJECTIONS. PATIENT WAS TREATED WITH COLD PACK, WET CLOTHS, LOLLIPOP, SMALL AMOUNT OF COKE OVER ICE; MOTHER ASSISTED WITH TREATMENT. AT NO TIME DID PATIENT FALL OR EXPERIENCE INJURY. PATIENT WAS ASSISTED TO FLOOR TO REST AND RECUPERATE. PATIENT AND MOTHER STATED AT 11:50 THAT HE HAD RECOVERED, AND PATIENT WALKED UNASSISTED THROUGH BUILDING AND OUT TO VEHICLE.
Information has been received from a health professional concerning a 19 year old female patient who on 20-APR-2009 was vaccinated with the first dose of GARDASIL and on 19-JUN-2009 received the second 0.5 mL dose of GARDASIL (lot # 661953/1130X). Concomitant therapy included patches of ORTHO EVRA. On 19-JUN-2009 after receiving the second dose of GARDASIL the patient experienced difficulty breathing, severe stomach pain, nauseas and chills and was brought to the ER room. The medical assistant stated that the patient was not admitted to the hospital but went home on the evening of 19-JUN-2009. It was reported that the patient will not receive the third dose of GARDASIL. The patient fully recovered on 20-JUN-2009. Follow-up information was received from a healthcare professional concerning the patient. It was reported that the patient did not receive concomitantly other vaccines at the time of the GARDASIL vaccination. However, the office has no information as to which hospital ER the patient went, neither the treatment that the patient received. The healthcare professional contacted during telephone follow-up could not supply the following information: Hospital name (ER). No further information is available.
HEADACHE; FEVERISH; LIGHT HEADED; This spontaneous report received from a patient concerned a male of unspecified age. 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 not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced light headed. On APR-2021, the subject experienced feverish. Treatment medications included: acetylsalicylic acid, and paracetamol. On 18-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, feverish and light headed was not reported. This report was non-serious.
Rash on chest and both arms. Administered ibuprofen to help reduce swelling/redness
Flushing of face and chest; Tingling in lips and arms; feeling warm; Most pronounced after combination of Athletic Greens and chai latte; Numb lips; allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received on an unknown date, refer case US2022AMR081860).   On 29th April 2022, the patient received the 2nd dose of Shingrix. On 2nd May 2022, 3 days after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the patient experienced flushing, tingling, feeling of warmth, food interaction and numb lips. The patient was treated with benadryl (nos) (Benadryl). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the allergic reaction was recovered/resolved and the outcome of the flushing was recovering/resolving and the outcome of the tingling and numb lips were not recovered/not resolved and the outcome of the feeling of warmth and food interaction were unknown.   It was unknown if the reporter considered the allergic reaction, flushing, tingling, feeling of warmth, food interaction and numb lips to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR081860   Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and was feeling a little tired and flu like symptoms. The patient also experienced flushing of his/her face, tingling in his/her lips and arms and feeling warm. Most pronounced was after the combination of Athletic Greens and a chai latte. However, even later in the day, his/her face and chest were flushed for no apparent reason. The patient separated out the chai from the AG, which reduced some of this, but the numb lips continue.  On 5th May 2022 the also experienced worst of the apparent allergic reaction, . It subsided after he/she took some benadryl. The patient discontinued the AG and as of today (day of reporting) the tingling/numbness in his/her lips and on his/her face persists. The patient asked for advice. Additional supportive information: The follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081860:Same reporter
Flu vaccine given 9-21-10 at 10:15 - Started with itching (generalized) at 12:00 pm - at 5:00 pm started noticing red spots all over - Bought OTC Cortisone cream some relief, unable to sleep. In am noticed itching et welts were worse. Was seen at health clinic, felt throat closing and SOB - presently breathing is better was Rx'd BEANDRYL - sent home to RTC if worsens. States allergy to silicone denies allergy to latex.
Within 18 hours of vaccine, I developed a terrible headache, cold chills, fever, muscle aches, stuffy nose, stiff joints.  My arm was sore with a rash and warm to touch.  Symptoms lasted into 3rd day.
This spontaneous report as received from a certified medical assistant refers to two to three patients of unknown ages and genders. The reporter stated that on unspecified dates, since 02-APR-2013, the patients received ROTATEQ dose, route application site were unspecified)(lot#1710AA; exp date 11-JUL-2013), and six patients received GARDASIL MARRS# 1305USA002203. The reporter stated that the ROTATEQ were exposed to an unsupported temperature excursion. These vaccines were exposed multiple times into the freezing range, the lowest temperature being 23F; the total time frame being 1 month. The number of excursions into the freezing range exceeded 5 times. The exact number of times these entered the freezing range was unspecified. No known adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Irregular EKG on 09May, sent for Echocardiogram on 11May; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2022 at 15:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMOXICILLIN. Vaccination history included: BNT162b2 (Dose 3, Batch/Lot No: 30130BA, Location of injection: Arm Left), administration date: 25Sep2021, when the patient was 70-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 23Mar2021, when the patient was 69-year-old, for Covid-19 immunization; BNT162b2 (Dose 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 02Mar2021, when the patient was 69-year-old, for Covid-19 immunization. The following information was reported: ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 09May2022, outcome "unknown", described as "Irregular EKG on 09May, sent for Echocardiogram on 11May". The event "irregular ekg on 09may, sent for echocardiogram on 11may" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of electrocardiogram abnormal.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-JAN-2009, the patient was inoculated with ZOSTAVAX by a physician at the office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-SEP-2014, the patient was treated at a health center for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
1/14/21 9pm  chills 1/15/21 8am chills, muscle aches, headache, nausea, fatigue, rigors low grade fever. 2 pm temp 100.8, bilateral ear drum pain 1/16/21 8 am fatigue.   1/17/21 2am woke up with chills nausea and ear pain. 1/17 in morning fatigue . 1/18/21 asymptomatic.
vial was initially stored in the refrigerator on 02Feb2022, and dose administered on 22Mar2022 beyond 30-day use; We discovered that we've given Moderna Covid-19 vaccine that was beyond the 30 day use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We discovered that we've given Moderna Covid-19 vaccine that was beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02Feb2022, and dose administered on 22Mar2022 beyond 30-day use) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We discovered that we've given Moderna Covid-19 vaccine that was beyond the 30 day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02Feb2022, and dose administered on 22Mar2022 beyond 30-day use). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We discovered that we've given Moderna Covid-19 vaccine that was beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02Feb2022, and dose administered on 22Mar2022 beyond 30-day use) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Date the vial was initially stored in refrigerator 02-Feb-2022 The vial did not undergo any temperature excursion. No treatment information provided.
This case was reported by a consumer via call center representative and described the occurrence of nerve damage in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced nerve damage and mobility decreased. On an unknown date, the outcome of the nerve damage and mobility decreased were unknown. It was unknown if the reporter considered the nerve damage and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The reporter knew the patient and reported on behalf of her. Age at vaccination was not reported. After a SHINGRIX shot, the patient experienced nerve damage and she could not move her arm. This was mentioned during passing. The reporter was angry so unable to probe for more information. The consent to follow-up was not given.
4FEB98 swelling of body & face & hives;mom breastfeeding & had eaten shrimp that day;pt had taken similac formula;
two years and 9 months old received Kinrix; Got Kinrix as 3rd dose of Dtap series; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 33-month-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: two years and 9 months old received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Got Kinrix as 3rd dose of Dtap series). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAR-2023 A nurse reported that a two years and 9 months old patient received her third dose of Dtap series vaccination with a Kinrix dose, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The reporter consented to follow up.
Thyroiditis subacute; arthralgia; asthenia; bone pain; dysphagia; fatigue; headache; myalgia; neck pain; pyrexia; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced thyroiditis subacute, arthralgia, asthenia, bone pain, dysphagia, fatigue, headache, myalgia, neck pain and pyrexia. The events were reported as non-serious by reporter. Outcome of the event was unknown. There is no product complaint associated with this case No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
One week post injection, lump in arm appeared, it was red and itchy,  swollen,  and painful - pain and swelling lasted for about 4 days,  redness and occasional itching  at site is still showing after 6 days.  at Day 6, which is day 13 post injection I still have a small bump, redness and occasional itching.
pt c/o body aches, sore jaw, nasal congestion, cough, feverish, shortness of breath on 3/30/11
Body aches; Covid toes( feet hurting, red/purple coloration); Covid toes( feet hurting, red/purple coloration); Low energy/fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (Covid toes( feet hurting, red/purple coloration)), ERYTHEMA (Covid toes( feet hurting, red/purple coloration)), FATIGUE (Low energy/fatigue) and ARTHRALGIA (Joint pain) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Post-traumatic stress disorder. Concomitant products included TRAZODONE for Post-traumatic stress disorder.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), PAIN IN EXTREMITY (Covid toes( feet hurting, red/purple coloration)), ERYTHEMA (Covid toes( feet hurting, red/purple coloration)), FATIGUE (Low energy/fatigue) and ARTHRALGIA (Joint pain). At the time of the report, PAIN (Body aches), PAIN IN EXTREMITY (Covid toes( feet hurting, red/purple coloration)), ERYTHEMA (Covid toes( feet hurting, red/purple coloration)), FATIGUE (Low energy/fatigue) and ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided.  Patient reported that she was experiencing an intense rash in the scalp that is causing hair loss and it got worse since last two months. She also reported that her Dermatologist thinks this is dermatitis or psoriasis and prescribed, whit Clobetasol (steroid medication), propionate shampoo and a ciclopirox shampoo.   This case was linked to MOD-2021-339457 (Patient Link).
Client stated she had chills, headache, tiredness, and felt dizzy. BP: 100/72 HR: 60 P:98 T:97.5
she had a reaction; Initial information received on 20-Nov-2017 regarding an unsolicited valid non-serious case from a non-healthcare professional (medical representative).  This case involves an adult female patient of an unknown age who experienced she had a reaction (adverse reaction), while she received vaccine influenza usp trival a-b high dose subvirion vaccine [Trivalent Influenza Vaccine].  The patient's medical history, past medical treatment(s), vaccination(s), concurrent condition and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect 0.5 mL once a day influenza usp trival a-b high dose subvirion vaccine (formulation: unknown) (batch number: UH898AC and expiry date: 30-Jun-2014) via intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date, (Latency: unknown) in the 2013-2014 season reporter was only aware that the patient stated she had a reaction (adverse reaction) she had no information further to provide on what the reaction was or the patients allergy profile or even patient's name after speaking with her.  No laboratory data was reported.  Action taken was not applicable.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was resolved on an unknown date.
Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. On approximately 29SEP2003, the patient developed a full case of chickenpox. No information about lot number, medications, age, gender, medical history, treatment, or outcome was given. Unspecified medical attention was sought. There was no product quality complaint. No further information is expected.
Patient was fully vaccinated with Moderna on 2/26/21 and 3/26/21. Patient had SOB x 1 week prior to admission. Patient was admitted 12/24/21 with COVID and is still admitted
Injection was in upper left arm, leading to numbness, pain and arm weakness, decreasing over the next 3.5 days to return to normal. Carpal tunnel syndrome is historically worse in the left arm for patient.
The day following vaccination the baby began having diarrhea bright neon green with big chunks of mucous which is a change from her normal yellow-brown seedy stool and is breast fed. This continued at a rate of 6-10 liquid stools bright neon green for 20 days.  She would wake at night and be visibly uncomfortable and was fussy, needing repositioning to pass gas and alleviate gastric discomfort. No fever but general malaise that lasted for about a week after the vaccine. She was taken to be evaluated by her pediatrician at day 12 after vaccination.
Pt devel local reaction, reddened area around inject site w/in 1 min following inject; applied cool compress & requested pt wait x 20 min; area around inject site was sl pink when pt left clinic; Advised mom to contact MD if needed;
The night after her vaccine she developed pain in top of shoulder and up neck. Arm was extremely sore. TYLENOL helped some.
Patient reported dizziness and lightheaded ness within 5 minutes post vaccination. He reported feeling like the room was spinning. Patient had not eaten breakfast or lunch. Provided supportive care (cold compress, asked patient to lie down with feet raised). After 30-45 minutes patient was driven home. Called patient about 90 minutes after leaving and patient reported feeling much better after eating,
Circular red, itchy, rash on arm of administration. Warm to touch and appears to be decreasing. Advised to use cold packs, antihistamines and pain relievers and report to MD.
Legally blind/I could no longer see the lights in my house; This is a spontaneous report from a contactable consumer (Patient).  A 59-years-old patient of an unspecified gender received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on an unspecified date as 2nd DOSE, SINGLE for covid-19 immunization Medical history included hypertension. The patient's concomitant medications included Hypertension medications . Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Consumer and secondary reporter(a friend of patient) both on the call. Consumer reported that since last 4 days after second Pfizer shot after the fourth day, patient was already legally blind. Patient could no longer see the lights in house. The outcome of event was unknown.
This spontaneous report was received via Pfizer from a physician which in turn reported to him by a pharmacist, refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 04-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis. On 04-OCT-2018, patient was vaccinated with influenza virus vaccine (unspecified) (manufacturer, dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis. The patient received both the vaccines in the same arm at different injection sites (product administered at inappropriate site). On an unknown date in October 2018 after the vaccination, the patient experienced redness (erythema), swelling and rash. The patient reported the reactions to the pharmacy on 07-OCT-2018. The outcome of product administered at inappropriate site, erythema, swelling and rash was unknown. Causality assessment of the events erythema, swelling and rash was not reported.
Drowsy, AMS, difficulty breathing, clutching at throat, was not moving air Benadryl 12.5 mg IM, patient lost consciousness, given EPI Pen x 2 Oxygen 5L Foaming at the mouth, suction provided Patient sent to ER
--- 2/15/2022 11:40 AM by private***   Patient is a 20 year old female that presents today for a video visit  ***   Patient received her second dose of the pfizer covid vaccine in the L arm about 4 days ago. She noted that next day there are two areas in the L armpit one just in front of the armpit and the second close to the back the armpit where there is localized area of puffiness/knot with soreness . She has difficulty laying on the L side secondary to this soreness which is intermittent and moderate in intensity.  ***   She denies associated fever no chills no night sweats. No shortness of breath  no cough.  ***   States she only had soreness at the site of injection with the 1st dose of the 5 Zyrtec COVID vaccine.  ***