chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Throat became seriously swollen. Difficult to swallow. Fever of 101.5, Extreme Fatigue, Body Aches. Severe headache. This lasted for 48 hours.
Lot # had been extended and kept frozen until date of administration but was given 2 days post expiration date.  Moderna contacted and deemed that the vaccine was viable so no revaccination was necessary.  No adverse side effects were reported by patient.
1 hive on cheek developed shortly after receiving both vaccines, also reported itching face resolved on own without intervention
Contracted Covid. Since then he has experienced long covid symptoms such as brain fog, memory issues, visual problems (floaters, sensitivity to light, etc), headaches and other cognitive challenges; Contracted Covid. Since then he has experienced long covid symptoms such as brain fog, memory issues, visual problems (floaters, sensitivity to light, etc), headaches and other cognitive challenges; Vaccine administered at inappropriate site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 17-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 12May2021 as dose 2, single (Lot number: EP6955), in left arm and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left leg, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset Dec2021, outcome "unknown", described as "Vaccine administered at inappropriate site"; DRUG INEFFECTIVE (medically significant) with onset 10Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 10Jan2022, outcome "not recovered" and all described as "Contracted Covid. Since then he has experienced long covid symptoms such as brain fog, memory issues, visual problems (floaters, sensitivity to light, etc), headaches and other cognitive challenges". The events "contracted covid. since then he has experienced long covid symptoms such as brain fog, memory issues, visual problems (floaters, sensitivity to light, etc), headaches and other cognitive challenges" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jan2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received MMR +  Varicella, PREVNAR on 1-26-10. Developed a rash over entire body on 1-29-10. Also completed Amoxicillin for BOM on 1-28-10. Inst. per PNP-C to take CHILDREN'S BENADRYL 1/2 teasp Q6 hours x 24 hours . Has no resp problems & no other sx. Eating well. Mom inst to take to ER for resp. problems. Will re-check in clinic 2/1/10. 03/11/2010- 2/8/10 100p, noshow for rechecked on 2/1/10 2 to rash developing on 01/29/10 after 01/26/10 vaccines. t/c to home # , mom states did not bring child on 2/1 because she gave Benedryl 1/2 t. x1 dose on 1/29/10 - rash resolved. No further problems. No other sx.
Deep soreness at injection site; This is a spontaneous report from a contactable nurse, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an intramuscular route of administration in the left arm on 15Feb2021 at 14:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included supraventricular tachycardia. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Feb2021 at 17:00, the patient experienced deep soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event deep soreness at injection site was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Anaphylaxis.  Lip swelling, hives, sob, nausea.  For 1 hour post Epi given.
Vx reconstituted with sterile water; Vx reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number PG35Z, expiry date unknown) for prophylaxis.   On 6th October 2021, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received Shingrix after it was reconstituted with sterile water instead of the supplied adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. It was unknown weather the dose was first dose or second dose. The reporter consented to follow up via email. This case has been linked to US2021209465, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209465:Same reporter. Patient 1 of 2.
Woke up AM of 11/16/06 with chills, fever, L forearm soreness and a red raised area on the L Deltoid. L deltoid had a burning discomfort, worse with range of motion or particularly with lifting. No itching, no shortness of breath, any other symptoms were negative.
Several minutes after receiving vaccines, pt. began sneezing. Eyes became red. Bilateral periorbital and cheeks developed urticaria. No resp. distress. BENADRYL elixor administered. V/S: 98.3, 109, 20, 99/57.
I received my Pfizer booster for COVID-19 on 09/25/2022. In the morning when I woke up I had cough, sore throat, and congestion. I did a COVID-19 home test and it was positive. The next day on 09/26/2022 I did a telehealth with my doctor who prescribed me PAXLOVID for 5 days. On 09/28/2022 I was feeling normal again but still tested positive for COVID-19. On 10/02/2022 I tested negative for COVID-19. I also tested negative on 10/06/2022 and 10/07/2022.
This child had his vaccines given on 7/14/06 at end of morning session about 12 noon. Mom  noted that later on that night the child developed 2 seizure. He was taken to ER where the seizure lasted 30 minutes. He was given valium supp and required O2 bagging secondary to resp failure which occurred after valium dose. He was admitted to hosp by 5AM. He was seen by neurology who felt seizure was due to Dtap vaccine and recommended child not receive pertussis in vaccine any more. DC DX: Atypical febrile Seizure. Seen in ER for unresponsive, drooling, body twitching, staring straight off episode and then briefly stopped twitching and then resumed the shaking. Patient was febrile at Urgent Care center where episode took place, this occurred 1 day after vaccination. Transported via ambulance to ER during transport received 23mg Valium IV times 2 before seizure stopped. 3 days prior to ER visit had runny nose, cough no fever.  Current Meds: antihistamines Temp in ER 37.7,  PE: Right inguinal node. Neuro: sleeping, clonus x2 beats 6/1 ankles. Pupils constricted but equal. Labs: WBC 11.8,  CSF: WBC 0, RBC 0, glucose 73, protein 23, culture negative Admitted for 24 hour observation.
Tired, chills, achy, slight fever of 99. Tylenol taken, increased water intake,  additional hours of bed rest.
started swelling in different parts of his body within 48 hours; This is a spontaneous report from a contactable consumer or other non-HCP. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (Age of vaccination: Unknown) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced started swelling in different parts of his body within 48 hours. The outcome of event was unknown.  Follow-up (08Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.
Body aches, chills lasted until 3/20/2021. Took over the counter iboprufen for the pain.
diagnosed with HPV, strain 16 & 18 in July 2019 which GARDASIL is supposed to protect against; diagnosed with HPV, strain 16 & 18 in July 2019 which GARDASIL is supposed to protect against; This spontaneous report was received from a consumer who refers to herself, a currently 25-year-old non-pregnant female patient. Concomitant medication included drospirenone (+) ethinyl estradiol (YAZ) and cetirizine hydrochloride (ZYRTEC). Concurrent condition included birth control and no drug reaction or allergies. There was no information about the patient's medical history provided.   On an unknown date in 2009,  the patient was vaccinated with full series of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscularly for human papillomavirus (HPV) prevention (exact dose, lot number and expiration date were not provided).  On an unknown dates, the patient had performed biopsy and pap-smear but the results were not provided.  On an unknown date in July 2019, the patient was diagnosed with HPV, strain 16 and 18 which quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was supposed to protect against. It was reported that the patient sought for medical attention. No treatment was given for the adverse events.   On an unknown date in November 2019, the patient had performed re-pap which came back to normal.  The outcome of the events was reported as recovered on an unknown date in November 2019. The causality assessment was not provided.
test (+) for Covid; Headache; L arm pain; tingling in L arm; This is a spontaneous report from a contactable other health care professional. A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FD8448, Expiration date: Unknown), via intramuscular route of administration in left arm on 19Aug2021 at 13:00 (Batch/Lot Number: FD8448) as dose 1, single (at the age of 54-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Aug2021, the patient experienced test positive for COVID-19. On an unspecified date in 2021, the patient experienced headache, his arm pain and tingling in L arm. The patient underwent lab tests and procedures which included computerized tomogram: negative on 23Sep2021, electrocardiogram: possible enlarged L atrium on 23Sep2021, full blood count: negative on 23Sep2021, CMD: negative on 23Sep2021, SARS-COV-2 test: positive on 21Aug2021. It was reported that on 21Aug2021, the patient was tested positive for COVID-19, 19 days later he got second COVID-19 vaccine. He reported that headache started the next day and progressively got worse. He went to the emergency room visit for headache on 24Sep2021. On 27Sep2021, the reporter seen patient in his office for follow up emergency room visit plus persistent migraine Toredol 30mg/1ml intramuscular was given with dexamethasone 4 mg intramuscular. He also presented with L arm pain and tingling in L arm where injection was given,  on 11Oct2021. He continued to had headaches. The outcome of the event headache was not recovered. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
pain at the injection site; fever; aches; high blood pressure; trouble sleeping; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles, sinus congestion and headache.   On 2nd October 2019, the patient received the 1st dose of Shingrix. On 2nd October 2019, 10 hrs after receiving Shingrix, the patient experienced injection site pain, fever and pain. In October 2019, the patient experienced blood pressure high and difficulty sleeping. On an unknown date, the outcome of the injection site pain, fever and pain were recovered/resolved and the outcome of the blood pressure high and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, pain, blood pressure high and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows:  The reporter stated that within 10 hours of vaccination he developed pain at the injection site, fever, and aches.  The events resolved within a few days. The patient stated he also had developed high blood pressure and trouble sleeping, which was unresolved till the time of reporting. The reporter consented to follow up. Time to onset was considered as 10 hours as per source document. This case is linked to case US2020007427 reported by the same patient by the same reporter.
Unresponsive for 10 seconds, heavy sweating, hyperventilating, pale/red color.
CONFIRMED COVID-19 INFECTION (FLU SYMPTOMS); 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: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced confirmed covid-19 infection (flu symptoms). Laboratory data included: COVID-19 PCR test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection (flu symptoms) was not reported. This report was non-serious.
Vaccine on 6/7/2021...after about 1 to 2 weeks, tingling hands, swelled foot, some infrequent shortness of breath, some slurring of words, unusual stutter, abdominal pain, pressure in chest front to back, soreness at shot location, later - a very high blood glucose reading. 6/25/2021 - glucose reading of 225, HBA1c reading of 8.8%! Later diagnosed with LADA because of glucose readings, AND because lifestyle is vegan vegetarian and active workouts, AND no prior high glucose readings. subsequent tests for auto immune, negative.
Received vaccine 1/25/21 around 10a. at 3am on 1/26/21 began having fever, aches and headache.
Patient presented in employee  Bivalent COVID clinic. Patient may have received a dose of monovalent COVID vaccine during clinic. Unable to determine if patient received monovalent or bivalent vaccine.
When patient came for her 2nd vaccine, she stated that her arm was red and hot for 7 days after injection
Extreme achiness and joint pain. Fever. Headache. Took 2 Aleve otc tablets from the evening after my shot through the night and next day every 7 hours. Didn't work well but made the day manageable. Needed Aleve and tylenol. Skin feels painful to the touch. Arm has extreme bruise-like pain.
Patient had increased swelling, warmth, erythema; found to have abscess of left thigh on ultrasound. Patient received antibiotics, abscess was incised and drained. Medical Record received on 12/15/2004 states pt had thrush.
Malaise; anxiety; sleeplessness; hair started coming in curly; Nasuea; chills; fatigue; myalgia in gluteus area / Myalgia in lower back / body aches; hip pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), ANXIETY (anxiety), INSOMNIA (sleeplessness), HAIR TEXTURE ABNORMAL (hair started coming in curly) and NAUSEA (Nasuea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise), ANXIETY (anxiety), INSOMNIA (sleeplessness), HAIR TEXTURE ABNORMAL (hair started coming in curly), NAUSEA (Nasuea), CHILLS (chills), FATIGUE (fatigue), MYALGIA (myalgia in gluteus area / Myalgia in lower back / body aches) and ARTHRALGIA (hip pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (Malaise), ANXIETY (anxiety), INSOMNIA (sleeplessness), NAUSEA (Nasuea), CHILLS (chills) and FATIGUE (fatigue) was resolving, HAIR TEXTURE ABNORMAL (hair started coming in curly) outcome was unknown and MYALGIA (myalgia in gluteus area / Myalgia in lower back / body aches) and ARTHRALGIA (hip pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab data included ct scan, bone scan and blood work.  No  Concomitant medications were provided. Consumer stated she may have taken Advil or Tylenol to help alleviate the possible adverse events and non-drug treatment physical therapy were reported.   This case was linked to MOD-2021-306447 (Patient Link).
This spontaneous report was received from a registered nurse and refers to a multiple patients of unknown age and gender. The patients' pertinent medical history and drug reactions and allergies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored GARDASIL 9 (lot # reported as M020103, expiration date reported as 30-AUG-2017, dose and frequency were not reported) intramuscularly. Concomitant therapy was not reported. No adverse effects were reported. There was no Product Quality Complaint (PQC). Lot number M020103 is an  invalid lot number for GARDASIL 9. Additional information has been requested.
This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 12-JUL-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB . Lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 88 hours with a lowest recorded temperature of 33 Fahrenheit (F) (0.555555555 Celsius(C)) and other one of 80 hours with temperature of 34 F (1.111111111 C) and 16 hours with temperature 49 Fahrenheit (F) (0.555555556 Celsius (C). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
On 12/6/21, case went to  Hospital  for chest pains. Heart attack determined. On 12/7/21 Tested positive for COVID pre-surgery. No COVID symptoms.
LARGE RED SOLID RASH AND QUARTER SIZED BLISTER.  URGENT CARE PRESCRIBED PREDNISONE AND KEFLEX.  1 DAY AFTER THE VACCINE THERE WAS A RED BASEBALL SIZED RASH.  2 DAYS AFTER THE VACCINE THE RASH WAS SOFTBALL SIZED.  3 DAYS AFTER THE VACCINE THE RASH COVERS THE MAJORITY OF THE UPPER ARM AND A QUARTER SIZED BLISTER APPEARED.
Information has been received from a literature article concerning a 18 year old female patient developed uveitis, following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17. The median time from vaccination to onset of ADRs was 30 days; time to onset was unknown in 1 case; the time to onset in this case was of 117 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports form the same literature source. Additional information has been requested.
PATIENT EXPERIENCED SHIVERING/CHILLS AND SORE THROAT ABOUT 7 HOURS AFTER RECEIVING VACCINE.  PATIENT TOOK TYLENOL WHICH RELIEVED SYMPTOMS.  THE FOLLOWING MORNING, WHEN THE PATIENT REPORTED EFFECTS, HE WAS JUST FEELING FATIGUED/WEAK BUT NO OTHER ORIGINAL SYMPTOMS.
The vaccine was administered very high up, more in the shoulder than in the arm. When the needle went into my shoulder, there was great pain. Unlike any I've had with the 40 or so flu shots I've had in my lifetime. By the end of that day, I had pain from the shoulder and down my arm. In the next few days, severe pain, muscle weakness, very immobile (unable to lift my arm without extreme pain).