chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; diarrhea; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (FIRST BOOSTER DOSE; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  Additional information: The BNT162b2 was also reported as second booster dose. The physician thought the event might have been related to the drug.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
The day after the vaccine 9/8/2021, I started having uterine cramping and spotting. This lasted 18 days. I then went into having my period. It was worse and heavier than normal. It also lasted longer than usual. I went to my GYN who recommended an ultrasound. I did that yesterday 10/7/2021 and am awaiting results.
Information has been received from a woman concerning her husband who on 11/05/00 was vaccinated and on 11/05/00 post vaccination he developed a temperature of 102 and bronchitis. She stated that on 11/06/00 her husband's temperature went to 104 and he was experiencing chills. Additional information has been requested.
A few hours after the vaccination I started to feel dizzy and my mouth started to feel strange.  It continually got worse and around 5pm I was having a hard time swallowing and it kept getting worse.  I felt like i was choking.  I could breath fine and speak the whole time. Due to the later hour i went to the ER where after examine gave epinefrin.  The Dr examined my throat by eye and x-ray.  He saw no signs of swelling.  He hypothesized this was an anxiety reaction as none of the symptoms indicated allergic reaction
3/24/10 one day after immunization - Rash on back, neck, face with itching. Dx: Dermatitis - Tx: PRELONE syrup 15 mg/5ml PO 3.75 ml 1 time a day for 5 days; Hydrochloride 10 mg/5 ml PO 4 x day 10 days. 3/31/10 Pt seen in ER for rash. 4/1/10 Rash - Tx: PEDIAPRED liquid, sodium phosphate 5 mg/5 ml 10 ml 1 time a day 4 days.
Bell's palsy; This initial spontaneous report was received on 11-DEC-2020 from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by a physician for: Bell's palsy. The outcome of the event was not provided. Therefore, the causality for the events was related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of Bell's palsy was considered to be medically significant.
Major depressive episode, severe arm soreness at injection site, redness and swelling at injection site, fever, chills, fatigue, headache, muscle aches.
Nausea, vomiting, bodyache, chills, fatigue, abdominal pain
Hot to the touch Injection Site; Itchy Injection Site; Swollen Injection Site; Red Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Hot to the touch Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site), INJECTION SITE SWELLING (Swollen Injection Site) and INJECTION SITE ERYTHEMA (Red Injection Site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE WARMTH (Hot to the touch Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site), INJECTION SITE SWELLING (Swollen Injection Site) and INJECTION SITE ERYTHEMA (Red Injection Site). At the time of the report, INJECTION SITE WARMTH (Hot to the touch Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site), INJECTION SITE SWELLING (Swollen Injection Site) and INJECTION SITE ERYTHEMA (Red Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up information was received from initial reporter: Event outcome updated and the reporter declined for a follow-up.
Treatment of COVID-19; 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 70-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: other medical history: Hypertension. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Apprx 45 minutes after receiving this vaccine pt reports throat tightness; slight lightheadedness & slight dizziness.  Pt was monitored for 30 minutes post vaccination d/t her allergy Hx. Pt took OTC non drowsy antihistamine for these s/sx.  PCP notified.
rare RYR1 myopathy; Being a congenital myopathy it is slowly progressive but it seems that the 3rd vaccine has accelerated this process to rapidly progressive; became very unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RYR1 myopathy" (ongoing), notes: congenital condition. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, I received all three Pfizer mRNA vaccines., I had no reactions or side effects with the first two), for COVID-19 immunization; Bnt162b2 (Dose 2, I received all three Pfizer mRNA vaccines., I had no reactions or side effects with the first two), for COVID-19 immunization. The following information was reported: MYOPATHY (medically significant), outcome "unknown", described as "rare RYR1 myopathy"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "Being a congenital myopathy it is slowly progressive but it seems that the 3rd vaccine has accelerated this process to rapidly progressive"; MALAISE (non-serious), outcome "unknown", described as "became very unwell".   Clinical course: The patient received all three Pfizer mRNA vaccines. The had no reactions or side effects with the first two but unfortunately became very unwell after the 3rd. After 9 months of deterioration the patient was finally diagnosed with a rare RYR1 myopathy. It is a congenital missense gene mutation which results in a substitution of an amino acid. This then has an effect on the protein that is produced from the chain of amino acids. Being a congenital myopathy it is slowly progressive but it seems that the 3rd vaccine has accelerated this process to rapidly progressive. As you are an expert on these vaccines patient wanted to hear your opinion. Is it possible that the vaccine could have provoked a reaction in patient's skeletal muscle condition and interfered with the misfolded protein caused by substituted amino acid: The gene mutation patient have was very rare and has only been recorded in 4 other people worldwide. Patient was sure it is impossible to cover such a rare eventuality in your clinical trials as little is know about these rare RYR1 missense variants. There are no FDA approved treatments for patient's condition or a cure but if patient had the chance to at least return to the way things were prior to the 3rd vaccine, patient would jump at that. Any information that may help me would be very gratefully received.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Ached all over - myalgias, fatigue, malaise, lethargic, cold, lightheaded, diaphoresis (head), frontal headache, cough. Pain at injection site (L) deltoid. Lasted 4-5 days. Tx - rest, acetaminophen.
Pt's husband claims approx. 3 hours post immunization, pt suffered pain in head, N/V; taken to ER via ambulance; 3 day admission; possible renal problems; inconclusive.
pt recv vax & exp gen rash;the nurse reported a total of 6 patients w/the same exp;
Swollen lymph nodes near her clavicle on the same side as the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes near her clavicle on the same side as the vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes near her clavicle on the same side as the vaccine). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes near her clavicle on the same side as the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Mom reports babe developed hoarseness, difficulty swallowing, irreg. breathing - occurring evening of day of vaccination lasting until midnight - called PCP, no tx indicated. Mom states reaction to polio.
develop hives on my inner thighs, wrists, mid abdominal area, chest, and lower legs. Hives were itchy and raised; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162HNMC) via an unspecified route of administration in the left arm on 14Apr2021 at 14:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's thyroiditis and covid-19.  Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN), both from an unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination. On 14Dec2020, the patient underwent COVID-19 test and the result was positive. On 06Jan2021, the patient underwent COVID-19 test and the result was negative. On 16Apr2021 at 02:00, around 36-48 hours after vaccination, the patient started to develop hives on his inner thighs, wrists, mid abdominal area, chest, and lower legs. Hives were itchy and raised - none apparatus near injection area on arm. No previous history of any allergic reactions to vaccines or otherwise. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event hives was recovering.  No follow-up attempts are needed. No further information is expected
I had two adverse reactions: 1) pain at injection site and fatigue starting the evening of the vaccination, lasting 2 days  2) on day 7 in the evening, my upper right arm started to itch.  The next morning, there was a large, red, hard area of swelling at the injection site that itched and was very sensitive.  This lasted 2-3 days, gradually fading and becoming less sensitive.  I've learned this is a reaction called "Covid arm."
5/6/22: 30 minutes after injection: chills & nausea.  One month intervals 6/?/22, 7/16/22, 8/30/22: chills & nausea.  Treatment: absolute immobility.
The patient presented back to the pharmacy 2 days after receiving a flu & pneumonia shot. He complained of redness & swelling near the injection site and chills and fatigue suggested treatment was to ice the area and return to pharmacy if not resolved in 2 days.
Full body rash, redness, swelling.  Facial swelling.  Irritability.  Started in the evening.  Patient treated with oral steroids and antihistamines
At 10 pm last night I blacked out while in the bathroom at my home. I had finished urinating, flushed my toilet and blacked out. The last thing I remember was the feeling of falling forward. I woke up sometime between 10 seconds to 2 minutes later feeling exceptionally dizzy and tired. I?ve never had any event happen like this before and was not under the influence of drugs or alcohol. Today I am still feeling slightly dizzy and not quite right.
p/vax pt devel bilious emesis,lethargy,currant blood stools; abdominal x-ray+; barium enema confirmed Dx intussusception + reduced successfully barium enema x3;
After 2nd HPV vaccine patient reported feeling fine for 6 hours, then got excessively sleepy for 2 weeks after and had swollen arm with a large hard lump the size of a golf ball at vaccine admin stie.  At least 1 week after had episodes of feeling faint, dizzy, and shortness of breath.  Felt light-headed and jittery for 2 weeks thereafter.  Self-treated with hot compresses on vaccine site and benadryl.
10 days after receiving the Janssen vaccine, patient experienced extreme / debilitating fatigue, muscle soreness, stiff joints that lasted 72 hours.  At the same time as the fatigue onset, a severe rash with inflamed welts and blood-filled blisters covering torso and abdomen - front and back also appeared.  The rash was severe for 3 days and slowly subsided; scars still visible today - red dots.
Low grade fever, 100.4, started 12-1-08 lasting 36 hrs.  "Injection site reddened and raised, half dollar size" per mother.  Painful to move arm.
Pt recv vax on 11/5/98; on 11/6/98 pt exp upper arm, hips, calf muscle ache, unable to sleep, unable to raise hands above head without pain
Mom called in at 3:41pm on 7/6/2020 and said pt was covered in a red, bumpy rash all over his body. The rash was not bothersome and there were no other symptoms. Advised mom to monitor patient and administer benadryl as directed. If symptoms worsened, patient would need to be taken to the ER for evaluation.
Patient called and described a red rash that developed around injection site. The rash was described as red, itchy, and hot. The rash was not severe and subsided quickly.
This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On 13-NOV-2014 the patient was administered improperly stored PROQUAD, .5 ml, subcutaneous (lot # and expiry date unknown). No adverse effects were reported. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with PROQUAD. This case is related to MARRS# 1411USA004937. Additional information has been requested.
Patient is 17 years old and was given a booster when boosters are only approved for those 18 years and older. On 11/23/21 when the error was discovered we contacted the patient's father and informed him of the error. The patient was fine at the time of this call. A follow up call was conducted on 11/26/21 and the father reported that his son was still feeling fine and no adverse events to report.
MOTHER CALLED OFFICE  AT  2:00PM REPORTED PATIENT HAVING  PURPLE LIP AND SWOLLEN LIP  IN CAR AND DIZZYNESS . AFTER LEAVING OFFICE  TOOK A NAP  AT HOME AND WOKE UP VOMITTING .   INSTURCTED PATIENT TO GO TO ER.
This spontaneous report as received from a physician refers to 2 patients of unknown gender and age. On an unknown date the patients were vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route not reported). On an unknown date the patients were diagnosed with zoster. At the time of reporting, the outcome of zoster was unknown. Additional information has been requested.
Information has been received from a physician concerning a male consumer who on an unspecified date was vaccinated with a dose of 0.65 mL of zoster vaccine live (Oka/Merck). Subsequently, the patient developed a mild outbreak of shingles. The patient was seen by the physician, it was unspecified if lab studies were performed. The patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested.
Dull Headache; Itchy hives /tchy hives which started on her right arm and expanded to her right hand and right shoulder; Itchy hives and rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Itchy hives /tchy hives which started on her right arm and expanded to her right hand and right shoulder) and RASH PRURITIC (Itchy hives and rash) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced URTICARIA (Itchy hives /tchy hives which started on her right arm and expanded to her right hand and right shoulder) (seriousness criterion medically significant) and RASH PRURITIC (Itchy hives and rash) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Dull Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (Itchy hives /tchy hives which started on her right arm and expanded to her right hand and right shoulder), RASH PRURITIC (Itchy hives and rash) and HEADACHE (Dull Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. 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.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Additional information included Patient demographics updated, Suspect product details updated, treatment medications added, Additional events and seriousness criteria added. Reporter address and phone number updated.; Sender'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.
Significant swelling of lymph nodes in arm that received injection. Whole body swelling including face, lethargy and muscle aches. Very painful armpit, treated with warm/cold compress. Missed day of work.
This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) and IMMUNODEFICIENCY (Immunocompromised) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) and IMMUNODEFICIENCY (Immunocompromised). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and CELECOXIB (CELEBREX) for Pain, at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) and IMMUNODEFICIENCY (Immunocompromised) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Three weeks after the first shot felt strange, and took Advil and felt better. About 4 months after vaccination, patient was diagnosed with Polymyalgia rheumatica. Patient had already started taking Celebrex after vaccination, but it did not alleviate the pain and inflammation. The doctor stopped the Celebrex and gave him Prednisone. The doctor told him to go ahead and take a third shot. Patient has not received a third shot yet. Reported immunocompromise due to Prednisone treatment. This case was linked to MOD-2021-313578 (Patient Link).; Sender'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. Events Polymyalgia rheumatica and immunodeficiency were automatically upgraded as a Serious event as per IME list. However, based on information available and as per medical criteria was classified as Non-serious.
This spontaneous report as received from a medical assistant via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported). The reporter stated that on an unknown date the patient because nauseous and dizzy after administration of GARDASIL. The outcome of nauseous and dizzy and relatedness between reported adverse events and GARDASIL were not reported. Additional information has been requested.
Soreness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M220A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness in the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.