chrisvoncsefalvay/vaers-outcomes huggingface dataset:
in 2-7 days: 2 inch red spot, pain and burningin 8-17 days: 6 inch red spot, pain and burning.; in 2-7 days: 2 inch red spot, pain and burningin 8-17 days: 6 inch red spot, pain and burning.; in 2-7 days: 2 inch red spot, pain and burningin 8-17 days: 6 inch red spot, pain and burning.; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0153; Expiration Date: on an unspecified date in Jul2021), via an unspecified route of administration, administered in Arm Left on 06Apr2021 18:30 as dose 1, single for COVID-19 immunization (Age at vaccination was 48-year-old). The patient medical history included malignant Melanoma, Mitral valve prolapse and Scoliosis. The patient concomitant medications were not reported. It was reported that, she was not allergic to medications, food, or other products. She was not a pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications the patient received within 2 weeks of vaccination. She was not diagnosed with COVID-19 prior to vaccination and not tested with COVID-19 since the vaccination. On 08Apr2021 12:00, the patient experienced in 2-7 days: 2-inch red spot, pain and burning, in 8-17 days: 6-inch red spot, pain and burning. Her doctor prescribed allergy relief (Diphenhydramine hydrochloride) and Antibiotics which made the situation worse. Patient has visited emergency room as a result of events. Therapeutic measures were taken as a result of events include allergy relief (Diphenhydramine hydrochloride) and Antibiotics. The outcome of the events was not recovered.  No follow-up attempts are needed. Iinformation about lot/batch number cannot be obtained.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 18-SEP-2014 the patient was vaccinated with an expired dose of RECOMBIVAX HB INJ 10/1.0 micro-G/ml (reported as "MCRG/ML"), lot # J014312, expiration date: 07-SEP-2014, 1.0 ml, intramuscularly. No adverse event were reported. Additional information has been reported.
Being tired; Achy; Slight headache; Had a temperature of 100; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "Being tired"; PAIN (non-serious), outcome "recovered", described as "Achy"; HEADACHE (non-serious), outcome "unknown", described as "Slight headache"; BODY TEMPERATURE ABNORMAL (non-serious), outcome "unknown", described as "Had a temperature of 100". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: NDC number of Pfizer Covid-19 Vaccine was not provided. Investigation Assessment was not provided. Caller was unwilling to complete the report. Caller was discussing medical history when she mentioned family and friends. Caller stated that her kids and son-in-law and sister and friends got the Pfizer Covid-19 Vaccine too and got one day of being tired and achy and then bounced back to normal.   RA Communication: caller did not want to file a report.  She states that these people did not really have problems other than the expected things.  One had a slight headache, one was tired, one had a temperature of 100.  She has nothing really to speak of.  Caller does not distinguish which person had which symptom, and does not provide any additional identifiers.  No additional information provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hospitalization for Afib for 5 days. Weight loss, fatigue and inflamation lost 30 pounds within 8 weeks and was unable to make a fist with his hands because of swelling. Also swelling in his feet. Found difficulty to walk and stand.
His face is now 'puffy'.  The puffiness is in the frontal part of his face, part of forehead, eyelids and cheeks.; His face is now 'puffy'.  The puffiness is in the frontal part of his face, part of forehead, eyelids and cheeks.; raised red rash and slightly itchy; raised red rash and slightly itchy; rash on his face; possible bacterial infection; This is a spontaneous report from a contactable consumer (patient's wife). A 58-year-old male patient, also reported as 68-years-old, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 17Mar2021 (at the age of 58-years-old), and the second dose of BNT162B2 (lot number unknown) via an unspecified route of administration on 07Apr2021 (at the age of 58-years-old), as single doses for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter stated that her husband received the first dose of BNT162B2 on 17Mar2021 and the second dose on 07Apr2021 and approximately 5 to 6 days after the first dose of the vaccine, her husband developed a rash on his face, but it was mild. She reported that as time went by the rash had gotten worse; further stating he went to the doctor on 08Apr2021 the day after the second dose and was told it was a possible bacterial infection and prescribed erythromycin. The reporter stated that as of 13Apr2021 the rash was considerably worse, and his face was puffy. The puffiness was in the frontal part of his face, part of forehead, eyelids, and cheeks, and the rash was now a "full-blown rash," it was a raised red rash and slightly itchy. The reporter stated they had an appointment with the doctor that afternoon (as of 13Apr2021). The events were reported as non-serious. The clinical outcomes of rash on his face, possible bacterial infection, his face was puffy, the puffiness was in the frontal part of his face, part of forehead, eyelids and cheeks, raised red rash and slightly itchy were not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
pt seen by MD 2AUG93 presenting w/macular-papular rash on body; MD dx vax react to MMR; no medication prescribed; Aveno bath if needed;
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 03-AUG-2015, the patient was vaccinated with the first dose of GARDASIL (dose and route were not reported, lot #K011562, expiration date 04-APR-2017). On 09-OCT-2015, the patient was vaccinated with the second dose of GARDASIL (dose and route were not reported, lot #K011562, expiration date 04-APR-2017). On 12-JAN-2016, the patient was vaccinated with the third dose of GARDASIL (dose and route were not reported, lot #K010215, expiration date 05-MAY-2017). There was no adverse effect reported. Additional information has been requested.
This spontaneous report as received from a physician refers to a 4 month old patient of unknown gender. Concurrent conditions and medical history were not reported. The physician informed that on 08-APR-2015, the patient was inadvertently vaccinated with the first dose of ROTATEQ series, route defaulted to oral (batch/lot # and expiration date not reported). No adverse effect was reported. Additional information has been requested.
About 3.5 hours after the injection, my son was in too much pain to walk. He would not walk again for 3 days. He spiked a fever and had a rapid heart rate for 48 hours. He was hospitalized as it appeared as though he had an infection.
Immediately I experienced the feeling that I would pass out. I went to the dcotor the next day as I was off balance and could not walk. I had sharp pains in my head lasting 8 months. My heart has fluttered for the last nine months. This lead me to feel unwell and off balance.
Client received three vaccines this day- Tdap, MCV4 and HPV9. Client was very anxious. The HPV was administered last, and the client immediately experienced a brief seizure, lasting about a minute (?). The mother was also present. The client came out of the seizure without incident. We stayed with her, letting her regain herself, about 30 minutes. No vitals were taken. The client seemed fine, just unable to remember what happened. The mom was very frightened, she has a son that has epilepsy. Follow up phone call the next day- mom reports client is doing just fine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "POTS" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 14Feb2023, outcome "not recovered", COVID-19 (medically significant) with onset 14Feb2023, 12 days after the suspect product(s) administration, outcome "not recovered" and all described as "COVID 19 Treatment". First tested positive 14Feb and started Paxlovid that day until 19Feb, was isolating until then. Remained at home and masking. Wound up symptomatic 25Feb, tested negative twice that day on at home test and negative 26Feb on lab test. Continued feeling unwell. Tested on ay home test 03Mar and was positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Feb2023) Positive; (26Feb2023) Negative, notes: negative twice that day on at home test and negative; (03Mar2023) Positive, notes: home test; (07Mar2023) Positive, notes: home test. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 14Feb2023 to 19Feb2023..  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Flu like symptoms after 2nd Gardasil injection  10/21/08 Reviewed endocrine clinic records of 2/10/06-3/11/2008. FINAL DX: Hashimoto's thyroiditis, hypothyroidism, dysfunctional uterine bleeding, poor circulation in feet Records reveal patient experienced rapid weight gain, irregular periods, dysfunctional uterine bleeding.  Tx w/thyroxine replacement therapy (synthroid).  Dx w/Hashimoto's thyroiditis w/hypothyroidism 2/2006.  10/10/08 Reviewed OB/GYN notes of 1/11/06-8/26/2008. FINAL DX: goiter, dysfunctional uterine bleeding,  Records reveal thyroid enlarged.  Referred to endocrinologist.  4/19/07 parent called office w/reports of body aches, dizziness, chest congestion, HA starting after 2nd HPV vaccine on 4/7/07.  Improved w/NSAIDS.
chills; fever; came down with a cold; This is a spontaneous report from a contactable consumer (patient) reported himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 09Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) and dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) taken for an unspecified indication, start and stop date were not reported. Patient report that this was not from the first COVID shot, explaining that patient had chills and a fever for a couple of nights and a few things listed as the common side effects but otherwise no reaction other than those listed on the information. Patient reported that, patient came down with a cold and taking Nyquil day and night. Patient scheduled second dose of the vaccine on 30Mar2021. Patient wanted to know can still get the second shot and patient has come down with a cold and was wondering if patient can get the second dose with a cold because patient has been self dosing with Dayquil and Nyquil. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Chills x 3 days and then fever, emesis, diarrhea  and shortness of breath
Metallic taste in back of mouth Warm flushing sensation in chest Sensation of throat closing
erythema multiforme onset 5 /12 days p/MMR; treated w/DPH only;
Symptoms: "COVID Arm" - rash, redness, hives, itching, burning, hot to the touch - down entire left arm, up left side of neck, across chest and back, constant headache, nausea. Duration: 3 weeks
Information has been received from a registered nurse concerning a 6 year old female who on 04/27/1998 was vaccinated with varicella virus vaccine live. On 12/19/2001 the child presented to her physician who confirmed chickenpox. At the time of this report, the outcome of the event was unknown. Additional info has been requested. The nurse also reported that a 5 year old male developed chickenpox following vaccination with varicella virus vaccine live (WAES0112USA02311).
First dose Moderna under 5yr old dose second dose given Pfizer under 5 yrold dose mother advised will discuss with Pediatrician to get third dose as pfizer or moderna  Other children with mother all older than 5 got pfizer today other memers of family had without any side affects
light headed; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart disease" (unspecified if ongoing), notes: Verbatim: Heart disease. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "light headed"; FATIGUE (non-serious), outcome "unknown", described as "tired".  Additional information: It was reported that, the patient had received first dose of the Pfizer COVID 19 vaccine and was observed for 15 minutes and he felt fine. When patient went home then he started feeling light headed and tired.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported that his left arm began to hurt immediately following the injection and that this pain increased over time. On exam the day following the injection the patient was noted to have a softball sized red welt with a raised red ring around it. Patient had a temp of 100.3 at this time. No itching at the site. Patient was prescribed BENADRYL and triamcinolone topical ointment. Symptoms: SkinRash, Rash & UrticariaPruritus. Treatment: Diphenhydramine, Triamcinolone.
Information has been received from a health professional concerning a 25 month old female pt who on 01/25/02 was vaccinated in the left anterior thigh with a first dose of varicella virus vaccine live (Lot # 640119/0965L). The health professional reported the pt "now has chickenpox". The reporter indicated the time of onset is questionable, but reports that sometime between 03/14/03 and 03/16/03 small raised areas were first noticed, and were thought to be insect bites. At an office visit on 03/19/03 the pt had 25 lesions on her trunk and face in various stages. The reporter indicated no other symptoms were noted. The health professional reported the chickenpox resolved, and no further information is available.
Patient received her Tdap dose early, at 25 2/7 weeks, instead of >27 weeks. EDD is 10/21/17.
Excursion from the freezer/administered to 118 patients(08Nov2021- 14 given); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer/administered to 118 patients(08Nov2021- 14 given)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer/administered to 118 patients(08Nov2021- 14 given)). On 08-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer/administered to 118 patients(08Nov2021- 14 given)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-383410, MOD-2021-383422, MOD-2021-383426 (Patient Link).
Severe left sinus pain. Tylenol Sinus PE. Pain subsided after medication.  Also has itchy skin around elbows on both arms and on the face around the lips - started 9/25, negative SOB or difficulty breathing/swallowing. Zyrtec 10mg twice daily and Benadryl at night help relieve itchiness.
This spontaneous report as received from a Medical Assistant referring to an unknown number of patients of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. It was reported that on an unknown date, the patients may have received an unknown number of doses of PROQUAD strength, dose and route of administration were not provided (Lot # M034692 with expiration date of 24-JAN-2018) for prophylaxis. The doses of the vaccine were following a temperature excursion of 14-46 degrees Fahrenheit for 63 hours. No adverse effects were reported in any patients. No product quality complaint was involved. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA007384.
Got a severe rash from my arm and my groin and all on my left side 4 days now very itchy and painfull; Hot flushes; Got a severe rash from my arm and my groin and all on my left side 4 days now very itchy and painfull; Severe diarrhea; Got a severe rash from my arm and my groin and all on my left side 4 days now very itchy and painfull; Dull headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Got a severe rash from my arm and my groin and all on my left side 4 days now very itchy and painfull), HOT FLUSH (Hot flushes), PAIN (Got a severe rash from my arm and my groin and all on my left side 4 days now very itchy and painfull), DIARRHOEA (Severe diarrhea) and RASH (Got a severe rash from my arm and my groin and all on my left side 4 days now very itchy and painfull) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PRURITUS (Got a severe rash from my arm and my groin and all on my left side 4 days now very itchy and painfull), HOT FLUSH (Hot flushes), PAIN (Got a severe rash from my arm and my groin and all on my left side 4 days now very itchy and painfull), DIARRHOEA (Severe diarrhea), RASH (Got a severe rash from my arm and my groin and all on my left side 4 days now very itchy and painfull) and HEADACHE (Dull headache). At the time of the report, PRURITUS (Got a severe rash from my arm and my groin and all on my left side 4 days now very itchy and painfull), HOT FLUSH (Hot flushes), PAIN (Got a severe rash from my arm and my groin and all on my left side 4 days now very itchy and painfull), DIARRHOEA (Severe diarrhea), RASH (Got a severe rash from my arm and my groin and all on my left side 4 days now very itchy and painfull) and HEADACHE (Dull headache) 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 provided.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Follow up information was received on 24 Apr 2021: included no new information and declined further follow up.
57 years old male with a PMH significant for hearing loss, T2DM, HTN who was sent to hospital on 10/10/2022 from an office visit at hospital with a chief complaint of diffuse abdominal pain of 4 weeks of duration. All communication was assisted by sign language interpreter. On 10/12/2022, he reported his abdominal pain has improved and he was able to eat and drink. AKI has improved and electrolytes were repleted. ID recommended monitoring symptoms as he has a mild case with no symptoms.
About 24 hours after receiving my vaccine, I developed a cough. After another 24 hours it turned into a severe cough and I started to experience a fever as well. When I woke up the following morning, I lost my voice. I sought care on 12/07/21, and was given an antibiotic and cough suppressant syrup. I was diagnosed laryngitis. I got my voice back around 12/07 and am still experiencing a lingering cough. My voice does go away still at times.
This case was reported by a physician via call center representative and described the occurrence of chills in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 2nd January 2019 10:00, the patient received the 1st dose of SHINGRIX. On 2nd January 2019, 7 hrs after receiving SHINGRIX, the patient experienced chills, headache, tachycardia, blood pressure high, heart rate increased and coronary artery disease. The patient was treated with amlodipine. On an unknown date, the outcome of the chills, headache, tachycardia, blood pressure high and heart rate increased were not recovered/not resolved and the outcome of the coronary artery disease was unknown. It was unknown if the reporter considered the chills, headache, tachycardia, blood pressure high, heart rate increased and coronary artery disease to be related to SHINGRIX. Additional details were provided as follows: On 2nd January 2019 at around 10 am, the patient had received his dose of SHINGRIX. The patient was fine until 5 or 6 o clock when he developed chills, shivering, headache, tachycardia and high blood pressure. The patient went to sleep at 5 or 6 in the morning due to the tachycardia. On 2nd January 2019, the patient's heart rate was normal 50 to 55 when he wokes up in the morning and it went up to 90 to 100 at night. Upon escalation, the patient stated that he took half amlodipine dose and drank fluids to treat symptoms. The patient took amlodipine for mild coronary artery disease. After collection of demographics the patient told that he was also a neurologist and said that safety could follow up with him directly.
I had the chills to the points that I could not stop shaking. Became very tired and could not stay awake so I had to get into bed at 9:30 whereas I normally retire at 1200 a.m. I could not get my breath and was panting and gasping for air. This lasted until 1100a.m. the next morning and I gradually regained my breath back. It  was a very scary , horrible experience.