chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: No reaction reported after 1st Pfizer COVID-19 vaccine dose. Received 2nd dose on 3/23/21, about 10 hours following second Pfizer COVID-19 dose patient facial swelling around his lower jaw area and right hand. Patient reported to the ED the following morning on 3/24/21 and states he has developed lumps over his bilateral hands, back of his head, and buttock. No urticaria, wheezing, or edema of the tongue or OP. Treated with IV Benadryl, steroids, and pepcid with improvement of his symptoms. He was observed for 4 hours in the ED without progression of allergic reaction. Returned to ED 4 days later on 3/28/21 complaining of pruritic rash on scalp and back of neck.  Symptoms: Angioedema, Rash & UrticariaPruritus Treatment: DIPHENHYDRAMINE, FAMOTIDINE, METHYLPREDNISOLONE
Shortly after injection, she became light headed with nausea, lip tingling, SOB and felt as if throat was closing.  Moved her to the ER where she was given EPI, Benadryl, Pepcid, Steroids, and Zofran Was later discharged home
anaphylactic reaction; Latex allergy; This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a child male patient who received DTPa-IPV (Kinrix) (batch number AC20B204AA, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, unknown after receiving Kinrix, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and latex allergy. On an unknown date, the outcome of the anaphylactic reaction and latex allergy were unknown.   It was unknown if the reporter considered the anaphylactic reaction and latex allergy to be related to Kinrix.  Additional information was provided as follows: The age at vaccination was not reported, however the patient's age could be 4 or 5 years old. The patient received Kinrix in 2013 and experienced anaphylactic shock. The patient had since been diagnosed with latex allergy. The reporter did not have expiration date of Kinrix. The reporter consented for follow up.
This spontaneous report as received from a certified medical assistant refers to four patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot# M025870, expiry date 24-MAY-2018; exact dose and route of administration were not reported), reconstituted with properly stored sterile diluent (MRK). The doses of the vaccine were exposed to a temperature excursion of 6 to 14 degrees Fahrenheit for a time frame of 6 hours, on an unspecified date. There were no previous temperature excursions. A Digital Data Logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA011270.
COVID 19 Treatment; COVID 19 Treatment; dose #1: Moderna/ dose #2: Moderna / dose #3: Moderna / dose #4 Pfizer / dose #5 Moderna Bivalent; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 20Sep2022 as dose 5 (booster), single (Lot number: AS715B), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Jan2021 as dose 1, single (Lot number: 030L20A), in left arm, on 17Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 04Nov2021 as dose 3 (booster), single (Lot number: 026021A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN, start date: Jan2010, stop date: 09Dec2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Apr2022, outcome "unknown", described as "dose #1: Moderna/ dose #2: Moderna / dose #3: Moderna / dose #4 Pfizer / dose #5 Moderna Bivalent"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Dec2022) strongly positive, notes: rapid antigen covid test; (16Dec2022) still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies and other medical history was None. Other medication in 2 weeks  was reported as Yes. Anti viral details was mentioned as Paxlovid, treatment start date as 10Dec2022, and treatment stop date as 07Dec2022, indication reported as Treatment of COVID-19. Sore throat and strongly positive rapid antigen covid test 4 days after completing 5 days of Paxlovid. Still testing positive with mild congestion five days later.
This spontaneous report as received from nurse refers to a patient of unknown age. The patient was administered intramuscularly the three doses in the GARDASIL vaccination schedule on 21-OCT-2011; 21-NOV-2011 and 20-FEB-2012 respectively. The outcome was unknown. It was unknown if the patient had sought medical attention. No adverse effect reported. Additional information has been requested.
Pt received dose of vaccine and duing observation period c/o floaters.  Taken to stretcher. Vital signs taken. BP 165/97 HR 77 SPO2 99 RR 18 Resolved after resting and drinking apple juice. Able to ambulate without issue.  Informed to follow up with PCP and eye doctor.
This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. The patient's relevant medical history was unknown. On 05-SEP-2013, the patient was vaccinated with ZOSTAVAX in an unknown arm (route, indication, dose and lot number were not provided). No concomitant medications were reported. On 07-SEP-2013, 3 days after onset of therapy the patient went into the pharmacy with an approximate 3 inch by 6 inch area at the injection site that was red, itching, and warm to the touch (started on approximately 05-SEP-2013). No laboratory data was provided. The outcome of an approximate 3 inch by 6 inch area at the injection site that was red, itching and warm to the touch was reported as not recovered. The causality between the events and the suspect product was unknown. Additional information has been requested.
Around 2 PM, donor stated that he noticed an area on his face approximately 2 inches in size that looked like blemishes, redness noted, and sensitive to touch.  Within a couple hours donor stated that no more symptoms present, completely recovered.
Discovered to be asymptomatic COVID-19 positive 10/25/2021.
*Throat tightness                                      Treated w/  0.3 ml of EPi *Chest tightness                                                         25 mg of benedryl *warm sensation                                                        10 mg of Decadron *Tingling                                                                   taken to ER by EMS *Lightheadedness
Information has been received from a physician concerning a female who on unspecified date was vaccinated with Gardasil and experienced severe pain at the injection site. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
mom notes high pitched screaming evening p/vax on/off x several hrs single episode of emesis episode of child screaming w/eyes up in head, lips blue, "not breathing" only last 10 sec crying immed;
My arm swelled substantially, first all around the injection site, and then gradually all the way down my arm to my wrist.  My arm seemed to get larger every day as the swelling crept down my arm.  After a week, it began to subside and did so gradually over the course of several days.  I used ice packs wrapped around my arm to attempt to reduce the swelling and took a couple of Benedryl.  I told the pharmacist the next time I was at the store.
Fever of 101, red face, rash all over body, muscle aches, lack of energy, fatigue.  Treated with Prednisone for rash. The rash is a little better. No fever.
Broke out in welts on back, thought to be pityriasis. Very itchy. Given hydroxyzine (can't recall dosage) seemed to help. Had a second outbreak on (approximate) first of Feb 2018. This time not just on back.  It was on basically all over my body. Received hydroxyzine in 25mg -3 times a day and one other medicine, pills. Meds didn't seem to work as itching seem to intensify. Bought over the counter GOLD BOND anti itch and CALADRYL. Helped a little. Itching was so bad I scratched until I bled. Have sores on body. Feb 7, 2018 returned to clinic and received Prednisone 20mg and Acyclovir 800mg to take and see if it helps relieve the itching. Also a cream was prescribed but wasn't in and will be mailed to me.
no additional AE reported; VARIVAX had a temperature excursion on 10-OCT-2020 and was administered; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 10-OCT-2020, varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T002846, expiration date reported as 22-JAN-2022, but upon internal validation established as 23-JAN-2022; strength was not reported) was improperly stored under minus 14 degree Celsius (C) to minus 10 degree Celsius (minus 14.3 C) for 1 hour and 15 minutes, and then under minus 9 degree Celsius to 8 degree Celsius (minus 9.3 C) for 32 minutes, as recorded by digital data logger. There was no previous temperature excursion.   On 12-OCT-2020, the patient was vaccinated with the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, route and frequency were unknown) for prophylaxis. No additional adverse event (AE) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA007244:
TINNITUS; CHILLS; HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included hypertension, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095,  expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced fever. On 13-MAY-2021, the subject experienced fatigue. On 14-MAY-2021, the subject experienced chills. On 14-MAY-2021, the subject experienced headache. On 19-MAY-2021, the subject experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, and fever on 18-MAY-2021, and fatigue on 21-JUN-2021, and had not recovered from tinnitus. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
First day after does I felt fine. A little soreness at injection site. But overall fine. Did yard work all weekend kind Sat and Sunday. Went to work on Monday was fine. Came home did peloton 45 min and then did more yard work with my husband.  That night I became extremely sore and tired went to bed at 9 pm.  That next day would be Tuesday the 19th I was tired all morning very low energy.  Then by 130pm it hit me like a ton of bricks, extreme fatigue and chills. Drove myself home, almost did not think I could drive the entire way  home ( about a 20 min ride). Made it home went straight to bed, body ache, chills, fever101.6 and smashing headache. Called out of work for Wed Jan 20th. I am an RN at an outpatient orthopedic facility. I have not missed a work day in 9 years. I exercise 6-7 days per week. I am never sick! I continue to run fever until Thursday pm.  No fever on Friday the  22nd. Just continue with extreme fatigue, smashing headache and dizziness. I decide by Sunday January 24th to go get tested for COVID  and did a rapid test and it came back negative.  I was told to report my adverse reaction. Today I feel better, first day I have not woken up with a headache. Have developed a slight headache not as bad.  Continue with the fatigue.  I would like to report this and have someone contact me. I do not know what to do about the second does! This has hit me so hard. Thank you!
Bruising; Redness in the band aid area; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruising) and ERYTHEMA (Redness in the band aid area) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced ERYTHEMA (Redness in the band aid area). On 30-Mar-2021, the patient experienced CONTUSION (Bruising). At the time of the report, CONTUSION (Bruising) was resolving and ERYTHEMA (Redness in the band aid area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a 60-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th January 2020). On 13th March 2018 09:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th March 2018, less than an hour after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovering/resolving and the outcome of the injection site warmth was unknown. The reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The reporter had a patient that received the SHINGRIX vaccine on right deltoid and experienced redness, swelling, and heat at the injection site within 30 minutes of the vaccination. The patient returned to the office on 15th March 2018 and described that the redness and swelling were resolving. The field representative was unable to provide additional details.
Muscle aches; chills; Fever; headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER 8730), via an unspecified route of administration in the right arm on 20Mar2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included stomach issues, arthritis, asthma and penicillin allergy. Concomitant medications included Omeprazole (MANUFACTURER: UNKNOWN) received within 2 weeks of medication as acid reducer from an unknown date. The Patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EK5730) via an unspecified route of administration in the right arm on 27Feb2021 at 14:00 as a single dose for Covid-19 immunisation. The patient did not receive any other vaccines within four 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 On 21Mar2021 at 14:00, the patient experienced Muscle aches, chills, headache, fatigue and fever (101.8) started about 12 hours after the shot (during the night), fever went down with tylenol followed by next day 99.9 on second night slept all day. Therapeutic measures were taken as a result of fever and included treatment with tylenol. The clinical outcome of the Muscle aches, chills, headache, fatigue and fever was recovering.   No follow-up attempts are needed. No further information is expected.
Dizziness episode with almost fainting that lasted about 10 minutes. Happened day after vaccine and then again 3 days after vaccine. nausea was present but not enough to vomit. Slight vertigo still present days after
chest cold; Bad sinus; Sore from head to toe; A spontaneous report was received from a consumer concerning a 65-Year-old, male patient was participating in the mRNA-1273 Emergency Use Program and experienced bad sinus, chest cold  and had felt sore from head to toe.  The patient reporter included no information about allergies, historical or current conditions. No relevant concomitant medications were reported.   On 18 Feb 2021, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced Lower Respiratory Tract Infection (chest cold), Sinus Disorder (bad sinus) and Pain (sore from head to toe). The seriousness criteria for these event is considered to be Medically important. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded.
Severe migranous headache with vertigo, nausea and vomiting 3 hours after GARDASIL injection. Improved with rest in dark room and Ibuprofen; She does admit to similar headache in past on 2 occasion in last 2 years. This was more severe
Angioedema LUMP IN THROAT Narrative:  WAS GIVEN AN EPI PEN AND TRANSPRTED TO A LOCAL ER WHERE SHE RECEIVED IV BENEDRYL AND STEROIDS
expired dose; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On 28-Jul-2021, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
pt recv vax & exp sz w/in 24-48 hr, associated w/fever & lasting 5min;pt went to have mult & recurrent sz;
Maculopapular rash to face, neck, and upper back for 2 weeks.
10-30-2009 states felt pain in legs on left side that has progressed to hands, today she has difficulty talking and has some numbness in the right foot. Is under case of Dr and will have MRI and appt with a neurologist. Headache and fever that occurred 1 week ago.  11/24/09 Medical records received for date 11/21/09 to 11/23/09. DX: back pain. Presenting c/o back pain, left leg pain/numbness/weakness, fever, since 10/29/09. MRI and xray (+) herniation, degenerative disc and stenosis. 11/30/09 ER records received for date 11/16/09. DX: low back pain.  Pt presented with lower back pain x3 days. Diag. ordered.
Patient had fluzone on 10/19/02. Presented to urgent care on 10/21/02 with left arm swelling and redness radiating up left side of neck. Swollen glands in neck.
Chest pain developed a couple days after getting first dose and occured multiple times after that over a course of a few days
Tightening of chest/difficulty breathing . Broke out in hives on upper arms and arm pits.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included spinal laminectomy (level 3, carried out one month ago with cadaver grafting). Previously administered products included Acetaminophen. On 9th October 2018, the patient received the 1st dose of SHINGRIX. On 9th October 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. In October 2018, the patient experienced fever, chills, headache, nausea and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, fever, chills, headache, nausea and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site pain, fever, chills, headache, nausea and injected limb mobility decreased to be related to SHINGRIX. Additional information was reported as follows: The patient was a family nurse practitioner. The patient stated that she was a vaccine champion at her clinic. One day before the date of reporting, the patient was vaccinated with SHINGRIX. She explained it was ridiculously painful and it hurt while vaccination and became worse the next day following it. The patient stated that she did not mind for the events fever, chills, headache and nausea but could barely move her arm and it throbbed constantly. One month before the date of reporting, the patient had level 3 cervical laminectomy with cadaver grafting, she required no pain medications other than Acetaminophen a few times post operation. The patient was dreading to get her second dose of SHINGRIX and wondered how she should possibly recommend the vaccine to her 92-year-old mother and her elderly patients. The patient stated that she knew that she was not the first to report this but had to say something, as the pain was unacceptably painful. The patient stated that her co-workers found it to be the same experience about SHINGRIX as that of the patient.
Pt is 31 yo female, s/p full Moderna COVID vaccination: dose 1 on 1/4 and dose 2 on 2/4. Pt is an employee of this institution. On 8/9, reports new onset fever, chills, cough, fatigue, muscle/body aches, loss of taste/smell, congestion/runny nose, and nausea/vomiting. Confirms possible exposure to COVID-19 positive person. Given prescription for bezonatate for cough.
Seven days after the first dose of the Moderna vaccine, I got a rash on the upper part of my arm around the injection site.  Itching and burning,
1st dose on November 2, 2022 - headache, body ache, fever - body aches lasted about 4 days but eased up each day. 2nd dose on January 1, 2023 - headache, body ache, fever, chills...this is just 24 hours after so we will see how long it lasts...