chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in heart area; Can't walk or get out of bed; Headache; Fingers hurt; Occasional tight band around chest; Severe muscle pain throughout the body; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 29Apr2021 (at the age of 74 years old) (Lot Number: EN727, unknown expiration) as 1st dose, single for COVID-19 immunization.  Medical history included penicillin allergy and diagnosed with COVID-19 (prior to vaccination, was the patient diagnosed with COVID-19: Yes).  The patient's concomitant medications were not reported.  The patient previously took codeine and experienced codeine allergy.  The patient experienced can't walk or get out of bed, headache, fingers hurt, severe muscle pain throughout the body, occasional tight band around chest, and sometimes pain in heart area on 30Apr2021. The patient did not received treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The patient had not yet recovered from the events.   Information on Lot/Batch number was available. Additional information has been requested.
Injection site reaction, swelling and inflammation running length of inside of arm/along inner forearm to wrist/hand, feeling of pins and needles, flu-like symptoms.
patient got first dose on 25Feb2021 and still has not gotten second dose.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got first dose on 25Feb2021 and still has not gotten second dose.) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got first dose on 25Feb2021 and still has not gotten second dose.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got first dose on 25Feb2021 and still has not gotten second dose.) had resolved. Not Provided
Sore arm at site immediately after injection, moderate abnormal fatigue approximately 2 hours before bedtime, right side neck pain, right side wrist pain. Following day: all joints hurt, neck lymph swollen, mild raspy breathing chest congestion, no appetite, fatigue, malaise, sensitivity to sounds, sensitivity to cold. Uncomfortable. Don't want to move. Just want to lie down.
pt recv vax & pt devel a rash w/papules on the bad & bilat antecubital & popliteal areas;pt recovered;
pt recv vax 2DEC97 & on 16DEC97 pt devel poss chickenpox, with one lesions behind ear & three to four in diaper area;pt also been cranky for couple of days;no fever was detected;
Swelling in throat mild, itchy, and a little nausea,  lasted until she took Benadryl.
I lost about 15 pounds in the last eight weeks. I went to the doctor last Friday for that. They did testing for that.  I got a little runny nose, then I start to cough and then I start vomiting. I have been having those for quite awhile. It will be a dry heave or snot or what's been in my stomach overnight. I am throwing up food sometimes after I eat or I just don't want to eat. Loss of appetite.  I think I had those symptoms for about two months. I am starting to get my appetite back now. They have done a bunch of bloodwork for that to find out what's going on. I had a Teledoc appt for the cold. I had to get back to my primary doctor and they did the testing first and then I'll see the doctor.
Employee had syncopal episodes times 2 - she reported she has vaso-vagal syndrome with injections. Employee called to report that after she returned to work she had nausea and vomiting times 2 and left work because of this - she also reported feeling weakness all over.
Painful red rash, minimal raising, extending distally and medially from point of injection, progressed over 2 days after 2nd vaccine, has not progressed any further today.  Did not improve with additional Zyrtec dose. Pain improved with ibuprofen. Limited changes with topical steroids.
fever; chills; shaking; Headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 13th January 2021 11:00, the patient received the 2nd dose of Shingrix. On 13th January 2021, 10 hrs after receiving Shingrix, the patient experienced fever, chills, shaking and headache. On 14th January 2021, the outcome of the fever, chills, shaking and headache were recovered/resolved.   It was unknown if the reporter considered the fever, chills, shaking and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was patient herself. The patient about 10 hours later of vaccination, began to get a fever, chills, shaking and a headache. The patient reported that going to bed and the adverse effects were resolved about 8 hours later when she awoke. The reporter did not consent to follow-up.
This spontaneous report as received from a healthcare worker refers to an approximately 3 year old male patient. The pertinent medical history was not reported. On 09-FEB-2015 (also reported as yesterday) the patient was vaccinated with improperly stored VARIVAX (Merck) dose 1, 0.5 ml, subcutaneously in the right thigh. No adverse effect was reported. Additional information is not expected.
Extreme chills with intense shivering.  Followed the next morning with extreme weakness so couldn't walk without help using walker. Unable to get out of chair. Weakness lasted all day after shot day till mid day of second day after shot.
Day of vaccinations: Excessive crying for hours with none of the usual comfort measures working, fever rising, would not sleep if set down. Day 2: Diarrhea, fever of 102, and excessive crying, Nursing more than usual. Day 3, Diarrhea and fussiness more than usual, still nursing more than usual. Currently on day 3.
Pt reported hives w/ facial swelling ~4hrs post vaccination.  Pt took benadryl.  Pt reported the reaction on 9/22 when the patient presented for her 2nd dose.  Pt was administered Janssen on 9/22 due to allergy. No further information available to this writer.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. No vial went any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Significant FU appended contains Second reporter Information is updated.
Initial report received from a non-healthcare professional on 22 September 2013. A 79-year-old female patient had received an intramuscular 0.5 ml dose of FLUZONE HD (Lot Number: U4761AA, Exp. Date: 03 May 2014) in the left deltoid on 21 September 2013 at 10:30 hours. The patient had history of stable hypertension, stable glaucoma and has a pacemaker since 12 Nov 2012 for left bundle branch block. the patient had received influenza vaccine every year and previously had the high-dose vaccine. The patient had not a similar event after any previous influenza vaccine. The patient was taking Amlodipine/Benazepril 2.5 mg - 10 mg. 1 Capsule qd hs; Metoprolol ER 25 Mg 1 po qd; Triam/HCTZ 37.5 / 25 mg 1 po qd; KLOR-CON M 20, 20 Meq - 1 tab every other day and 2 tabs on opposite days; Latanoprost 0.005%, 1 drop each eye daily; Multi-vitamin, Calcium/Vitamin D Chocolate Chews as concomitant medications. On 21 Set 2013 At approximately 13:00 hour (approximately 2 1/2 hrs after receiving vaccine), the patient had sudden onset of nausea and felt hot/sweaty like was going to be sick. Feeling lasted about 5-10 minutes. No other complaints or symptoms. Home blood pressure taken at that time and was found to be normal at 120/60 with a pulse of 60. The patient had drunk some grape juice and as stated within 5-10 minutes felt back to "normal". As of 22 Sep 2013, the patient had normal baseline, no other complaints with the exception of slight soreness of the muscle at injection site left arm as expected with the shot. Documents held by sender: none
At 8:00-8:45 - started sneezing uncontrollably -it lasted until I went to bed - for about an hour - couldn't stop; about 8:30 I felt like I had hit a wall. Totally exhausted. Went to bed. 1:00 am woke up with a temp of 99.8. My baseline temp is 96. It lasted about 24 hours. I had temp and fatigue until 24 hours later - Friday morning. Went to work on Friday morning - so I felt better. So about 30 some hours of symptoms. Did not treat symptoms.
1st dose in 2020 and never received the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comments: The pharmacist reported via chat that a patient never received the second dose.   The reporter did not had the exact date of first dose, lot number and expiration date, or patient details.  At the time of reporting, the second dose had not been administered. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
After my 2nd shot I have developed Osteoarthritis; This spontaneous case was reported by an other health care professional and describes the occurrence of OSTEOARTHRITIS (After my 2nd shot I have developed Osteoarthritis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OSTEOARTHRITIS (After my 2nd shot I have developed Osteoarthritis). At the time of the report, OSTEOARTHRITIS (After my 2nd shot I have developed Osteoarthritis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Syncopal episode: +lighthead, +dizziness, +diaphoretic. Patient placed on cot in supine position within medically monitored clinic area. Vitals obtained: BP- initial 88/54, 112/68, 117/72, 118/70; HR 66; SpO2 97% on room air. Patient given orange juice and fruit snacks. Patient felt better.
This spontaneous report as received from a consumer refers to a 4 years old male patient. The patient was vaccinated with a dose of VARIVAX (merck) (lot #, dose and route not reported) in 2012. No other co-suspects were reported. No concomitant medications were reported. The patient's mother reported that after recent testing on an unknown date, she learned that her son had no immunity to chicken pox virus. No treatment information was reported. The outcome of the event was unknown. The relatedness for the event was not provided for VARIVAX (Merck). It was unspecified if the patient sought medical attention. The twin sister's event is reported in Case # 1210USA007903. Additional information is not expected.
Vaccination administered at 3:42pm. Member voiced he had a dry throat and was provided water. He was observed for 15mins without any noticeable concerns noted. He was scheduled for his 2nd vaccine and released. Member returned to 2nd floor conference room C at 4:37pm as he indicated his tongue felt thick and swallowing wasn't "natural". He advised he sat in his car for a while and came back in and took 2 benadryl.  I escorted member down to ACC and handed him off with report. He was in no acute distress, able to talk and ambulate. While checking into ACC he indicated he felt the benadryl was helping and felt a little better. (Initially during the 15 minute observation, member advised his mouth was dry and asked for water, which after drinking he said he was fine and that it helped. He was in no distress at that time. )
Patient - on Monday Oct 13, 2008, Rash - on Left hip - Long and narrow and then spread next day to stomach, went to MD - Tues. Pain, itching, lethargy, no sleep
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (unknown) and experienced not responding to therapy. The subject was reported to have no response to the primary series. The office did a titer level, details not provided. The vaccine record showed the subject had 3 doses of ENGERIX B.
Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Mar2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "not recovered".  Additional Information: The patient reported that the onset of Tinnitus was after receiving the COVID  vaccination. The patient never experienced it prior to receiving the vaccination in Mar2021, and since then have had continuing effects of Tinnitus.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning an 8 year old male who on 01/02/2002 was vaccinated with in the left arm with a first dose hepatitis B virus vaccine rHBsAg(yeast) On 01/02/2002 the patient experienced swelling under arm which lasted a year. In approximately January 2003 the patient recovered. The patient was not seen by the physicain. Additional information has been requested.
Patient was previously infected with COVID?19, November. 2020 and experienced heavy fatigue, skin pain, difficulty breathing and fever over 102 for 9 days. Patient was injected with Johnson and Johnson COVID vaccine in May 2021 and within hours following injection experienced severe injection site pain, lethargy, and fever over 101 for 3 days.  Immediately following  Pfizer booster in November. 2021, patient experienced  injection site pain and fever over 101 for 36 hours. In each case patient experienced a full recovery. Patient is in above average physical condition with daily physical activity.
I got sick on the 12, I took the test, and it was negative; on the 13th very sick, I took another test, and it was positive. I called my doctor; I spoke to him on the 14th. I had really bad headache, nausea, chills, very weak, a fever was very low, 99, plus I had a cough and congestion. I gave the doctor my symptoms and he gave me anti-virus and started taking it on the 14th.
This spontaneous report was received from a certified medical assistant, refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patients were vaccinated with improperly stored oral, ROTATEQ, lot # L020859, expiry date 19-JAN-2017; lot # K020181, expiry date 24-JUN-2016, (dose, frequency and route of administration not reported). It was reported that the vaccines were exposed to temperature of 12.6 degree Celsius for 2 hours and 9 minutes because of data logger. No previous temperature excursion reported. No adverse effect reported. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Patient had significant anxiety prior to administration. After administration, initially patient felt fine. A few minutes after patient felt faint , hands and forehead were clammy. Mom  was present. Blood pressure was checked, diastolic was slightly high at 90mmHg.  Patient's eyes closed for a second but patient was never unconscious. Patient did not fall. Patient did not hit head on anything. Patient was given water and sat there for about 7 minutes. Then patient was walked outside next to Mom and Pharmacy Grad Intern. Patient was not feeling well initially outside but did feel better after a while. Mom refused an ambulance. Mom and patient left at 10:50am and patient was feeling much better
PATIENT WOKE UP AND HAD IRRITATION AT SITE OF INJECTION. UPON INSPECTION SHE REPORTS IT WAS RED, SWOLLEN, AND ITCHY. REPORTS ONLY USING HYDROCORTISONE 1% CREAM TO RELIEVE ITCHING.
abnormal periods since getting booster dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, in Jan2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 23 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "Known allergies: Seafood" (unspecified if ongoing); "shellfish" (unspecified if ongoing), notes: Known allergies: Seafood, shellfish, pineapple; "pineapple" (unspecified if ongoing), notes: Known allergies: Seafood, shellfish, pineapple. There were no concomitant medications. Vaccination history included: COVID-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN, Prev dose product: COVID 19, Prev dose brand unknown: True, Prev dose brand name unknown: COVID19 Vaccine, Prev dose lot number: EN6201, Prev dose lot unknown: False , Prev dose administration date: Feb2021, Prev dose dose number: 2, Prev dose vaccine location: Left arm), administration date: Feb2021, when the patient was 22 years old, for COVID-19 immunization, reaction(s): "2 dose: pain in lungs for 24 hours after vaccine"; COVID-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Prev dose product: COVID 19, Prev dose brand unknown: True, Prev dose brand name unknown: COVID19 Vaccine, Prev dose lot number: FK4175, Prev dose lot unknown: False, Prev dose administration date: Jan2021, Prev dose number: 1, Prev dose vaccine location: Left arm), administration date: Jan2021, when the patient was 22 years old, for COVID-19 immunization, reaction(s): "1 dose: tightness of chest and pain in lungs for 28 hours", "1 dose: tightness of chest and pain in lungs for 28 hours". The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Feb2022, outcome "unknown", described as "abnormal periods since getting booster dose". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: Other vaccine in four weeks and medications in two weeks were reported as no. COVID prior vaccination was no and patient was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Racing of the Heart; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Racing of the Heart) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PALPITATIONS (Racing of the Heart). At the time of the report, PALPITATIONS (Racing of the Heart) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported.
One day following injection, her arm became hot, bright red with a 2" x 1" raised area. She had "shooting pain" down her arm with any movement.
had a reaction; raised (spot) on her injection site and her chest; itchy (spot) on her injection site and her chest; warm (spot) on her injection site and her chest; spot on her injection site and her chest; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy (spot) on her injection site and her chest), VACCINATION SITE WARMTH (warm (spot) on her injection site and her chest), VACCINATION SITE SCAR (spot on her injection site and her chest), VACCINATION COMPLICATION (had a reaction) and VACCINATION SITE RASH (raised (spot) on her injection site and her chest) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A2A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy (spot) on her injection site and her chest), VACCINATION SITE WARMTH (warm (spot) on her injection site and her chest), VACCINATION SITE SCAR (spot on her injection site and her chest) and VACCINATION SITE RASH (raised (spot) on her injection site and her chest). On an unknown date, the patient experienced VACCINATION COMPLICATION (had a reaction). At the time of the report, VACCINATION SITE PRURITUS (itchy (spot) on her injection site and her chest), VACCINATION SITE WARMTH (warm (spot) on her injection site and her chest), VACCINATION SITE SCAR (spot on her injection site and her chest), VACCINATION COMPLICATION (had a reaction) and VACCINATION SITE RASH (raised (spot) on her injection site and her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details include dexamethasone and ice.
Hives, 20 minutes, post vax. Employee took Benadryl 50mg, repeated that night. In the AM, employee went to her doctor as she was not better. Her doctor gave her Solu-Medrol IM, as her lips were swollen and 40 minutes later, employee reported chest pain, shortness of breath. Employee was given an Epi IVP.
Headache, muscle soreness within 30 minutes of leaving the site. Then within 2 hours body fatigue, neck pain, jaw pain and ear pain with swelling. Dr visit by Wed afternoon and meds to fight ear pain and swelling.