chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOSS OF TASTE; SORE ARM BY THE ROTATOR CUFF; FLU/ALLERGY LIKE SYMPTOMS/COUGH/HEADACHE/SORE THROAT/TIREDNESS; SNEEZING; EYE WERE RUNNING; ITCHY EYES; ITCHY EARS; SCRATCHY THROAT; POST NASAL DRIP; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included kidney stones, and covid-19 test positive, and concurrent conditions included sinusitis. The patient was previously treated with paracetamol, benzonatate for cough, zinc, and ascorbic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04121A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Oxygen saturation (NR: not provided) 97-98 %. On 12-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 20-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On APR-2021, the subject experienced flu/allergy like symptoms/cough/headache/sore throat/tiredness. On APR-2021, the subject experienced sneezing. On APR-2021, the subject experienced eye were running. On APR-2021, the subject experienced itchy eyes. On APR-2021, the subject experienced itchy ears. On APR-2021, the subject experienced scratchy throat. On APR-2021, the subject experienced post nasal drip. On 06-APR-2021, the subject experienced sore arm by the rotator cuff. On 21-APR-2021, the subject experienced loss of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm by the rotator cuff, and the outcome of loss of taste, flu/allergy like symptoms/cough/headache/sore throat/tiredness, sneezing, eye were running, itchy eyes, itchy ears, scratchy throat and post nasal drip was not reported. This report was non-serious.
Scratchy throat; itchy, burning eyes, slight fever, severe headache   Lasted for 24 hours. Took Benedryl. Eyes felt like pieces of glass were in them.  Severe headache lasted 24 hours.
Booster dose given afternoon Monday March 21. Pt woke on Tuesday March 22 at 8 a.m. with RLQ abdominal pain; ER found appendicitis requiring surgical extraction. Pt reported no pain or GI problems prior to Tuesday morning.
This non-serious initial spontaneous case, was received from pharmacist on 13-Oct-2017, concerning a 69-year-old female patient. The patient's medical history included unspecified post-transplant complication. The patient concomitant medications included unspecified anti rejection medications post organ transplantation. On 11-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, batch number: 179402, expiry date: Jun-2018, route of administration: intramuscular, anatomical location: left deltoid). On 12-Oct-2017, after 2 days of vaccination, the patient had dark redness, which was 3 inches in diameter and warmth around the injection site. No treatment was taken for the events. The patient was recovered from the events within 2 to 5 days. Follow up report received on 23-Oct-2017: The outcome of the event from not recovered to recovered within 2-5 days was updated. The reporter confirmed the vaccination date as 11-Oct-2017. The narrative was amended accordingly.
COVID; COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4236025-00.  A 52-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BISOLVON AMOXYCILINA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: Blood iron: (Oct2022) Extremely low. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: She had contracted COVID in Dec2022.  The reporter's assessment of the causal relationship of "covid" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".
Moderna COVID-19 Vaccine EUA.   Fever, chills, body aches, headache started 1:30AM on 5-13-21 and lasted for 18 hours.  Fever vacillated between 99 degrees and 100.4 degrees.  The headache was the level of a migraine and lasted for 18 hours.  The chills and body aches were not severe.  Took Tylenol, bed rest, drank plenty of water.
Sick all weekend; vomited several times; severe pounding headache; nauseated; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Jul-2021. The most recent information was received on 26-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick all weekend), VOMITING (vomited several times), HEADACHE (severe pounding headache) and NAUSEA (nauseated) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included Surgery in September 2020. Concurrent medical conditions included Immunocompromised (Chronic  low white blood cells count since birth, but discovered at 16 years of age (09-Oct-1971)) since 10-Sep-1971, Drug allergy (sulfa), Allergy to antibiotic (macrodantin), Drug allergy (gantrisin), Allergy to antibiotic (erythromycin), Allergy to antibiotic (ampicillin), Drug allergy (chlorhexidine), Nerve pain (chronic nerve pain in foot from accident) since 06-Oct-2014, Thyroid nodule since May 2009, Gastritis (acid reflux) since 2010 and Osteoporosis (left hip) since 2016. Concomitant products included LORATADINE for Allergy, VITAMIN D3 and MAGNESIUM for Bone density abnormal, ATORVASTATIN for CRP increased, TRAMADOL for Chronic pain, FAMOTIDINE (FAMODITINE) for Gastritis, CALCIUM CITRATE for Osteoporosis, VITAMIN C [ASCORBIC ACID] for Prophylaxis, COENZYME Q10 [UBIDECARENONE] for Supplementation therapy.   On 27-Jan-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021 at 2:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced ILLNESS (Sick all weekend), VOMITING (vomited several times), HEADACHE (severe pounding headache) and NAUSEA (nauseated). On 28-Feb-2021, ILLNESS (Sick all weekend), VOMITING (vomited several times), HEADACHE (severe pounding headache) and NAUSEA (nauseated) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ILLNESS (Sick all weekend), VOMITING (vomited several times), HEADACHE (severe pounding headache) and NAUSEA (nauseated) to be possibly related.    As treatment the patient took  previously prescribed medication (that was prescribed to her after foot surgery several months earlier) for vomiting and it calmed her nausea but not the headache. The next day of the onset of the events, headache was less severe but patient was till nauseated. As the day progressed, she had to take another unspecified one of her prescribed anti-nausea pills to settle her stomach following which she was able to eat lightly.   This case was linked to MOD-2021-270193 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant follow up; patient demographics, medical history, event details updated. Concomitant medications added.
On 04/04/21, around 11 AM, the customer walked in for his COVID vaccine appointment.  After registering for the vaccine , the patient sat in the designated area and one of our immunizing technicians administered the vaccine while I was observing and I left the immunization area while my technician was finishing up cleaning. When the patient asked the immunizing technician a question about side effects, she offered him to talk to the pharmacist at the consultation window. While I was assisting the next customer, I heard a loud sound and saw the customer collapsing on the floor. I ran outside and checked his pulse, and asked to call 911. He was conscious and breathing. I went inside the pharmacy to get EpiPen and informed the customer that I will be administering EpiPen, but he denied it. In the meantime, the immunizing technician was already on hold with 911 and informed that they are on the way. The customers in the waiting area also kept him engaged and were watching him if he is alert. The store manager on duty was also in the pharmacy area. I came inside the pharmacy and offered the patient a chair to sit in. Paramedics arrived in a few minutes to transport him to the hospital. The patient came back to the pharmacy around 2:30PM to collect his immunization card and when I inquired about how he is doing, the patient informed me that he is feeling more better and the ER determined that there was no allergic reaction to the vaccine but the patient most likely stood up too quickly after the vaccine was administered.
Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient reported arm pain and tingling
Hard to pick up things; warm at the injection site; itchy at the injection site; muscle aches on the whole side of the arm; sore at the injection site; red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of GRIP STRENGTH (Hard to pick up things), INJECTION SITE WARMTH (warm at the injection site), INJECTION SITE PRURITUS (itchy at the injection site), MYALGIA (muscle aches on the whole side of the arm) and INJECTION SITE PAIN (sore at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced GRIP STRENGTH (Hard to pick up things), INJECTION SITE WARMTH (warm at the injection site), INJECTION SITE PRURITUS (itchy at the injection site), MYALGIA (muscle aches on the whole side of the arm), INJECTION SITE PAIN (sore at the injection site) and INJECTION SITE ERYTHEMA (red at the injection site). At the time of the report, GRIP STRENGTH (Hard to pick up things), INJECTION SITE WARMTH (warm at the injection site), INJECTION SITE PRURITUS (itchy at the injection site), MYALGIA (muscle aches on the whole side of the arm), INJECTION SITE PAIN (sore at the injection site) and INJECTION SITE ERYTHEMA (red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.
I experienced body aches, high fever, chills, fatigue, which lasted for 2 days. I was unable to work or do anything for 2 days.
sore arm; pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) and PAIN IN EXTREMITY (sore arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 22-Dec-2020 and the estimated date of delivery was 28-Sep-2021. On 15-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  On 15-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Pregnancy test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Event- Sore arm  added outcome unknown
Intermittent nausea/vomiting that started 1 day after vaccine administration, has persisted on an intermittent basis since then.
This spontaneous report as received from a consumer refers to herself, a 68 year old female patient. On an unspecified date in 2009 (date assumption based on AE onset information) the patient was vaccinated with ZOSTAVAX. Patient route of administration and lot no. information was not provided. Sometime in June 2012 the patient contracted shingles, which was "about three years after" receiving ZOSTAVAX. She described this first occurrence as mild. On 29-JAN-2013 the patient experienced her second case of shingles, which she described as severe. She has seen the HCP for treatment three times (on unspecified dates) since 29-JAN-2013. Treatment received: VALTREX, Prednisone, "steroid shot" and LORTAB. The outcome of contracted shingles "about three years after" receiving ZOSTAVAX is unknown. The outcome of second case of shingles was reported as not recovered/not resolved. Additional information has been requested.
Has a temperature this morning of 104.4; This is a spontaneous report from a contactable Consumer or other non-health professional. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not used other Products. No Investigation Assessment was provided. Consumer stated that, the patient experienced temperature of 104.4 after he got his second shot of Pfizer yesterday on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 104.4 on an unspecified date. No therapeutic measures were taken in response to event. The outcome of the event was unknown.   Reporter was concerned about whether patient need to visit emergency room or was that the normal reaction. Reporter was provided with the number of Pfizer Medical Information Department.  Follow-up attempts are needed; information about lot/batch number requested.
Developed shoulder pain after influenza injection in 28 Sept '13. Shot given high, with vaccinator standing over her. Has had pain for 7 months with certain movements in spite of P.T.
Baby developed high fever.  Baby had severe pain in leg where shot was administerd.  Baby cannot bend leg.  Baby's whole body is rigid.  Baby had diarrhea and vomiting.  Baby is in a lot of pain.
Incorrect dose was administered. 0.5 ml was administered Correct dose is 0.25 ml.
This vaccine recipient was not registered to receive the flu vaccine and should not have been vaccinated. The vaccinated child was mistaken for the child who was registered and was supposed to receive the vaccine. The child did not experience an adverse reaction to the vaccine.  The school nurse and principal met with the child's parents at the school. The parents preferred to have the child vaccinated at her PCP.  The parents completed a vaccination consent form for this vaccine administration and will let this vaccination administration stand for this years flu vaccination. Parents were concerned that medical information be entered into the Vaccine Registry. That has been done. Influenza Incident Report filed with OnSite Medical direction.
Information has been received from a licensed practical nurse concerning a 23 year old female who on 07-MAY-2008 was vaccinated with her first dose of GARDASIL vaccine (yeast) (Lot# 659964/1978U) and on 10-JUL-2008 was vaccinated with her second dose of GARDASIL vaccine (yeast) (Lot# 660391/0063X). There was no concomitant medication. On 10-JUL-2008 the nurse reported that the patient was presenting with an abnormal tuberculosis test (TB).The nurse states that the TB test had a ring around the puncture. The TB test was conducted 2 days ago but the results were read today. At the time of reporting the patient had not recovered. Additional information has been requested.
Fever, vomiting, rash all over body, irritable and crying started 5-6 hours after vaccine rash lasted 1 week vomiting x 1 day fever 1 day. The right thigh was swollen and red - groin to knee was red.
Itching; Injection site the size of a golf ball; Injection site red; Pain in the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain in the shoulder), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Injection site the size of a golf ball) and VACCINATION SITE ERYTHEMA (Injection site red) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) 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 PAIN (Pain in the shoulder). On 12-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Injection site the size of a golf ball) and VACCINATION SITE ERYTHEMA (Injection site red). On 06-Mar-2021, PAIN (Pain in the shoulder) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Injection site the size of a golf ball) and VACCINATION SITE ERYTHEMA (Injection site red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: The consumer declined for further follow-up. She was doing fine. She had the adverse reaction(which were reported) after 1st shot for few days. After getting the 2nd shot -she did not have any problem and she is doing good.
This case is part of a cluster of 3 cases and is linked with AER# 2013-04277, 2013-04363, (adverse events after DAPTACEL lot number C4310BA reported by the same HCP). Initial report received from a healthcare professional on 01 April 2013. A 19-month-old male patient, whose medical history and concomitant medications were not reported, had received a dose of DAPTACEL (lot number: C4310BA, route of administration was not reported) in right thigh on 01 February 2013. The patient also received PREVNAR 13 (lot number: F45137, route of administration was not reported) in left leg on 01 February 2013. On 01 February 2013, the patient experienced "legs swollen" both legs and had trouble walking after vaccination. Laboratory investigations were not reported. No treatments were not prescribed. The patient outcome was not reported. Follow-up information received from a healthcare professional on 08 May 2013. The patient had recovered from the events on an unspecified date. Documents held by sender: None.
Recurrent episodes of hives and SOB occurring 2-3 times per week since 2 days after receiving typhoid vaccine. Symptoms: Hives Dyspnea (shortness of breath)
Bells' Palsy, started on March 4th, right sided facial droop, and visual changes.  Admitted to Hospital, worked up for CVA, and started on steroids and valacyclovir
pain in his shoulder,pain from his elbow to his neck.; pain in his shoulder,pain from his elbow to his neck.; Her husband still had pain in his left arm which is where her received the Moderna Booster dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NECK PAIN (pain in his shoulder,pain from his elbow to his neck.), ARTHRALGIA (pain in his shoulder,pain from his elbow to his neck.) and VACCINATION SITE PAIN (Her husband still had pain in his left arm which is where her received the Moderna Booster dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012S21A, 045A21A and 022H20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes. Concomitant products included TIZANIDINE, CODEINE, PARACETAMOL (APAP/CODEINE [CODEINE;PARACETAMOL]), GABAPENTIN and INSULIN for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (pain in his shoulder,pain from his elbow to his neck.), ARTHRALGIA (pain in his shoulder,pain from his elbow to his neck.) and VACCINATION SITE PAIN (Her husband still had pain in his left arm which is where her received the Moderna Booster dose). At the time of the report, NECK PAIN (pain in his shoulder,pain from his elbow to his neck.), ARTHRALGIA (pain in his shoulder,pain from his elbow to his neck.) and VACCINATION SITE PAIN (Her husband still had pain in his left arm which is where her received the Moderna Booster dose) had not resolved.      The reporter stated like patient had no adverse reactions after first and second Moderna vaccination. It was reported the pain became so severe that the patient went to go see a pain specialist. The patient was prescribed pain medications and muscle relaxants, and these did not work so the physician tried steroid injections. The caller said that her husband still had pain in his left arm.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient had trouble standing back up from sitting position (staggered) when leaving.  Wife said not from vaccine that this has been happening for about a week or so and under doctor's care.  Gave patient water to drink and had him sit for about 30 minutes (patient did not want to lay down and felt fine sitting).  Patient was then able to get up and was balanced/stable walking. Said he felt fine. I got him a shopping cart as support just in case.
Pt to office for ear check. Note to have varicella skin lesions (about 50). Pt known to have received vaccine at previous provider on 3/5/03. Otherwise asymptomatic.
symptoms lasted four days day 8- itchy and pain on the left shoulder, same side of injection old tb scar was bright red and had two bloody blisters (this was the injection arm) rash started around injection site
ON THE THIRD DAY POST VACCINATION PT WOKE UP WITH HEAD ACHE, WEAKNESS, BODY ACHES, THE 4TH DAY STARTED  DRY COUGHING , SORE THROAT, ON THE 5TH DAY BEGAN WITH COUGH AND YELLOW SPUTUM. BODY ACHES, FATIGUED
Measles like rash, itching with no resolution with steroids and antihistamines and still has on 3/12/15.