chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started with burning muscles throughout my body. Around 9 PM I started to get a headache. Then chills followed by intenses fever and sweating. All night and through to the next morning I had a high fever, though I didn?t take my temperature. I was achy all over, had an incredibly horrific headache which strong migraine over the counter pills did not help,  I would go back and forth from shivering to sweating (my body would be drenched in sweat) and just feeling miserable. I slept off and on until about noon. Then all symptoms slowly went away. By about 2:00 I was up and around though tired. By early evening I was perfectly fine.
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 58-year-old male patient who received SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. On 16th October 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 17th October 2018, 1 days after receiving SHINGRIX, the patient experienced nausea and weakness. On an unknown date, the outcome of the nausea and weakness were recovered/resolved. It was unknown if the reporter considered the nausea and weakness to be related to SHINGRIX. Additional details reported as follows: This case was reported by the patient's wife. The patient was a pharmacist, who received a dose of SHINGRIX to himself at home. The day after the vaccination, the patient experienced nausea and weakness. In October 2018, 5 days later the events were resolved. The patient had denied permission to contact their physician. This case has been linked with case US2018195930 (vaccinated with same lot number and expiry date), reported by the same reporter.
patient was extremely dizzy and nauseous after receiving vaccine. stated room was spinning. after 15 minutes and having a glass of water she felt better
Received flu shot 10/29/08 @ 10:30 am.  At 5:30 pm she had sudden numbness and swelling of her lower lip, also had nausea, vomiting & chills.  No dyspnea.  No ocular edema.  Treated with MEDROL dose pack- improving as of 10/31.
Patient had a stroke on left cerebral stroke on 9/24/21.  She is an otherwise healthy child and no existing cardiac, neurologic, or hematologic causes were identified during her hospitalization.  She did have some hypercoagulation labs pending at time of discharge from the hospital.
This spontaneous report as received from a registered nurse on 15-OCT-2014 concerning an unspecified number of patients. On an unknown date the patients was vaccinated with RECOMBIVAX (route, dose was unknown) which was improperly stored. No adverse effects reported. No product quality complaint was involved. It was reported that this case was opened on 26-AUG-2014 for temperature inquiry only. The outcome of the events was unknown. This case is linked to cases MARRS # 1410USA008635, 1410USA013358, 1410USA013360, 1410USA013361. Additional information is not expected.
Fever, hot flashes, chills, headache, jerking of arms and legs beginning 9 pm. The jerking lasted maybe 20+ mins. The rest about 36 hours. But hot flashes continued and a few weeks later were severe, occurring 50-100x per day, all day and night.
Woke up with A-fib (6:00 am) on 3/29/2021. Had old medication on hand Metoprolol tartrate 50 mg   Took 50 mg at 9:00 am and then at 9:00 pm.  Took same dose next day (3/302021).  Third day dropped dose to 25 mg every 12 hours; continued with that for a total of 3 days. Then dropped to 25 mg per 24 hours for 2 days total.  By bed time of same day A-fib started (10:30pm) heart beat was not in A-fib, but erratic - skipped beats, long pauses. Waking up the next day (3/30/2021) rhythm was mostly normal with occasional skips or pause. This has slowly stabilized to normal all the time  about a week after A-fib started. Note: I have had 2 pulmonary vein ablations. The last one was about 7 years ago. I have been in normal rhythm ever since except when I contracted the flu in January 2018. I was treated  at that time with the Metoprolol and normal rhythm was restored in about a day.
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-MAR-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Narrative: 73 yo male patient died of unknown causes on 11/23/2021. No info in chart providing any issues leading to pt's death. Pt had received covid vaccines on 2/23/21 & 2/2/2021. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration. See pts problem list: PROBLEM LAST MOD PROVIDER Diabetes mellitus (SCT 73211009) (ICD-10-CM 03/15/2021 E11.9) Atrial fibrillation (SCT 494436004) (ICD-10-CM 09/14/2020 I48.91) Constipation (SCT 14760008) (ICD-10-CM K59.09) 09/17/2018 Benign essential hypertension (SCT 1201005) 02/03/2016 (ICD-10-CM I10.) Hyperlipidemia (SCT 55822004) (ICD-10-CM E78.5) 02/03/2016 Cobalamin deficiency (SCT 190634004) (ICD-10-CM 02/03/2016 D51.8) Decreased vitamin D (SCT 131114008) (ICD-10-CM 02/03/2016 E55.9) Hepatitis B carrier (SCT 235871004) (ICD-10-CM 02/03/2016 Z22.51) Impaired glucose tolerance (SCT 9414007) 02/03/2016 (ICD-10-CM R73.9)
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L007560, expiration date 01-JU-2017 or lot # L013429, expiration date 21-JUL-2017 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 48 degrees Fahrenheit for 89 hours. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
PATIENT CALLED STATING HER LEGS (THIGHS AND CALVES) TURNED BLOTCHY, BRIGHT PINK AFTER HER WARM SHOWER. STATED NOTHING NEW WAS TAKEN ORALLY OR TOPICALLY. STATED THIS OCCURRED 24 HOURS AFTER HER SHOT AND LASTED FOR 15 MINUTES THEN SUBSIDED.  UNSURE IF IT WAS ITCHY.
Tired the next morning after the second shot; This is a spontaneous report from a non-contactable other healthcare professional (patient) received via Regulatory Authority. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 16Feb2021 (Lot Number: EN5318; at the age of 26 years old) as dose 2, single for COVID-19 immunisation. Medical history included COVID-19. She was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. She did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162B2 on 26Jan2021, administered in the left arm on 26Jan2021 (Lot Number: EN5318; at the age of 26 years old) for COVID-19 immunisation and experienced sore arm. On 17Feb2021, the patient experienced tired the next morning after the second shot. She has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the event. The patient recovered from the event on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
pt recvd vax 7JAN93 & office visit on 20JAN for cold sx & fever 101; cxr revealed pneumonia; tx w/Rocephin/Ceclor/Ventolin; Office visit 2FEB; taken to ER on 9FEB-dead on arrival; cause of death not currently available;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 11Oct2021 as dose 2, single (Lot number: El3248), in left arm, on 05Sep2021 as dose 3 (booster), single (Lot number: FC3182), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: FC9893) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "HLD" (unspecified if ongoing). There were no concomitant medications. The patient did not receive any other medications in 2 weeks. Past drug history included: Omeprazole, reaction(s): "Known allergies: Omeprazole". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. It was reported that from 27Apr2022 to 01 May2022, the patient was given treatment for COVID-19. No follow-up attempts are possible. No further information is expected.
Patient is 17 years, 7months (under 18 years of age). Patient states no symptoms or adverse effects currently or 15 minutes post vaccine. Patient and parent notified. Issue was discussed with medical director.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of ROTATEQ single dose, orally, lot#M045545, expiration date 10-JUN-2018, were administered to the patients. No adverse effects have been reported. The doses were stored in a temperature of 30 Fahrenheit degrees for 2 hours and 15 minutes. Data logger was involved. There was no previous temperature excursion reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA003399: US-009507513-1708USA005632:
(R) upper thigh local reaction from PREVNAR and HIB vaccination given 7/25/13.
On 1/24/2022 patient was mistakenly given Pfizer 5-11 yrs vaccine instead of Pfizer 12+. Patients mother was immediately informed. Patient did not report any adverse side effects
This spontaneous report as received from a consumer (patient's sister) refers to a 61 year old female patient. On 10-JAN-2013 the patient was vaccinated with PNEUMOVAX23. Dosing information, route of administration and lot number were not provided. On 11-JAN-2013 (reported as the following day) the patient became very ill with respiratory distress. The patient was hospitalized. The patient eventually entered a nursing facility and her adverse respiratory symptoms continued. Outcome of "very ill" was not reported. Causality assessment was not provided. Additional information has been requested.
Case number PHEH2013US024192 is an initial spontaneous report received from a pharmacist on 14 NOV 2014. This report refers to a 11-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 006031A and expiry date: JUN 2014) intramuscularly on 0.5 ml on 13 NOV 2013. No adverse event was reported following the administration error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 14 NOV 2013. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
longer than six months from first dosage.; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   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: 23-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient asked should he/she take second dosage of Shingrix if it had been longer than six months from first dosage. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Fingers are numb/left arm is numb/left arm will feel numb/feels like she needs to pop it; Left side of the neck is stiff; Left  arm is sore weak  and heavy; Her left arm is heavy; Sore arm/left arm is sore/sore arm is consistent/left arm will feel numb and is painful; ongoing left arm injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Fingers are numb/left arm is numb/left arm will feel numb/feels like she needs to pop it), MUSCULOSKELETAL STIFFNESS (Left side of the neck is stiff), MUSCULAR WEAKNESS (Left  arm is sore weak  and heavy), LIMB DISCOMFORT (Her left arm is heavy) and PAIN IN EXTREMITY (Sore arm/left arm is sore/sore arm is consistent/left arm will feel numb and is painful) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccination (has received the flu shot in left arm). Past adverse reactions to the above products included No adverse event with Flu vaccination.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Fingers are numb/left arm is numb/left arm will feel numb/feels like she needs to pop it), MUSCULOSKELETAL STIFFNESS (Left side of the neck is stiff), MUSCULAR WEAKNESS (Left  arm is sore weak  and heavy), LIMB DISCOMFORT (Her left arm is heavy), PAIN IN EXTREMITY (Sore arm/left arm is sore/sore arm is consistent/left arm will feel numb and is painful) and VACCINATION SITE PAIN (ongoing left arm injection site pain). At the time of the report, HYPOAESTHESIA (Fingers are numb/left arm is numb/left arm will feel numb/feels like she needs to pop it), MUSCULOSKELETAL STIFFNESS (Left side of the neck is stiff), MUSCULAR WEAKNESS (Left  arm is sore weak  and heavy), LIMB DISCOMFORT (Her left arm is heavy), PAIN IN EXTREMITY (Sore arm/left arm is sore/sore arm is consistent/left arm will feel numb and is painful) and VACCINATION SITE PAIN (ongoing left arm injection site pain) outcome was unknown.            Patient has received both doses of the Moderna COVID-19 vaccine and states that she had a booster appointment but has not gone due to fear of becoming paralyzed in arm.   No concomitant medication reported.  No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Significant Follow-up Appended events added
02/16/2021 started feeling bad, had no taste, no smell, high fever, very fatigued, chills, headache, hard time breathing. I went to the DR on 02/19/2021 tested positive for Covid.  Was given prednisone and some other medication I cannot remember the name of it. After about 5 days of meds, I did start to feel better.
1. The following day, severe pain/burning sensation in both forearms. From elbow joint, down through the forearms. Could not pick up anything without paid, heavier than an empty coffee mug. Duration: until today, and ongoing. 2. 5 days after vaccine, dizziness, fatigue. 6 days after partial fatigue. 3. 5 days after vaccine, swollen tongue, lasted for 4 days. 4. 7-14 days after vaccine, several mouth sores (inside and out).
This spontaneous report was received from a physician and refers to a 14 year old male patient. The patient's concurrent conditions included asthma. The patient's concomitant therapies included QVAR and albuterol. The patient had not drug allergies. Information regarding the patient's pertinent medical history and historical drugs was not provided. On 12-APR-2018, the patient was vaccinated with his first dose of GARDASIL 9 (dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. The reporter stated that there were not adverse effects after this first dose. However, on 22-OCT-2018, the patient was vaccinated with his second dose of GARDASIL 9 (dose, route and anatomical location were not provided) lot # R008163, expiration date 18-NOV-2020, for Human Papilloma Virus (HPV) prevention. Since this date, the patient had been experiencing ringing in the ears (tinnitus). The patient was scheduled to be seen in the physician's office on 30-OCT-2018. At the reporting time, the patient was not given any treatment and no laboratory diagnostic studies were performed. The outcome of tinnitus was reported as not recovered/not resolved. The causality between the event tinnitus and GARDASIL 9 was unknown.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). The pharmacist reported that on an unknown date the patient experienced a rash. The outcome of rash was unknown. Additional information is not expected.
Severe pain in right side of neck.; Fluid build up in right side of neck.; Swelling in right side of neck; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (at the age of 56-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies. Concomitant medication(s) included lisinopril, and metformin. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (at the age of 56-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 01:15 AM (at the age of 56-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. On 10Apr2021 at 12:00 PM, the patient had fluid build-up in right side of neck. Severe pain in right side of neck. Swelling in right side of neck. All behind right ear. Started day after vaccine on 10Apr2021. The patient had emergency room (ER)/department or urgent care visit on 12Apr2021. The patient not required treatment for the events. Symptoms resolved 13Apr2021. On an unspecified date in 2021, post vaccination, the patient was covid tested, nasal swab taken, and the result was negative. The outcome of the events was resolved on 13Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
01/06/2021  Due to Lisinopril allergy, patient observed for 30 minutes after vaccination.  As she was leaving, patient stated her throat felt dry and stratchy.  Patient denied shortness of breath, rash, hives, dizziness, headache, and nausea.  Patient escorted to Dr. for evaluation and management.  Dr. ordered 25mg Benadryl PO, medication was administered at 1528 and patient was monitored by medical staff.  Patient reports feeling much better at 1615.  01/07/2021  0810  Patient reports all symptoms resolved on 01/06/2021 by 2000.
pt recv vax & exp a stiff neck & neck pains in the spring of 1994;also reported having a stiff elbow (like a tennis elbow), somewhat relieved by cortisone inj);MRI negative;
headache, joint pain, fatigue, chills, sore throat, arm pain/tenderness and mild swelling/redness around injection site. Symptoms peaked ~24-36 hours after injection before diminishing
11/19/01 @0930 spoke with pt. C/O hives on both arms and chest area. Not sure if anywhere else don't think so. At injection site LD red, hot, swollen area 8cm around site. C/O itching no SOB, no difficulty breathing. Instructed to call MD or go to ER. Dr office called instructed to take benadryl 50mg po q/4 until itching subsides. On 11/20/01 spoke with pt rash fading, still itches, not as bad, no SOB, states did have hives over entire body. arms, chest, neck, legs and back. Instructed to call 911 or go to ER if any difficulty breathing by MD.
Was referred by Dr for evaluation of reaction to first COVID vaccine. First vaccine on 12/21/2020 Pfizer-BioNTech. Administered by her place of work. Vaccine was administered in left arm. Had same symptoms as when she had COVID in 10/2020 these symptoms lasted for 12 hours. Started the following day 24 hours after vaccine administration. Symptoms include injection site redness for 6 days, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, and overall feeling of un wellness lasting 12 hours. First symptoms was eyelid heaviness and weakness. No treatment, symptoms resolved on their own. Second vaccine due 1/11/2021.             Was covid positive 10/2020- no appetite, aches, chills, sweating, weakness, heavy eyelids, fatigue, ongoing for 3 weeks.             Has had difficulty in the past to flu vaccines with local injection site reactions. 09/2020 flu vaccine no symptoms. Has had pneumonia vaccine with no difficulties. Has not received shines vaccine yet.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient had no known allergies. She treated with Paxlovid (anti viral) for COVID-19 from 07Dec2022 to 11Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.