chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tired; arm soreness; This is a spontaneous report from a contactable consumer or other non health care professional. A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not provided) via an unspecified route of administration on 23Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. known allergies were unknown. The patient experienced arm soreness and tired on 24Feb2021. It was unknown whether therapeutic measures were taken as a result of reported events. It was unknown, whether the patient was diagnosed with COVID-19, prior to vaccination and since the vaccination. Outcome of the events was unknown.  Information on lot and batch number has been requested. Follow-up attempts completed. No further information expected.
Patient began to feel numbness in her face and arms.  She was advised to seek medical attention but declined.
Muscle spasms, paralyzed arm, lots of pain.  Still weakness and some paralysis in arm.
This spontaneous report was received from a Registered Nurse referring to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, 26 improperly stored doses of GARDASIL 9 Lot # N000326 expiration date 14-OCT-2019 and Lot #N004799 expiration date 15-NOV-2019 (strength, dose and route were not reported) were administered to multiple unspecified patients for prophylaxis. The doses were improperly stored at a temperature between 47°F to 77°F and 32°F to 35°F during a time frame of 10 minutes and 120 minutes, respectively. There were no previous temperature excursions and the call was due of a data logger. No adverse effects were reported.
More than 35 days second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days second dose). On 03-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) no antibodies.         The patient received first dose in late 2020. When doctor recently ran a test on him, he did not have any antibodies.  No concomitant medications were provided by the reporter  No treatment information were provided by the reporter. Patient received his booster shot on 22 Oct 2021 of 0.25 mL.
Temp 99.7 degrees F tympanic. (L) arm started swelling after mom picked up child from school at 2:55pm - he had received his vaccines that morning approximately 8:40am. 9-26-12 nurse from school called mom today to say his arm was swelling but mom did not need to take him out of school. Mom brings him to Hlth Dept at 4:30 9/26/12 for eval. (L) arm measures 8 2/8 inches & (R) arm measures 7 1/8 inches. Pt c/o axillary pain - lymph node involvement.
Tingling/numbness on left pinky and left pinky toe.  Tingling sensation on left side of head
Patient reports on 11/4/2021 around 6:00pm lips started stinging and swelling.  "Felt like a fever blister was coming up.  Kept getting worse.  Got up and looked at my lips.  Started researching and saw that is something that happens." Patient reports going to bed at 10:00pm and could still feel it.  Kept applying chapstick.  Patient reports it's going away but still present this morning.  Patient reported to health department on 11/5/2021 at 9:30am.  Patient denies any trouble breathing, denies coughing, denies trouble swallowing.  Patient reports taking Benadryl for reaction.  Patient reports taking one Benadryl at 7:00pm and then another at 10:00pm just before going to bed.
Patient received the Moderna Covid-19 at facility Friday, Feb 12th around noon. At 12:34PM, while driving the left side of her face went numb, the left ear lost hearing and her throat on the left side felt pinched. In 2 hours the feeling in her face returned, her left ear has lost some hearing and periodically gets shooting pain in that ear. Per Head and Neck provider:   left facial numbness improved but hearing has not.  She has had episodic bilateral lower facial hypesthesia since .    Other symptoms include joints pains for a few days, scratchy red eyes, bilateral facial rash, intermittently feels cold, intermittent cognitive changes   Left nonpulsatile tinnitus  Disequilibrium and lightheadedness No spinning vertigo
At 8:30pm I started to have severe chills and was shaking this last into the night, then proceeded to get a fever and a sever headache. The headache was severe for more than 36 hours and then dull for another 12 hours.  Fever and chills lasted about 18 hours.
One week post vax pt experienced chickenpox with hundreds of lesions. The pt was afebrile. Pt sought unspecified medical treatment. Pt was treated with Benadryl, calamine lotion, and Aveeno baths.
Vaccine Dose #2 administered 14 days after Dose #1, given too early. MOC denies patient symptoms, problems s/p vaccination. MOC called and notified of vaccination error. Educated that dose 2 invalid due to timing. Reviewed CDC recommendations to repeat dose in 3-8 weeks.
ataxia / uncoordinated gait, stumbling, light-headed, felt intoxicated, confused, difficulty focusing. Resolved by 48 hrs post vaccine
Heart beat is irregular.; Throwing up; severe shaking; achy joints; Really high fever; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 31-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration, administered in Arm Left on 21May2021 12:45 (at the age of 31-years-old) as 2nd dose, single dose for COVID-19 immunization. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration, administered in the left arm on 30Apr2021 at 02:00 PM. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021 at 06:00 AM, the patient experienced  with heartbeat was irregular, throwing up, severe shaking, achy joints and really high fever. No therapeutic measures were taken as a result of events caused. The outcome of the events was recovering.  Information on batch number has been requested.
RADIATING PAIN IN UPPER BODY FROM INJECTION SITE; FROZEN SHOULDER; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initially received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A expiry: unknown) dose was not reported, 1 total was administered in left arm on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced radiating pain in upper body from injection site, frozen shoulder and pain at injection site (dose number in series 1). It was reported that, from the first injection the patient had pain at injection site and pain had not decreased but increased and it radiated all over upper body. The patient visited several doctors (physician office visit) about it (dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total was administered on unspecified date in JAN-2022 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine ad26. cov2.s (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, radiating pain in upper body from injection site, and frozen shoulder. This report was non-serious.
Massive headache that started behind eye, made eye swollen and bloodshot, couldn't really see out the eye, sensitivity to light.  Lasted for a whole day,  headache lingered for three  more days.     Another headache like that (without the eye involvement) happened the next month and then the month after, but for shorter periods of time.
12 hours after receive vaccination Pt reports that she had fever 103 F. "I got a really bad reaction to the rabies booster, that night my whole body ached and I had a fever (103) and chills and spent all night tossing and turning from the chills and fever combo". Symptoms resolved in 12 hours. Pt took two NYQUIL - 325mg of acetaminophen.
Pt's BP was elevated, appeared flushed & stated "her heart felt like it was racing". Pt. felt cold & clammy. Nurse continued to take BP & pulse for next 45 min. By 2:40p.m., pt's BP was normal as well as pulse & respirations.
Died; A spontaneous report was received from a consumer concerning a 58-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient was died.  The patient's medical history was reported as underlying health issue. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: if reported or unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, patient with underlying health issue died after getting the Moderna COVID-19 vaccine.  Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on an unknown date. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 58-year-old female who died on unknown date after first dose of mRNA-1273, lot # unknown. Very limited information regarding this event has been provided at this time, therefore it is difficult to assess a cause and effect relationship. No further information will be available. Of note, patient's medical history included unknown underlying health issues.; Reported Cause(s) of Death: Unknown cause of death
Splitting headache, chills, fever 101.5, nausea, extreme fatigue started about 18 hours after injection even with Tylenol 1000 mg started immediately after injection + taken every 6 hours.  Now alternating Tylenol  + Ibuprofen every4 hours. Was late to take last dose, went 6 hours without Med + symptoms returning.. Had left arm pain  and continue to hAve injection redness.
Child received the vaccination and began to get sick almost immediately. Body aches -low grade fever- lasted 7-8 days- On 02/03/2010 she had paralysis on (L) side of face - CT scan- Sinus infection on 02/04/2010. Dr several days later noted tongue had been effected. MRI performed. Client has been referred.
Sore throat  Chills Dizziness  Sinus pressure  Pain in left ear
the patient received improperly stored vaccine; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Information on pertinent medical history and drug reactions/allergies was not reported.   On 30-SEP-2019, the patient was vaccinated with an improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, (dose and dose number were not reported) (lot # S004251, expiration date 22-SEP-2020), administered for prophylaxis.   The vaccine was exposed to a temperature of 1.4 degree Celsius multiple times for a time frame of 20 minutes as recorded by a digital data logger. Previous temperature excursions included 10.5 degree Celsius for 56 minutes.
Information has been received from a physician concerning a 74 year old Caucasian male with a benign calcified nodule in right mid lung and no unknown drug allergies who on 25-JUL-2006 was vaccinated with a second dose of Pneumovax 23 (o.5 ml) (IM), in the right deltoid. It was noted that the patient originally received Pneumovax 23 "10 years ago." The physician decided to revaccinate the patient. Subsequently, the patient developed a fever of 102 degrees and lost 10 pounds. On 26-JUL-2006 the patient developed "chills with rigors, temperature 101, erythema at injection site, severe weakness, tremors, diarrhea, nausea, and vomiting." The physician put the patient on steroids. The patient was given PHENERGAN. It was reported that the patient "may take" TYLENOL as directed for fever if needed. The patient was reportedly "getting better". No further information is available.
pt had MMR 10 days prior to sx-petecchial rash & bruising w/oozing, blood from gums, epistaxis & hemacult positive stool over 24hr period;adm to hosp 10JUL97;platelet coung on admission 5,000;recv IV-IG to normalize platelet count;
Fever to 1015 x 2.5 days also very fussy; Mom did not notify clinic until 18mo visit;
Received vaccine in left deltoid at 1055 am. Once outside, she noticed redness and itching of right shoulder. Observed in clinic for 5-10 minutes. Stated the itching had subsided. Left clinic.
I have a burning sensation in my breasts, more so in my left breast. I also have tenderness and swelling in my breasts. I have itching in my armpits and I noticed a texture change in my hair.
Felt fatigue and febrile for several days after vaccine.  On 3-10-2008, noted onset of urticaria and wheezing.
Investigator indicated event not related to Engerix-B vax; Randomized to recvd Engerix-B (as the control vax) while a participant in Merieux trial of HIB; exp seizures;
Patient said she experienced stomach discomfort a couple of days after vaccination.  She said it continued so she went to an urgent care on 7/2. She then went to the hospital and on 7/5 and had an MRI. She said they found an unidentified bacteria in her stomach.
Adult patient received the dose after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received the dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received the dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received the dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received the dose after its expiration date 13-Jul-2022).    This case contains information for the 32nd of 56 patients described by the reporter.  Concomitant medication was not provided.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Doses were administered after 30-day use by date or after manufacturer date of expiry. It was unknown to HCP when the vials were stored in the refrigerator and when the doses were administered. The vial did not undergo any temperature excursions.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:case
Lower leg soreness in both legs, worse in right upper calf; improving but not resolved. Advised to visit provider immediately
devel high fever >103 & had myoclonic jerk the evening p/vax;fell asleep x 10-15min-eyes open & eyeballs moving back & forth;arms, legs &neck twitched approx 1min;mom awoke cried a little-nl & fell back asleep;
This case was reported by a pharmacist via call center representative and described the occurrence of feeling bad in a 57-year-old female patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). Concomitant products included dTpa vaccine (Reduced antigen). On 20th March 2018, the patient received SHINGRIX. On 20th March 2018, the patient received SHINGRIX. On 20th March 2018, immediately after receiving SHINGRIX, the patient experienced feeling bad and feeling cold. On an unknown date, the outcome of the feeling bad and feeling cold were recovering/resolving. The reporter considered the feeling bad and feeling cold to be related to SHINGRIX. Additional details were reported as follows: The reporter was not aware of any medical history, current medications and other medical intervention and he reported no allergies. The patient received a dose of SHINGRIX in her right deltoid. The patient felt of a vice around her arm when the fluid went in and a cold feeling down to her hand. The reporter stated that the patient denied nerve pain. The pharmacist stated that it took 10 to 15 minutes of massaging the site and the patient moving her arm for it to improve. The reporting pharmacist stated she was 100 percent sure that the patient's reaction was related to SHINGRIX.
Pt. woke up with stomach pains the morning after vaccine, and vomiting, Pt. was very weak and feeling bad for 4 days afterwards  He was told by his doctor to expect this so after 4 days we became more concerned. He vomited off and on for 3 days but was able to eat limited food and drink water throughout the days that followed. He complained of stomach pains, severe back pains and on the Saturday after I took him in to the urgent care. Blood work was done, and the doctor sent him home and told me to bring him back the following Tuesday for repeat blood work. The following week I took him back in to get a follow up blood test to see if his bilirubin and liver enzymes went down.  We received a call to take him to the hospital. He was treated for pancreatitis and spent a week in the hospital and is now in a rehab because he is very weak. He also now has a catheter.
Moderate to severe swelling with rash. Swelling is down but rash continues and is effecting upper arm, neck and face.
Receive vaccine while pregnant; A spontaneous report was received from a consumer concerning a 37 years old, female patient who received the vaccine during pregnancy/vaccine exposure during pregnancy.   The patient's medical history included ventricular tachycardia, allergies, asthma, and atrial fibrillation. Products known to have been used by the patient, within two weeks prior to the event, included progesterone.  On 16 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) in the arm for prophylaxis of COVID-19 infection.   On 16 Jan 2021, the patient was administered the vaccine during pregnancy. The patient is on the week 16 of her pregnancy.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The event vaccine administered during pregnancy was considered resolved on 16 Jan 2021.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Hospitalization for unresponsiveness related to COVID-19 on dates 8/10/2022-8/13/2022. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, and zinc 50 mg PO daily.
Left Shoulder locking up and inability to bend elbow or put his coat on after the injection.
On Sunday around 2:00 p.m. I got cold inside.  Around 10:00 p.m. that same day I got a headache and my arm where I got the shot was swollen in that area and it hurt. On Monday, March 8th  my headache was gone and the coldness went away, but my arm was still swollen, sore and red. On Tuesday, March 9th I called the doctor and he told me to put ice on it. When I get other shots my arm swells a little and it is gone in two days along with the redness, but not this time. It is warm to the touch too.
Right sided bell's palsy history of left sided bell's palsy Went to the ER Treated with prednisone taper and acyclovir followed up with PCP who increased antiviral to valacyclovir at more therapeutic dose Has not improved yet after 1 week
Incorrect vaccine give.  Pt is not 65 years of age and should have not received FLUAD 65+.  Pt states she is "feeling just fine."
One day after receiving FLULAVAL patient complained that she was experiencing pain from her shoulder to her chin. Patient didn't receive treatment as of yesterday.
couldn't sleep for 2 days because I sleep on my left side; vomiting; chills; Fatigue; joint pain; headaches; still having nausea; haven't eaten in two days; This spontaneous case was reported by a consumer and describes the occurrence of haven't eaten in two days, couldn't sleep for 2 days because I sleep on my left side, vomiting, chills, and Fatigue in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was Provided by Reporter.     On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced EATING DISORDER (haven't eaten in two days), VOMITING, CHILLS, FATIGUE, ARTHRALGIA (joint pain), HEADACHE, and NAUSEA. On an unknown date, the patient experienced SLEEP DISORDER (couldn't sleep for 2 days because I sleep on my left side). The patient was treated with ZOFRAN at an unspecified dose and frequency. At the time of the report, EATING DISORDER (haven't eaten in two days), SLEEP DISORDER (couldn't sleep for 2 days), VOMITING, CHILLS, FATIGUE, ARTHRALGIA (joint pain), HEADACHE, and NAUSEA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   concomitant medications are not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: The TCR form received does not contain any new information.