chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus and ringing in the Right Ear; Cannot sleep at night; Pressure in her head; Inflammation in her head; Migraine headache on the left side of her face; Fever; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (Tinnitus and ringing in the Right Ear), INSOMNIA (Cannot sleep at night), HEAD DISCOMFORT (Pressure in her head), INFLAMMATION (Inflammation in her head) and MIGRAINE (Migraine headache on the left side of her face) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced HEAD DISCOMFORT (Pressure in her head), INFLAMMATION (Inflammation in her head), MIGRAINE (Migraine headache on the left side of her face) and PYREXIA (Fever). On 05-Apr-2021, the patient experienced TINNITUS (Tinnitus and ringing in the Right Ear) and INSOMNIA (Cannot sleep at night). On 27-Mar-2021, PYREXIA (Fever) had resolved. On 05-Apr-2021, HEAD DISCOMFORT (Pressure in her head), INFLAMMATION (Inflammation in her head) and MIGRAINE (Migraine headache on the left side of her face) had resolved. At the time of the report, TINNITUS (Tinnitus and ringing in the Right Ear) and INSOMNIA (Cannot sleep at night) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-089220 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089220:
Area of erythema, induration, pain from axilla to elbow inferior to site of injection. Pain also present. No respiratory distress.
STUDENT BECAME PALE AND WEAK 19 MINUTES AFTER RECEIVING H1N1 VACCINE.  STUDENT REMAINED CONSCIOUS AND STEADILY IMPROVED AFTER RESTING AND DRINKING WATER.  BP STABLE AT 90/62
White blood cells are also affected; Her spleen doesn't work like it should; Low white blood cells count; Noticed that the "shot was running out of her arm" the vaccination provider was mopping it but she is concerned she did not receive the full dose.; Received the third dose; Received the third dose; Feels uncomfortable/Just feel like I already am missing the parts in my blood; Lymph node sides are low; she thinks that it wouldn't hurt her to re-do the vaccine because she needs the maximum dose since she's immunocompromised; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 29Aug2021 as dose 3, single for COVID-19 immunization. Medical history included end stage liver disease (pre-existing immunocompromised medical conditions), hemochromatosis (pre-existing immunocompromised medical conditions), hepatitis C (pre-existing immunocompromised medical conditions), blood damage from severe cirrhosis (pre-existing immunocompromised medical conditions), spleen itself doesn't function as well because it's like more than double the size, it's huge, it's enlarged to a gross amount in my stomach (goes down beyond/below my belly button, it's way out of my ribs like into my abdomen), so it's not working properly and called it hypoplasia and immunocompromised. The patient's concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as dose 1 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 08May2021, as dose 2, single for COVID-19 immunization. On an unspecified date, the patient white blood cells was also affected, her spleen doesn't work like it should, low white blood cells count, noticed that the shot was running out of her arm the vaccination provider was mopping it but she is concerned she did not receive the full dose, received the third dose, felt uncomfortable/just felt like she was already missing the parts in her blood, lymph node sides are low and she thought that it wouldn't hurt her to re do the vaccine because she needs the maximum dose since she's immunocompromised. On an unspecified date, the patient underwent lab tests and procedures which included low white blood cell count. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Soreness in left arm, but not severe by any means.  By 8pm, felt chills. By 10pm, had 99.6 fever. Took one Tylenol 500mg. By 5am, has 100.8 fever. Took two 500mg Tylenol. By 10am, has no fever. Just tired and a little weak. Rested throughout the day and felt better. No more fever since. Feel a little odd numbness  on my tongue, but no lost  of taste. Still have the odd numbness on the tongue. All other symptoms are gone (still a little sore in the left arm, but not a big deal).
Sick; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via Social media.  This case is linked to case 2020SA292550 (same reporter)  This case involves a patient (demographics unknown) who was sick (illness), when received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number: not reported; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. Every time when the patient received the vaccine the patient got sick. The patient had not received the flu shot since they retired (date unspecified) and did not get sick even once.  It was unknown if the patient experienced any additional symptoms/events  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 7th February 2018, the patient received the 1st dose of SHINGRIX .5 ml. In February 2018, 1 day 6 hrs after receiving SHINGRIX, the patient experienced injection site pain, dizziness, headache, skin warm, chills and increased blood pressure. In February 2018, the outcome of the injection site pain, skin warm and increased blood pressure were recovered/resolved. On an unknown date, the outcome of the dizziness, headache and chills were unknown. The reporter considered the injection site pain, dizziness, headache, skin warm, chills and increased blood pressure to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced a little soreness at the injection site, facial warmth and her blood pressure was elevated to 183 per 85 however it was back to normal at the time of reporting. The reporter advised the patient to consult with her doctor. The patient told to the reporter that, she wanted to be contacted by someone directly.
Menstrual cycle 5 days early and three to four times as heavy as normal.  Almost no coagulation, extremely high flow. Terrible cramping above my endometriosis normal cramping. Very weak after 12 hours of heavy flow.
patient called regarding swelling at injection site on arm.  she said she had a lot of swelling at injection site and it was about the size of half of an egg. patient said it started about 1 & 1/2 hours  after dose was administered
I have developed hives and was prescribed famotidine and prednisone. These helped a little but I am still suffering with hive like rashes. When I scratch myself you can see where I scratched after a few minutes.
2/2/21 pm-chills, 2/3/21 chills, fever 101.0 F, shortness of breath, body aches, nausea and painful injection site. 2/4/21 body aches, other symptoms resolved.  Did not seek medical attention.  Took Tylenol & liquids.
Systemic: Dizziness / Lightheadness-Medium, Systemic: possibly drop in heart rate but bp was normal at 110/70. measured twice-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: blood pressure and heart rate was measured. Pt described as "not feeling well" and possibly feel weak and dizzy. symptoms resolved afte rabout 30 minutes.; ambulance was called and bloodpressure and heart rate was also checked again by emt. pt was found to be normal and did not need to go to er.
C-section delivery, no complications. Hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions, historical conditions or concomitant therapies were reported. On 0n 01-JUL-2016, the patient was vaccinated with improperly stored MMR II (lot # L024265, expiration date 01-JUL-2017, route of administration not provided). The vaccine was stored in an improper temperature of 50.8F for a cumulative period of 38 hours. The temperature excursion was captured by digital data logger. No adverse effects were reported. Additional information has been requested. This is one of the several reports received from the same reporter.
Arm soreness to the touch for a few weeks after first dose/pain in the arm; Sharp pain for 4 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sharp pain for 4 days after first dose) and PAIN IN EXTREMITY (Arm soreness to the touch for a few weeks after first dose/pain in the arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sharp pain for 4 days after first dose) and PAIN IN EXTREMITY (Arm soreness to the touch for a few weeks after first dose/pain in the arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sharp pain for 4 days after first dose) had resolved and PAIN IN EXTREMITY (Arm soreness to the touch for a few weeks after first dose/pain in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug information was reported.   This case was linked to MOD-2021-039270 (Patient Link).
Strong pain; Itchy throat; Cough; Fever; Nausea; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Strong pain), THROAT IRRITATION (Itchy throat), COUGH (Cough), PYREXIA (Fever) and NAUSEA (Nausea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN (Strong pain), THROAT IRRITATION (Itchy throat), COUGH (Cough), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PAIN (Strong pain), THROAT IRRITATION (Itchy throat), COUGH (Cough), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants or treatment medications were reported.
heart racing which patient to be admitted caused admitted to hospital; slept day and night; thought she was going to die; not eating; severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing which patient to be admitted caused admitted to hospital) in a 56-year-old female patient 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PALPITATIONS (heart racing which patient to be admitted caused admitted to hospital) (seriousness criterion hospitalization). On an unknown date, the patient experienced HYPERSOMNIA (slept day and night), FEELING ABNORMAL (thought she was going to die), DECREASED APPETITE (not eating) and HEADACHE (severe headaches). The patient was hospitalized on 07-May-2021 due to PALPITATIONS. At the time of the report, PALPITATIONS (heart racing which patient to be admitted caused admitted to hospital), HYPERSOMNIA (slept day and night), FEELING ABNORMAL (thought she was going to die), DECREASED APPETITE (not eating) and HEADACHE (severe headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported.  Patient's mother state that the patient had vaccine a week ago (Date unknown). On an unknown date the patient had severe headaches, slept day and night, not eating, thought she was going to die and heart racing which caused admitted to hospital on 07-May-2021.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Generalized edema L arm from elbow to shoulder and torso itching, diaphoretic, no SOB. Heart 90, resp 20 B/P 142/6/. 25mg Benadryl PO, 60mg Prednisone PO.
Fever got up to 101.2F, legs swollen and red. Child would not let you touch him from waist down. Lasted till late PM on 7/27/05. Gave Tylenol for fever and pain. On 7/28/05, child is doing better but legs still swollen.
Reports throat feels "Itchy" with mild chest tightness.  VS stable. Resolved during observation time period.  VS stable when left medical observation to go home.
Patient c/o felling faint, light headed, SOB, nausea, but no vomiting with pain at the injection site  with in 3hours.  Patient was advised to go to er.
NAUSEA AND VOMITING. HAD TO CALL 911. PATIENT WAS LOSING CONCIOUSNESS. PATIENT FELT BETTER AFTER VOMITING AND DID NOT NEED HOSPITAL VISIT. EVEN THOUGH IT WAS RECOMMENDED.
Hoarseness, sore at injuection site, dizzy, skin sore to touch, cloths rubbing, chest tightness, aches
Area on lt lateral leg - red rough, non tender area - 3 cm x 1 1/4 - at site of varicella - onset 10/6/14. Followed by wide spread red, papular rash, temp - 102.4 - onset 10/5. Duration 4 days.
This spontaneous report as received from a certified medical assistant (C.M.A.), refers to a patient of unknown age and gender. On 08-AUG-2013 the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose and route not reported), instead of ZOSTAVAX (Merck). No product confusion discovered, just medication error. No adverse event reported and no other information to report. Additional information is not expected.
Fever- Information has been received from a consumer conserning her daughter who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Sebsequently, the patient developed a high fever.  Additional information has been requested.
Erythema and swelling to left upper arm. Started 2/25/20. Pain started at 5:00pm on 2/24/20.
No additional AE reported.; Caller reports a dose of MMR II was administered intramuscularly. No additional AE reported. No PQC reported.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, drugs reactions or allergies and concomitant medications were not reported.  On 14-APR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) lot # U022983, expiration date: 22-JUL-2023, 0.5 milliliter, intramuscular for prophylaxis (incorrect route of product administration). No additional adverse events reported.  The lot # U022983 was verified to be valid number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (expiration date: 22-JUL-2023).
Patient reported that an hour or two after receiving second dose of Moderna vaccine, he had excrutiating pain on the left side of his skull and vision problems. He has been seen by his PCP for follow-up and other causes of symptoms are being investigted.
Information has been received from a registered nurse concerning a 4 year old female with  no past medical history or allergies who on 11/01/2000 was vaccinated with varicella vaccine. On the same day the pt was vaccinated with MMR vaccine, IPOL vaccine, Prevnar vaccine, and diphtheria toxoid/pertussis vaccine/teta. Subsequently, on 06/20/2001, the pt developed varicella lesions at least 50 which were atypical in appearance. The RN further stated that the lesions were multiple pink macules and few vesicles on the pt's trunk, under her chin, uttocks, lower extremities, hands, feet, mouth and scalp. she had no fever or any other complaints. The pt sought unspecified medical attention. No further info is available.
worse side effects after the second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (worse side effects after the second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 ADVERSE DRUG REACTION (worse side effects after the second shot). At the time of the report, ADVERSE DRUG REACTION (worse side effects after the second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I had a swelling in my throat that lasted about 45 minutes that started about 20 minutes after dosage. Had heart palpitations for 1 1/2 days.
This spontaneous report was received from a office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In December 2015, the patient was vaccinated with a dose of VAQTA 5/1.0 U/ml (dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. Then, on 13-JUN-2017, the patient was vaccinated with other dose of VAQTA 5/1.0 U/ml (lot # N005605 with expiration date of 08-APR-2018; dose, route and anatomical location were not provided), also for prophylaxis, which was outside of the prescribing information. No adverse effects were reported. Additional information has been requested.
Gradual diagnosis of increasing drowsiness first noted by parents June, 2010 and steadily worsening over next 1-2 years finally with diagnoses of classic narcolepsy after sleep testing in 1/2013.
trigeminal and occipital neuralgia; trigeminal and occipital neuralgia; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   On 29-OCT-2014 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster)(for prophylaxis). Shortly after receiving inoculation, the patient suffered sharp stabbing pain in the back of his lower head, left ear, and left upper quadrant and was diagnosed with trigeminal and occipital neuralgia.  As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live(ZOSTAVAX), patient sustained severe and permanent personal injuries. further, as a tragic consequence of wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.
No further AE; PCC transfer RN calls to report VAXELIS and ROTATEQ given during a TE.  No further AE.  No PQC.  See TE case 02473804; This spontaneous report was received from a registered nurse and refers to a unknown patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-SEP-2023, the patient was vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, one time, lot #u7535aa, expiration date: 23-SEP-2025, administered for prophylaxis (strength, and route of administration were not provided); and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, one time, administered for prophylaxis lot #X007337 and expiration date 29-OCT-2024 (strength, lot #, expiry date, and route of administration were not provided). Those vaccine underwent temperature excursion before administration (Product storage error). No additional adverse event was reported (No adverse event).