chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 20-AUG-2016, the patient was inoculated with ZOSTAVAX in the pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 22-AUG-2016, the patient was treated by the physician for the onset of a severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Loses eyesight in her left eye; Women having multiple cycles/Women having unusual cycles; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS UNILATERAL (Loses eyesight in her left eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reporter by reporter.  Concomitant products included THYROID for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLINDNESS UNILATERAL (Loses eyesight in her left eye) (seriousness criterion medically significant) and MENSTRUAL DISORDER (Women having multiple cycles/Women having unusual cycles). At the time of the report, BLINDNESS UNILATERAL (Loses eyesight in her left eye) and MENSTRUAL DISORDER (Women having multiple cycles/Women having unusual cycles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: Blood Cholesterol 245.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication use information was not provided by reporter.  On an unknown date  the laboratory exams performed to further understand the event included blood work , 2 magnetic resonance imaging and  done and the results were unknown.  Per reporter, patient had no high blood pressure bloodwork and MRIs showed nothing (results not provided) and planned to visit eye specialist.  Company Comment: Very limited information regarding the events has been provided at this time.  Further information  expected.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Followed up received on 8-JUL-2021  No High Blood Pressure and nothing on MRI Blood work. On 08-Jul-2021: Upon internal review on 16-Sep-2022 non-significant corrections performed to update case received from field; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information  expected.
itching and redness on face, neck, and arm on the same side of body where vaccine was administered occurred approximately 2 hours after administration.
Pt was given MMR on 7/10/07 and noticed passed in mail so another was given on 7/13/07. 2 given in 3 day span. No reported adverse reaction.
A week after the injection, redness and swelling at site of injection, soreness in the armpit/lymph node area; lasting at least 3 days, but decreasing over time
Patient received vaccine 12/30, on 1/11 patient noted a circular rash around injection site that is tender and warm to touch
Patients husband said that she normally needs a walking stick to help her get around, but that two days after her second shot she could not get out of bed. She went to the ER, but they couldn't figure out what was going on and sent her home with APAP.  She went back to the ER 5-4-2021 and she was diagnosed with a TIA.
diabetes, overpeeing, always thirsty, headache, upper abdominal pain, fatigue
Received Yellow fever immunization 3-18-09 prior to trip to a foreign country. Developed flashing spells 3-29-09. Received 3 L IVF prior to departure. symptomatology worsened : inability to speak, walk or perform ADL'S. Hospitalized X 3 days. Symptomatology slowly improved. Dx with pneumonia and encephalitis.   4/28/09 Spoke with patient/MD who reports initially felt the perception of a flushing sensation in the head without actual facial flushing or fever.  Received IVF from family member (no medical facility) prior to boarding plane for foreign travel. Aboard the flight pt's family noted that pt c/o H/A, vomited and began speaking incoherently. Now weak and with fever requiring that pt be carried from the plane. Taken to unknown hospital for tx of mental status changes, confusion.  Unable to feed self.  Difficulty in walking.  Dx: Pneumonia however pt says no cough or other PNA sx and that pt does not believe that was the correct dx. D/c somewhat improved after 3 days. Spoke with ID and neuro colleagues upon arrival in this country who say most likely dx was YF vaccine rxn/encephalitis. Almost completely recovered with some residual fatigue and weakness (minimal) and decreased patience.
Rash with blisters like a burn on arm very painful; Rash with blisters like a burn on arm very painful; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Oct2021 at 13:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Sep2021 at 15:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 08Oct2021 at 18:00, the patient experienced rash with blisters like a burn on arm very painful. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash with blisters like a burn on arm very painful was resolving at the time of the report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
7:45 P.M. shortly after the injection (about 0 minute) my head started to whirl - got lightheaded - felt like I was going to pass out. Also it increased the tinnitus that I have in my ears to a very high pitch - this lasted about 5-10 minutes. Felt washed-out the rest of evening
PAIN INJECTION SITE, HEADACHE, CHILLS,PAIN ON JOINTS, TIRED,FEVER BODY PAIN. SINTOMES FOR 3 DAYS.
pt recv vax 22APR96 12PM&@ home mom gave amoxicillin&p/noticed pt turning blue&shaky;pt was brought back to clinic 1PM;seen by MD;t100.0,P52,RR60,BP 80/60;pt spacey then shaking all over&sleepy;on exam pt mottled cool extremities
In the early to mid afternoon the patient developed redness of the eyes, chest pain, upset stomach, fever, and chills.  Patient denied any local site reactions. 'Chest pain' description was ambiguous.  Did not sound like cardiac in origin.  Was referred to physician or call 911 nonetheless.  Patient called physician. Was told to stay home and 'lay low' for 48 hours.  Following up with patient about 20 hours after initial call with complaint, patient said all symptoms had resolved entirely or mostly.  Chest pain completely resolved.
This spontaneous report as received from a other health professional refers to a 20 year old patient. The patient's medical history included tonsillitis. Her concurrent conditions and concomitant therapy were not provided. On 14-DEC-2017, the patient was vaccinated with GARDASIL 9 (dose, frequency, lot# and expiration date were not provided) for prophylaxis. On an unspecified date in January 2018, the patient had bruising, some tenderness and unspecified rash on both knees. However, it was clarified that the rash did not appear at the injection site. On 20-JAN-2018, the patient complaint of pain when bending both knees (arthralgia). On an unspecified date, the patient visited the urgent clinic and was prescribed with unspecified antibiotic which helped with the joint pain in her knees. However, the outcome of contusion, arthralgia, rash and tenderness was unknown. The causal relationship between GARDASIL 9 and the above mentioned events was not provided.
nausea, injection site pain, lymphadenopathy Narrative: 53 yo female with unknown past medical history reported having injection site pain, nausea, lymphadenopathy for 4 days after her first dose of vaccine on 2/9/2021. Pt stated that symptoms started 2 hours after the vaccine and lasted for 4 days. This ADR was reported on 3/2/2021 when patient returned for the second dose of vaccine.
Patient received a third pfizer shot when first two shots were moderna.  Patient confirmed Pfizer vaccine was appropriate but did not have vaccine card.
pt recv vax 17DEC98 & 20DEC98 pt devel fever of 100.9;22DEC98 became fussy @ feedings & devel nocturnal restlessness;had no bowel movements between 17DEC98 & 22DEC98;next day was eval by MD & p/given laxative had bowel movement;devel hives;
NO ADVERSE EVENT OCCURRED  A 17 year old EMS worker who was coming through out COVID-19 vaccination clinic received the vaccine.  At the time, no one realized he was only 17 years old.  Since the vaccine is only indicated for 18 years or older adults, I thought it best to report it here since it was technically an error.   I spoke with the patient on 12/31/2020 to notify him of the error and he felt fine.  He had no adverse reaction to the vaccine
Extreme muscular leg pain, in both legs.  Started in the evening of the day of the shot.  Took 400mg ibuprofen to help, and it did.  Following day, the day after the shot, leg pain was gone.   In the middle of the night (Sept. 3, early morning around 3 AM) woke from sleep to heart racing.  Didn't feel quite right, got up out of bed and felt faint. Went back to bed to lay down and fell asleep.  Upon waking at daylight, heart racing continued all day until late evening of Sept 3.  Contacted doctor Sept 3rd to notify that bpm was fluctuating from 80-127.  At 3:08 pm, my resting bpm was 117.  Heart palpitations throughout day.
Moderna- 01/23/2021 C19 dose #1 Moderna- 02/20/2021 C19 dose #2 8/13/2021- Pt reported cough with green sputum, dizzy, positive test from 8/2/2021, constant headache and GI issues  8/15/2021- came to ED with same symptoms and worsening, no vomiting, known C19 positive from 8/2/2021 while visiting family in another location, no Covid testing in ED
Had us down; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that the 2nd shingles shot had him/her down for 12 hours and was fine at the time of reporting. This case has been linked to US2022AMR046621, reported by the same reporter. The follow-up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR046621:Same reporter.
Within 8 minutes if getting the vaccine, I had immense pressure in my head and ear, a floating sensation, legs felt like rubber, severe pressure headache with waves of cool and warm sensations throughout my body. I turned extremely pale. My blood pressure was slightly higher than usual. They gave me BENADRYL. The intensity lasted for 2 hours. The next day it started back and never ended. I got vertigo and brain fog on top of everything. Now my immunoglobins are off. My IGG and IGM are low. My IGA is elevated. My kappa Lambda ratios are abnormal. I am high in lambda and have a protein 2M spike of .2 and a protein M1 spike of .1. I have severe panic attacks with depression and anxiety. I have headaches every day. The tingling in my extremities continues in the top and bottom area. I was given steroids with seem to do the best. I was also placed on FLONASE and that has helped with the headache. I am seeing a psychologist for the depression and anxiety. I have declined some treatment because I feel like they are just grasping. Medications that I took prior to the vaccine are not causing anaphylaxis. I ended up in the ER from taking azithromycin which I have taken many times before. I have been following the directions of the COVID-19 clinic. I have had 2 gynecological viral infections that I never had prior to so I know it's doing something to my immune system.
Within a few hours of vaccination pt experienced sore arm, rash to upper body, then fever.
Pt experienced malaise, pain, tingling in both hands for 12 hours. Pt later, felt myalgia that lasted for two weeks, post vax. After 2 weeks, pain remains in hands and feet.
1345 Participant complained of stiffness & numbness (R) arm, and continued to 4th & 5th digit. Vaccine site was WNL, no inflammation or irritation present. No signs of distress. Advised to follow up with PCP or emergency rm if continued.
fever, distinct macular violacious rash on face + occipital lymphadenopathy; re-check several days later had resolved * imp: atypical rubella secondary to vax
This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a female patient who received FLUARIX (batch number 7HZ73, expiry date 30th June 2016). On 31st October 2015, the patient received FLUARIX (intramuscular). In 2015, less than a week after receiving FLUARIX, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unchanged. It was unknown if the reporter considered the injection site lump to be related to FLUARIX. Additional details were provided as follows: This case was not previously reported to anyone. The consumer called the reporter to inform that she experienced lump at injection site (left arm) after vaccination with FLUARIX. The call was transferred to Medical Information. No further details were available regarding the lump at the time of reporting.
The vaccine registry was down when we gave the 2nd dose of Pfizer vaccine and when the system came back up to check this was actually is 4th dose of vaccine.
Patient reports dizziness and fainting. Upon assessment, pt. was diaphoretic and pallor. Put pt. on oxygen at 10 LPM. Took vitals BP: 76/46, O2 at 99% on 10L of oxygen, HR 45. Placed patient down on the ground with legs elevated. After 15 minutes, pt. reports feeling better. Retook vitals: BP: 129/82, 97% on room air, and HR 73. Informed patient to monitor for worsening symptoms at home and drink plenty fluids at home.
Fever; Headache; Sick to stomach; Trouble eating; Insomnia/ trouble sleeping for almost 48 hours; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 24Apr2021 at 13:15 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included PROPRANOL, ABILIFY, WELLBUTRIN, and ALLOPURINOL, from an unknown start date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 03Apr2021 at 13:30 at the age of 28-year-old as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021, the patient experienced fever, headache, sick to stomach, trouble eating, insomnia/ trouble sleeping for almost 48 hours. The patient could almost fall asleep in a haze but then had been shooting back awake. The patient had never felt like he was fully asleep. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event fever, headache, sick to stomach, trouble eating, insomnia, and trouble sleeping for almost 48 hours were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/26/2023 SHORTNESS OF BREATH I21.4 ACUTE NON ST ELEVATION MI 4/14/2023 SHORTNESS OF BREATH G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/26/2023 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 4/14/2023 ACUTE NON ST ELEVATION MI
Initial unsolicited report received from a pharmacist on 26 October 2016. This case involves a 68-year-old male who was vaccinated with a dose of Fluzone Hd (batch number: UI712AA, expiry date: 25 May 2017) intramuscularly in left deltoid and dose of Pneumovax (batch number, expiry date and route of administration was not reported) in left deltoid on 11 October 2016. Illness at time of vaccination includes none reported and pre-existing physician diagnosed allergies, birth defects, a medical condition was reported allergies: none known. Concomitant medication was not reported. On 11 October 2016, same day following the vaccination, patient experienced pain in entire left arm that limits movement and was unable to sleep due to the pain. Lab data and corrective treatment were not reported. Patient was not recovered from events. List of documents held by sender: none.
labeling of proquad should be much larger, a more obvious color differential, different font size and include the word "combination" on it; the unspecified 12 month old patient was inadvertently administered one dose of PROQUAD and one dose of VARIVAX; No adverse effects reported.; Information was received from a physician referring to a 12 months old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were unknown.  On an unknown date, the patient was vaccinated inadvertently with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose detail, strength, route, lot#, expiration date were unknown) and one dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose detail, strength, route, lot#, expiration date were unknown) for prophylaxis (accidental overdose). No adverse effects were reported.   The reporter stated that the labeling for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) should be much larger, a more obvious color differential, different font size and include the word 'combination' on it (product label issue).
Chilling, inc temp 100.4; Dad states inject site somewhat swollen, no redness, told to give APAP & DPH;
Arrhythmia; Palpitations; Feels like something is not ok//like heart does something and then she doesn't feel it anymore; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia), PALPITATIONS (Palpitations) and FEELING ABNORMAL (Feels like something is not ok//like heart does something and then she doesn't feel it anymore) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 045A21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ARRHYTHMIA (Arrhythmia), PALPITATIONS (Palpitations) and FEELING ABNORMAL (Feels like something is not ok//like heart does something and then she doesn't feel it anymore). At the time of the report, ARRHYTHMIA (Arrhythmia), PALPITATIONS (Palpitations) and FEELING ABNORMAL (Feels like something is not ok//like heart does something and then she doesn't feel it anymore) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported. Also it was stated that patient doesn't have any history of Myocarditis/pericarditis and COVID-19 infection.  Company comment: This  spontaneous case concerns a 36-year-old female patient with no medical history reported, who experienced the unexpected non serious event/AESI of Arrhythmia after mRNA- 1273 Moderna vaccine. The onset of the event occurred 2 to 4 days after the booster dose of mRNA- 1273 vaccine. Patient experienced palpitations, but medical consultation was not done.  The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This  spontaneous case concerns a 36-year-old female patient with no medical history reported, who experienced the unexpected non serious event/AESI of Arrhythmia after mRNA- 1273 Moderna vaccine. The onset of the event occurred 2 to 4 days after the booster dose of mRNA- 1273 vaccine. Patient experienced palpitations, but medical consultation was not done.  The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
SWELLING ON THE SIDE OF FACE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: bell's palsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced swelling on the side of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swelling on the side of face was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
low grade fever 98.5, achey all over, pain urinating, headache, swolen@ injection site with pain