chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the SHINGRIX vaccine on Friday 2-16-18. I woke up about 3-4 AM the next morning with a stomach ache, I started to feel nauseous. I was able to go back to sleep eventually. When I woke up the next morning I really felt awful. My muscles hurt. Actually everything hurt, I felt like I was going to be sick and when I tried to get up I was really weak. I also had the chills. Tried to eat some breakfast but didn't really want it. I was able to eat 1/2 a banana and a sip of juice but had to go back to bed because I felt like I could faint. Truthfully, I don't remember ever feeling just all over awful. I was able to sleep for a couple of hours. I checked to see if i had a fever but I didn't. I'm not one to stay in bed so I forced myself to get up. All day it was the same feeling and if I did one thing I was exhausted. I couldn't get rid of the chills either. That's scary. Sunday my arm was really red where I got the shot and it hurt and later on in the day it started to itch. I was still so very tired but started to feel a little more human. Still no appetite. Today is Monday the 19th and I'm much improved but still so very tired and don't quite feel myself.
after 5-6 minutes post vaccination while sitting in waiting / monitoring area, patient got very dizzy and fell off her chair on to the ground. she immediately got up with help from staff and sat back on the chair. paramedics were called on her request and after monitoring and running diagnostics patient asked to be taken to emergency room to be further monitored because she felt dizzy and had bumped her head when she fell off the chair.  she returned a few hours later on her own after getting discharged from the hospital to get her vaccination card.
Monday noted that her vein on the dorsal hand was swollen on left > right hand. Since then swelling and pain has increased and decreased over time. Pain is much better. Seems to come and go. Weakness in hands as well.
1 hour after shot numbness left side of face. 19 hours later extreme fatigue.  24 hours later dizziness.  11 days later extreme anxiety. 12 days later chills, body ache,  fatigue, and anxiety.  13 days later severe ocular migraine.
This spontaneous report as received from a physician via a field representative refers to a 89 year old female patient. In 2008 the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). At some time over the past few weeks, approximately in 2013 the patient developed ophthalmic zoster. The outcome of ophthalmic zoster was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Headache started seven days after vaccine. started with an ocular migraine and then changed to a headache centered on right temple. radiated to scalp and neck unless i took both advil and ibuprofen. Headache lasted ten days and then stopped.
Unnecessary severe pain; Numbness in 2 fingers; Tingling in 2 fingers; Whole arm affected; Even after getting the vaccine later got two more; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced pain (Verbatim: Unnecessary severe pain), numbness in fingers (Verbatim: Numbness in 2 fingers), tingling of extremity (Verbatim: Tingling in 2 fingers), arm discomfort (Verbatim: Whole arm affected) and extra dose administered (Verbatim: Even after getting the vaccine later got two more).  The outcome of the pain and arm discomfort were not reported and the outcome of the numbness in fingers and tingling of extremity were not recovered/not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the pain, numbness in fingers, tingling of extremity and arm discomfort to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the pain, numbness in fingers, tingling of extremity and arm discomfort to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that even after received Shingles vaccine he/she had to later receive two more doses of Shingles vaccine. The patient stated that protect yourself from very unnecessary severe pain. The shingles vaccine left patient with numbness and tingling in two fingers on his/her right hand and his/her whole arm was affected. The patient received extra dose of shingles in error, which led to extra dose administered. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR038386:deletion case
Pt seen 9-4-05 for PE, given DTaP and Varivax in Left thigh, appox. 4pm.On 9-5-08 at 7pm noticed red, hot to touch, hard, grapefruit size area at site of one injection on left thigh.  Seen on office 9-6-2008 the following morning. Dx left ear infection (LOM) and Left immunization site with possible cellulitis vs local reaction.  advised benadryl Q6 hours while awake and put on Cefdinir, warm compresses to area.Left upper lat. thigh imm. site was 8 cm x 8.5 cm erythema and induration. Mom told to call if worse. Per telephone conversation, w/mom 9-8-08, site had faded lots on 9-7-08, but 9-8-08 no hardness can be felt, much lighter, almost a faded bruise look, not hot to touch.  Mom did not give any bedadryl, did give cefdinir.
About 7 days after my vaccination, I started to develop a rash  on my arms 2 inches below my vaccine site. After about 15 minutes it started on the other arm. Then 15 minutes later, it started showing up on my leg. It was very itchy, swollen, but I took Benadryl and went to sleep. I woke up and the rash was gone.
Growing Cellulitus at injection site while high fever, headache and flu-like symptoms, a day after vaccine. Symptoms progressively got worse and went to the E.R. with a temperature of 104. I am continuing to be seen and will have follow-up blood work. The cellulitis has grown and is very painful.
August 25th I noticed a rash on my lower mid back that itched.  Monday nigh august 30th I started to experience neuropathy  pain on my left hip . September 1st Dr. examined my rash and confirmed it was shingles. Also I have not had my ministration and was suppose to get on august 30th according to my period calendar.
Moderna COVID-19 Vaccine EUA Around 4pm on January 14th, left upper arm began to swell and feel sore, becoming very painful, radiating down left arm and up left shoulder and had pins and needles in my left hand and could not really lift my left arm.  Around 5pm I began developing a headache.  At 6:30pm I developed a 101 degree fever, and took ibuprofen 600mg, my headache was more severe, I had chills, body aches and my left clavicle became swollen.  My heart was pounding and I felt short of breath.  The racing heart and breathing resolved by 8pm.  By 1am on January 15th my fever was 101.8, I had significant swelling in my left arm, left shoulder, back of my neck, upper back, and back of my head.  I had a severe headache.  I took ibuprofen 600mg at that time.  The swelling improved by 3am.  By 8:30 am my fever was 100.7.  I took 600mg of ibuprofen again and by 9:30am my temperature was 99.8 degrees.  I continue to have a mild headache and fatigue.
Had the vaccine but it didn't work / Suspected Vaccination Failure; Had the vaccine but it didn't work / Hurts like H; hurts / horrible pain; pain inside and outside on the skin, like knives stabbing me; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the vaccine but it didn't work / Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: Had the vaccine but it didn't work / Hurts like H), pain (Verbatim: hurts / horrible pain) and skin pain (Verbatim: pain inside and outside on the skin, like knives stabbing me). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and skin pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and skin pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and skin pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 12-MAR-2023 The case was received from the patient interactive digital media. The patient stated that it hurted like "H"? The patient had the Shingles vaccine but it did not worked. The patient stated yes absolutely had horrible pain inside and outside on the skin as well.  The pain inside was like knives stabbing me, relentlessly night and day. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and concomitant therapy was not reported. On 23-JAN-2013, the patient was vaccinated with a first dose of (recombinant) (manufacturer unknown) (lot number, dose and route were not reported). On 10-AUG-2015, the patient visited the office to receive a second dose of RECOMBIVAX lot number, dose and route were not reported). No adverse effects were reported. Additional information has been requested.
chills, numbness to right finger tips and sever pain in right arm at injection site down to wrist. Narrative:
Office practice was to draw up all doses from vial in the morning. They did not routinely do a double check and discarded vial. They uses bivalent NDC, lot and expiration that was on a sticky note to enter all data into EMR. At some point they realized that some days they had pulled monovalent and administered instead of the intended bivalent booster.
Fever of 104, stopped walking for 6 days, stopped talking (babbling) for a year and 4mos, stopped socializing (eye contact, interactions of any kind).
This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient tested positive for COVID-19), DRUG INEFFECTIVE (Lack of drug effect) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 026L20A) for COVID-19 vaccination. Co-suspect product included non-company product LEVOTHYROXINE for Hypothyroidism.Concurrent medical conditions included Hypothyroidism.On 05-Jan-2021 at 8:09 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter.On 02-Feb-2021 at 7:51 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter.On an unknown date, the patient started LEVOTHYROXINE (Oral) 88 microgram once a day. Last menstrual period and estimated date of delivery were not provided. On 28-Oct-2021, the patient experienced COVID-19 (Patient tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 28-Oct-2021, DRUG INEFFECTIVE (Lack of drug effect) had resolved. At the time of the report, COVID-19 (Patient tested positive for COVID-19) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 28-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No treatment medication was reported. Company Comment: This is a Spontaneous case concerning a 26-year-old female patient, pregnant, who experienced the non-serious unexpected AESI of COVID-19. Also, the special situations of Maternal exposure during pregnancy and Drug ineffective was reported. The event occurred 8 months and 27 days after the administration of the second dose of the mRNA-1273 vaccine of a proper schedule of product administration (29 days between first and second dose). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious. This case was linked to MOD-2022-473095 (Patient Link). Sender's Comments: This is a Spontaneous case concerning a 26-year-old female patient, pregnant, who experienced the non-serious unexpected AESI of COVID-19. Also, the special situations of Maternal exposure during pregnancy and Drug ineffective was reported. The event occurred 8 months and 27 days after the administration of the second dose of the mRNA-1273 vaccine of a proper schedule of product administration (29 days between first and second dose). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious.
Headache, Fever, EXTREMELY TIRED, EARACHE, CHILLS, PAIN AT INJECTION SITE Narrative:  ADR SYMPTOMS LASTED UNTIL 1/28/2021. HEADACHE AND EARACHE AND FATIGUE RETURNED 1/30/2021  Other Relevant History:
Moderna COVID-19 vaccine, 0.5ml, was administed using supplied needles. During IM injection, the vaccine leaked from the hub where the syringe and the needle connect.  A large drip was seen on patient's arm. Patient also felt the leakage.   Moderna was contacted, and we were given the information that no data exists on what to do in this situation and to use professional judgement. It was decided to administer a second injection, in the same arm (left arm) on the same day, 20 minutes following the first, erroneous administration. We plan to  give the second dose in the series as planned, four weeks later.
they had Covid-19 15 days ago.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (they had Covid-19 15 days ago.) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine (Dose 1), Moderna COVID-19 Vaccine (Booster) and Moderna COVID-19 Vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (they had Covid-19 15 days ago.). At the time of the report, COVID-19 (they had Covid-19 15 days ago.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Caller wanted to know when patient can get the bivalent booster dose since had Covid-19, 15 days ago. Patient was now feeling okay. They had the 2 initial doses of the Moderna Covid-19 vaccine and the 2 booster doses, the last one of which was administered around 9 months ago. No treatment information was provided.
This case was reported by a consumer via call center representative and described the occurrence of pulmonary pain in a female patient who received Influenza vaccine. In November 2015, the patient received Influenza vaccine. In 2015, 14 days after receiving Influenza vaccine, the patient experienced pulmonary pain. On an unknown date, the outcome of the pulmonary pain was unknown. It was unknown if the reporter considered the pulmonary pain to be related to Influenza vaccine. Additional details were received as follows: The patient stated that, 2 weeks ago from reporting date, the patient received a dose of Flu vaccine and now (approximately 2 weeks after vaccination) the patient experienced very soreness in right lung. The patient was curious about the ingredients in this years Flu vaccine.
Infection due to COPD/Infection in lower lobes; This spontaneous case was reported by a consumer and describes the occurrence of LOWER RESPIRATORY TRACT INFECTION (Infection due to COPD/Infection in lower lobes) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD (COPD for 10 years) and Hypertension. Concomitant products included LISINOPRIL for Hypertension.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Oct-2021, the patient experienced LOWER RESPIRATORY TRACT INFECTION (Infection due to COPD/Infection in lower lobes). The patient was treated with LEVOFLOXACIN for Infection, at a dose of 750 milligram once a day. At the time of the report, LOWER RESPIRATORY TRACT INFECTION (Infection due to COPD/Infection in lower lobes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: abnormal (abnormal) showed infection in lower lobes.         The booster dose was scheduled for 11-Nov-2021.  The patient had taken levofloxacin for 7 days for that infection. The patient was not sure if the infection was gone or not.  The patient has completed the antibiotic regimen therapy.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received, contains no new information.
Golf ball size ball of swelling right above collar bone on left side of the neck. It?s painful and moves when it?s touched. Almost feels fluid like. Swelling on neck, armpit, and side of breast by armpit.
Narrative: Covid +, PFizer x 2, resp failure, SOB, cough, fever, fatigue, chills, dec appetite, weakness, hypoxic, hx of CHF, covid pneumonia Oxygen, dex. Outside window of remdesivir. TCU for rehab
pt recv vax 1015AM & mom noticed red splotches an abd & lt forearm & site of inj;mom bathed child & noted dec in redness but 2hr later rash spread to rest of body & was red & elevated;fever;eyes & fingers swollen this AM;
Patient had injection and within 20 minutes began to have tingling in her arms and then swelling in her throat and wretching. Patient was taken to ER by EMS and was given zofran for nausea which resolved. Patient had no other symptoms.
Extremely heavy menstruation over one week after second injection on March 31, 2021. Very unusual since I now only have a light cycle 3 times a year.  First shot was March 10th, experienced only arm soreness.
Patient received third dose Moderna half dose booster 0.25mL in LD on 11/22/2021. The following day 11/23/21 she developed excruciating right shoulder and right neck pain, described as bone breaking pain, on the side opposite the injection site (left arm) . Very painful to move head, arm , twist, or take deep breaths.  Headache also present on right side. Pain escalated the next day and was treated with ibuprofen  400mg every 6 hours. Pain  persisted intensely for about 5 days and then she had gradual decreased over two. She was feeling better 12/14/2021.  She has remote history of inflammatory vs rheumatoid arthritis 3 decades ago which involved right shoulder.
Fever of 101.5 degrees.  Two events of diarrhea and 1 episode of vomiting.
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Injection arm is numb
Rapid and heavy heart beat, tight chest, dizziness, no fever but incredibly hot to the touch.
This spontaneous report was received from a medical assistant and was referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, multiple patients were vaccinated with improperly stored doses of VARIVAX injection, lot number M033904, expiration date 20-JUL-2018, subcutaneously (dose was not reported). The doses of the vaccines were reconstituted with properly stored sterile diluent (STERILE DILUENT). The doses of the vaccine were stored at a temperature of 42 degrees Fahrenheit for 17 hours, and previously at a temperature ranging from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 16 hours (dates of temperature excursions were not provided). The call was not because of a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA003689:
Chills, fever, nausea, headache  Fever spiked pretty high. Episode lasted 12 hours.  Headache still lingering past 12 hours.
It is still red and swollen at the injection site; It is still red and swollen at the injection site; It is warm to the touch; there is still a lump; it is red and sore; This is a spontaneous report from a contactable consumer. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration on arm left 13Mar2021 13:15 (age at vaccination 70-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included alprazolam (XANAX); lorazepam (LORAZEPAM), Vitamins, Unspecified sleeping medicines. The caller stated she had the first dose of this vaccine on 13Mar2021 in her left shoulder. On 14Mar2021, patient stated that it is still red and swollen at the injection site, it is warm to the touch, there is still a lump there and it is red and sore. Consumer asked if this is normal and how long she should expect it to last. She is due for her next dose on 03Apr2021 and said she will get it in the other arm. Reporter states that no medical conditions, she is healthy. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Thirty-six hours after booster shot (around 3:30 a.m. on Dec. 20), I passed out after feeling dizzy and a few minutes after regaining consciousness, I had a seizure that my husband witnessed.  Had a strange feeling throughout my body.  Should have gone to hospital but did not.  Went to bed and never followed up with doctor/hospital because of my busy holiday schedule.
This spontaneous report as received from a pharmacist refers to two unspecified infant patients of unknown age and gender. No historical and current conditions were reported. On an unknown date, the two infant patients was vaccinated with ZOSTAVAX in error. No adverse effects reported. No PQC involved. This case is linked to case 1609USA006501 (same reporter link). Additional information has been requested.
Pain in right shoulder (shot was administered too high). Hurts to move arm in certain directions, hurts to lie on arm.  Sharp pain.  Has not subsided.