chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upset stomach; red rash at injection site; red rash at injection site; Sore arm; past 36 days from first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ABDOMINAL DISCOMFORT (upset stomach), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past 36 days from first dose), INJECTION SITE RASH (red rash at injection site) and INJECTION SITE ERYTHEMA (red rash at injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032L20A) for COVID-19 vaccination.     No relevant medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and METOPROLOL for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past 36 days from first dose). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), INJECTION SITE RASH (red rash at injection site) and INJECTION SITE ERYTHEMA (red rash at injection site). On 15-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach). On 11-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past 36 days from first dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), INJECTION SITE RASH (red rash at injection site) and INJECTION SITE ERYTHEMA (red rash at injection site) had resolved and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown.            No treatment medication was reported.  Action taken with mRNA-1273 with respect to events was not applicable.
This spontaneous report was received from a  doctor of pharmacy concerning an approximately 66 year old patient of unknown gender. On 10-OCT-2013, the patient was vaccinated with an expired dose of, 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as H013020 and 09-OCT-2013 respectively), subcutaneously. No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Parasthesia- numbness and tingling bilateral upper and lower extremities with most symptoms primarily on right lower extremity
Patient received shingles vaccine in (L) arm. Within 24 hours started breaking out in itchy patches of blisters. Started under neck, then down underside of (R) arm & one spot on (R) inner thigh. Came back to clinic & diagnosed with shingles. Treated with ZOVIRAX Cream & triamcinolone 0.1% cream. Instructed patient to return to clinic tomorrow if symptoms worsen.
Breakthrough case admission after two vaccines Pfizer 6/22/22 Lot# FM7553;  Pfizer 7/13/22 Lot# FM7553
Pt presented for medical care related to her anthrax vaccination that she received on 17 Feb 08, prior to deploying.  Previous to this, for both of her two (2) anthrax shots, she developed large local reactions requiring incise and drainage per the pt.  Today she notes that, after receiving the vaccine, she had developed a large swelling of the area that was very painful to even light touch.  She noted that this was different from the first two in that it developed so quickly.  She denied any difficulties breathing or other rash.  Upon examination, the area of vaccination (right mid-lateral upper arm just ont he lateral border of the biceps) was extremely indurated with swelling measuring about 12cm in diameter and raised approximately 1 cm.  There was some fluctuance, warmth, and extreme tenderness.  The area was incised but only bloody return.  Cultures were not available to rule out cellulitis and the patient was started on Cipro for possible cellulitis (pt is PCN-allergic).
Patient reports itching on back and chest area. No rashes or hives present; patient reports feeling better after a few minutes and was cleared by EMS
15 minutes after her vaccine, I went to check on the employee and she stated she didn't feel well. She was brought into an office for further evaluation. She stated she felt that her mouth was "foamy", had shortness of breath, and that she was hot. She was instructed to remove her lab coat and sit down. Vitals were monitored: BP-122/80, pulse- 76. A damp paper towel was placed on her neck and she was given a water and granola bar. She denied difficulty breathing. Approximately 5 minutes after that, she stated she couldn't swallow. EMS was activated at 08:55. An EPI PEN was administered at 09:00 in the right thigh. EMS arrived at 09:03 and the decision was made to transport her. She requested to be transported to the Facility. They left the center at 09:08.
Bottom lip is tingly; Back hurting; Nerve pain in both her jaws; Both sides of her jaw hurt like throbbing nerve pain; Mouth pain was in the back by the molars; Flu like symptoms; Gums started feeling inflamed; Dry pain in the gum area; Left arm was sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vaginal bleeding. Concomitant products included Herpes zoster (Shingrix).   On 6th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 6th October 2019, less than a day after receiving Shingrix, the patient experienced gingival inflammation and gum pain. On 7th October 2019, the patient experienced influenza-like symptoms. On 10th October 2019, the patient experienced back pain, nerve pain, jaw pain and oral pain. On 14th October 2019, the patient experienced tingling lips. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, gingival inflammation, gum pain and influenza-like symptoms were recovered/resolved and the outcome of the back pain, nerve pain, jaw pain, oral pain and tingling lips were unknown.   It was unknown if the reporter considered the pain in arm, gingival inflammation, gum pain, influenza-like symptoms, back pain, nerve pain, jaw pain, oral pain and tingling lips to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. The patient stated that her left arm was sore for 2-3 days then resolved The patients gums started feeling inflamed as if she had eaten glass, gum pain. The patient stated that the pain was the gum area above the 4 top teeth and below the bottom 4 teeth. The patient had a flu-like symptoms. The patient had back hurting and also both sides of her jaw hurt like throbbing nerve pain. The mouth pain was in the back by the molars but they looked normal. The mouth pain was intermittent. The patient experienced the right side mouth jaw pain which woke her up in the middle of the night. The patient also felt that her bottom lip was tingly. Under her tongue and on the right side she is feeling a painful radiating nerve mouth pain on the upper and lower. The patient stated that the flossing helps the pain. The patient stated that she was not a hypochondriac. The patient do not go to the physician all the time but she already talked to her dentist about the events occurred  and was going to see the MD. The patient mentioned that something which consider to be medical history regarding one time she went to the doctor because she had vaginal bleeding and how it was good that she went to the MD because she ended up needing surgery on her uterus. This case has been linked with case US2019186112, reported by the same reporter.
I was having pain in my right rib cage but thought it was gas so I ignored it. In the night it became severe and couldn't breathe. My wife noticed and rushed me to the emergency room. They told me  they found pulmonary embolus in my lungs. I've never had lung issues before in my life. They put me on blood thinners for the rest of my life. They can't identify what caused the issue since I never had any injury. Every now and again I still feel a bit of pain.
3 Days after the 2nd Covid shot my daughter started her period despite the fact that she is on birth control daily to help with bad menstrual cramps and migraines that seem hormone triggered and she hasn't had a period for a few months. After the 2nd shot her period came back within days and lasted for two weeks which has never happened in her entire life and is not normal in my experience for any woman. It was heavier than normal bleeding for longer than she has ever experienced. Then again the next month she got a very painful period again despite taking her Norlyda pill as prescribed daily. It really seems like all of this was connected to her receiving the second vaccine. A friend of mine warned us of this as it happened to her too and her periods had been regular her whole life so it really stood out to her too as abnormal. Our greatest concern is for our daughter's future fertility.
Patient went to doctor's office for ongoing care for arthritis.  Within 2-3 days of vaccine, it affected left side. Started to feel weakness on left arm, it got numb, and then arm became unusable within 72 hours.  On Tuesday called doctor to report it and told to go to the ER if it gets worse. Patient called doctor's office every day through Friday. On Friday, arm turned purple and blew up like a balloon/eggplant, site painful and weakcould barely lift it.  On 8/24, patient went to ER and they were baffled with arm--suggested it could be a muscle tear.   Rheumatologist provided the referral to orthopedic doctor.   On 8/25 patient went to Dr. (orthopedist) did not do any testing but thought it was not a muscle tear but a neuropathic reaction to vaccine.  Doctor increased Prednisone dose but did not help much.  Patient has seen several specialists listed and regular doctorsee below.  Rheumatologist would have most complete record from all specialists.  Per the specialists, they could not prove it was not the vaccine.   After 3 weeks, swelling started to improve and bruising took 6 weeks.    Patient tapered off tapered Prednisone back to 10mg within 2 weeks.   Patient went to Dr. (neurologist) who helped him with care for the Flu vaccine adverse events.  Visually there is improvement on arm but pain and strength has not improved. Strength on arm is getting worse over time and cannot even straighten arm. Problems that occurred with Flu vaccine were ongoing.
Chills  and body aches - began 12 hours after injection lasted 12 hours Headache and fever - began 18 hours after injection lasted 24 hours.  Pain at injection site - began 6 hours after injection lasted 48 hours.  Feeling  ?hung over? - tired, brain fog, slow moving - began 18 hours after injection lasted 12 hours
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
rash that started out on same arm of vaccine 1 wk post 2nd covid vaccine that has spread to rest of body.  presents like allergic dermatitis.  other causes for allergic dermatitis were ruled out
tired; weak; coughing; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the left arm on 01Apr2021 at 13:30 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. Medical history included heart condition. The patient did not have a history of allergies to any food or medications or other products. The patient received unspecified medications within two weeks prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021, after nine days of vaccination the patient experienced still tired, weak and coughing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of the events tired, weak and coughing was not recovered at the time of report.    No follow-up attempts are needed. No further information is expected.
Fine on wake up day after vaccine.  Approx 8:30 AM noticed fever.  99.1, slowly and steadily increased to 100.9 over the day.  Flu like symptoms with body aches and headache all day.  Symptoms controlled by Acetaminophen.  Feeling fine on wake up 2 days after vaccine.  Also note that lot #'s of vaccine were difficult to read as they were handwritten, so I'm not confident in those codes.
Anaphylaxis, respiratory distress, tachypnea, rapid heart rate, hives head to toe, swollen shut eyes, swollen lips, tongue & throat.   911 called, Epi Pens x3 used, benadryl, solumedrol, IV fluids, protonix all given
No adverse events known at this time. We are reporting an administration error where the patient received the incorrect vaccine and dosage for their age. Patient received a full dose of Pfizer-BioNTech COVID-19 vaccine.
ran fever of 102 @ 530PM on 4NOV94 felt achy all over; tx APAP; 5NOV94 @ 1PM fever of 100.4; treatment APAP; @ 545PM fever of 99.6; 6NOV94 @ 1PM nl 98.8 @ 6PM 99.6; on 7NOV94 1PM t97.6;
17 year old patient received first dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received first dose of Moderna COVID-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received first dose of Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received first dose of Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications and No Treatment medications were reported.
Severe pain in left shoulder. Limited range of motion. Oct 10,2021,  I went to orthopedic Dr and was diagnosed with injury due to administer of vaccine, It was given too high up on my arm.  I was given a cortisone shot, however I am still in pain and with limited range of motion.   I called the pharmacy and they were unconcerned.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:01/08/21pfizer,Lot#EL3248 2nd dose: 01/29/21Pfizer,Lot# EN5318 Diagnosed covid positive:04/20/21 Exposure: Symptoms:
I tested positive for COVID19 in December and had developed a slight ringing in my left ear (tinnitus) due to the virus. After I took my first dose of the vaccine the tinnitus became much louder and noticeable and is still very loud. I did not have a noticeable increase after my second dose of the vaccine. It stayed consistent throughout.
Patient came to the pharmacy the day after getting a flu shot with a red rash on the arm of the injection that extended to the elbow. I advised him to contact his doctor because I was unsure if it was just a rxn or an infection.
diluted with sterile water and administered it; diluted with sterile water and administered it; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30th April 2023) and (batch number T014300, expiry date unknown) for prophylaxis.   On 15th August 2022, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 15th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 17-Aug-2022. Reporter's comment: The pharmacist stated they accidentally diluted Menveo with sterile water and administered it to patient. The reporter consented to follow up. Additional Supportive Information: Accidentally diluted Menveo with sterile water and administered it to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was linked with the case US2022120207 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022120207:Same reporter
Fully vaccinated with Moderna and contracted Covid19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Fully vaccinated with Moderna and contracted Covid19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Fully vaccinated with Moderna and contracted Covid19). At the time of the report, COVID-19 (Fully vaccinated with Moderna and contracted Covid19) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.  Company comment:This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced non-serious unexpected event of special interest (AESI) COVID-19. The event occurred unspecified time after the second dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced non-serious unexpected event of special interest (AESI) COVID-19. The event occurred unspecified time after the second dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Child was given adult tetanus 8/26/03-child showed his arm to mom 8/29/03-localized hive -? at site of injection. No respiratory sx. Applied Benadryl topical cream to site-doing fine. Meds: Prilosec, Zantac, Reglan.
A month after the Vaccination want to donate blood and for the first time in my life and now I have high blood pressure
This spontaneous report received from a health care professional concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced down for 6 hours with exhaustion. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of down for 6 hours with exhaustion was not reported. This report was non-serious. This case, involving the same patient is linked to 20220413004.
I tested positive for the COVID-19 (omicron); I tested positive for the COVID-19 (omicron); Dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Oct2021 (Lot number: FF8841) at the age of 55 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 16Mar2021 (Lot number: EN6199) as dose 2, single and intramuscular, administered in arm left, administration date 24Feb2021 11:00 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Patient did not have Relevant medical history. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 20Oct2021, outcome "unknown", described as "Dose number=3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Dec2021, outcome "recovering" and all described as "I tested positive for the COVID-19 (omicron)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Dec2021) positive for omicron, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Patient did not received any other vaccine in four weeks. Patient did not had Covid prior vaccination. Facility type Vaccine: Workplace clinic.  No follow-up attempts are possible. No further information is expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium