chrisvoncsefalvay/vaers-outcomes huggingface dataset:
36 year old female patient inadvertently received an expired dose of Tenivac, no AE; Initial information received on 09-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 36 years old female patient who was vaccinated with an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 08-Feb-2021, the patient received a 0.5 ml booster dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot C5578AA and expiry date: 28-Jan-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that the caller stated a patient was administered Tenivac on 08-FEB-2021. The caller stated that it was discovered that the vaccine was expired as of 28 JAN 2021. The caller would like to know the efficacy of the vaccine at this time and how to proceed to care for the patient. Event Information for further details. Additional description of event adverse events: Patient inadvertently received an expired dose of Tenivac intramuscularly yesterday (08 Feb 2021), Dose was intended to be the booster dose. Reported did not know where on the body the dose was given.  Reporter relationship: health care professional (HCP) Product used: used first time product used: yes still using product: no  At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I received my second dose of the COVID vaccine around 12:30 pm. At around 4:00 pm, I noticed that my lips were slightly swollen. I went and bought liquid Benadryl. At around 5:45 pm, I took 20ml of the liquid Benadryl. I proceeded to sleep the rest of the night. I woke up around 8:20 am the next morning and noticed that my lips were significantly more swollen. I took 20ml more of the liquid Benadryl and noticed that my tongue was a little swollen as well. At around 9:40 am, I took 20ml more of liquid Benadryl.  I noticed no change in my swelling and my throat started to feel like there was a lump. At around 10:20 am,  I drove to the emergency room. The doctor noticed swelling in my lips and some in my tongue and throat. I was given cimetidine and methylprednisolone through an IV, which reduced the swelling. I was discharged 2 hours later after the swelling went down and was given 2 prescriptions to take the next 4 days, which were prednisone 20mg  (three tablets once a day) and famotidine 20mg (twice a day). There is some swelling in my lips in the morning (for the last two days) until I take the steroids, then it reduces the swelling. The overall cost of the emergency room visit was $1669.17.
She began having an ear ache and now has shingles. She went to the MD office and is now on an antiretroviral. She has no appetite, has bumps on the face, and is always tired now. From the first shot she began very tired and nauseated.   She did also have some shortness of breath after the first shot as well.
Pain in legs worse at night; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 03Mar2021 at 13:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included deep vein thrombosis (DVT) on an unknown date in 2012, mitral valve repair (Heart ring mitral valve), allergy to shellfish and hazel nut.  Concomitant medications included rivaroxaban (XARELTO), metoprolol (MANUFACTURER UNKNOWN) and ezetimibe (ZETIA),all from unknown dates taken for unknown indications. The patient previously took gadolinium (MANUFACTURER UNKNOWN) for unknown indication from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 08Mar2021 at 07:00 ,the patient experienced pain in legs, which was worse at night. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event pain in legs was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Brain fog, chronic fatigue, moderate to severe joint pain, joint swelling, chronic fatigue, atypical exercise response (exercise induces excess fatigue)
Very sore, swelling and tender at shot site.  Also warmth and itchy periodically through second day after shot.   Headache and fatigue which lasted through first day after vaccine.
Moderna 3/2/21, 3/30/21. Positive on 7/27/22
Patient developed urticaria and flushing of the face and neck, "scratchy throat", rapid heart rate - with onset approximately 15 minutes after the Moderna vaccine was administered.  Patient was given epinephrine (1:1,000) 0.5 mg IM and diphenhydramine 25 mg IM.  Patient was transported to the closest ED, where she reports she was given famotidine, additional diphenhydramine, and solumedrol, then monitored for 4 hours.  She reports being discharged from the ED after approximately 4 hours of observation.
Reactions/Some people had dermal fillings and received the vaccine; Caused dermal fillers to swell up / Swelling in the areas of dermal fillers; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (Reactions/Some people had dermal fillings and received the vaccine) and SWELLING (Caused dermal fillers to swell up / Swelling in the areas of dermal fillers) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Reactions/Some people had dermal fillings and received the vaccine) and SWELLING (Caused dermal fillers to swell up / Swelling in the areas of dermal fillers). At the time of the report, VACCINATION SITE REACTION (Reactions/Some people had dermal fillings and received the vaccine) and SWELLING (Caused dermal fillers to swell up / Swelling in the areas of dermal fillers) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SWELLING (Caused dermal fillers to swell up / Swelling in the areas of dermal fillers) to be related. No further causality assessment was provided for VACCINATION SITE REACTION (Reactions/Some people had dermal fillings and received the vaccine).    No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Severe chills for 4 hours. Started at 10:00pm. Chattering teeth, shaking, shivering, cold hands and feet. Used an electric blanket. Headache, took Advil. 1 in the morning two later that day. Lasted about 12 hours. Worsened as the day progresses
Colleague was fully vaccinated and tested positive for COVID on 8/16; Colleague was fully vaccinated and tested positive for COVID on 8/16; This is a spontaneous report from a contactable other health care professional. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection.), dose 1 intramuscular, administered in right arm on 28Jan2021 (at the age of 51-year-old) (Batch/Lot Number: EN5318) as DOSE 1, SINGLE and dose 2 intramuscular, administered in right arm on 18Feb2021 (Batch/Lot Number: EN5318) (at the age of 51-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine and list of any other medications the patient received within 2 weeks of vaccination reported as unknown. Prior to vaccination, was the patient diagnosed with COVID-19: unknown. Known allergies and other medical history were unknown. Facility where the most recent COVID-19 vaccine was administered at workplace clinic. Patient was fully vaccinated and tested positive for COVID on 16Aug2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive (Nasal swab) on 16Aug2021. Treatment received for the adverse event was unknown. The outcome of the events were recovered on Aug2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events vaccination failure and COVID-19 cannot be totally excluded.
48 hours after vaccine administration mom called with pt's symptoms of red rash below injection site at time of visit (3/17/17) pt presented with 17 x 12 cm erythematous, indurated, warm, slightly tender area to left upper arm. Treatment: TYLENOL/ibuprofen as needed and heat as needed.
Mild, momentary vertigo and leaden movements approximately 7 hours after injection. Dissipated within 10 minutes. Fast heart rate noticed approximately 10 hours after injection, measured at  about 15 BMP higher than average (Measured 90, average 75-80) Heart rate dropped back to normal range within half hour of measuring. Feverish feeling, but temperature measured normal. Mild headache developing after heart rate returned to normal. Feeling reminiscent of mildly high blood pressure, but no equipment to monitor available.
Redness-itching-blistering at injection site at about 12 hours after injection-warm compress. BENADRYL PRN.
While being injected the syringe broke, leaving the needle injected in my left arm and spilling an unknown amount of the vaccine dose. I was then injected with another full dose in the right arm. My left arm area hurts, my right arm area is completely fine.
Broke out in hives approximately 9am on 8/22/13 - very sudden per mom; was < 24 hours since vaccines; no difficulty breathing went to ED; face, neck and torso not on limbs - on prednisone and BENADRYL.
While driving, 4 days after 1st dose: Sudden elevated heart rate, tunnel vision, sudden numbness in legs and arms, jaw clenching, dry mouth, shortness of breath. May have been triggered by bright lights/high beams from opposing traffic. Immediately went to Hospital emergency room, was treated with IV fluid and released about 3 hours later. Cause was noted as "panic attack" although I have no history of such.
Developed Covid19   . Itchy throat cough, congestion, mild fever, body aches, followed a couple days later by runny nose and sneezing. Treated with rest, vitamin c
Patient fainted in chair and then fell out of chair and hit her head in observation room after receiving 2nd dose. She regained consciousness immediately. She stated she does have anxiety about vaccinations.
Was diagnosed as havign visual snow; Information has been received from the mother of a 17 year old male patient. No medical history, concurrent conditions nor concomitant medications were reported. In March 2019, the patient was vaccinated with dose 1 of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route of administration, lot number and expiration date not reported) for prophylaxis. In 2019 (reported as "few months ago"), the patient started to experienced vision issues and was "recently" diagnosed by an ophthalmologist with visual snow (visual snow syndrome). On an unknown date, blood tests were performed; results not reported. At the time of the report, the patient had not recovered from visual snow syndrome.  The causal relationship between visual snow syndrome and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)
I mistakenly gave patient the Pfizer covid vaccine for 5 years to 11 years to patient and she is 15 years of age I spoke to the provider and made an incident report provider reached out to patients mom and mom states she will make a follow up appt for correct covid vaccine.
On 4/10/2003 patient stated area of redness surrounding vaccination site but confined to size of semipermable dressing. On 4/11 area of redness and erythema increased, warm to touch, swollen, nodal involvement.  No fever, diagnosis: cellulitis dicloxicillin 500 mg po qid x 10 days prescribed.
At around 2pm I began to feel worse and by 4pm it had completely taken ahold. I had the chills, felt like I had a fever (which I did not). Felt like a freight train had run me over. Headache also. I went to bed at 6pm after taking a bunch of over the counter meds to knock me out. Woke up at 2am still feeling bad and now had the runs. Went back to be at around 3am and slept until 10am. I am just now feeling almost human. It got so bad that my wife was going to take me to the hospital and I vetoed..
P/vax pt had t>104, shaking; taken to MD; dx AOM; pt also c/o abd distress, diarrhea & cough & unusual twitching; pt still has daily T of 102 & nightly twitching during sleep;
Very cranky day shot given p/shot several hrs later t to 102.6R, blotchy rash, some myoclonic jerks, very irritable, fine macular sl MP rash generalized, & few blotchy urticaria type areas; early otitis;
Anxiety, insomnia, coughing and headaches.  Very nervous while sleeping.  Easily loose temper, continuous sweating.  Hemorrhoids.  Malabsorption syndrome.
43 total patients received doses every day from 1Oct2021 to 9Oct2021 from 9 vials of the same lot (014F21A) that all were stored in the refrigerator on 1Sep2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (43 total patients received doses every day from 1Oct2021 to 9Oct2021 from 9 vials of the same lot (014F21A) that all were stored in the refrigerator on 1Sep2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (43 total patients received doses every day from 1Oct2021 to 9Oct2021 from 9 vials of the same lot (014F21A) that all were stored in the refrigerator on 1Sep2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (43 total patients received doses every day from 1Oct2021 to 9Oct2021 from 9 vials of the same lot (014F21A) that all were stored in the refrigerator on 1Sep2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
neurologic pain, distal weakness of extremities; pain over the sacral spine, difficulty urination & defecation;
Vertigo, ongoing, Hematuria - started 10/21 stopped 10/22, increase joint and back pain.  Ongoing
S: Mom states pt with swelling-redness to right thigh since 8/19/04 8AM.  O: 10cmx5-8cm to outer thigh area P: Benadryl 3/4 ID, Keflex 250mg/5cc tsp PO TID x 10 days.
pt recvd vax 12MAY92 rt thigh; 13MAY92 24 hrs later site was swollen, itching, low grade fever, poor appetite; 14MAY92 AM red spots noted, splotchy areas sl warm to touch, fretful AM; splotchy area;
She was scheduled to get her 2nd dose but didn't receive it because she was nervous about fever; she is pregnant after receiving 1st dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (she is pregnant after receiving 1st dose) and PRODUCT DOSE OMISSION ISSUE (She was scheduled to get her 2nd dose but didn't receive it because she was nervous about fever) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (she is pregnant after receiving 1st dose). On 15-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (She was scheduled to get her 2nd dose but didn't receive it because she was nervous about fever). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (she is pregnant after receiving 1st dose) had resolved and PRODUCT DOSE OMISSION ISSUE (She was scheduled to get her 2nd dose but didn't receive it because she was nervous about fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported No treatment information was provided
In addition to the injection site being sore and skin redness associated with the injection,  I am experiencing severe heaviness with my right arm, which I did not read as a potential side effect.   It has created difficulty with my arm mobility.
didn´t received second dose / 1st dose was given during 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2021151599, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151599:Same reporter.
Hospitalized for COVID + hypoxemia on 01/02/2022. Still admitted. Treated with dexamethasone and Remdesivir for 10 days. Treated with baricitinib 4 mg daily. Treated with dexamethasone, zinc 50 mg daily vitamin D3 50 mcg daily and vitamin C 1,000 mg daily
shot hurt when given unlike any other vaccine I have received About 3 hours after shot, my arm got really red, swollen, hard, and warm to the touch  It almost looks like I have Cellulitis and may have to go to Urgent Care Arm is very sore  I am very tired and achy and have very little energy after the shot This hurts worse than a tetnus shot
After receiving 1st injeciton experienced mild arthralgia cervical adenopathy, muscular neck pain 72 hours after injection on same side as injection. After 2nd injection symptoms within 48 hours exacerbated "intensified s/s".
Within 30 seconds of receiving last injection, client reported feeling dizzy and fell sideways, losing consciousness. Slight jerking movements noted. Within 30 seconds, client regained consciousness and sat upright. No injuries sustained. Client reported having no breakfast prior to coming to clinic; juice given. Client observed in clinic for 15 minutes. He denied continued dizziness and left clinic accompanied by mother.
Ringing in ear and hearing loss. Right ear started 1 day post vaccine. Persists to date of submission of this report
I recived the following shots in Oct 6th .PFizer 0 500  R FJ2601 ML / Fluceliam Segirus 0.5 ML  942437 / Moderna covb Moderna 0.5 ML K37164B Cough / breathing very low oxygen down to 57 levels
Tooth ache; Swollen face/swollen nose/swollen cheeks; one eye swolllen; started experiencing allergic side effects; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TOOTHACHE (Tooth ache), SWELLING FACE (Swollen face/swollen nose/swollen cheeks), EYE SWELLING (one eye swolllen) and HYPERSENSITIVITY (started experiencing allergic side effects) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included KETOROLAC and MELOXICAM for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced TOOTHACHE (Tooth ache), SWELLING FACE (Swollen face/swollen nose/swollen cheeks), EYE SWELLING (one eye swolllen) and HYPERSENSITIVITY (started experiencing allergic side effects). At the time of the report, TOOTHACHE (Tooth ache), SWELLING FACE (Swollen face/swollen nose/swollen cheeks), EYE SWELLING (one eye swolllen) and HYPERSENSITIVITY (started experiencing allergic side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included None for swelling, some pain medications and antibiotic.  Concomitant medication also included clomaxin.
not feel well; fever; felt flu-like; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "not feel well"; PYREXIA (non-serious), outcome "recovered", described as "fever"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "felt flu-like".  Additional information: It was reported that a family member received the 1st dose of the Pfizer COVID 19 vaccine about 6 months ago. For a few days after the dose, they did not feel well, ran a little bit of a fever and felt flu-like. The family member hasn't felt up to getting the 2nd dose. Caller states the patient is in their mid 60's. The caller states mid 60's, age 63 years or 64 years. Caller considers the event insignificant. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
? right arm/shoulder pain, c-spine stiffness, headache, body aches.  After 2nd dose same sx and nausea, dizzy, blurred vision and most concerned about right scapula feeling ?weak? and intermittent right arm ?paresthesia?
Patient was given Moderna monovalent booster instead of Moderna bivalent booster.  Patient was contacted and informed and was ok with receiving their bivalent booster in 2 months.
Per patient " ...I started to experience chest pains. Mild at first, but they got worse...." (Husband said it was ok for VAERS to contact patient via phone for info if needed)