chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received from a healthcare professional on 26 July 2012. Local reference no- 12-0425. A 26-years-old female patient whose medical history and concomitant medication were not reported was inadvertently squirted vaccine ACTHIB (Lot number: UH416AA) into eye on 26 July 2012. The reporter stated that she inadvertently squirted vaccine into eye while its administration. She is contact lenses user. She experienced burning sensation in eye and cloudy vision like sheath over eye. She took out her contact lenses and flushed eye. Patient was planning to make appointment to ophthalmologist. Laboratory details and corrective treatment were not reported. The patient continued to experience cloudy vision in eye. Documents held by sender: none.
Cold-like symptoms; Loss taste; tender arm; had arm tenderness right after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold-like symptoms), AGEUSIA (Loss taste), TENDERNESS (had arm tenderness right after the 2nd dose) and TENDERNESS (tender arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 018B21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 24-Apr-2021, the patient experienced TENDERNESS (had arm tenderness right after the 2nd dose). On 14-Jun-2021, the patient experienced TENDERNESS (tender arm). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold-like symptoms) and AGEUSIA (Loss taste). At the time of the report, NASOPHARYNGITIS (Cold-like symptoms), AGEUSIA (Loss taste), TENDERNESS (had arm tenderness right after the 2nd dose) and TENDERNESS (tender arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, COVID-19: negative (Negative) Test results - Negative.         No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up received  and it contains the information :Patient said that she is doing fine and declined for further follow-up
Initial unsolicited report received from a pharmacist on 2 September 2015. This case involves a 73 years old female patient who was vaccinated with a dose of FLUZONE HD (batch number, dose, dose in series were not reported) via unspecified route in left deltoid on 1 September 2015. Pre-existing physician diagnosed allergies and concomitant medications were unknown. Illness at time of vaccination was reported as none. On 1 September 2015 (within 2 hours) after vaccination the patient returned to pharmacy with pain and bleeding at injection site and also had pain in shoulders and upper back. The patient was advised to seek treatment from an emergency room or urgent care at that time. Lab data and corrective treatments were unknown. The outcome of the events were unknown. List of documents held by sender: none.
pt recv vax 27MAY98 2PM & exp fever (100 oral), sore neck, h/a, chills @ 830PM;fever (102.9 oral) & all above sx @ 1030PM;APAP given;
Rash on hands 5 days after - mild. Seen 2nd time - 10/25/16 - Eczematous rash, hands, arms, torso.
she developed anemia; loss of weight; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (she developed anemia) and WEIGHT DECREASED (loss of weight) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised, COPD and Rheumatoid arthritis.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAEMIA (she developed anemia) and WEIGHT DECREASED (loss of weight). At the time of the report, ANAEMIA (she developed anemia) and WEIGHT DECREASED (loss of weight) had not resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  It was reported that the patient already received all of their Moderna doses and boosters, but after receiving the shots she developed anemia and loss of weight. Every time the events got worse upon taking booster.   Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747917 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747917:Same reporter (SPIKVAX 2023-2024)
Fever, muscle aches, weakness, eye irritation and thick discharge, throat irritation, difficulty breathing, wheezing on expiration. Took 2 Benadryl and respiration and eye issues went away. Body aches, fever, weakness persisted for two days.
I am breastfeeding my daughter exclusively. She was born December 9, 2020. She is roughly 3 months old. She had an all body rash
No additional AEs; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report was received from a healthcare worker and refers to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 24-AUG-2022, the patient was vaccinated with improperly stored one dose rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, for prophylaxis orally (strength, and route of administration were not provided) lot #w004504, expiration date: 16-JUN-2023 or lot# W002562 which has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) expiration date reported as 12-OCT-2023, the same as internal validation (product storage error). The healthcare worker did not specify which actual lot the patient received. Administrated vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at 11.3 Celsius degrees for 34 minutes, no previous temperature excursion were reported.  There were no adverse events reported (no adverse events).
Within 30 min after, felt a hollow ear on my left side, but that only lasted a few minutes. The next morning, it felt like something hit my left eyeball or something popped in my left eyeball, then immediately saw a grey film over my left eye that lasted about 30 min then slowly went away. My left arm vase very painful, radiating up my neck to my jaw and temple. I proceeded to get a migraine type headache. There is a large swollen, red lump on my left arm 2 days later.
The nurse who administered the vaccine was looking at the wrong paperwork and she administered a .25 dose instead of a .5 dose for his primary dose.  By the time she realized it, the client was gone.  I have tried calling him but, his voicemail is full so, I will continue to try and get in touch with him to get him back for another .25 dose.
A pharmacist reported a pediatric dose of VAQTA was administered to a 19 year old; No additional AE reported; This spontaneous report was received from a pharmacist referring to a 19-year-old patient of unknown gender.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), 0.5 milliliter for prophylaxis (route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number and expiration date were unknown by the reporter). It was specified that the dose administered was a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (incorrect dose administered). No adverse events were reported.
I have had neck pain sometimes severe enough to cause headaches for days at a time. Also, fatigue, not enough to keep me from doing things, but I feel like I tired out very quickly. Before I went to the doctor I went several times for acupuncture, massage, and a chiropractor. None of that relieved it so I finally went to the doctor. I was also taking Tylenol to try to cut back on the pain. My doctor referred me for physical therapy which I am still taking. She also referred me for osteopathic manipulation therapy. That has helped a little bit, not a whole lot. My doctor also recently referred me to a neurosurgeon. They did an MRI. Now the neurosurgeon is sending me for pain management with another doctor who I have not seen yet.
Second dose: slight red dots on her skin; Second dose: heart rate 110 beats per minute; Second dose: high fever; This is a spontaneous report from a contactable consumer (boyfriend/partner) via PPDi.  A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: unknown), via an unspecified route of administration (of unspecified age) on 06May2021 as a dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient experienced slight red dots on her skin on 07May2021, high fever and heart rate of 110 beats per minute on unspecified date in May2021. Reporter queried for does she need to go to the doctor. At the time of the report, the outcomes of the events were unknown.  Communication: Advised caller to contact primary care doctor if needed. The caller was provided with website withheld, phone number of withheld, option 3. Caller will call at a later time. No follow-up attempts are needed. Information on lot/batch number cannot be obtained.
Total reduction in ankle swelling/Complete reduction in ankle pain; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Total reduction in ankle swelling/Complete reduction in ankle pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B04A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Blood pressure high. Concomitant products included ENALAPRIL for Blood pressure management, LEVOTHYROXINE for Thyroid disorder, CALCIUM, MAGNESIUM, VITAMINS NOS and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Total reduction in ankle swelling/Complete reduction in ankle pain). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Total reduction in ankle swelling/Complete reduction in ankle pain) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment information provided.
immed p/vax pt very irritable, unusual screaming for 30 mins-1hr then would fall asleep p/30 mins of sleep awoke screaming; temp 100 - 100.6; dec feeding, whiny & fussy all noc;
Father presented to child health for immunization. At interview reports questionable febrile seizure on 10/19/03 and had a work up at hospital. Child had temperature of 103 and seized with rash. Spoke with child's MD 11/4/03: EEG and work up negative. Spoke with mother 5PM 11/4/03 (per interpreter); child well at this time. Medical records received on 11/14/2003 states pharyngitis.
Product temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-387782 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Added patient details(initials,age,gender) and vaccine information (dose number, date of vaccination)
He called today and said his arm broke out in rash around the area he got the shot last week on 7/13/23. He got the shot on 7/7/23. He said its not sore but just itches. He said it sarted out as an area as big as his fist, but now its down to just a couple of bumps. no pain or swelling, just itching
patient received mistakenly the wrong vaccine at the wrong age /no AE; patient received mistakenly the wrong vaccine at the wrong age /no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case was received from an other healthcare professional via Medical Information (Reference number- 00444616).  This case involves a four-month-old female patient who was administered DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE [QUADRACEL] mistakenly at the wrong age (wrong product administered and overdose).  The caller stated that QUADRACEL was gave at the wrong age today and last week. Also stated that wrong vaccine was given at the wrong age. Caller clarified QUADRACEL was given today, 25-Jan-2021 to a 4-month-old and states she does not know what happened, but she believed they were supposed to be given DTaP (Daptacel) and IPV (unsure the trade name) separately.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE, PNEUMOCOCCAL VACCINE and HIB VACCINE CONJ (TET TOX) [HIBERIX].  On 25-Jan-2021, the patient received 0.5 mL dose (once) of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (lot number C5755AB and expiry date 07-Oct-2022) via intramuscular route at the left thigh for prophylactic vaccination.  It was a case of actual medication error due wrong vaccine administered and overdose (latency was on same day).  At the time of reporting, no adverse event 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. 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.
Developed Hives all over body. Pt woke up with the hives day after receiving vaccine.
Right ear pain started on the Wednesday afternoon, two days after Vaccine shot. By Friday evening the ear pain was intense and it had moved below the ear to lymphnode area. Saturday, his ear was really swollen and red. He went to the Urgent Care and they prescribed an antibiotic Cephalexin thinking it could be some sort of ear infection or insect bite. Sunday morning he woke up with his face droopy. We tried to get an appt. with Urgent Care, but they sent us to the ER. The ER did a physical assessment and concluded he had an ear infection and Bells Palsy. The prescribed another antibiotic Doxycycline, an antiviral Famciclovir and a steroid of prednisone. By Monday he was extremely nauseas and had started having vertigo. We went to Urgent Care and they prescribed him Ondansetron for nausea and made the assessment that he had Shingles in his ear. We saw PCP on Wednesday and he assessed that this was a zoster ear infection causing facial paralysis and vertigo, also known as a rare condition called Ramsay Hunt Syndrome and that it was most likely attributed to his Covid vaccine shot and not to get the second vaccine shot. The Dr. took him off the antibiotics and put him on a higher dose of prednisone, a different antiviral (valacyclovir) and Meclizine for vertigo symptoms. He sent referrals for Neurology, ENT and Eye Dr. He saw the Neurologist that Friday and he concurred Ramsay Hunt Syndrome, most likley from Covid Vaccine and do not get the second vaccine shot. The neurologist referred him to Physical Therapy to treat his vestibular issues. He ordered an MRI and some blood work. We are still waiting for the results. We saw an ENT an he had him have a hearing test which showed moderate high frequency hearing loss. The ENT prescribed Gabapentin for the ear and face pain. He started to see a physical therapist this week, he had his MRI on Wednesday and we see the ENT again on Monday. He has no improvement yet, other than the nausea has subsided.
Menstrual cramps (typically do not happen at this point in cycle) beginning day after injection. Cramps in conjunction with typical headache and stuffy nose side effects. Also had pinching pain in muscle of left arm where birth control implant used to be
Patient came in today on 7/14/21 and stated that he has been experiencing symptoms after the vaccination. He had a rash and severe itchiness that has since gone away. He states that he has been having leg cramps and has been experiencing muscle weakness. The muscle weakness has been getting progressively worse. He is also experiencing nerve tingling, all of which he did not attribute to the vaccine until recent news about Guillen  Barren Syndrome associated with the Johnson and Johnson Covid 19 vaccine.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Additional Details: Patient was anxious about getting vaccines. Plan was to get 3 vaccines Tdap, flu and hep b. when asked how patient was feeling after Tdap as she seemed anxious. she stated she was not feeling well, lips were pale had pt lay down on her right side then immediately on her back gave her cool paper towel on forehead and she started feeling better, monitored bp first bp was 86/52 then raised her legs, 10:48 bp was 92/56 got her water to drink tol well. Stated she was "panicky" "anxious"  no breafast.
doctors administered Fluzone High Doses to a patient 55 years old, with no reported adverse event; doctors administered Fluzone High Doses to a patient 55 years old, with no reported adverse event; Initial information received on 22-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 55-year-old unknown gender patient who was by mistakenly given dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Product administered to patient of inappropriate age and overdose).  It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine.  The patient had no medical history, concomitant disease or risk factor  At the time of the event, the patient had ongoing Diabetes mellitus.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It is unknown if there were lab data/results available.  It was an actual medication error case due to product administered to patient of inappropriate age and overdose (latency: same day).  It was reported "the doctor wanted her diabetic patient to have a higher antigen load and didn't know the age indication for High Dose. I reviewed the PI and showed him where it states the age indication for 65 plus".  At time of reporting, 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  There will be no information available on the batch number for this case.
Starting on the 9th I had a rash that moved around my skin throughout my body, to sensitive areas, like hands, wrists, arms, chest. shoulders, legs, ankles, face. It's like a red itchy rash. it's been ongoing so far. they prescribed me Prednisone for 5 days. It has helped little bit. The rash is still ongoing. I saw another doctor because I ran out of the Prednisone.
Approx 730 the evening of the vaccine I was resting laying down with both legs up (horizontally). I suddenly felt a "snap" in my left calf which led to severe muscle pain. I can barely walk. It is still painful today. About the same time I developed chills which lasted till about 1PM today. Within 10 minutes of the shot I was dizzy and nauseous (lasted about 15 min). About 20 minutes after the shot my face turned red and lasted about 5 hours.
3:41PM PT STATES SHE FEELS LIKE 'SHE MAY PASS OUT'. PLACED IN WHEEL CHAIR - SYNCOPE X30-60 SEC.  MOVED TO COT; NOW RESPONSIVE. BP 150/90, HR 96, R 16, 02 SAT 99%.  PT CALLED HUSBAND TO COME PICK HER UP.  3:46PM PT STATES 'THIS IS HER TYPICAL POTS EPISODE'.  STATES SHE WAS WORKING ON HER KITCHEN AND PROBABLY JUST OVER DID IT. BP 128/80. STATES SHE FEELS BETTER NOW. 3:50PM A/O, PINK, W/D, RESP WITH EASE. BP 132/78, HR 77. 4PM SITTING UP - DRINKING WATER. STATES 'FEELS PRETTY GOOD'. 4:08PM TO EXIT PER WHEEL CHAIR; ASSISTED INTO AUTO TO BE TAKEN HOME PER HUSBAND. A/O, PINK, W/D, RESP WITH EASE. 4-14-21 9:30AM TC: PT STATES SHE 'FEELS SO MUCH BETTER NOW'.
Information has been received from a health professional concerning a 59 year old female patient with Percocet and penicillin allergies who on 01-FEB-2007 was vaccinated with the first dose of hepatitis A virus vaccine inactivated (Lot #656495/1209F) in the left deltoid. Concomitant vaccination on 01-FEB-2007 included the first dose of hepatitis B virus vaccine rHBsAg (Lot # 653788/0412F) in the right deltoid. Subsequently on 01-MAR-2007, the patient was administered a second dose of hepatitis A virus vaccine inactivated (Lot # 655999/1010F) in the right deltoid one month after the first dose. Concomitant vaccination on 01-MAR-2007 included the second dose hepatitis B virus vaccine rHBsAg (Lot # 653788/0412F) in the left deltoid. There was no illness at the time of vaccination. On 14-MAR-2007, the patient complained of leg pains. The outcome of the leg pains was not reported. Additional information has been requested.