chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Normal pain at injection site; whole body pain; some mental fog over two days.; continuous pain in left arm radiating from the shoulder blade to the elbow; continuous pain in left arm radiating from the shoulder blade to the elbow; slight numbness of forearm into the fingers.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 17:15 (Lot number: EW0172) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "familial adenomatous polyposis" (unspecified if ongoing), notes: familial adenomatous polyposis, Gardner syndrome, j-pouch surgeries (no colon).; "known allergies: Sulfa" (unspecified if ongoing), notes: Sulfa food intolerance that causes gut swelling; reactions have improved over the last 4 years.; "Gardner syndrome" (unspecified if ongoing), notes: familial adenomatous polyposis, Gardner syndrome, j-pouch surgeries (no colon).; "j-pouch surgeries (no colon)." (unspecified if ongoing). Concomitant medication(s) included: IMODIUM; COLESTID; VITAMIN D NOS; VITAMIN B12 [MECOBALAMIN]. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Aug2021 20:00, outcome "not recovered", described as "Normal pain at injection site"; PAIN (non-serious) with onset 27Aug2021 20:00, outcome "not recovered", described as "whole body pain"; FEELING ABNORMAL (non-serious) with onset 27Aug2021 20:00, outcome "not recovered", described as "some mental fog over two days."; PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset 27Aug2021 20:00, outcome "not recovered" and all described as "continuous pain in left arm radiating from the shoulder blade to the elbow"; HYPOAESTHESIA (non-serious) with onset 27Aug2021 20:00, outcome "not recovered", described as "slight numbness of forearm into the fingers.". Therapeutic measures were not taken as a result of vaccination site pain, pain, feeling abnormal, pain in extremity, pain, hypoaesthesia.  Additional information: No other vaccine was given in four weeks. The patient reported normal pain at injection site, whole body pain, some mental fog over two days. So far the only lasting effect (as of today) is a continuous pain in left arm radiating from the shoulder blade to the elbow and slight numbness of forearm into the fingers. The patient did not had COVID prior vaccination and not tested for COVID post vaccination.   No follow-up attempts are possible. No further information is expected.
Fatigue and soreness day of and three days after, rash on arm showed up 10 days after first injection, has been steadily growing and getting worse for the last two days
2nd dose after the recommended schedule; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 19th May 2019, batch number 23JK5 and expiry date 13th April 2020).   On 30-JAN-2023, the patient received the 2nd dose of Shingrix. On 30-JAN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose after the recommended schedule). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The reporter called and reported that a patient received their second dose of Shingrix after the recommended schedule and wished to know if the vaccine needed to be reapplied.  The reporter gave information about vaccine and patient.  The reporter consented to follow up. The reporter declined written information. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule (Drug dose administration interval too long).
(L) shoulder pain begin approximately 24hr after vaccine. Pain with MVT shoulder.  Tx - sling, ice, ibuprofen, Physical Therapy
Chest pain beginning before bed, around 10:00 PM. Severe chest pain waking her up in the early morning hours, around 4:00 AM.  Went to  ER at 6:30 AM after consulting with pediatric on-call RN.
loss of hearing in one ear; This is a spontaneous report from a non-contactable consumer. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Loss of hearing in one ear. The patient received treatment for the event: Steroid. The patient was not diagnosed with COVID-19 prior to vaccination. The outcome of the event was not recovered.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Red & swollen arm, fever, chills, headache, body tremors, weak, muscle fatigue; started 5 hours after shot, got worse over night, was very painful in the morning to the point of sobbing and having to call into work sick, ended within 30 hours of getting vaccine; arm still a little soar 1 week after shot (felt like a bruise)
Developed Middle Ear Myoclonus in right ear.  One month later developed mild Tinnitus in left ear. I don?t have any of the normal characteristics for sudden onset of tinnitus or Middle Ear Myoclonus.  My hearing test was normal, I don?t smoke or drink, I don?t work around loud noises, Weight and blood pressure is normal etc.
Vaccine given 6 days post expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication information provided.  No treatment medication information provided.    This case was linked to (Patient Link).
the patient was diagnosed with uveitis; This is a spontaneous report from a non-contactable physician via Pfizer Sales Representative. A 16-year-old male patient received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration at single dose on an unspecified date for immunisation. Medical history none (a very healthy teenager). Concomitant medication included influenza vaccine on an unspecified date for immunisation. On an unspecified date, the patient was diagnosed with uveitis 29 days after the first dose of TRUMENBA with outcome of unknown. The influenza vaccine was given prior to uveitis diagnosis but he has never experienced an adverse event from the influenza vaccine in past years.  No follow-up attempts are possible. No further information expected; Information about batch/lot number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for the reported event of uveitis due to temporal relationship. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including eye examination at baseline and during subject drug therapy and Head CT/MRI, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
dizziness, hearing  and vision (tunnel vision) impairment, speaking impediment (stuttering, etc.), thought processes are unclear and hazy, memory affected, flushed, cold hands, nervousness and unsteady walking
No adverse event; Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (batch no. 0554A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (unknown route) 1 dosage form. On 08-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine).    Concomitant medication not reported.   It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The vial did not undergo any temperature excursions.  Vial size given as 10 dose vial.  Vial was initially stored in the refrigerator on 07 Apr 2023 and Date of administration of vaccine on 08 Apr 2023.  Treatment medication not reported.  This case was for patient 1 out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-738752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738752:Patient 2
BREATHING DIFFICULTY, RESOLVED ON ITS OWN. NO COURSE OF TREATMENT NEEDED DR. ADVISED TO GO TO ER IF SOB OCCURRED AGAIN.
Myalgia, fatigue, swelling and tenderness in lymph nodes Narrative: 7 days after injection had mild swelling and tenderness in left axillary lymph nodes
Muscle weakness, mild muscle flutters/spasms, achy, arm has sense of feeling heavy, weak sense of grip.  Day 8 redness and swelling, around injection site.  Headache, overall sense of not feeling well.
About two weeks after receiving my vaccine, I started to feel shortness of breath, itchiness and sometimes my nose and face feel like something is making it tingle. I have rashes from time to time on my body. I start to feel like I'm having hot flashes. It is very uncomfortable. I purchased Benadryl and hydrocortisone cream to help with the rashes and itchiness. I sometimes experience nights that I am unable to sleep because of the itchiness.
Swelling, warmth, erythema to left thigh at vaccination site starting 2 days after vaccination. She also developed a "slapped cheek" type rash to her face.
Headache, chills, fever, vomiting and body aches - lasted 24 hrs
pt recv 2nd dose of vax & exp nausea, shaking, chills, hot & flushed skin-swollen glands (lt) underarm & neck lt side;to ER
Paranoid; not yet received a second dose at this time; This spontaneous case was reported by a consumer and describes the occurrence of PARANOIA (Paranoid) and PRODUCT DOSE OMISSION ISSUE (not yet received a second dose at this time) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (not yet received a second dose at this time). On an unknown date, the patient experienced PARANOIA (Paranoid). In March 2021, PRODUCT DOSE OMISSION ISSUE (not yet received a second dose at this time) had resolved. At the time of the report, PARANOIA (Paranoid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitants medications were provided.   Treatment medications were reported.   Reporter did not allow further contact
Pt. presented  at office for 18 mo WCC on 10-10-13. T: 99.2, pt asymptomatic for viral or bacterial illness. Pt. received vaccine at 4:00 PM and developed fever of 102 degrees during the night. Pt's mother did not note time during the night.
Arm stayed red; hard lump; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm stayed red) and MASS (hard lump) 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, the patient experienced ERYTHEMA (Arm stayed red) and MASS (hard lump). At the time of the report, ERYTHEMA (Arm stayed red) and MASS (hard lump) had resolved. Not Provided          No Concomitant medications were provided.   No treatment medications were provided.   This case was linked to MOD-2021-019262 (Patient Link).
Severe pain in arm, shoulder, and neck.  Limited range of motion for 4 days.  I could not pick things up with my left arm or turn the steering wheel on my vehicle.  Had difficulty sleeping because of pain.  Feels almost back to normal as of today, 1/25, but still slight discomfort.
Vomiting green mucus; Vomiting green mucus; This spontaneous case was reported by a consumer and describes the occurrence of DISCOLOURED VOMIT (Vomiting green mucus) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOLOURED VOMIT (Vomiting green mucus). At the time of the report, DISCOLOURED VOMIT (Vomiting green mucus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.
Fainted after first shot (10 mins after), fever, chills, pain 3 days after.  Then had stomach problems for month after.  Vomiting, stomach pains, was hospitalized, and found nothing.  In ICU for 2 days.  Still has no need to eat.  Nausea, no menstrual cycle for month, no period for 3-4 months at a time.  Lost a lot of weight.  Sick in stomach. 8/22/08-records received for DOS 8/7/08 and 8/9/08-Diagnostic laparoscopy. Normal pelvic findings. C/O abdominal pain. One month prior began having vague abdominal pain mostly in lower abdomen on right side. Impression: post op ileus. Ten days prior flexible sigmoidoscopy normal with internal hemorrhoids. Returned after laparoscopy with C/O abdominal pain with nausea. NG tube placement.
Hives all over body Friday. They have her prednisone. Zantac. Zyrtec. Monday morning woke up with whole face swollen.
itching on her left arm (wrist and hand); headache; sore arm; swelling at the injection site; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE SWELLING (swelling at the injection site), PRURITUS (itching on her left arm (wrist and hand)) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and VACCINATION SITE SWELLING (swelling at the injection site). On 13-Mar-2021, the patient experienced PRURITUS (itching on her left arm (wrist and hand)) and HEADACHE (headache). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 13-Mar-2021, PAIN IN EXTREMITY (sore arm) and VACCINATION SITE SWELLING (swelling at the injection site) had resolved. On 14-Mar-2021, PRURITUS (itching on her left arm (wrist and hand)) and HEADACHE (headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter.   This case was linked to MOD-2021-042820 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07-MAY-2021 and contains  details of second dose AE and informed that both 1st and 2nd dose AEs are now resolved. Declined further follow up.
Constant face itching and tingling.  I noticed it a day after the shot.  It has been getting worse as the days progress.  At first I thought it was my face cream, however I have washed it off and the itching has not gone away since receiving the shot.
TOOK VIVOTIF EVERY DAY INSTEAD OF EVERY OTHER DAY; This spontaneous case report (PVX2019-2799) was received from a nurse on 13-Nov-2019. It described a male consumer who "took Vivotif every day instead of every other day" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took Vivotif every day instead of every other day.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: It was reported that a patient took Vivotif every day instead of every other day of an unknown indication (Inappropriate schedule of product administration). The causality of the event is assessed as not related.; Sender's Comments: It was reported that a patient took Vivotif every day instead of every other day of an unknown indication (Inappropriate schedule of product administration). The causality of the event is assessed as not related.
Dose given from vial opened/punctured on 09/01/2021. Vial not discarded after the recommended 12 hours after puncture. Dose given on 09/03 from previously punctured vial. Vial kept at in refrigerator at appropriate temperature with no temperature excursions. Reported to Moderna.
No additional AEs or PQC reported.; Caller reports vaccine administered after temperature excursion.  No other information provided.  No additional AEs or PQC reported.     Include in the Description (cut and paste with responses) details of the improperly stored temperature excursion.; This spontaneous report was received from  a medical assistance and referred to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 02-JUN-2022, the patient was vaccinated with an improperly dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, lot #U034712, expiration date: 30-JUL-2023, administered intramuscularly for prophylaxis (strength was not provided)(product storage error).   The administered dose of the vaccine was stored with the temperature of 34.2 degrees Fahrenheit, the time frame was 12 hours. There was no previous temperature excursion. No adverse effect reported.
On 9/16, developed petechiae and bruising.  Went to urgent care, found to have platelet count of 3,000.
Small nickle size itchy rash progressing to 3x size originally noted. Lightheadedness, nausea, and chest pain.
experienced a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experienced a side effect). At the time of the report, VACCINATION COMPLICATION (experienced a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported No treatment was received by the patient   Reporter did not allow further contact
Information has been received for a physician's "office staff" concerning a 26 year old female who on 08-FEB-2007 was vaccinated with a 0.5 ml dose of Gardasil (lot 654702/0011U). On 08-FEB-2007 the patient experienced burning and pain in the arm and the injection site, so much so that she could not move her arm. The patient sought unspecified medical attention. Subsequently, the patient recovered from burning and pain in arm an injection site so much so she could not move her arm. Additional information has been requested.
No adverse symptoms were reported.; The patient was administered a dose of improperly stored PROQUAD; The patient was to receive a dose of MMR II, however, the PROQUAD was being stored in the refrigerator and the wrong vaccine was inadvertently grabbed.; This spontaneous report was received from a registered nurse, referring to a 25-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 24-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) a dose administered for prophylaxis (lot number S031705 which has been verified to be valid, expiration date reported and validated as 06-APR-2021) (strength, route of administration, vaccination scheme, frequency and anatomical site of injection were not reported) (product storage error). To reconstituted the vaccine properly stored sterile diluent was used. In addition, the nurse reported that, the patient was there to receive a dose of measles and mumps virus vaccine, live (M-M-R II), however, the measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) was stored in the refrigerator and the wrong vaccine was inadvertently grabbed (wrong product administered). The administered dose of the vaccine experienced a temperature excursion of -9 degrees Celsius (C) to 8 C (4 C), during a time frame of 1104 hours (also reported as "46 days"), as recorded by a data logger. There was no previous temperature excursion. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001420:
Itching palms, hives on chest & front/back of midriff, tingling lips, tongue and roof of mouth