chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second dose of Moderna to be given 57 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna to be given 57 days after the first dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna to be given 57 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna to be given 57 days after the first dose) 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.   Concomitant medications were not provided
PT CALLED COMPLAINING OF FEVER, ABDOMINAL PAIN, AND BACK PAIN 48 HOURS POST VACCINATION.  PT DID NOT INDICATE ANY ANAPHYLAXIS REACTION, SHORTNESS OF BREATH, RASH, OR DIFFICULTY BREATHING.
Onset wheal inferior to site of administration approx. circ. 1.5 cm - ice applied to area.
I experienced a lump on my breast 6 months later and it turned out to be breast cancer.
Severe leg pain in both legs the night of vaccine. Severe arm pain the day after vaccine. Red, warm, itchy lump at vaccine site 1 week after vaccine.
6 DAYS p/vax pt devel fever & several spots; seen by MD & pt did not appear ill; devel T105; hosp due to parents anxiety; appears to have viral illness; mostly w/fever which is improving;
Information has been received from a consumer concerning her baby who on 13-OCT-2009 was exposed via her mother with the first dose of GARDASIL. Concomitant therapy included MACROBID and OTC nausea medicine. The consumer reported that on an unspecified date she had an ultrasound performed and it was found that her baby will need to have "open heart surgery when she is born" because the baby's "Tetralogy Fallot" condition. It was noted that the consumer had been seeing a number of specialist that performed several tests (results not provided) in regards to the baby's condition. At the time of the report, the baby's outcome was unknown. Tetralogy Fallot was considered a congenital anomaly. The mother's experience has been captured in WAES 1004USA01925. Additional information has been requested.
erythematous, hot, swelling 2" x 3" mostly 2/3 below shot site;
This spontaneous report as received from a Certified Medical Assistant (CMA) refers to multiple unspecified patients of unknown age. On an unknown date the patients were vaccinated with improperly stored VAQTA (dose, frequency, route and lot # were not reported). No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Post-acute COVID-19 syndrome.     No Medical History information was reported.    In 2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medication was provided by reporter.  No treatment medication was provided by reporter.  Reporter stated she has been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and has seen 88-90% success rate in resolving the symptoms of long-haul COVID.  It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 Patients received bivalent booster with 38 having improvement of symptoms and 50s or more. Patient was treated skin lesions, scary brain, body aches. No adverse reactions occurred.  This case contains information about patient 37 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
large red circle/spot around the injection site on my arm.  It's warm to the touch, slightly swollen and slightly itchy but not too bothersome overall.  This occurred about 11 days after my dose 1 vaccination date.  No treatment, other than taking antihistimine (Zyrtec).
Swollen area to the left deltoid , very warm to touch 2 days after the injection. Very painful . The the site is hard. Pt to apply warm compresses, , motrin ,  contacted medical who advised the same. To seek medical if any changes
Husband not able to receive dose 2 within the recommended time frame; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Husband not able to receive dose 2 within the recommended time frame) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Husband not able to receive dose 2 within the recommended time frame). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Husband not able to receive dose 2 within the recommended time frame) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-098866 (Patient Link).
6 Aug 08 Pt states pain is 8/10 starting at (R) mid deltoid radiating towards up towards clavicle and neck and down towards midway of elbow. Pt had decreased range of motion. No swelling observed.
On Tuesday, immediately after injection, I experienced numbness in my left hand, which has continued off an on.  I attributed this to ongoing neck issues, so didn't think much of it, because I have it off and on. Numbness in right hand started about four hours after injection.  This caught my attention. Extreme pain and redness in left arm started about three hours after injection.  I could not use my left arm or lift it up.  I applied ice for 10 minutes on and off every 15 minutes for a little over an hour before going to bed.  It grew worse throughout the night. Fever started about six hours after injection and climbed to 101.1 before bedtime.  Fever vacillated between 99.9 and 101 for about 16 hours on Wednesday.  My neck hurt and I felt as if I had the full blown flu, but I couldn't sleep.  No appetite. Wednesday afternoon, I developed pain in the right wrist and weakness in wrist and hand.  It is painful to perform simple operations; for example, it is impossible for me to open a pop top can of soup.   Left hand weakness and pain developed today, Thursday morning; pain in right hand, but especially the  wrist, has worsened.
All over body rash several days after vaccination. Rash continues 1 week post- vaccination but apperas to be subsiding.
Someone came to pharmacy to let us know someone fainted.  I asked them to call 911 while I headed to that direction.  The patient, was on her way to the pharmacy.  Her face was red and her eyes were watery.  Sat her down and asked her what happened and she said she just fainted and am feeling fine now.  EMT came and took her vitals.  All were within normal range (BP, O2, HR).  She said she has fainted in the past before when she got both the covid and the flu shot together (a few hours late).  She elected not to go to hospital and her roommate and friend came to pick her up and will keep a watch on her.
Patient now admitted to Hospital. At direction of  the Provider currently taking care of patient I am entering this report. Per providers note and conversation  - patient is experiencing facial droop, numbness and migrating neurologic symptoms severe enough to present to emergency room and then be admitted to Hospital floor for further monitor and testing. Demyelinating disease with possible transverse myelitis is suspected.
On Feb. 21, 2021, over several hours, I lost all hearing in the left ear.
Mother states child's left thigh is red and swollen. He doesn't want to walk on leg.
One hour after receiving 1st dose of hep B c/o nausea, lightheadedness, fatigue, stiff neck.
body pain; severe fatigue; achy shoulder, neck; achy shoulder, neck; not sleeping well; can't even lift arms up due to the pain; got sick; had no energy; very lethargic; if paitent walks a mile, that's a long walk for patient; lost four to five pounds in the last couple of months; the bottom of feet started to grab and cramp up and hurt; the bottom of feet started to grab and cramp up and hurt; This is a spontaneous report from a contactable consumer. This consumer reported similar events for five patients. This is third of five reports. This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. On unspecified date, patient experienced body pain; severe fatigue; achy shoulder, neck; not sleeping well, can't even lift arms up due to the pain, got sick, had no energy, very lethargic, lost four to five pounds in the last couple of months, the bottom of patient feet started to grab and cramp up and hurt. It was reported if patient walks a mile, that's a long walk for patient. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541547 Same reporter/drug, similar events, different patients.
side spasticity of muscles upper and lower extremities daily for 10 days lasting 5-10 minutes; Lingering memory concerns; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 05Aug2021 15:11 (Lot number: EW0178) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic medical condition controlled" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose at 14:27 (Batch/Lot no: EW0170) via intramuscular in Left deltoid), administration date: 15Jul2021, when the patient was 74 years old, for COVID-19 Immunization, reaction(s): "Metal taste R mouth"; Bnt162b2 (First dose at 14:27 (Batch/Lot no: EW0170) via intramuscular in Left deltoid), administration date: 15Jul2021, when the patient was 74 years old, for COVID-19 immunization, reaction(s): "R paresthesias", "hand - neck pain", "hand - neck pain", "Headache", "vision impaired", "memory loss". The following information was reported: MUSCLE SPASTICITY (non-serious) with onset 2021, outcome "unknown", described as "side spasticity of muscles upper and lower extremities daily for 10 days lasting 5-10 minutes"; MEMORY IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "Lingering memory concerns".  Additional information: The patient was 74-year-old, since her vaccine she has had a birthday and was now 75-year-old. The patient provide information to you regarding the reported adverse event(s) with the use of the product. The Pfizer product had a causal effect to the adverse event was reported by reporter. No prior vaccination. No relevant test. First injection: Metal taste R mouth, R paraesthesia, R hand - neck pain and headache, vision impaired, memory loss. Second injection: L (left) side spasticity of muscles upper and lower extremities daily for 10 days lasting 5-10 minutes, Lingering memory concerns.  Follow-up attempts are completed. No further information is expected.
Information has been received from a health professional concerning an approximately 10 year old white male who on 01-FEB-2001 was vaccinated with Varivax (lot 636569/0926R). Subsequently, the patient experienced a generalized rash with <50 lesions. The case was documented or evaluated by a physician. The patient was not hospitalized. It was noted that he did have known contact with another case of varicella. No additional information was provided. Additional information has been requested.
Child is experiencing shivering, headache, swollen red arm, he can't touch or move it, and slight fever 99.6.
Developed urticarial rash, spread throughout day.  Also developed chills.  Developed knee pain and limp.  Developed fatigue.  Most impressive was the rash, which was diffuse and spreading throughout the day.
1-2 minutes post vaccination, patient reported that she  felt dizzy after she got off from the seat. She was advised to take a seat. Within few minutes, she complained of blurred vision.. 'not able to see things clearly.. and 'not feeling well.' She broke out into sweat and her face started to look pale.   Her mom was at her side.  Upon obtaining permission from her mom, EMS was called to avoid patient's  condition getting worse . Cold /wet cloth was  applied to the patient's face and she was alert and responsive.  Within 5 minutes, EMS arrived.  Her vitals were normal. Patient complained of feeling nauseous and stomach cramps (she did mention that her menstrual cycle was to start soon. ).  After 20 minutes or so after EMS arrived, patient seemed to be better and decided to go home.  I followed up with the patient after few hours, patient reported of feeling fine.
1st occurrence: After 1st vaccination on March 6th, 2021- intense pain in left leg, passed out, went to urgent care   2nd occurrence:  After 2nd dose on March 27th, 2021 - on the 28th  flu like symptoms- on the 29th intense leg pain, passed out, transported to hospital by ambulance, doppler revealed blood clot, blood work normal, placed on Eliquis  I have since been to the hematologist and had a work up... blood tests are normal
Left arm and hand swelling within 15 minutes after first vaccine. Later that evening his left left was swollen also on the same side that he received his vaccine. 2-3 days his injection site was sore.
second dose on 31Jan2023 and third dose 10Mar2023; second dose on 31Jan2023 and pediatric dose of Engerix-B on 09Dec2022; Underdose; Adult use of a child product; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 55-year-old female patient who received HBV (Engerix B adult) (batch number AX2D5, expiry date 07-DEC-2024) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) (batch number 337TC, expiry date 29-MAR-2024) for prophylaxis and HBV (Engerix B pediatric) (batch number N73FA, expiry date 31-MAY-2024) for prophylaxis.   On 10-MAR-2023, the patient received the 3rd dose of Engerix B adult. On 31-JAN-2023, the patient received the 2nd dose of Engerix B adult. On 09-DEC-2022, the patient received the 1st dose of Engerix B pediatric. On 09-DEC-2022, not applicable after receiving Engerix B adult and Engerix B adult and an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: Adult use of a child product). On 31-JAN-2023, the patient experienced drug dose administration interval too long (Verbatim: second dose on 31Jan2023 and pediatric dose of Engerix-B on 09Dec2022). On 10-MAR-2023, the patient experienced drug dose administration interval too short (Verbatim: second dose on 31Jan2023 and third dose 10Mar2023). The outcome of the underdose, adult use of a child product, drug dose administration interval too long and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUN-2023 The reporter was medical assistant. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that it was discovered that an employee that was no longer with the clinic administered a pediatric dose of Engerix-B to a 55 year old patient, which led to underdose and adult use of a child product. The patient received 2nd dose of Engerix-B adult later than the recommended schedule, which led to lengthening of vaccination schedule. The patient received 3rd dose of Engerix-B adult earlier than the recommended schedule , which led to shortening of vaccination schedule.
This spontaneous report received from a medical assistant referred to an multiple unknown patients of unknown age and gender. It was reported that the multiple patients were vaccinated with PROQUAD (Dose, frequency were not reported) (Lot numbers: 042818, Expiry date: 26-APR-2017; lot: M026879, Expiry date: 27-NOV-2017; lot: M031566, expiry date: 24-DEC-2017, lot: M004897, Expiry date: 26-JUL-2017) which were improperly stored on multiple dates. The reported vaccine was stored at -13.1 degree C for 10 hours. No adverse effects reported. There was no previous excursion. This is one of the two reports received from the same reporter. Additional information was requested.
Moderna given to a person under the age of 18.    Was leaving for base camp a couple days after the second dose and wanted vaccination prior to attending base camp.
Severe head pain w/nausea, Labs, CRP, CBC-W, RBC Sed Rate, West Nile - Blood, CT-Scan, Dr. Visits for head pain 9/26, 9/29, 10/4, Hospital ER and admit, 10/4 - 10/5 2018. ER 10/21/2018. Neuro visit 10/22/2018. Ongoing treatment head pain not resolved. Pharmacy was informed of egg allergy and nasal infection at the time of administration of the vaccine. I am still being treated for head pain, additional tests, Dr. visit Hospitalization and or E.R. visits may occur as the head pain continues. (The pain is not a migraine, that has been ruled out.) The pain is so severe it is disabling, and constant.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 19-OCT-2015, the patient was accidentally vaccinated with doses of PNEUMOVAX 23, (dose, route of administration, injection site, lot number and expiration date were not reported) and PREVNAR 13 (manufacturer unspecified), (dose, route of administration, injection site, lot number and expiration date were not reported), both indicated. No adverse effects were reported. Additional  information has been requested.
The patient was given a dose of Pediatric Pfizer instead of Pfizer 12+. When this error was identified, the patient was contacted and given the correct vaccine.
pt recv vax & mom reported MD dx pt w/chickenpox;f/u 13MAR98 150 lesions, 1 day low grade fever, recovering;
swollen lymph node under left collar bone 2 days after now on day 4 and larger; Also bad nightmares after each vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 16:15 (Batch/Lot number: unknown) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "High BP" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN [LOSARTAN POTASSIUM]; TIROSINT. Vaccination history included: Covid19 vaccine (Dose number: 1, product=COVID 19, Brand name unknown=COVID19 Vaccine,, Administration time=12:00 PM, Vaccine location=Left arm, adverse event: Also bad nightmares after each vaccine), administration date: 01Feb2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "bad nightmares"; Bnt162b2 (Dose Number: 2, Product=COVID 19,, Brand=Pfizer,, Administration time=12:00 PM, Vaccine location=Left arm,, adverse event: Also bad nightmares after each vaccine), administration date: 01Mar2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "bad nightmares". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 16Nov2021, outcome "not recovered", described as "swollen lymph node under left collar bone 2 days after now on day 4 and larger"; NIGHTMARE (non-serious) with onset 16Nov2021, outcome "not recovered", described as "Also bad nightmares after each vaccine". Therapeutic measures were not taken as a result of lymphadenopathy, nightmare.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. facility type vaccine: Pharmacy or Drug Store.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101616528 same patient/drug, different AE and dose.
Patient did not experience an adverse event.  Patient received her 2nd dose of the Moderna vaccine from vial open 30 hours prior.   Patient at the time of discharge was not in distress and presented within normal limits.   Vial opened on 8/19/2021 at 0818 Doses administered on 8/20/2021 at 1441
Fever started at 830pm on 11/29/2017. Dad noticed patient had hive like rash. Rash appears to have worsened since then. Had another 101 fever this morning 11/30/2017. Rash does not seem to bother patient. Mom gave BENADRYL for hives. Rash occurred 9 hours after getting 4 month vaccines. Concern for possible mild allergic reaction to vaccine contents vs urticarial rash secondary to viral URI.
Really sore arm at the time of injection. About 3 days later it still was sore and there was a large bump. Now a week out I still have a itchy bump at the site of injection