chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OFF LABEL USE; PRODUCT USE IN UNAPPROVED INDICATION; This spontaneous report received from a pharmacist concerned a 75 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with mrna 1273 (Moderna) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on 10-FEB-2021 for prophylactic vaccination (Dose number in series 1). The reporter did not report any adverse events following vaccination with mrna 1273 (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose was not reported, 1 total administered on 14-MAY-2021 for prophylactic vaccination (Dose number in series 2), which was off label and product use in unapproved indication (Dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported. As reported, the patient was looking to receive their "third dose of Pfizer COVID-19 vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and product use in unapproved indication was not reported. This report was non-serious.
fever next day p/DTP 19FEB93; apnea, cough treated w/ATB;
Gradual increase.  Flu like symptoms low grade fever, headache, diarrhea, unable to eat, weight gain,  muscle aches, extreme fatigue, increased episodes of Asthma attacks. Asthma more severe attacks.  Unable to taste, or smell.
anxiety; short of breath; weak; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety), DYSPNOEA (short of breath) and ASTHENIA (weak) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant (24 years ago.) in 1996 and Dialysis (dialysis for a long time in left arm).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced ASTHENIA (weak). On 15-Mar-2021, the patient experienced ANXIETY (anxiety) and DYSPNOEA (short of breath). At the time of the report, ANXIETY (anxiety), DYSPNOEA (short of breath) and ASTHENIA (weak) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Heart rate: increased (High) heart beat fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Followup information was received and outcome of events, second dose  were updated. On 22-Jul-2021: Updated Patient denies for further follow up.
soreness in her left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included vitamin d deficiency (recently diagnosed).   On 29th December 2020, the patient received the 1st dose of Shingrix. On 29th December 2020, 4 hrs after receiving Shingrix, the patient experienced pain in arm. On 28th February 2021, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information reported as follows: This case was reported by patient herself. The patient received the 1st dose of Shingrix in the left arm and experienced soreness in her left arm which started 4 hours after vaccine administered. The event resolved on 28th February 2021. The reporter refused offer to email Shingrix PI but did take MI telephone number to give to HCP. The reporter consented to follow up and given permission to contact her healthcare professional. For tolerance of 2nd dose refer case US2021AMR074345; Sender's Comments:  US-GLAXOSMITHKLINE-US2021073782:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2021AMR074345:same reporter
Tested positive on 6/17.  Spoke to dr and started paxlovid. Developed scratchy throat and sinus pressure that got progressively worse.  Next day, had sore throat and nasal congestion and mouth pain w/ body aches.  No fever. Intermittent chills.  Developed rash following day.
My menstrual cycle has been off since receiving the vaccine.  I skipped my first period post vaccine and then have had inconsistent cycles and very heavy flow.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given a dose from vial that had been punctured more than 12 hours prior) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given a dose from vial that had been punctured more than 12 hours prior). On 12-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient was given a dose from vial that had been punctured more than 12 hours prior) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.
Flashing lights in the far corner of right eye for 30 plus hours; fever of 101; headache; nausea; joint pain; weakness; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 10:00 (Lot number: EW0176) at the age of 61 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Known allergies: Foods" (unspecified if ongoing); "Known allergies: Chicken, beef" (unspecified if ongoing); "Known allergies: dairy" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: VIVELLE [ESTRADIOL]. The following information was reported: PHOTOPSIA (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "Flashing lights in the far corner of right eye for 30 plus hours"; PYREXIA (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "fever of 101"; HEADACHE (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "headache"; NAUSEA (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "nausea"; ARTHRALGIA (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "joint pain"; ASTHENIA (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "weakness"; FATIGUE (non-serious) with onset 26Sep2021 19:00, outcome "recovering", described as "Tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of photopsia, pyrexia, headache, nausea, arthralgia, asthenia, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 Prior to vaccination. The patient has not been tested for COVID-19 Since the vaccination. Other medications the patient received within 2 weeks of vaccination: Vivelle Patch  No follow-up attempts are possible. No further information is expected.
Primary 1: 22JAN2021,Primary 2: 27FEB2021; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1: 22JAN2021,Primary 2: 27FEB2021) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1: 22JAN2021,Primary 2: 27FEB2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1: 22JAN2021,Primary 2: 27FEB2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1: 22JAN2021,Primary 2: 27FEB2021).    No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-630784 (Patient Link).
Chills and fever night of injection, nauseated, felt poorly x 3 days, swelling/sore right arm.
This spontaneous report was received from a lincenced nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 8 days (192 hours, worst case), and a temperature excursion of 47 to 77 degrees Fahrenheit for 1 hour, however it was reported that no previous temperature excursion was performed. The call was because of a "data logger". This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1707USA013301: US-009507513-1707USA013302: US-009507513-1707USA013303:
cold; fatigue; pain in her shoulders; feeling nauseated; whole body ache/My whole body aches; little bit sick to my stomach; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) dose unknown via an unspecified route of administration on 13Mar2021 (at the age of 64-year-old) as dose number unknown, single for COVID-19 immunisation. Medical history included cancer (She is concerned because her husband has cancer). The patient's concomitant medications was not reported. On 13Mar2021 the patient experienced fatigue, pain in her shoulders, feeling nauseated, whole body ache/my whole body aches, cold on 17Mar2021, little bit sick to my stomach on unknown date in Mar2021. Patient was not received treatment for the events. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Left arm is hot, very swollen, sore.  Good sized knot.  Some itching.  Started day after vaccination and has gotten much worse.  Taking Benedryl and OTC pain relievers.
Patient called pharmacy on 10.19.2015 @ 2:30 pm, stating that his arm was VERY sore, and that it felt like it was about to "fall off" when he touched it. He also said his "entire body" was sore, and that he could not get out of bed. He compared the pain to that of rotator cuff surgery.
Patient reported that injection site was red, itchy and sore since last night. Limited to round area around injection site.
Patient noted that her tongue began to swell 3 hours or so after getting the injection. Also reports a slight fever that was not measured
Patient reported feeling hot, felt head and it felt hot to touch. Nurse on site was called to check BP -- which was 142/90 hr 101. pt was told to take off mask and relax and drink some water. After about 20-25 minutes, pt felt ok and BP was 124/83 hr 91. Patient was monitored longer and then sent home.
The symptoms described below are felt throughout the entire left arm and left upper back: 1- Internal pain and permanent discomfort focused, stabbing and fatiguing. 2- Exhaustion in the arm. 3- Irritability in the skin, like a burning sensation. 4- Feeling of loss of strength. 5- A kind of numbness. 6- Weakening of the arm. 7- Cramping of the fingers of the hand of the arm where the vaccine was applied (only happened once). 8- Sensation of muscle stiffness.  There is no position you can put your arm in that can eliminate these sensations.
Very sore and tender arm, unable to lift above shoulders, bruising at site of shot. Then the next day very tired, low energy, fatigue, headache, muscle pain, joint pain and chills.
RECEIVED BOTH DOSES OF PFIZER COVID-19 VACCINE ON 01/31/21 & 02/21/21. ON 02/22/21 WENT TO ER WITH COMPLAINTS OF TACHYCARDIA AND SHORTNESS OF BREATH. PLAN TO ADMIT TO HOSPITAL DUE TO INCIDENCE OF SVT.
Provider asked me to fill out report. Unsure if this was cause for condition of ADEM to occur. Presented to clinic w/sudden loss of vision 1 month post injection. Was sent to local ER then to hospital and was admitted for testing and treatment.
Patient was given Meningococcal B in error. Patient is 12 years of age which is under qualified age group for this vaccination.
Information has been received from a physician concerning a female patient who on approximately 26-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck). On 02-AUG-2010, the patient reported a small rash on unknown area of her body. The outcome of the patient was not reported. The patient did not seek medical attention. Follow up information has been received from the physician concerning the 60 year old female patient with right shoulder and upper back rush and scabbing at the time of vaccination and not know drug allergies who on 20-JUL-2010 was vaccinated in the arm with the first dose of ZOSTAVAX (Merck) (Lot # 665522/1765Y). Concomitant therapy include CYMBALTA, EVISTA, hydrochlorothiazide (manufacturer unknown), LIPITOR, lisinopril (manufacturer unknown), PREMARIN, PROVIGIL, trazodone HCl and VALTREX. The physician reported that less than a week after receiving the vaccination, on 04-AUG-2010, (also reported as 02-AUG-2010), the patient ultimately got shingles. At the time of the report, the patient had recovered. No further information is available.
p/vax pt preg;pt exp last menstrual period 7/2/99;a pap smear done 7/21/99 was WNL;pt phoned MD worried noting pain on rt side w/no spotting;pt exp spontaneous abortion 10wk from last menstrual period;trisomy 12 discovered;
Patient received Moderna bivalent booster dose that had undergone a temperature excursion.; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    This case is for  61th patient out of 77 patients. No concomitant medications were reported. It was reported that the vaccine was administered to 77 patients before it was known if the vaccine was ok to use after the excursion. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Pneumococcal vaccine given following proper protocol without incident on 7/25/05. On 7/26/05 at approx. 10:00am received call from mother stating the injection site on left tricept was red and warm to touch. States no drainage from site. Mother stated she had Children's Motrin and was advised to give appropriate dose and apply cold compresses and to notify us of status of child. 7/26/05 3:30pm- Mother called concerned about elevated temp (103.7). Advised to give cool sponge bath and to contact her pediatrician if not improved after the next dose of Motrin and advised to call us with status of child. 7/27/05- Mother called and stated that she took child to doctor and was started on antibiotics. Mother expressed concern because child was still running a fever. Mother stated left arm had increased area of redness and swelling. She stated no drainage from site. 7/29/05- Mother called and stated she returned to the doctor on 7/28/05 for a re-check and that the child was admitted to hospital. Stated affected arm was red swollen and warm and without drainage. 8/1/05- Mother called and stated child was discharged from hospital on 7/30/05 with the diagnosis of cellulitis and that she was doing fine.
Chills and fever x 2 days, redness and tenderness at injection site x 4-5 days discomfort with movement of arm.
suspected vaccination failure; got them anyway in his eye; sores all over his/ head and on his face; This case was reported by a consumer via social media interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), ophthalmic herpes zoster (serious criteria death and GSK medically significant) and skin ulcer (serious criteria death). On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and skin ulcer were fatal. The reported cause of death was vaccination failure, ophthalmic herpes zoster and skin ulcer.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and skin ulcer to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient received the Shingles vaccine and patient got shingles in his eye. The patient also had sores all over his beautiful bald head and on his face. The reporter stated that the patient passed away without his wife being able to directly kiss him because of that. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Reported Cause(s) of Death: Opthalmic herpes zoster; Skin ulcer
Starting approximately one week after vaccination I started to experience onset of loud  tinnitus primarily in my left ear. I have experienced mild tinnitus for 8 years but this was much more severe. The night of 04/19/2021 I noticed the onset of dizziness which progressed to strong vertigo the morning of the 20th. It was so severe I was unable to work and stayed in bed for the better part of two days. It was accompanied by the increased tinnitus.   I scheduled an appt with my primary care physician for 04/23 and by Thursday 04/22 the vertigo had decreased to a general dizziness with tinnitus in my left ear.  Dr prescribed Meclizine 25mg to me which has not appreciably addressed the symptom which as of 05/21 continues to be a constant mild dizziness with pronounced tinnitus in my left ear. I am planning to see an ENT that specializes in AIED (auto immune inner ear disorder) which I suspect was triggered my my immune system response to the vaccine.   I should note that 8 years earlier I had a milder but similar case of vertigo w tinnitus which was never diagnosed despite extensive testing (vestibular migraine as a diagnosis by exclusion). It gradually subsided over 2 years with only mild tinnitus remaining as a symptom.
Received dose Friday evening. Awoke in middle of night with large emesis. Felt unwell next morning but fine by Saturday evening. He felt well on Sunday but today 11/08/2021, he felt ill. Temperature 100.8, vomiting and not able to keep fluids down. Low energy. Had BM today that was normal. Ordered ondansetron. Mom will hydrate and if he is continuing to vomit, he will go to the ER.
At 09:05 administered Tdap, MENACTRA, and GARDASIL 9, immediately following last injection (GARDASIL 9), patient became lethargic and pale with eyes closed. Able to answer questions appropriately but speech slow. Cool pack placed to back of neck. When asked, mom stated he had not had anything to eat or drink yet that morning. Obtained juice pack and assisted to sip occasionally. Client able to sip juice when offered. At 09:10, status unchanged and head began nodding to front and side. Assisted to transfer to cot and placed in supine position with knees bent. Cool pack to back of neck and bilateral axilla. Fan positioned to blow on client. Continued to be able to answer questions appropriately but speech slow, eyes closed, and pale. Occasional shivering; no diaphoresis. When asked, stated he was cold. Fan removed but cool packs left to back on neck and axilla. After approximately 20 minutes, client appeared more alert, eyes open, and stated he felt like he could sit up. Assisted to sitting position on cot and continued to sip juice when offered. After approximately 5 minutes in sitting position, client stated he was beginning to feel lightheaded. Assisted back to supine position with knees bent. Remained in this position for 10 minutes. At 09:45, stated he felt that he could sit up again so assisted into sitting position on cot for 5 minutes. Continued to sip juice when offered. Assisted to chair for 5 minutes until he agreed he felt well enough to stand. Walked around workup room with assistance. Gait slightly unsteady. Assisted to mom's car without difficulty. Instructed mom to stop for food after leaving public health department.