chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023; No Adverse Event; 6 patients administered doses after the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients administered doses after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients administered doses after the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients administered doses after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (6 patients administered doses after the BUD) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023).    This case belongs to the 3rd out of 6 patients who had received the vaccine as described by the reporter. No concomitant information was reported. It was reported that the 6 patients had received the vaccine beyond BUD. No symptoms reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713876 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2023: Live Follow-up received: Updated suspect batch number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713876:(Master Case pt 1 of 6)
arm muscle was sore; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm muscle was sore) and PYREXIA (fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced MYALGIA (arm muscle was sore) and PYREXIA (fever). On 23-Mar-2021, MYALGIA (arm muscle was sore) and PYREXIA (fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. Treatment includes Tramadol.   This case was linked to US-MODERNATX, INC.-MOD-2021-083468 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083468:Case for dose 2
Hepatitis B #2 vaccine administered IM at 9:30AM 11/18/02. Ate bread 10:45AM. 11:15AM complained of swollen lip, flushed face, difficulty (mild) swallowing, upset sickly stomach. Did not seek treatment until 2:02PM. Given Benadryl 50mg PO then. At 2:10 given epinephrine .3CC SQ. 911 called and responded. Taken to ER for persistent symtpoms. ER doctor treated as anaphylaxis. Patient put on Prednisone (oral) and Benadryl. Allergen unclear - bread vs. Hepatitis B. Referred to private MD for follow up.
Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: Patient received vaccine on 6/7/2022 around 3pm.  Patient starting experiencing coughing, fever and shortness of breath at 7:15am on 6/8/2022.  Patient passed away by 8:15am from a sudden cardiac event.
Three hours after administration, projectile vomiting, fever 103.4 degrees F, apparent discomfort, listlessness.  One-nine days sinus infection (diagnosed).
strong burn on administration; extreme muscle pain  and immobility of left arm; flu like aches that proceeded to takeover body  for 48 hours, included neck pain and headache for same 48 hours
Fine rash on torso, itching. Treated with Prednisone 20mg 1/day x 4 days. BENADRYL 25 mg every 6 hours x 2 days.
most people are getting side effects after getting the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (most people are getting side effects after getting the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (most people are getting side effects after getting the vaccine). At the time of the report, VACCINATION COMPLICATION (most people are getting side effects after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was provided. No concomitant medication was provided.
Lethargy, decreased appetite, low grade fever off and on, and fine rash that started on hands and feet and then spread up extremities.  Mom was giving Tylenol for the low grade fever and giving Pedialyte to prevent any kind of dehydration.  She also started giving Benadryl on Saturday per primary provider instruction.  Called mom on 8/16/21 to follow up and was told that the child is pretty much back to his normal self.
Localized swelling (quarter size), redness warm to the touch fever x 2days 101 increase.
Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and needed to be returned. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not have been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccine exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between dates of 2/12 - 12/18/14 under lot number (J012212).
I started feeling funny not long after the shot. I had some pain that in my eyebrow area. I was so exhausted that I started crying, and my legs and arms were very heavy and it was  hard to move them. Then, in my left hand going up all the way to my shoulder, starting with my fingers, they went numb. It tingled so bad that it hurt. Then, it started in my legs. This happened on all 3 dose, but on this, I also got really nauseous and dizzy.
Initial report received from a consumer's parent on 03 February 2011. A 4-year-old female patient received on 13 December 2010 an intramuscular injection (site not reported) of FLUZONE, lot number U3573FA. The patient had no medical history and took no concomitant medications. She had no illness at the time of vaccination, had no other vaccines within 4 weeks of the FLUZONE and had no adverse event following prior vaccinations. Three days after vaccination on 17 December 2010, the patient developed an oral temperature of 102.9 (units not provided) and rapid breathing. The patient was seen 2 hours later in an Urgent Care facility where her temperature was 99. No fever reducer was given. The patient was given albuterol and her symptoms cleared up. The patient's mother stated that about 2months earlier the same situation occurred without having received a vaccination. The mother felt that the symptoms were not related to the vaccine. The outcome was reported as recovered. Documents held by sender: None.
Vaccine exposure during pregnancy. A spontaneous non-serious report of administration to pregnant female was received from a nurse concerning a 23 year old female patient. On 30-Sep-2008, FLUMIST was administered to the patient at the health department. The patient was two to three weeks pregnant. In November 2008, the patient discovered she was pregnant. She had no symptoms or problems at the time of the report. There was no adverse event associated with this FLUMIST exposure to a pregnant female. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient/subject experiences any adverse events during the pregnancy.
ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 22 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUN-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 07-JUN-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from affected vials due to temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915719, 20210916300, 20210916959, 20210916965, 20210917160, 20210915661, 20210915646, 20210915623, 20210916808, 20210916715, 20210917163, 20210916520, 20210915731, 20210915748, 20210915852, 20210916129, 20210916228, 20210916312, 20210916401, 20210916415, 20210916455, 20210916465, 20210916498, 20210916553, 20210916584, 20210916658, 20210916697, 20210916768, 20210916808, 20210916811, 20210916849, 20210916910, 20210917074, 20210917226, 20210917500, 20210917515 and 20210917603.
MMR administered on 8/29/07. Mother states that on 9/8/07, patient broke out in a total body rash. Child has red/macular rash (total body).
My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Autoimmune reaction - knee swollen, on crutches, had to have fluid removed, take steroids, get cortisone injection, etc Also joints on hands now sore (a couple months later), severe headaches for the first couple months after the injection. Dr put me on hydroxychloroquine. Autoimmune response was significant and continuing. Currently doing PT for knee, other joints involved.  Currently trying to get it under control via medication, dietary changes, lifestyle changes, physical therapy. Temporary handicap tag on car because walking far is challenging.
Pt presents to HD 08/10/09 @ 800am with c/o of redness and itching, burning at site of varicella vacination to LPUA SQ site from shot given 08/07/09.  There is a 30wX40l erthythematous area to site does not feel warm or hard no swelling noted.Site is tender to touch.  She states she tried ice over the weekend and applied cortisone cream for itching.  I referred her to PCP.
muscle ache/muscle ache at the Shingrix injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was unknown.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The age group was not reported but was selected as per the vaccine indication. The patient experienced muscle ache at the Shingrix injection site. The patient asked how long it could last.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 30-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
SINUS,LOWER BACK PAIN,HEADACHES,LOSS OF MEMORY,JOINT PAIN,HEART BURN,DRY MOUTH AND LIPS,SLEEPING DISORDER.
Patient claims that she has had severe headache and soreness at injection site for 2 days.
Fever, nausea, severe headache, sweating, shivering, no energy and muscle aches.
This spontaneous report was received from a 67 years old male patient who was reporting on himself. None drug reactions/allergies were reported. The patient's concurrent conditions included high blood pressure, an unspecified cardiac disorder (reports as heart regulator) and high cholesterol. His concomitant therapies included unspecified medications for high blood pressure and for high cholesterol and an unspecified heart regulator. On 11-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneously; lot # and expiration date were not reported). On approximately 14-SEP-2015 (also reported as 3 or 4 days after receiving the vaccination), the patient experienced an unspecified injection site reaction, soreness and muscle pain. He also developed small black streaks on his back. He stated that he was itching but it was unspecified if he was itching all over his body or not. Blood work was performed and an unspecified specimen samples were taken. It was also reported that the patient did not seek medical attention and that no treatment was given for the adverse events. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sore arm; Hurt; Shivers; Tired; Fall; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 19May2021 (Batch/Lot number: unknown) at the age of 54 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Scoliosis" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Wasp allergy" (unspecified if ongoing). Concomitant medication(s) included: AMANTADINE; ADDERALL; ATORVASTATIN; CLOBETASOL; OCREVUS. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sore arm"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Hurt"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Shivers"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Tired"; FALL (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fall".  Additional information: Patient's concomitant medication included CALCIU (as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was having trouble breathing, she said it was like an asthma attack. Patient stated she does have asthma but feels this was due to the vaccine.
This spontaneous report as received from a pharmacist refers to a 69 years old female patient. The patient was vaccinated with ZOSTAVAX on 24-OCT-2012 (dose/frequency, route, lot #/Exp. Date were unspecified by reported). No other co-suspects were reported. No concomitant medications were reported. After day or two later post vaccination, approximately on 25-OCT-2012, the patient got shingles. No treatment information was reported. The patient seeks medical attention. The outcome of shingles was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Numbness and tingling in my fingers on left hand, Left arm feeling very heavy and sore
Nauseau, vomitting, lightheaded,  tingling around lips thought they were swollen, speaking weird cause of feeling of swelling and left palm and forearm numbing and thighs of legs.  Stomach cramping and diarrhea   after 1st night and still coninuing tonight as of 04/16/2021.  On first night (04/08/2021) extreme painful body aches.
Fever, body ache, vomiting, swelling, redness, red streak, pain at injection site. Temp: 102 degrees F on Tuesday. Wednesday - afebrile.
Vomiting, headache, loss of balance, double vision, numbness, Bells palsy, back pain, restless legs, unable to go to the bathroom, all starting in the morning and continuing to get worse. New symptom everyday. Bedridden for days.
4 days after first injection, I developed herpes simplex in my right nostril, 3 on my upper right lip, and one between my right nostril and right lip.; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiration date was not reported) via an unspecified route of administration, administered in Arm Right on 17Feb2021 03:45 PM (at the age of 73-year-old) as, single for covid-19 immunisation at hospital. The patient Medical history included high BP, epilepsy, environmental allergies, and asthma and patient had allergy to latex. Concomitant medications included topiramate, losartan, omeprazole, levothyroxine sodium (SYNTHROID), atorvastatin calcium (ATOR) (all medications received in two weeks). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient did not receive any other vaccine within four weeks of vaccination. On 21Feb2021 at 04:00 PM, after 4 days after first injection the patient developed herpes simplex on her right nostril, 3 on upper right lip, and one between right nostril and right lip. Patient never experienced an outbreak such as this in over 50 years and was remained confined to home since this pandemic began. Patient was treated with unspecified OTC medication for the event. The event was reported as non-serious. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 16-JUL-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # H0188796 and expiry date: 24-OCT-2014) which was improperly stored. Primary reporter was reporting excursion o 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
About midnight post vaccination, patient felt chills, HA, nausea.   Took Tylenol and slept.   Then she slept and woke up with hands tingling, thumbs to palms and fingers spread out and bent, barely able to move them.  Neighbor nurse came over to evaluate for stroke.   Similar symptoms were bilaterally.  Nurse gave epipen on hand.   Hands improved within a few minutes.   She could move them normally in about 5 minutes and did not return.   Still felt nauseous, no appetite.
Pt recv vax on 2/24/99; on 2/27/99 pt exp headaches until 3/20/99
Vertigo, dizziness, inability to focus. Some feelings of euphoria associated with the Vertigo.
Patient was seen 3/20/2023 and received a dose of the Flu vaccine. However, the patient had already received the flu vaccine for this season in September 2022. The patient also had already received his first two doses in a previous flu season.
24 hours after the booster I woke up to a pounding headache, Chills, Severe headache, I hurt all over to move and it felt like I had the flu. That day I also got Flu along with COVID vaccination one on each arm so both arms were in pain and a bad rash. I didn't go back to the doctor due to the Adverse event, I went because of the rash. the flu symptoms lasted about 24 hours and they were gone. I didn't actually see the doctor I just had a Virtual appointment. I still have headaches so I'm doing physical therapy to see if it'll help some. everything else has gone away.
Patient came into pharmacy on 5/8 in the morning stating that she had received a pneumonia vaccine on 5/6 and that she had a bad reaction to it.She proceeded to show me her arm which was red to the elbow.She also showed me photos on her phone with what looked like her arm swollen at the injection site.She asked me to call her physician and let him know that she had a bad reaction to the vaccine, which I did. The MD office sent in a prescription for cehpahlexin for her.
SEVER ACHES AND PAINS OF MUSCLES AND JOINTS Narrative:  AFTER 1ST VACCINATION: EMPLOYEE STATES SHE EXPERIENCED A HYPERPIGMENTED AREA AT THE INJECTION SITE THE SIZE OF A GOLF BALL (NO PAIN) WHICH LASTED 3 WEEKS) AFTER SECOND INJECTION: SHE EXPERIENCED SEVERE ACHES AND PSAIN OF MUSCLES AND JOINTS WITH RELIEF FROM TYLENOL