chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a dose of expired Engerix-B; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 47-year-old male patient who received HBV (Engerix B) (batch number GR55T, expiry date 28th August 2020) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th July 2021, the patient received the 1st dose of Engerix B (intramuscular) and Engerix B Pre-Filled Syringe Device. On 13th July 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient received a dose of expired Engerix-B. The reporter consented to follow up.
Very dizzy lightheaded tunnel vision eyes shifting back-and-forth from right to left very fast.
Soreness at injection site Chills, body aches, and fever - unable to go to work the following day.
vomiting, hives on breasts, chest and neck and sever nasal congestion. had to administer epi-pen
Admission to hospital for fever, tachypnea, tachycardia, leukocytosis, and lactic acidemia.    Pain and swelling of left arm.  Patient was admitted to the hospital for IV antibiotics, hydration, and supportive care.  LUE duplex was negative.  Discharged after 3 days as in patient.
Red welt about 2 inches in diameter at injection site, swelling itching hot to the touch. Currently treating with OTC Benadryl and hydrocortisone cream. Started treatment 1/18/2021 ( 8 days after injection, so results of treatment not yet known.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022; No adverse event; Dose was administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 21-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022).    No concomitant product use was reported. Reportedly, Patient received Full dose. Vial did not undergo any temperature excursions. No treatment information was provided.
Case number PHEH2015US019328, is an initial spontaneous report received from a health care professional on 24 Sep 2015. This report refers to a 15 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO, batch number: M14097, expiry date: 31 Dec 2015) on 15 Aug 2015 and the vaccine administered was stored in 34.0 degrees Fahrenheit and 50.2 Fahrenheit for 48-120 hours. No adverse event was reported following this maladministration. Follow-up information received on 25 November 2015: The patient's vaccination status was current. Concomitant products included GARDASIL., received on 15th April 2015. The patient's details (height and weight) were provided. MENVEO was administered intramuscularly on the left deltoid.
There was a full, tingling feeling in my right cheek, below my eye almost immediately after the shot. Four days later, I developed stinging and swelling ion the outside of that same eye and underneath. Today is day 6 and my right eye and cheek are still swollen, itchy and burning.
Child w MIS-C admitted to PICU: hypotension, hyperbili, hepatosplenomegaly, 4d fever, neg cultures, neck pain, abd pain, tachycardia.
- extremely itchy and red rash behind my thighs, on my butt, lower back, and arm pit area  I took an over the counter antihistamine and a prescription antihistamine and the rash went away overnight.
Information has been received from a physician concerning a 11 year old male who on 11-MAY-1989 was vaccinated with a first dose of MMR II. On 27-FEB-1997, the patient was vaccinated with a second dose of MMR II (routes, sites, and lots number were not reported). On 25-NOV-2009 the patient experienced right parotitis. The right side of the patient's neck was swollen. The patient was afebrile. On 29-NOV-2009, the patient was diagnosed with mumps. The outcome for mumps was not reported. Follow up information has been received indicating that the 21 year old male patient (also reported as 19 years old) on 24-NOV-2009 experienced mumps (previously reported as 25-NOV-2009). The patient was diagnosed on 27-NOV-2009, the patient was afebrile. This is one of several reports from the same source. No further information is available.
Rash on groin, behind knees, antecubital fossa, and under arms; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Rash on groin, behind knees, antecubital fossa, and under arms) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 07-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced RASH (Rash on groin, behind knees, antecubital fossa, and under arms). At the time of the report, RASH (Rash on groin, behind knees, antecubital fossa, and under arms) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered RASH (Rash on groin, behind knees, antecubital fossa, and under arms) to be possibly related.    No treatment medication was received.  It was reported that, patient had very itchy urticarial rash, at times measles like that is persistent. Worsens with heat.  Patient is on fertility treatment.  In the follow up patient states that she is still suffering from rash.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow-up received and patient is still having issues with rash
FOUR HOURS AFTER THE SHOT HAD SOB, FEVER OF 103 DEGREES. DID NOT GO TO THE ER DUE TO THE COST. BETTER THE NEXT DAY. fEVER WENT DOWN. ALL SYMPTOMS GONE BY THE FOLLOWING DAY.
Night of 10/20/15 child developed redness on left deltoid area measuring 50 mm x 50 mm. Per mother child complained of pain, itchiness and mild fever.
Nausea. Mild fever like sx. Shaky, clammy, dizzy.
Patient received the 1st dose but she never received a 2nd dose and currently wanted to get a booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient received the 1st dose but she never received a 2nd dose and currently wanted to get a booster) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if the patient had relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 01-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient received the 1st dose but she never received a 2nd dose and currently wanted to get a booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient received the 1st dose but she never received a 2nd dose and currently wanted to get a booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient received the 1st dose but she never received a 2nd dose and currently wanted to get a booster).    Concomitant medication was not provided.   Treatment information was not provided.   Reporter did not allow further contact
Unusual amount of blood dropped down my arm immediately after the injection (seemed strange for an injection in the upper arm). Redness and swelling at injection site that  progressed over night and the next days becoming a hard red lump. Very itchy on the same day of the injection and following days.
Mother called to report swelling/redness in right thigh 1" across, no fever or pain at injection site, no heat, no streaking redness. Developed fever on 1/6/18 of 103.3, responded to Tylenol.
Narrative: A 73yo male with PMH of PUD, Pancreatic Cyst, HTN, Depression, Hepatitis, Cervical Radiculopathy, Episodic Opioid Dependence, Neck Pain, Low Back Pain, OA, DM and Gout He received his first Covid-19 vaccine per protocol on January 28, 2021 AM and the second dose on February 18, 2021 AM Chief of Ambulatory Care reported the patient with a historical ADR of Pharyngitis, which started two days post the second vaccine and resolved after few days.
Patient woke up with goofy voice and can hardly talk; Patient woke up with goofy voice and can hardly talk; This spontaneous case was reported by a patient and describes the occurrence of DYSPHONIA (Patient woke up with goofy voice and can hardly talk) and DYSARTHRIA (Patient woke up with goofy voice and can hardly talk) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Nov-2022, the patient experienced DYSPHONIA (Patient woke up with goofy voice and can hardly talk) and DYSARTHRIA (Patient woke up with goofy voice and can hardly talk). At the time of the report, DYSPHONIA (Patient woke up with goofy voice and can hardly talk) and DYSARTHRIA (Patient woke up with goofy voice and can hardly talk) outcome was unknown.            No concomitant medication information was provided.  Patient had previous doses of Moderna covid-19 vaccine -1st dose on 02-Feb-2021 (lot 007M20A and expiry date unknown), 2nd dose on 02-Mar-2021 (lot 010A21A and expiry date unknown), first monovalent booster dose on 16-Nov-2021 (lot 058F21A and expiry date unknown) and second monovalent booster dose on 16-Jun-2022 (lot 059A22A and expiry date unknown).  No treatment medication was provided.
Six hours after shot I developed a dry cough, pain through body, in joints and feeling of tacks being pushed into every inch of my skin.  I had the chills and electrical shock feelings throughout my body, pins and needle (neuropathy) sensations throughout body, difficulty moving or walking because of the pain.  Most symptoms subsided in 10 except for the dry cough which lasted 4 weeks.  The neuropathy is still ongoing and has settled in my hands and feet.  When I do normal everyday actions it gets worse and moves up my arms and up my legs.  When I try to walk 10,000 steps a day or do yoga the pain is excruciating  but subsides back to my hands and feet in 4 days.  My doctor told me to take Lions Mane for at least 2 bottle worth which is 2 months. I am still taking it.  I started taking Logo Nutritionals Complete Thymic Formula for the last month and I have not been exercising and rest throughout the day.  I still have the neuropathy in my hands and feet that is irritated by wearing shoes or doing activities like cooking or baking so I try not to do too much, just the minimum to get by and rely on my family to do the rest. I have had the same reaction to the first dose of Shingix and all three of my Covid Pfizer shots but have felt completely better within 10 of those shots.  I believe my immune system was overwhelmed because I had my 1st Shigrix shot on 10/10 20/21 my Covid Pfizer booster on 11/19/2021 my 2nd Shingix 12/10/2021 and flu shot 9/10/2021.  I had the same side effects for all my Pfizer shot and the 1st Shingrix but symptoms subsided in 10 days except for this last Shingrix shot.
Patient states that they had a reaction the day after their shot. Lasted a couple days. Was very red, encompassing most of the upper arm, and was warm to the touch. Patient stated it went away on its own after a couple days.
Delayed throbbing, radiating pain in arm after 2nd dose; Initial soreness in arm after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Initial soreness in arm after 2nd dose) and PAIN (Delayed throbbing, radiating pain in arm after 2nd dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029l20a and 003a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Initial soreness in arm after 2nd dose). On an unknown date, the patient experienced PAIN (Delayed throbbing, radiating pain in arm after 2nd dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and TYLENOL at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Initial soreness in arm after 2nd dose) and PAIN (Delayed throbbing, radiating pain in arm after 2nd dose) outcome was unknown. Not Provided          Patient tried pain relieving creams No  Concomitant medications were provided
The patient experienced no symptoms.; on 9-JUN-2020 a patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 09-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) administered by subcutaneous route, as prophylaxis (lot number S031704 which has been verified to be valid, expiration date reported and validated as 06-APR-2021) (dosage, vaccination scheme, frequency and anatomical site of injection were not reported). The vaccine was reconstituted with properly store sterile diluent (DILUENT MERK) (lot number T001631 which has been verified to be valid, expiration date reported and validated as 11-JUN-2022). The administered dose of the vaccine experienced a temperature excursion of -13.3 degrees Celsius (C), during a time frame of 1 hour and 15 minutes, as recorded by a digital data logger. There were previous temperature excursion of -1.8 C, during a time frame of 4 hours and 27 minutes and of -13.4 C, during a time frame of 1 hour. The patient experienced no symptoms.
Low grade fever that responded well to Tylenol.  Body aches and mild diarrhea that lasted 6 - 8 hours.  Just didn't feel well most of the next day.   I had no adverse reaction to the first dose on February 17th, only to the second on March 10th and the third (booster) on October 19th.
Normally I don't have a period and it started to come back heavy in March, Now it comes for 2 weeks at a time very heavy and painful and they are not on track to when they should be. I have had pain the last cycle, I went in and they told me there was a cyst and I have to see a gyno.
Patient reported developing chills, diaphoresis, low grade fever, arm pain and fatigue an hour after receiving the Pneumovax. She had resolution of symptoms after taking Tylenol.
fever; aches/pains; chills; This is a spontaneous report from a contactable consumer (patient husband). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 09Feb2021 (age at vaccination 60-year-old) as dose 2 single for COVID-19 Immunization. Medical history and Concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 Immunization. It was reported that patient had fever, aches, pains, and chills after the second dose of the vaccine yesterday 09Feb2021. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Rubbery legs, possible GBS: radiculoplexus neuropathy. Treated with IVIGG 2/10-2/15/2010 treatment ongoing.
+ pruritic rash arond injection site that is raised - no treatment needed - recommended no further Havrix
Client left exam room at 11:52 AM following immunizations. At approximately 12:00 PM the client's mother yelled "excuse me, she's going into a convulsion." Clinical staff responded immediately. Client was found on mom's lap, fully conscious, alert and oriented, and displaying no seizure-like activity. She did appear weak and pale and was complaining of chest pain and not feeling well. No respiratory distress was noted. The client was moved back to the exam room and vitals were taken at 12:06 PM: BP: 80/50 Pulse: 54 Respirations: 16 Temperature: 98.5 F. The client remained alert and oriented and answered questions appropriately. At 12:09 PM she reported that her chest no longer hurt and she was feeling better. The client's grandmother called EMS and they left the clinic shortly after to wait for EMS in the lobby (grandmother's request). A nurse accompanied the family to the lobby. EMS arrived at 12:20 PM. A follow up phone call was made to the client's mother on 5/8/18. She indicated that she took the client to Hospital, where they found the client to be stable and did not admit her.
pt recvd pain in shoulder & arm muscle which is annoying;has gotten no better, no worse since time of inj
Itching throughout my body every day. All over, from head to toe. This started after first shot. I have not changed anything in my life, no new foods, no new detergents, perfumes, cleaners, body washes etc. Nothing new. This itching starts as bright red patches, not hives.  The itching comes and goes, throughout the day, terrible. Have tried Benadryl, Cortisone, still happens every day. Its been 2 months of this.
Next day reaction included fatigue and chest pain, chest pain continues multiple days when exerting body in physical activity
FLUSHED, FATIGUE, FEVER, HEADACHE Narrative:  TEMPERATURE 99.8, SYMPTOMS  LASTED 24 HR  Other Relevant History:
I felt nauseas; lightheaded; hand numbness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "I felt nauseas"; DIZZINESS (non-serious), outcome "unknown", described as "lightheaded"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "hand numbness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hive, (Swelling, heat and itchyness) surrounding injection site1 week after the first Moderna COVID vaccination
a raging rash / rash started on his right arm/ rash did spread to his other arm/ rash is super itchy; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 01Apr2021 (Lot Number: ER8737) as single dose for covid-19 immunisation. The patient medical history and  concomitant medications were not reported. The patient received first Pfizer COVID vaccine on 01Apr2021 and experienced a raging rash 24 hours later (02Apr2021), still had the rash, he was due for second dose on 23Apr2021. He's had this rash 13 plus days. The rash started on his right arm, not the arm where he received the Covid 19 vaccine. The rash was super itchy, super annoying. The rash did spread to his other arm. He did see his doctor as soon as he could. His doctor told him maybe the rash was related to the Covid 19 vaccine, maybe it's herpes zoster, maybe it's contact dermatitis, it's probably not the Covid 19 vaccine. His primary care doctor prescribed him a topical steroid, Clobetasol and Benadryl for itching. He then saw a dermatologist. The dermatologist took a closer look and decided to prescribe an oral steroid, Prednisone, he's on his second day of taking the Prednisone. The dermatologist told him to get the second Covid 19 vaccine even if his rash isn't resolved by then but the first doctor her saw said he might need to worry about anaphylaxis. That's scary. He wanted to get the second Covid 19 vaccine. He stated maybe his body started making all these T-cells the next thing he knew he had this rash.  He stated his PCP and dermatologist advised him to call Pfizer regarding the treatment of his rash, he wanted Pfizer to recommend what to do to get rid of the rash. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.