chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; expired MMR II was administered, to a patient. The HCP stated that the vaccine expired 10/3/2020.; This spontaneous report was received from a nurse and a medical assistant and refers to a 4 year old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 20-DEC-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status rHA, 0.5 ml , lot # R028381 with expiration date of 03-OCT-2020, for prophylaxis (route of administration was not provided). No adverse event occurred.    No temperature excursions occurred.
On 9/19/01, mother states that infant had reaction to Pneumococcal vaccine on 2/6/01. Also, had increased heart rate, breathing difficulty and temperature of 103F. She states he was given 2 shots and a breathing treatment.
Pt was give DTap before pt needed it. Pt has had 4 dose already.
Child vomited in car on way home with in 15 minutes of getting shot.  Vomiting continued until stomach empty.  Then dry heaves every few hours until 4 am on 12/10/2009.  No fever with vomiting.  His color was brown/green/grey.  Late morning of 12/10/2009 stomach was better and he was able to eat. Only was lethargic through out day, no vomiting.
Since shortly after booster shot I've had watery eyes with tears leaking out both sides of the eye, bilaterally. Have had blurry vision where I need to blink several times to clear vision. Have had significant pain to right elbow joint of unknown etiology. Have had increasing bouts of insomnia. Mild pain in right abdomen.
the following day after administration patient's developed very sore gums and roof of mouth became sore with skin peeling off, patient presented on 9/6 asking for guidance stating symptoms are still there and are worsening not improving
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 04-DEC-2014, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.On or about 19-SEP-2015, the patient was treated for a painful rash that was diagnosed as shingles. While shingles is an incurable condition, the patient was prescribed valacyclovir (VALTREX) to manage her symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
After 3rd Rabies vaccine injection, pt's right upper arm experienced numbness and tingling in hand with loss of feeling in right hand for 5 hours duration. Complained of dizziness and feeling "just not right". Stated temperature was 103F-101F, during the night. No breathing or swallowing difficulties. Temperature is now 98.9F. Treated with Benadryl.
loss of appetite; weight loss; nausea; fatigue; This case was reported by a consumer via call center representative and described the occurrence of appetite lost in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 27th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2020, 2 days after receiving Shingrix, the patient experienced appetite lost, weight loss, nausea and fatigue. On 1st August 2020, the outcome of the nausea and fatigue were recovered/resolved. On an unknown date, the outcome of the appetite lost and weight loss were not recovered/not resolved.   It was unknown if the reporter considered the appetite lost, weight loss, nausea and fatigue to be related to Shingrix.   Additional information was provided as follows: The patient experienced fatigue, nausea, weight loss and loss of appetite after receiving the first dose of Shingrix in right deltoid. Fatigue and nausea were resolved after 3 days. The patient had lost ten pounds but gained four back. The patient had visited her physician and a CT scan, X-rays and blood work were unremarkable. The reporter consented to follow up.
6 days after arm was sore at injection site, felt as if I had an Internal bruise, lasted about one day
Cried x 2 1/2 hrs initially straight then 1/2 hr break followed by additional 2 1/2 hrs. Crying then whimpered all night. Fine next morning.
day following vax pt exp severe headache, fever 102f-103f x2days. lymph nodes under rt armpit swollen, rt arm swollen 2x2cm, redness p/4days. recv dermd & phenergan combination
Janssen COVID-19 Vaccine EUA Patient received Janssen Vaccine on 4/30/2021. Presented to ED on 7/9/2021 with Altered Mental Status and Shortness of Breath. Admitted with Respiratory failure. Patient admitted 7/9/21 for COVID-19 pneumonia. Intubated 7/10 and completed treatment with decadron and remdesivir daily (7/9 - 7/13). Treated with ceftriaxone and azithromycin. Patient expired on 7/26/2021.
This case was reported by a sales representative via another sales representative and described the occurrence of influenza B virus test positive in a child (age 6 - 10 years) female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (release date 20 July 2011). Less than one year after vaccination with FLUARIX, the subject contracted influenza B virus. The subject tested influenza B virus test positive and experienced vaccination failure. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. No additional information was reported. This case is linked to two additional reports received by the same reporter involving vaccination failure following FLUARIX vaccination. Linked cases include: A0980137A and A0980250A.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not provided. On 17-OCT-2017, the patient was vaccinated with expired M-M-R II (dose and route of administration not specified) lot # L039613, expiration date 08-OCT-2017 for prophylaxis. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT) lot number N021895, expiration date 29-NOV-2019. The patient experienced no adverse events. The outcome of expired product administered was unknown.
Fever up to 100.7, chills, myalgias, headache, and fatigue for about 36 hours total after 2nd dose of vaccine
She has experienced issues with restriction of motion in her left arm; 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 63-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "She has experienced issues with restriction of motion in her left arm".  Additional information: The patient reported that with her previous Pfizer BioNTech COVID-19 vaccinations and boosters she had issue with restriction of motion of her left arm.  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-202201369373 same patient, drug, event, different dose;US-PFIZER INC-202201369370 same patient, drug, event, different dose;US-PFIZER INC-202201369372 same patient, drug, event, different dose;US-PFIZER INC-202201369371 same patient, drug, event, different dose;
About an hour after shot felt like he was getting a mouth ulcer and throat scratchy. Felt tired in afternoon. Woke up the next morning with swelling of lips, couldn't swallow. Had some swelling in nose (pimple) and said ears were ringing. Treat in ER - BENADRYL, steroids, Famotidine. Taking Prednisone still.
Started with severe pain in right hip and right knee.  Over the next year was treated with pain relievers and finally diagnosed with arthritis.  Also developed numbness and tingling of hands, feet and neck area.  I've had physical therapy to relieve pain.  This is on going.
Nausea and dizzy @ 7:00pm 9/14/15. Raised red rash the size of a quarter and tennis ball with itching and burning @ 1:00pm on 9/15/2015.
Case number PHEH2014US012229, is an initial spontaneous report received from a nurse on 16 Jun 2014. This report refers to a 17 year old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A13011), subcutaneously on 16 Jun 2014. No adverse event was reported following this administration error.
Drug ineffective; SARS-CoV-2 Infection; This is a literature report.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), 5 months after the suspect product(s) administration, outcome "unknown"; COVID-19 (medically significant), 5 months after the suspect product(s) administration, outcome "unknown", described as "SARS-CoV-2 Infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: PCR Ct greater than equal to 30; SARS-CoV-2 test (normal high range 30): Symptomatic, positive antigen test, notes: day 0; Symptomatic, positive antigen test, notes: day 6; Asymptomatic or negative test result, notes: day 8; Symptomatic, positive antigen test, notes: day 11; 17.2, notes: day 12, Symptomatic, positive antigen test; 22.9, notes: day 14, Symptomatic, positive antigen test; 29.9, notes: day 16, Symptomatic, positive antigen test; Asymptomatic or negative test result, notes: day 18; Asymptomatic or negative test result, notes: day 20; were obtained through Laboratories, notes: Laboratories; Unknown Result; Viral test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200065235 Same article/ drug/event and different patient:;
I just wanted to let you know that I experience a fever up to 101.9 along with chills, body aches, and fatigue for 24 hours on Saturday, following my 2nd dose on Friday. I was fever and symptom-free on Sunday morning.
Symptoms that she had when she had COVID19 in March; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Symptoms that she had when she had COVID19 in March) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included COVID-19 in March 2020.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (Symptoms that she had when she had COVID19 in March). At the time of the report, SUSPECTED COVID-19 (Symptoms that she had when she had COVID19 in March) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. Very limited information regarding the symptoms has been provided at this time. Further information has been requested.; Reporter's Comments: Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. Very limited information regarding the symptoms has been provided at this time. Further information has been requested.
After vaccination, pain started immediately at site of vaccination. Doctor recommended that patient takes Tylenol when arrives at home. Patient only took one dose of Tylenol because nausea started after first dose. Nausea and pain in arm kept getting worse and by evening, patient was not able to eat or drink. At about 11 PM, patient also started feeling really warm/hot and vomited fiercely off an don throughout the night. Patient was tossing and turning all night. At about 5 AM, when woke up, patient felt really dizzy and fell against a wall and bruised her eye, mouth and fainted. When came to, patient called her daughter who in turn contacted her mom's doctor and the doctor told them to take the patient to the ER (it was about 7:30 AM). In ER, patient was given medication for nausea and Vicodin for the pain. At about 4:30 PM, patient was moved from the ER to a room. Patient was released the next afternoon (about 4:30 PM). By Monday evening, pain on arm had lessened and the dizziness and nausea had diminished by next day of when patient was released.  Nurse follow up on 08/04/04 states: "Vaso-vagal syncope; arm pain."
Numbness, tingling, weakness, SOB, resp failure Dx'd as Guillain-Barre Syndrome.  Treated with IVIG + PLEX (I think).
felt herself "miserable"; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt herself "miserable") and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and J13L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION COMPLICATION (felt herself "miserable") and NAUSEA (nausea). On 25-Feb-2021, VACCINATION COMPLICATION (felt herself "miserable") and NAUSEA (nausea) had resolved.
decribes as a mild case of hives presented on the back of both arms and across patients back.  was resolved with diphenhydramine but returned when it wore off.
Severe vertigo. Sudden onset. Dizziness, vomiting, no balance. Spent the night in the ER. I am still suffering from lack of balance and muffled hearing in my left ear after 9 days since onset. I can?t work or drive or take care of my family.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
IMMOBILE IN BED WITH ICING; MIGRAINES; UNABLE TO WALK; RIGHT HIP PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the subject experienced immobile in bed with icing, migraines, unable to walk, and right hip pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the right hip pain, migraines, immobile in bed with icing and unable to walk was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Walking down stairs with suitcase knees were in pain, leg was in pain, hands were in pain. My health has gone down since then. In June my blood work which had been normal on my yearly visits came back off to the point the Dr retested thinking it was a mix up at the lab. My sed rate was 50 and my potassium was over a 10 the Dr called me to take the test again. It came back normal. I was referred to a auto immunity Dr but the tests came back negative. I have been slowing going down. My sed rate got up to 97. My knees hand wrists are in constant pain. I am falling down a lot. I have had many tests and they still cannot find a reason. I have a 3.5 average in college and cannot walk the campus as I did last year. I have missed classes in the first two weeks of my 2nd year due to the pain. Up until the time I had this HPV vaccine I was fine. Now I am so much pain I am in tears daily.
2/9/06 Right arm swollen with rash from site of injection radiating to right elbow.  Using ice pack to area.
Hot feeling at the injection; Soreness at the injection site; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 61-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season (intramuscular). On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site warmth, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site warmth, injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site warmth, injection site pain and injection site erythema to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. In October 2019, the patient received flu vaccine in the left arm. The patient did not know the manufacturer of the flu vaccine she received. The patient reported redness at the injection site, soreness at the injection site, and a hot feeling at the injection site that began a couple hours after receiving the flu vaccine and resolved after a couple of days. The reporter consent to follow up. This case has been linked with case US2020167496 and US2020167494, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020167496:Mother in law's case US-GLAXOSMITHKLINE-US2020167494:Husband's case
Nausea, extreme chills, Muscle and joint pain, headache, spinal cord pain, dizziness.
Sore arm at the injection site; Little bit tiredness; Mild headache; Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the injection site), FATIGUE (Little bit tiredness), HEADACHE (Mild headache) and EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site), FATIGUE (Little bit tiredness) and HEADACHE (Mild headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency and IBUPROFEN for Adverse reaction, at an unspecified dose and frequency. On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm at the injection site), FATIGUE (Little bit tiredness) and HEADACHE (Mild headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient do not take any concomitant medicine since they do not have any comorbidities. Expiry date of vaccine was  16 Oct 2021.Dose quantity was 1/2 dose.   This case was linked to MOD-2021-361496 (Patient Link).
Generalized vaccinia trunk, arms, legs. Flu-like symptoms of malaise, headaches. Patient had vaccination as child without incident.
Strong pain located in the place of the shot; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Apr2021 at 11:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. It was unknown if the patient was pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 19Apr2021 at 18:30, the patient experienced strong pain located in the place of the shot. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event and included treatment with pain killer (unspecified) in the afternoon (PM) and acetaminophen (EQUATE) 500mg. The clinical outcome of the event strong pain located in the place of the shot was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT STATES INJECTION DID NOT FEEL RIGHT FROM THE TIME IT WAS GIVEN. ACUTE ONSET OF PAIN @ 1PM BY EVENING WAS HAVING BACK SPASMS & BACK PAIN. COULD NOT LIFT LEFT ARM, PATIENT CALLED NFP NEXT DAY & INSTRUCTED TO CALL PRIMARY CARE PHYSICIAN. SEEN BY PCP 11/2/07 DX WITH INFLAMED ROTATOR CUFF, GIVEN IBUPROPHEN 800MG TID, ICE BID,& REFERRED TO PT. UNABLE TO GO @ PRESENT DOING HOME EXERCISES PER PCP'S INSTRUCTIONS.