chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On or about 11-MAY-2011, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical localization, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and she subsequently contracted a persistent strain of herpes zoster or shingles. On or about 05-AUG-2014, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster (onset date unspecified). She was prescribed acyclovir for management of her painful symptoms and chronic pain. On or about 15-FEB-2017, she was treated for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was prescribed valacyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure, herpes zoster and chronic pain was unknown. The reporter considered vaccination failure, herpes zoster and chronic pain to be related to ZOSTAVAX.
Headache, Myalgia,  injection site discomfort, fever, and chills Narrative:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 46 year old female. 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 (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 21-JAN-2022) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient received additional two dose of non-company suspect vaccine included: Moderna covid-19 vaccine (Elasomeran) (dose number in series 2) first dose as (batch number: 076c21a, form of admin, route of admin, and were not reported) dose was not reported, administered on 24-OCT-2021 for prophylactic vaccination, and second dose (batch number: 033h21a, form of admin, route of admin, and were not reported) dose was not reported, administered on 22-JAN-2022 for prophylactic vaccination.  On 19-MAY-2022, the patient tested positive for Covid-19 with 2 rapid test and had runny nose at same time (suspected covid-19 infection) (dose number in series 2). This led to suspected clinical vaccination failure (dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20220548145-COVID-19 VACCINE Ad26.COV2.S-suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Tingling in both hands with numbness, left arm were injection was given Tingling is all the way up to shoulder.
Raised red patch. Sore and hot to the touch. Vaccine site reaction 3 inches x 1 inch.; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 17Apr2021 at 16:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The concomitant medications included escitalopram (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 20Mar2021 at 14:30 as a single dose for COVID-19 immunisation. On 20Apr2021 at 19:30, the patient experienced raised red patch, sore and hot to the touch and the vaccine site reaction of 3 inches x 1 inch. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event raised red patch, sore and hot to the touch, vaccine site reaction 3 inches x 1 inch was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Capillaritis (diagnosed by a dermatologist).  Appeared on the inner side of my left knee shortly after the  Priorix MMR and is the size of the palm of my hand.  This is now a permanent condition
1/5/2021 8am pain started in the left shoulder, trapezius muscle and neck pain. Took 600mg of Ibuprofen with no relief. Pain lasted until 2-3pm on 1/5/2021
Pt reported to pharmacy today that approximately 4 hours after getting vaccination, he awoke from a nap, with itching sensation tingling/numbness in mouth and shortness of breath. Took oral BENADRYL and was completely resolved as of today per patient. Stated previously unable to tolerate "allergy shots" but unsure what specifically he was allergic to.
This spontaneous report was received from a nurse practitioner refers to an unspecified patient of unknown age and gender. On 30-JAN-2018, the patient was vaccinated with a improperly stored dose of VARIVAX (dose, frequency and route of administration were not reported) (lot # N023961 and expiration date 01-SEP-2019) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # N015479 and expiration date 23-JUL-2019). The vaccine was stored in between -50 degrees Celsius (C) to -15 C for 5 minutes and 18 seconds. The previous temperature excursion was between -14 C to -10 C for 11 minutes and 55 seconds. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No product quality compliant (PQC) was involved.
Fever, chills, body aches, headache, back ache, nausea, no appetite
2/17/15 - patient had redness and itching at injection site. 2/23/15 - seen in ER, diagnosed with cellulitis and dermatitis and given azithromycin.
sore arm; body aches; headache; severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced DIARRHOEA (severe diarrhea). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, DIARRHOEA (severe diarrhea), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She said she'll go out to the store today to get Pepto- Bismol or something. When referred to her HCP, she said she has a VA doctor and you can't just call up a VA doctor. She would have to go to the emergency room. No concomitant medication were reported No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Additional information was received on 14-May-2021. Outcome of the events was updated.
Severe fatigue, headache, nausea, and body aches over the course of 12 hours
The vaccine caused a sore arm, chills, earache and body aches on the first day after the vaccine.   On the second day, patient developed a flat, red rash around the neck, and one very swollen lymph node along the collarbone (same side as the injection site).
The pt developed 50 x 50mm circular red and warm to touch area on left deltoid at injection site. Mother gave the pt Motrin and has been placing cool compresses.
Tired for 5 days; Lip tingling for 4 days; This is a spontaneous report from a Pfizer- sponsored program. Immediate Family and Household Vaccination Program from a non-contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient experienced tired for 5 days, lip tingling for 4 days. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received 3 immunizations on 10/1 (FLUZONE HD + PNEUMOVAX on left arm, SHINGRIX on left arm). Reports feeling symptoms of soreness, nausea, vomiting, overall malaise the following day (10/2/2020), and reports going to ER where she received treatment for potential cellulitis. During admission, reported having elevated white blood cell counts which improved following a blood test on Sunday (10/4).
Started around 10:30pm and continued until about 5am: All over muscle and joint ache, chills, shivering, headache, thirst, sweating, unable to take a deep breath without coughing. Time of injection for 24 hours: lingering pain at injection site.
Patient presented for Mental Health concern and was asymptomatic positive. Patient has had one dose of Jessen.
Urgent diarrhea 3 1/2 hours after shot was administered. Next morning (day 2, 15 hrs after vaccine was administered) woke up feeling fatigued. Remained fatigued all day. So much so that I had to lie down for a few hours. 24 hrs after shot injection, I feel nauseous with a strong headache.
Headache, march 30 at 5pm Feverish, march 31 at 4am Lightheaded and fatigued, march 31 at 4am
fainted; Can't do a lot,has been staying in bed; Dizzy; Aches and pains; Fever of 102.5 degrees; right arm soreness; Vomiting a little; very nauseous/nausea; Headache; Dry heaving; She can't drink a lot of liquids; Can't keep food down; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 25-year-old patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023b21 and 016b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) and ISOTRETINOIN for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced FOOD INTOLERANCE (Can't keep food down), RETCHING (Dry heaving), DYSPHAGIA (She can't drink a lot of liquids), PAIN IN EXTREMITY (right arm soreness), VOMITING (Vomiting a little), NAUSEA (very nauseous/nausea) and HEADACHE (Headache). On 06-May-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), BEDRIDDEN (Can't do a lot,has been staying in bed), PAIN (Aches and pains), DIZZINESS (Dizzy) and PYREXIA (Fever of 102.5 degrees). On 05-May-2021, PAIN IN EXTREMITY (right arm soreness) had resolved. On 06-May-2021, SYNCOPE (fainted) and DIZZINESS (Dizzy) had resolved. On 07-May-2021, PYREXIA (Fever of 102.5 degrees) had resolved. At the time of the report, FOOD INTOLERANCE (Can't keep food down), BEDRIDDEN (Can't do a lot,has been staying in bed), RETCHING (Dry heaving), DYSPHAGIA (She can't drink a lot of liquids), PAIN (Aches and pains), VOMITING (Vomiting a little), NAUSEA (very nauseous/nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Body temperature: 102.5 (High) 102.5 degree F.         No treatment medication were received.  Company Comment : Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Patient administered ZOSTAVAX 1/18/13. Stated at visit 1/21/13 that her arm had a large area of redness and swelling at the time of the 1/21 visit the redness/swelling markedly better.
This spontaneous report was received from a vaccine coordinator and refers to an unknown number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with an unknown number of improperly stored doses of PNEUMOVAX 23 (dose, frequency and route of administration were not reported) lot# M042324 and expiration date: 10-JUN-2018. No adverse effects were reported. The PNEUMOVAX 23 was stored in 48 Fahrenheit degrees (F) for 1 hour 20 minutes and in 47 F for 23 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA009251.
pt recv vax in 18NOV95&JAN96 pt donated blood through red cross;FEB96 recv notification from the red cross that blood tested positive for HTLV I;pt prev donated blood 35 times&has had no hx of positive
Localized tenderness, drainage from injection site "pus". Improving spontaneously. Small elevated lesion with 2 mm surrounding erythema, without induration - c/w minor staph skin infection.
sluggish Narrative: Pt was "sluggish" compared to baseline 1-2 days post vaccine
low grade fever; Nausea; Fatigue; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Muscle aches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PYREXIA (low grade fever), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Muscle aches). At the time of the report, PYREXIA (low grade fever), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Muscle aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided. No relevant concomitant medications were reported. No treatment information was provided
lightheadedness; nausea; headache; This is a spontaneous report from a non-contactable other healthcare professional. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: EN6205)), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. On an unspecified date, during his 15-minute waiting period after the injection, the patient began to experience light headedness, nausea and headache. Treatment included: water and Pepcid. Follow up response to treatment: good, symptoms resolved prior to discharge. Patient discharge: stable to go home and follow up with PCP. The clinical outcome of the light headedness, nausea, headache was recovered on unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Patient received influenza vaccine at 4 months of age. Patient did not have an adverse event from this. Patient should have been administered influenza vaccine at 6 months of age per CDC guidelines.
My daughter had a seizure the morning after her vaccination (approx. 18 hours later).  The seizure was a tonic-clonic seizure that lasted approx. 20-30 seconds.  She had only a low-grade fever of 100.5 F. Took her to urgent care immediately following. She had no other episodes prior or since the administration of the vaccination, has since had a normal EEG.
When the student was administering the vaccine on patient's arm she either retracted the syringe too fast or pulled out the needle too fast and more than half the dose was wasted. After speaking with Moderna we re-administered the dose on his left arm per CDC recommendation.
Temperature 103-104 degrees F, "pressure in chest" same day x 1, arm pain x 6 days, fever 10/10 --> 10/15, dizzy, pale, weak, side pain.
11/2/2018-Two days after vaccination developed generalized body aches, nausea and chills for 2 days. 11/6/2018-Nausea off and on, chills. 11/8/2018-Temperature 99.8, noticed red papules on abdomen with itching. 11/9/2018-Generalized erythema rash on upper chest, red papules on abdomen, back, buttock, bilateral anterior and posterior upper legs. No vesicles noted.
Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Severe, Additional Details: pt did not have reddness or pain at site, but fainted and had a seizure
p/vax pt started having itching & notice a rash on chest & abd;rash still on chest & abd spreading to back, arms & legs;still itching referred to MD;rash in 2-3mm in diameter raised to pinpoint;
expired FLUZONE HIGH-DOSE QUADRIVALENT was administered to a patient with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 88 years old female patient who experienced expired fluzone high-dose quadrivalent was administered to a patient with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 20-Sep-2022, the patient received a  0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE once  (lot UJ774AA; expiry date: 30-JUN-2022) via intramuscular route in the right deltoid for immunization.  On 20-SEP-2022 the patient reported a non-serious event expired fluzone high-dose quadrivalent was administered to a patient with no reported adverse event (expired product administered) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
8Jan91 to ER: was seen at 700pm, T 101.5 (R), vomiting, diarrhea, 7Feb91 generallly "just cranky" Dx as acute gastroenteritis, recommended bland diet, clear liquids, Seen by MD
Woke up at 4am day after shot with pins and needles tingling in right arm hand and fingers down to my right leg foot and toes.  Very bad pain until about 2pm then let up.  Now comes and goes daily with shocks in back shoulder blade, neck and arms occasionally then goes away.  Pain in my right hand and right leg and foot happens at night and very painful  when trying to sleep.  Usually goes away in hand but lasts throughout the day in calve and foot/ankle.  Pins and needles when walking.  Very painful on day 10 today.
Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 9/15/2022.The information was presented to the staff on 9/27/22. The patient was called on 9/28/22. Patient made aware received a  0.25 mL of Moderna Bivalent Booster dose. Patient verbalized understanding. Patient denies having distress at this time. Patient denied having to go to the Emergency room or Primary Care provider. Informed the patient according to Moderna the recommendation was to re vaccinate with full dose in 8 weeks from 9/15/2022. Patient stated would like to be re vaccinated. Patient made aware will reach out to patient regarding receiving full vaccination. Patient verbalized understanding. Patient encouraged to reach out to primary care physician regarding medical needs. I reviewed side effects and serve allergic reactions with parent.  Encouraged patient to seek emergency services for severe allergic reactions by calling 911 or going to the nearest hospital. Patient verbalized understanding.
PATIENT CALLED PHARMACY ON 04/05/2021 TO REPORT THAT SINCE HIS VACCINATION ON 03/12/2021 HE HAD BEEN HAVING ARM PAIN. HIS PHYSICIAN STATES THAT HE MAY HAVE NERVE DAMAGE SINCE HIS PAIN RADIATES FROM THE INJECTION SITE DOWN TO HIS THUMB AND BACK TO THE BACK OF HIS NECK. HIS PHYSICIAN TRIED HIM ON GABAPENTIN FOR THE NERVE PAIN (NO NERVE TESTING DONE) BUT THIS HAS NOT RESOLVED THE PAIN. HIS PHYSICIAN STATES THAT IT MAY HEAL. HE WANTED TO CALL IN TO REPORT. HE WILL PRESENT ON 04/09/2021 FOR HIS SECOND DOSE.
104.0 fever first 24 hours with severe chills and severe all over body soreness and muscle tightening. Severe fatigue. Rash on top of hands more of right side than left side. Very swollen right upper arm, axillary and into neck. Severe headache. All listed lasted for 4 days. Still have temperature though has come down and rash on hands.
Patient recieved vaccine and was moved to observation area. Patient suddenly lost conciousness and fell from chair to the ground. Pt regained conciousness within 30 seconds. Patient was alert and orient upon regaining conciousness. Patient verbalized he was having no trouble breathing and vitals were taken. Patient vital signs were within normal ranges. Patient verbalized that his left arm hurt and fingers were numb on that side. Patient was taken to urgent care clinic and evaluated by physician. Patient signed an AMA form and was released from hospital.  Patient encouraged to follow up with primary care doctor.