chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (She tested positive) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032Z21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (She tested positive). The patient was treated with COUGH SYRUP [AMMONIUM CHLORIDE;CHLORPHENAMINE MALEATE;DIHYDROCODEINE BITARTRATE;METHYLEPHEDRINE HYDROCHLORIDE-DL] from 26-Jun-2021 to 04-Jul-2021 for Coughing and COVID-19, at a dose of UNK, bid. At the time of the report, COVID-19 (She tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.         Patient visited an Urgent Care Center and tested for COVID on 26-JUN-2021.  The patient was told she was positive on 28-JUN-2021. The patient had COVID-19 symptoms as cough, headache, diarrhea, nasal congestion, loss of taste and smell.  On 26-Jun-2021, PCR (Polymerase chain reaction) test was done: No result was provided.  No concomitant medications were reported.  Patient was treated with Steroids (Z pack) from 26-Jun-2021 to 02-JUL-2021.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Folow up was received. Treatment medications and symptoms of COVID-19 were added.
Pregnant, due date 5/20/2021. Side effects that started about 4h after vaccine: fever, headache, nausea, vomiting, diarrhea, confusion.
hives started 12 days p/vax given 16JUL98;to MD office 4AUG98 w/urticaria since 28JUL98;
Felt very ill starting 6 days after the injection.; Bad head pain and nausea which was constant; Bad head pain and nausea which was constant; "I" didnt have an appetite but was able to eat some food.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 18Feb2021 at 14:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. 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 vaccination. The concomitant medications included morphine sulfate (MANUFACTURER UNKNOWN), hydrocodone (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC), all taken from unknown dates for unspecified indications. On 24Feb2021, at 16:00, 6 days after the injection the patient felt very ill, bad head pain and nausea, which was constant and also had an overall sick feeling. The patient did not have an appetite but was able to eat some food. The patient reported that laying down was the only thing that made him feel slightly better. The closest thing he could compare it to would be a bad hangover that lasted 6 days without feeling better at all. On the seventh day, the patient started feeling a little better. The patient was continuing to improve but was still not completely better on the eighth day (day of report). The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not 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 events felt very ill, bad head pain, nausea, overall sick feeling and did not have an appetite was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected
Localized injection site reaction. Several hours after administration of vaccine small area of bruising and golf ball sized lump hot to the touch. The following day swelling spread with redness and heat throughout the upper arm. Signs of possible infection.
Initial Report Received: 12-Dec-2018. A nurse reported that patient, a 45-year-old female patient (race not provided) was administered with HEPLISAV-B (hepatitis B vaccine) for an unknown indication and received an extra dose of HEPLISAV-B. Relevant medical history included pneumonia and encephalopathy. The patient had no known allergies. The patient was not on any known medications. The patient received the first dose of HEPLISAV-B in Sep-2018, the second dose of HEPLISAV-B on Nov-2018, and the third dose of HEPLISAV-B on 12-Dec-2018 (lot # 1033384, expiration date 06-Apr-2019, NDC 43528-002-01). No further information was provided. The patient did not provide permission to contact her. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the event of extra dose administered as non-serious. The event of extra dose administered is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of extra dose administered as non-serious. The event of extra dose administered is unlisted per HEPLISAV-B USPI.
This spontaneous report was received from a medical assistant on behalf of the mother's patient, referring to a 15 year old male patient. Concurrent condition, drug or allergic reactions and medical history were not reported. On 18-JUL-2014, the patient was vaccinated with the first dose of GARDASIL (lot # K007828; expiration date 02-MAR-2017), (dose was not provided) intramuscular, the second dose was on 10-NOV-2014 (dose, route of administration, lot number and expiration date were not reported) and the third dose was on 08-JUL-2015, 0.5 ml (route of administration, lot number and expiration date were not reported). On 08-JUL-2015, after receiving the third dose of GARDASIL the patient experienced headache. The patient received medical attention calling the physician and treated the headache with ADVIL. Lab diagnostic studies were not performed. The outcome of headache was reported as recovered/resolved on 09-JUL-2015. This case is one of two adverse events cases reported by this Healthcare worker. Additional information has been requested.
Painful Lump underarm toward breast, unable to lift arm. Pain is in arm and shoulder. Unable to work for 2 weeks after booster. Went to Dr no appt avail in meantime med assist recommended Start taking asprin until she is able to see Dr.
Flu and pneumonia vaccine in same arm. Upper arm was red, swollen, warm to touch. Area about 4 X 4 inches. Recommended coolpacks and Tylenol or Advil.
Tight neck. Tiredness, pain, numbness, irregular blood pressure, chest pain, persistent pain in the extremities, joints and bones. Metabolic changes, weight gain, memory problems. Symptoms persist after 4 months.
1 Swelling and redness of left arm. 2 Slight fever - took Tylenol and Benadryl Q 4-6 h. 3 Extreme fatigue.
Vial was not stored in the refrigerator, It was directly thawed from the freezer before administration; administered with expired vaccine 15-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine 15-Apr-2022) and PRODUCT PREPARATION ERROR (Vial was not stored in the refrigerator, It was directly thawed from the freezer before administration) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine 15-Apr-2022). On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (Vial was not stored in the refrigerator, It was directly thawed from the freezer before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine 15-Apr-2022) and PRODUCT PREPARATION ERROR (Vial was not stored in the refrigerator, It was directly thawed from the freezer before administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Number of doses administered were 11 doses, probably 3 vials. The vials were not stored in the refrigerator, they were directly thawed from the freezer before administration. No temperature excursions were reported. No patient administered with the vaccine has reported any event at the time of the call.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Follow-up received includes patient details and dose details added.
Case number PHEH2012US022267 is an initial spontaneous report received from a nurse on 01 Nov 2012. This report refers to a male child. His vaccination history included administration of Dtap (other manufacturer and batch number: unknown) on an unspecified date after which he experienced redness, swelling an itching. He was vaccinated with MENVEO (batch number: A11047 and expiry date: 30 Mar 2014) on 29 Oct 2012. After vaccination his entire upper arm had swelled and was red and itchy. No further information about outcome, seriousness and causality was available.
Within 15 minutes of receiving flu shot, developed mild headache, slight nausea and "funny" feeling in chest. Headache resolved on its' own, nausea persists 30 minutes after shot. Chest feels "tight" but patient denies difficulty breathing. BP 106/72 in R arm at 5:10pm and 110/76 in L arm at 5:15pm. Pt reports normal BP approximately 110 systolic. At 5:45, pt reports feeling flushed and having upset stomach. But patient was then at home and reports overall feeling better now that she is home.  Patient was instructed to seek care at urgent care if symptoms worsened or remain unresolved.
site of injection resulted in 30 mm induration with warmth but no fever by 2 days post vaccination; increased to 40 mm by 3-4 days post vaccination still without fever with soreness;  1 week post vaccination, 5 mm induration, no warmth and pain is minimal
This is a spontaneous case, initially received from a pharmacist on 15-Oct-2018, concerning a 65-year-old, elderly, male patient. The patient had no relevant medical history and concomitant medications. On an unspecified date, vaccines suffered two temperature excursions. In the first case, the maximum temperature was 48.4 Fahrenheit and was out of range for 3 hours. In the second case, the maximum temperature was 46.4 Fahrenheit (which was 8-degree Celsius) for 3 hours. On 13-Oct-2018, the patient was administered intramuscularly FLUAD (TIV) [dose: 0.5 ml, anatomical location: left deltoid, batch number: 250783, expiry date: 30-Apr-2019] which underwent temperature excursion. At the time of this report, no adverse events were reported. This case is linked to 201804513 due to same reporter. The reporter assessed the case as non-serious. Non-significant follow-up received from the pharmacist on 17-Nov-2018: The reporter confirmed that no adverse events were reported after vaccination administration. No changes were made in the narrative.
Patient received vaccine and became light headed and dizzy within 10 minutes,  patient was relocated to a cot and placed supine. Patients blood pressure was taken and was noted to have a systolic pressure of 186. After approximately 10 minutes another blood pressure was taken with a systolic over 200.  Patient began feeling shivers and heightened anxiety. Following additional assessments patient was advised of seeking medical attention and stated that she would have herself privately transported to a local hospital for assessment. Following approximately 10-15 minutes, patient was noted to have a drop in blood pressure of about 15 points but still decided on seeking medical attention. Patient was picked up by her husband and transported to a local hospital.
pt was vaccinated and then went back for a flu shot 5 days after flu shot was hospitalized for MIS-C covid tests negative she had high immunity and body started to fight the flue vaccine and fought her owns organs instead
adult given pediatric dose; adult given pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 66-year-old male patient who received HAV (Havrix pediatric) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   On 4th September 2022, the patient received the 1st dose of Havrix pediatric. On 4th September 2022, unknown after receiving Havrix pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: Pharmacist stated an adult patient was inadvertently given a pediatric dose of Havrix. No further details provided. Pharmacist provided consent for safety follow up. Reporter consented to follow up. Additional supportive information: As adult patient received pediatric dose which led to adult use of a child product and accidental under dose.
Is it safe to take PII(36):ATMaPlF6kgvWjcX to help with side effects after dose number 2/is ok to help elevate symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Is it safe to take PII(36):ATMaPlF6kgvWjcX to help with side effects after dose number 2/is ok to help elevate symptoms) 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) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Is it safe to take PII(36):ATMaPlF6kgvWjcX to help with side effects after dose number 2/is ok to help elevate symptoms). At the time of the report, VACCINATION COMPLICATION (Is it safe to take PII(36):ATMaPlF6kgvWjcX to help with side effects after dose number 2/is ok to help elevate symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  Treatment medication was not provided
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 15-SEP-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.
About a week and a half after each dose, I had ankle pain so severe that I could not walk at times. It came and went at random times. It continued on and off for about six weeks following the second vaccine before clearing up. I suspect it affected my immune system and flared my rheumatoid arthritis.
Discovered lump in left breast within weeks of the injection which did not go away.  Later had a double mastectomy to remove tumor.
tingling in hands/ feet- worse in the mornings.; Intermittent tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient was 29 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 15Dec2021. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; FISH OIL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown.), administration date: 20Jan2021, when the patient was 29 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown.), administration date: 30Dec2020, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 15Oct2021, outcome "recovering", described as "tingling in hands/ feet- worse in the mornings."; TINNITUS (non-serious) with onset 15Oct2021, outcome "recovering", described as "Intermittent tinnitus". Therapeutic measures were not taken as a result of paraesthesia, tinnitus.  Additional information: patient did not have covid prior vaccination. patient did not have covid tested post vaccination. Known allergies reported as No. Patient did not received other vaccine in four weeks .Other medications in two weeks reported as Prenatal, fish oil.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that after vaccination had all the potential side effects. The reporter asked how long the side effects were last. .
Patient was 14 when vaccine was administered (authorized for 18 and older). No known adverse events.
A feeling of heaviness from right shoulder into hand.  Soreness and muscle ache given prednisone metro dose pack.  Observation for 2 hours
Rec'd #1 shot on 2/20/21.  1st day fine, 2nd day very sore arm, 3rd day arm fine.  Then on March 1st around 7:00 pm my arm at the injection site starting itching really bad.  Looked at arm and it was very red and very swollen at the injection site.  The red/rash, swelling and extreme itching remained all night, the 2nd day and I woke up today, Wed. March 3rd and everything is fine.  My wife looked this up online and it appears that it's a delayed reaction to the Moderna vaccine called "Covid Vaccine Arm" and the article said to report this.  i
I received my first Pfizer vaccine on January 5, 2021  lot #EK 5730 while at work. I received my second Pfizer vaccine on Feb 5 2021 Lot # EL 3429 while at work.I received my booster Pfiizer vaccine after retiring June 25 2021 on October 6, 2021 lot # FE 3592 and came down with Covid on Oct 22, 2021
Patient received vaccines at 10am on 12/11/21. At midnight on 12/12/21 patient began making a gagging noise and had facial twitching. Mother of patient brought him to ED where he could not stand and had extremity twitching. Patient was intubated for status epilepticus and transferred to Medical Center.
Strong Reaction after First Vaccine; Headache after First Vaccine; Extreme Nausea after First Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Strong Reaction after First Vaccine), HEADACHE (Headache after First Vaccine) and NAUSEA (Extreme Nausea after First Vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (Patient taking Celebrex as needed. She states only 2 or 3 times a year she uses Celebrex.). Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE REACTION (Strong Reaction after First Vaccine), HEADACHE (Headache after First Vaccine) and NAUSEA (Extreme Nausea after First Vaccine). On 16-Feb-2021, VACCINATION SITE REACTION (Strong Reaction after First Vaccine), HEADACHE (Headache after First Vaccine) and NAUSEA (Extreme Nausea after First Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by reporter.   This case was linked to MOD-2021-223072 (Patient Link).
Onset 5/12/2021 of late local injection site reaction located on the right arm; on exam area is well-demarcated, erythematous, warm, raises and edematous measuring approximately 7cm length x 4.5cm width; patient reports pain/tenderness and itching. No systemic symptoms; no fever/chills or flu-like illness.
devel sz activity on 14APR94 was treated @ ER; transferred to another hosp; MOC reports cold symptoms & fever up to 99.6 for 3 days prior to sz;
Within 24 hours of final oral typhoid dose, developed urticaria (no new foods, detergents, soaps, perfumes, insect bites per patient) on both upper extremities, back face. She called our clinic from work; advised topical/oral diphenhydramine. Has had improvement, but rash still present.
Breakthrough COVID-19 + case after completion of full primary vaccination series. Required ICU care.
5 days of increasing slowness in muscles of calves with ascending parasthesias (tingling and numbness up through the legs resulting in difficulty walking. Diagnosed with Poly neuropathy Guillian-Barre Syndrome (positive albumin in CSF fluid) and acute Epstein Barr Virus infection. Treated with IVIG 25gm daily for 5 doses.
Approximately 10 minutes after vaccination given, client became clammy, pale and lost consciousness briefly. Client placed in chair, feet elevated, and ammonia satts given. Client awoke. Paramedics called and came and assessed client. Client left with family.
Hepatitis B vaccine received on 12/28/09, 1/29/10 and 8/11/10; This spontaneous report was received from a nurse and refers to a female patient of unknown age. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 28-DEC-2009, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant)(manufacturer unknown), on 29-JAN-2010, she received the second dose of the vaccine and on 11-AUG-2010, she received  the third dose of hepatitis b vaccine (recombinant)(manufacturer unknown) (lot #, expiration date, route of administration, anatomical location not provided) all as prophylaxis (inappropriate schedule of product administration). The patient also experienced shingles (herpes zoster) (captured in MARRS# 1806USA004086) and had an allergy to lisinopril (manufacturer unknown) with a reaction of cough (captured in MARRS# 1911USA009757).; Sender's Comments:  US-009507513-1806USA004086: US-009507513-1911USA009757:
Chills, chest pain (right side), difficulty breathing 100 degree temperature, weakness, hoarseness awoke with symptoms 1-2 AM on 13th.  Feel weak but better 12/14 at 09:00.