chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received their 1st dose as 0.25 mL instead of 0.5 mL for their first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received their 1st dose as 0.25 mL instead of 0.5 mL for their first dose.) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received their 1st dose as 0.25 mL instead of 0.5 mL for their first dose.). On 10-Dec-2021, ACCIDENTAL UNDERDOSE (Received their 1st dose as 0.25 mL instead of 0.5 mL for their first dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was not on any concomitant medication.  No treatment medications were reported.
Started feeling itchy & tender around spot of injection & noticed it was a little red as well. Red, raised area with clear edges, warm to touch.
Shivering. Also tired, but that is probably because I walked 5+ miles today. I have a sore arm, but that was expected.
Injection 12/17 (her 3rd in the series). Within 24 hours, she had a diffuse itchy whole body rash and erythema c/w allergic reaction.
Marked swelling, redness and warmth around site, nausea and vomiting. Resolved in 2-3 days.
High fevers up to 105.8-106 about 5-6 hours after MMR. Family called local dr, rotated Tylenol and Motrin. Fever broke overnight 10/24/2010 so lasted for 3 days.
nasal congestion; headache; This is a spontaneous report from a contactable consumer (patient). This 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283 and expiry date unknown), via an unspecified route of administration on 16Jan2021 20:15 at a single dose on the right arm for COVID-19 immunization. Medical history included high blood pressure, NTM lung infection, and laryngopharyngeal reflux (LPR). Concomitant medications included amlodipine, HCTZ, potassium bicarbonate, sodium alginate (GAVISCON ADVANCE), and telmisartan. The patient has no known allergies. Patient is not pregnant. The patient did not receive other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. On 18Jan2021, the patient experienced nasal congestion and headache. No treatment was received. Outcome of the events was recovering.
flu; Initial information received on 24-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who experienced flu (influenza), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Within seconds of injection:  Immediate fish bowl feeling. Everything seemed louder and like outer body. Very cloudy feeling until she got home to take a nap. Felt better after hour nap.   About 12 hours after injection: Low grade fever (101) Body aches Headache Chills Pain at injection site
Fever of 101; This spontaneous case was reported by a physician assistant and describes the occurrence of PYREXIA (Fever of 101) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PYREXIA (Fever of 101). At the time of the report, PYREXIA (Fever of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: 101 (High) 101 Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-435165, MOD-2021-435192 (Patient Link).
patient was given Shingrix Subcutaneous instead of Intramuscular.; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   On 19th July 2021, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 19th July 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: Pharmacist reported that the patient was given Shingrix subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
pt states that developed a red bump the size of a quarter on her left arm around the injection site.  Lymph nodes are inflamed. she has cough, and headache.  Pt still as these symptoms but has not taken any medication. She will contact her PCP.
Sore arm, bump under skin, nausea, vomiting, had chills and felt hot.
Patient reports approximately 1 week ago from hospitalization that he experienced shortness of breath significantly more than he has in the past during a walk to get the mail.
lost sense of taste; This case was reported by a nurse via call center representative and described the occurrence of taste absent in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 8th October 2019, the patient received Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 4 months after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced taste absent. On an unknown date, the outcome of the taste absent was not recovered/not resolved.   It was unknown if the reporter considered the taste absent to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Shingrix in one arm and flu in the other and lost her sense of taste after receiving these shots and it has not resolved.  The reporter did not consent to follow up.
after a week of the first shot, still swollen and hives developed around injection site and itchy at times, lymph of the injection underarm swollen about size of penny.  no other discomfort elsewhere.
7x7 cm circular area of swelling, redness, upper left lateral arm: mildly warm, tender to touch no induration.
devel t104.5 & sz 26AGU92; seen in ER & adm ti ICU for 2 1/2 days; rx seizure medicine; grandma states had some fluid on brain;
Coma, Sudden death. Shortness of breath, thirsty, strange conversation, heart attack. Thereafter his medical records have all information. Kidneys were at 13%. That's why public health said to request this form to see what went on. This adversity was never reported.
Patient reports swelling of the face and lips a day after receiving Moderna vaccine, this lasted for 3 days. Customer also reports hives and itching which lasted for 10 days.
Enlarged nodes in neck on the right side just above the collar bone.  Sore like a bruise, especially to touch.
Red arm below injection site; arm thick below injection site; Warm arm below injection site; This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities, induration and skin warm. On an unknown date, the outcome of the erythema of extremities, induration and skin warm were unknown.   It was unknown if the reporter considered the erythema of extremities, induration and skin warm to be related to Shingrix.  Additional details were provided as follows: The case was reported for the pharmacist's father. The age at vaccination was not reported. After receiving Shingrix, the patient's arm was red, thick and warm below the injection site. The reporter consented to follow up. This case had been linked with case US2021221657, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021221657:Same reporter
Narrative: site soreness x day 1; fever, chills, body aches, sleeplessness x day 1-4
Cough, Runny nose followed by nausea, headache which lead to migraine lasting 2 days, 4 days of appetite changes and weight loss.
I had extreme pain the next day in my arm. My shoulder became stiff. Then it felt like I pulled something in my shoulder. I have had pain and limited mobility with my shoulder since and it has also caused muscle spasms in my neck from the shoulder. I have to go to physical therapy twice a week now and possibly receive injections.
Patient stated she had chills and night sweats after taking the second dose, she "Felt like she had long haul covid:, but has never tested positive for covid; Then in May started having abd fullness, 50lb weight loss, and splenomegaly; she is now being worked up for Lymphoma/myeloma at medical facility.
A report has been received from a health professional concerning a 35 year old female patient. Medical history and concomitant medications of the patient was not reported. The patient had been receiving FLUMIST (Intranasal) started on an unknown date. The patient could not remember when she received FLUMIST or when the flu began. She said she was sick for about four days. She was treated with TAMIFLU. Action taken with FLUMIST was not reported. The outcome of the event of contracted type a flu and sick was unknown. The reporter considered the event contracted type a flu was considered to be non-serious. The company physician considered the event sick to be non-serious due to sick.
pt presented w/chicken pox on 20MAR98;father reports broke out w/a couple of pox @ bath time on 19MAR98;pt has only had a stomach 18MAR98 but has not had a fever & has been eating;had been exposed @ daycare;
Information has been received from a physician concerning a 14 year old female who on 08-SEP-2008 was vaccinated with GARDASIL vaccine 0.5ml. Second suspect therapy included VAQTA vaccine (inactive) (manufacture unknown) which was vaccinated at the same time. On 08-SEP-2008 the patient experienced syncope. The patient sought unspecified medical attention. On the same day, the patient recovered. Additional information has been requested
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 214K22A and 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 22-May-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 10 microgram. On 21-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    Concomitant medications were not reported.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:
My chronic condition was in remission. I hadn't had symptoms in over 6 years. Shortly after receiving the vaccine, my joint pain became unbearable. Every single joint in my body was affected. I waited 2 weeks before contacting rheumatology. They were able to get me in and they drew blood. My levels were increased. They started me on Plaquenil. I am still using this medication. I have not been able to stop taking it.
severe headaches began approx. 2 weeks after 2nd dose and have continued daily. This is june 7th; This is a spontaneous report from a contactable consumer, the patient. A 73-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 right arm on 27Apr2021 at 10:00 (at the age of 72-years-old) as a single dose for COVID-19 immunization. The patient medical history included chronic obstructive pulmonary disease (copd), and thyroid disorder (reported as thyroid). The patient had no known allergies to medications, food, or other products. The patient concomitant medications taken within two weeks of vaccination included fluticasone propionate, salmeterol xinafoate (ADVAIR); salbutamol (VENTOLIN); levothyroxine (MANUFACTURER UNKNOWN); and pramipexole (MANUFACTURER UNKNOWN), all from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Mar2021 at 10:00 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10May2021 08:00, the patient experienced severe headaches began approx. 2 weeks after 2nd dose and have continued daily. This is June 7th. Therapeutic measures were taken as a result of severe headaches that began approximately two weeks after second dose and had continued daily and included treatment with over the counter (otc) medications. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the event was not recovered. The lot number for BNT162b2 was not provided and will be requested during follow up.
Severe large itchy and burning hives.  Lasted for 48 hours.  Hives would come and go on various body locations.  Woke up on 8/7 with swollen lips and eyes.
Case number PHEH2014US000918 is an initial spontaneous report from the pharmacist received on 08 JAN 2014 with a follow-up received on 02 FEB 2014. This report refers to a 12-year-old female patient who was accidentally vaccinated with 0.5 ml of FLUCELVAX (batch number: 010011A, expiry date: JUN 2014) intramuscularly in to the left deltoid on 07 JAN 2014. No adverse event reported following this medication error (inappropriate age at vaccine administration).  Follow-up received from the pharmacist on 02 FEB 2014: Updated site of administration of FLUCELVAX.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 02 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; LOSS OF APPETITE; This spontaneous report received from a consumer concerned a 71 year old male. The patient's weight was 230 pounds, and height was 67 inches. The patient's concurrent conditions included: high blood pressure, cholesterol, enlarged prostate, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and had no illicit drug usage or drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: unknown) dose was not reported,1 total administered on right arm on 01-APR-2021 for prophylactic vaccination. Concomitant medications included simvastatin for cholesterol, tamsulosin for enlarged prostate, and metoprolol for high blood pressure and ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride (multivitamins) daily for drug used for unknown indication. On 20-OCT-2021, the patient developed symptoms of slight headache, nasal congestion, dry cough, fever, loss of appetite, weakness and fatigue. On 20-OCT-2021, the patient spoke with the nurse who recommended Advil for the headache and asked him to get tested for Covid-19. The exact date when the patient was tested for Covid-19 was not known. On OCT-2021, the patient tested for Covid-19 via nasal swab (COVID-19 PCR test) and the result came back positive (confirmed covid-19 infection and confirmed clinical vaccination failure) the next day after the test.  The slight headache was gone by next day (21-Oct-2021), the fever lasted four days (24-Oct-2021), the loss of appetite, the fatigue and weakness lasted for a week (27-Oct-2021) and the nasal congestion and the cough resolved a week ago (11-Nov-2021). There was no reaction or soreness after receiving the Janssen COVID-19 vaccine back in APR-2021. The patient had completely recovered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection on 11-NOV-2021 and loss of appetite on 27-OCT-2021, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211142942- covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination failure . This event(s) is considered not related. 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
I had the shot around 1:30 pm on Saturday May 8th. On Sunday May 9th around 3:00 am I woke up and the left side of my body (my entire left side.. face, leg, arm) was numb. I checked to make sure my left side wasn't sagging and I could talk.   I went to back to bed and woke around 8:00 am on Sunday May 9th. I wasn't numb, but the left side of my face was a little stiff. Today is May 11th and the left side of my face is still a little off (it is not numb ... but a stiff feeling)
Severe total body urticaraa, including on lips, but no respiratory distress, no choking. Afebrile, symptoms began to subside within 15 mins of administration of Benadryl.
pt recv vax; episodes of jerking all extremities;Avoid further pertussis by MD;
Have a high fever 24hrs after the vaccine. 101.4; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Have a high fever 24hrs after the vaccine. 101.4) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Have a high fever 24hrs after the vaccine. 101.4). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PYREXIA (Have a high fever 24hrs after the vaccine. 101.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 (High) high fever 101.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided.
I had coughing and congestive. It felt like a modern cold. I had no fever or body ache. Theses symptoms lasted for about 3 days. I went a clinic to get tested for Covid-19 test, positive results. They also did a Flu test.
Mild fever(103-104F): Resolved 2 days after Soreness in arm/armpit/neck: Resolved 3 days after Migranes(mild/ severe): Partially resolved Swollen gums: started 3 days injection, currently unresolved Vertigo/dizziness  (mild/ severe): currently unresolved
became feverish 30OCT92; achy; awoke w/sore throat, stuffy nose, h/a, upper back pain, pt could not move neck;
Information has been received from a physician concerning an 18 year old female with no pre-existing medical conditions or drug allergies who on 06-JUL-2007 at 1pm was vaccinated intramuscularly in the right arm with a first dose of GARDASIL (lot# 654741/1208F) and experienced syncope post vaccination. The patient was monitored in the office and fully recovered on 06-JUL-2007, no sequelae. On 25-SEP-2007, the patient was vaccinated  (site and route not reported) with the second dose of GARDASIL (lot# not reported) and experienced no adverse event post vaccination. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. No additional information is expected.
Patient called stating injection site was red, hard & hot. She went to ER & was given antibiotic & steroids, which interacted w/other rx's so she did not take. She went to he primary MD in the morning & was prescribed antibiotic, pain med & fluconazole for (R) arm.
Information has been received from a physician concerning a 78 year old female who on 12-SEP-2007 at 14:00 was vaccinated IM with a first dose of ZOSTAVAX (lot #658208/0886U). On 12-SEP-2007, at 14:30, the patient developed facial swelling and hoarseness of voice. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information is available.