chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tiredness; headache; congestion; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Manufacturer Unknown), for Covid-19 immunization; Bnt162b2 (Dose: 2, Manufacturer Unknown), for Covid-19 immunization; Bnt162b2 (Dose 3 (1st Booster dose), Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 03May2022, outcome "not recovered", described as "congestion"; HEADACHE (non-serious) with onset 03May2022, outcome "not recovered"; FATIGUE (non-serious) with onset 03May2022, outcome "recovered" (May2022), described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Description of event: This 90 year old female nurse reported that she received her second booster dose of the Pfizer Covid 19 vaccine on 02May2022. On 03May2022 the patient developed tiredness, headache and congestion. On 08May2022, the patient tested positive for Covid 19. Her tiredness has resolved, the headache and congestion are ongoing. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
SWOLLEN FACE; LEFT EYE WAS VERY SWOLLEN SO IT WAS DIFFICULT TO SEE OUT OF IT; ITCHY FACE; HOT FACE; This spontaneous report received from a patient concerned a female of unspecified age. 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 (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the subject experienced swollen face. On JUN-2021, the subject experienced left eye was very swollen so it was difficult to see out of it. On JUN-2021, the subject experienced itchy face. On JUN-2021, the subject experienced hot face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen face, hot face, left eye was very swollen so it was difficult to see out of it and itchy face was not reported. This report was non-serious.
No adverse event; The patient received expired Moderna Covid-19 vaccine for her second primary series dose; More than 35 days between the first and second doses of the primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received expired Moderna Covid-19 vaccine for her second primary series dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between the first and second doses of the primary series) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 042C22A and 074B22A) for COVID-19 prophylaxis.     It was reported that patient had no relevant medical history, allergy, concomitant diseases and risk factor or medications were reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 Vaccine.    On 24-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received expired Moderna Covid-19 vaccine for her second primary series dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between the first and second doses of the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received expired Moderna Covid-19 vaccine for her second primary series dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between the first and second doses of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received expired Moderna Covid-19 vaccine for her second primary series dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between the first and second doses of the primary series).    No concomitant information was reported. It was reported that patient had no other adverse reactions from both doses. No treatment information was provided.
Pt recv vax on 10/23/98; 2 wk post vax pt exp varicella pox lesions over body
3mins after receiving my first dose of moderna I experienced blurry vision and dizziness; 3mins after receiving my first dose of moderna I experienced blurry vision and dizziness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (3mins after receiving my first dose of moderna I experienced blurry vision and dizziness) and DIZZINESS (3mins after receiving my first dose of moderna I experienced blurry vision and dizziness) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (3mins after receiving my first dose of moderna I experienced blurry vision and dizziness) and DIZZINESS (3mins after receiving my first dose of moderna I experienced blurry vision and dizziness). At the time of the report, VISION BLURRED (3mins after receiving my first dose of moderna I experienced blurry vision and dizziness) and DIZZINESS (3mins after receiving my first dose of moderna I experienced blurry vision and dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
This spontaneous report as received from a nurse refers to a curently 7 months old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date in 2017, the patient was vaccinated with an improperly stored ROTATEQ lot # N013885 (dose was not provided). Data logger was not involved. No adverse effects were reported. The vaccine was stored in between 9 degrees Celsius (C) to 25 C for 3 hour and 45 minutes. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA012873: US-009507513-1712USA012874: US-009507513-1712USA012876: US-009507513-1712USA012877: US-009507513-1712USA012878: US-009507513-1712USA004451:
Headache, muscle/body aches, fever, chest pain, nausea, and Tachycardia.
I started having aches and pains all over on my joints and I had sore throat, cough, and fatigue. I drank plenty of water to keep me hydrated. I already had PAXLOVID at the house because I was about to travel. I took a home test and it was positive, and I started to take the medication and it helped so much. I felt pretty miserable I had a fever on the 19th of February I started feeling much better. I took another COVID-19 test on Feb 20th and it was negative. I also tested again on Feb 22 and it was negative as well. I was also taking guaifenesin and MUCINEX as treatment and this did help.
I had heart palpitations and an allergic reaction when I received the shot - so I stayed in the building for 30 minutes. Then my arm started hurting immediately. That afternoon I couldn't lift my arm. The site where I received the injection became redder. There was a lot of swelling in that area. I was nauseous and fatigued for three weeks. And rectal bleeding occurred the night I received the vaccine.
Patient came in for a scheduled appointment for her COVID-19 booster on 01/17/2022.  Pt was checked-in at register for her appointment. Patient stated she left her CDC card at home and technician notified pharmacist that she had her previous 2 doses at our location. Patient was given the COVID-19 Pfizer vaccine as booster. After administration of the vaccine, patient stated she want a new CDC card. Upon looking up patient's past history of vaccination dates and LOT numbers, I noticed patient's last dose was on 09/18/2021. Patient's booster vaccine was administered one month and a day earlier than the recommended 5 month interval from her second dose. Confirmed with patient that she has no known health condition(s). Notified patient that she received her COVID-19 booster vaccine earlier than the recommended interval. Asked patient for her primary care physician's contact information and whether she would like the pharmacy to contact her physician but patient denied. Told patient to notify her primary care physician also but patient did not seem to want to contact her physician.  Patient left the pharmacy feeling fine.
ITCHING ALL OVER WITHOUT A RASH; FEELING FEVERISH; HEADACHE; FEELING HOT LIKE A FEVER; BONE PAIN; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, alcohol use, and non-smoker, and other pre-existing medical conditions included no known drug allergies. no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, Laboratory data included: COVID-19 (NR: not provided) Negative. On 12-APR-2021, the subject experienced feeling hot like a fever. On 12-APR-2021, the subject experienced bone pain. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced itching all over without a rash. On 13-APR-2021, the subject experienced feeling feverish. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling hot like a fever, bone pain, headache, itching all over without a rash, and feeling feverish. This report was non-serious.
titers came back low; This case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a 19-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.       Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comments: The patient needs a booster dose because her titers came back low, and when she tried to get it from the pharmacy, they would not administer the 1 ml dose because she was not 20 years of age.  The patient received all 3 doses 3 doses in 2003 and 2004. The titers were checked on the 18th and were 6.8. The reporter give consent to follow up. Additional supportive information: The patient received all 3 doses and titers was 6.8, which led to therapeutic response decreased. The lab test date and TTO was not captured since Month and year of titer check was not provided.
Tingling in feet, leg spasms, weakness when walking, extreme leg pain due to CIDP. Treatment - IVIG. Currently doing physical therapy before able to return to work.
20 mins p/DTP/OPV pt had h/a & vomited x 1; mom feels had an elevated temp but did not check it;
Patient was administered their second dose at a 27 day interval instead of 28 days. The patient waited his 15 minutes and seemed fine when he left.
Pt reports pain, swelling, itchiness, redness and unable to move  left arm at site of injection. Symptoms started 2  after the injection day.
The pt experienced redness, swelling and pain at the site of DTAP injection on the left deltoid. Resolved with Benadryl and Advil.
An attorney reported that a male child received a series of mercury containing vaccines including Hib (manuf unk), Tetramune, DTP (manuf unk), and hep B from March 1998 through June 1999. It is alleged that, as a result of the "high mercury exposure levels" from the vaccines he received, the child "has developed severe neurodevelopmental disorders" and "has suffered serious permanent injury." No further info was available as of the date of this report.
a female Patient was administered her first dose ofGARDASIL 9 on an unspecified date when she was 12 years old, came back at 19 years of age to get her second dose of GARDASIL 9; No adverse effect; This spontaneous report was received from a pharmacist referring to a 19 years old female patient. The patient's pertinent medical history, concomitant therapies and drug reactions/allergies were not provided.  When the patient was 12 years old, on an unspecified date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, unit, lot#, expiration date and route of administration were not reported). The patient came back at 19 years of age on an unspecified date to get her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, unit, lot#, expiration date and route were not reported) (inappropriate schedule of product administration). No adverse effects were reported.
Case number PHEH2016US023749, is an initial spontaneous report from a nurse received on 14 Sept 2016. This report refers to an 81 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619221) into right deltoid, at a dose of 0.5 ml, intramuscularly on 13 Sep 2016. It was reported that the vaccine administered had experienced several temperature excursions (-2.7C for 6 hours and 4 minutes -3.6C for 21 hours and 48 minutes -3.4C for 21 hours and 2 minutes -3.3C for 21 hours and 3 minutes -3.3C for 8 hours and 4 minutes 1.2 C for 1 hour and 1 minute 1.7C for 1 hour and 5 minutes). It was reported that the vaccine was not frozen. It was started that, patient was not experienced any adverse drug reaction, patient was revaccinated FLUVIRIN that experienced temperature excursions prior to vaccination. No adverse event was reported following this medication error (incorrect product storage). No additional information was provided.
Expired MMR vaccine was inadvertently administered to the patient. No symptoms or adverse effect observed.
This spontaneous report was received from a registered nurse refers to a 13 year old patient. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 02-AUG-2016, the patient was vaccinated with a first dose of PROQUAD, therapy type: rHA, lot # L046508 (expiry date: 17-MAY-2017) at a dose of 0.5 ml, subcutaneously. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-395985.
PT mother states her son received the second dose Pfizer vaccine on 05-01-2021. She states that her son is autistic and that within fours hours of receiving the vaccine, he developed a fever of 100F then 101F, which he had for two days. His mother states she took him to the doctor where three EKG?s were performed and his results were abnormal for all three EKG?s. His doctor told the mother to take him to the ER. At the ER an EKG was taken as well as an x-ray of the chest. The ER doctor came back and told the mother that her son needed to be seen by a cardiologist. At this time PT mother is awaiting for a cardiology appointment.  PT mother does not have lot # to provide at this time.
thrombocytopenia.  Platelets 10 on 10/17/23.  Treated with decadron for 3 days with improvement in platelets to 115 on 10/20
Hives bilateral arms, chest and face within minutes of vaccine, patient observed and evaluated by PA in office and advised to take BENADRYL and if any throat swelling, tongue swelling difficulty breathing to call 911.
Felt really tired, strange, fever, felt like my heart was fluctuating, excoriating pain across my lower back, funny feeling like I wanted to wrap my arms around my self and wrap into a ball and lasted until I got into the ambulance was started getting treatments. When I got to the hospital my temp. was 102.3.  Symptoms started on the 5/23/2022 around 10:00 pm  but Was admitted 5/24/2022 to 5/26/2022 . Treated for cervical rediculophy (CRC) with nerve block, with neck pain and nerve pain down the arm, tachycardia 102. Antibiotics, IV's of various things in both arms. Vancomycin 700mg, Cefepime 1gm/vial both given more then once.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 06-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
pain great enough to keep from rasing arm-swollen, red x 48hr;hot to touch;shoulder to elbow, red;feels much better 11/1/99;
Pt Fainted into her mother arms. Came back about 1 minute. was alert and oriented. no anaphylaxis. mom mentioned patient did not eat for the afternoon. she was given a pepsi and potato chips after anaphylaxis was ruled out and low blood sugar was suspected
No severe effects but there is a rash that appears to be a bug bite and a bruise located on the left forearm, away from the site of injection (near shoulder).  > 24 hrs not gone yet.   - I will probably call a health care provider/professional if they don't go away.
Patient received 0.5ml rather than 0.25ml as a booster dose of the vaccine
This spontaneous report as received from a registered nurse on 15-OCT-2014 concerning an unspecified number of patients. On an unknown date the patients were vaccinated with GARDASIL (route, dose was unknown) which was improperly stored. No adverse effects were reported. No product quality complaint was involved. It was reported that this case was opened on 26-AUG-2014 for temperature inquiry only. The outcome of the events was unknown. This case is linked to the cases MARRS# 1410USA008635, 1410USA013360, 1410USA013358 and 1410USA013359 with the same reporter link. Additional information is not expected.
Intense body aches (I was less achy after my first marathon) that kept me from sleeping despite taking tylenol and sleeping medication from 11pm to about 10am. Added advil to the tylenol and the body aches lessened and I was VERY tired until about 5pm the next day (slept most of that time.) Injection arm was very sore for several days. Everything I experienced seemed to track with the expected vaccine side effects though. I was never worried that my experience was abnormal.
He has developed constant, chronic fatigue, upset and painful stomach lasting for about a month. This started 2 weeks after his second dose. We aren?t sure if it?s related, but just in case we want to report it. The cause of his symptoms is still unknown at this time.
No adverse effects were reported; she received tbe first dose of GARDASIL 9 in October of 2018 and tbe second dose in June of 2019; This spontaneous report was received from a female patient of unknown age referring to herself. No information regarding her pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On an unknown date in October 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date in June 2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, exact dose, route of administration, lot # and expiration date were not reported) for the same indication. No adverse effects were reported.
Immediately following vax c/o chest tightness & feeling "cold all over"- diaphoretic & pale; given Epi; p88, BP 80/40; chest tightness relieved & less pale; Pt declined transport to ER; Reporter felt pt was stressed about vax & became faint
Sudden infant death approx 3 hrs p/recvd DTP/OPV/HIB TITER; no response to full advanced cardiac life support;
vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus a the time of administration".  Patient reported no adverse reactions.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Headache-Mild, Systemic: Lymph Node Swelling-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: feels liquid type of swelling at underarm running down to side of right chest (pec).
G62.9 PERIPHERAL NEUROPATHY 10/11/2022 CHF EXACERBATION, UNSPECIFIED
Information has been received from a health professional concerning an 11 year old female patient who on 28-AUG-2007 was vaccinated IM with a second dose of Gardasil.  The reporter reported that patient had hives on 30-AUG-2007 for which BENADRYL was recommended.  No further information was available.  The outcome was unknown.  Additional information has been requested.