chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse (L.P.N.) concerning a 12 month old female with no pertinent medical history or allergies who on 23-AUG-2008 was vaccinated with a dose of VARIVAX vaccine (Oka/Merck). Secondary suspect therapy included a dose of MMR II vaccine. "13 days later", on 07-SEP-2008 the patient developed a rash on the abdomen which spread to the chest, back and abdomen. The rash was described as little red dots and not a typical chickenpox rash. The rash had gotten progressively worse since starting, but since 09-SEP-2008 it had stayed the same. On 10-SEP-2008 the patient visited the office. No laboratory or diagnostics tests were performed. The vaccine was administered at another facility. At the time of this report, the event persisted. Follow up information received from the L.P.N. who reported that the 13 month old female with no known allergies who in September 2008 developed rash approximately 10-12 days after shots. The rash disappeared, no fever and other problems. Additional information is not expected.
Patient was given a dose that had expired (the vial was drawn from earlier in the day and was never pulled once it hit the 6 hour mark). Patient waited the allotted 15 minutes after the vaccination with no adverse reaction/signs/symptoms. Patient left the store before we found out about the event.
My son tested positive and I had a scratchy throat so I did a rapid test and it came back positive. I experienced bad congestion. 10 days later I retested and it was still positive. On day 14 my test came back negative. After testing negative is when I started to experiencing a cough, low blood pressure in low 80s over 60s and dizziness. I still have a lingering cough and dizziness.
pt recvd vax 10AM-11AM pt w/cyanotic, hyporesponsive event w/T102.9 taken to ER & given blow by 02;
02/05/2022- Day after shot did not want to move or even be alive. Could eat nothing. Total lack of energy. Slept 14 hours. I wasn't awake long enough to see how bad I really felt. 02/06/2022- Still no energy at all. Chronic cough so bad lungs now hurt. Coughed up mucus all day. Very dizzy. Hard to focus. Started having yellow diarrhea. No appetite at all. 02/07/2022- Same symptoms as day before.
Left sided chest pain, with medial specific shooting pain at location of upper breast.  Elevated heart rate.  Dry heaving.  Hospitalized 9/15/2021 0830.  Treatment included IV saline and something for nausea.  PO tylenol for pain.  Patient was released at approximately 1500 9/15/2021
VACCINE ADMINISTRATION ERROR. RECIEVED BIVALENT BOOSTER 12+, SHOULD HAVE RECIEVED 5-11YRS BIVALENT BOOSTER.
This spontaneous report as received from a healthcare worker - Certified medical assistant (CMA) on 13-OCT-2015 reported that unspecified patients received improperly stored GARDASIL (reported by CMA as GARDASIL, M-M-R II (Reference MARRS # 1510USA006844), RECOMBIVAX HB (Reference MARRS # 1510USA011361), and PNEUMOVAX 23 (Reference MARRS # 1510USA009474). Lot numbers and expiration dates of vaccines that were administered were not known. No adverse effects were reported. No further information was provided. On 15OCT2015, the healthcare worker - Certified medical assistant (CMA) called back to provide data as follows on administered dose: Patient (gender not reported, patient initials provided) received a dose of improperly stored GARDASIL  (Lot number K016966, expiration date 10MAY2017) on 12-OCT-2015. The healthcare worker did not report that any other products or doses were administered to patients as noted previously. (This is conflicting information. It is unclear if other patient had received a dose of improperly stored vaccine(s). No adverse effects reported. No further information provided. Additional information has been requested. This is one of several reports received from same source.
Got fully vaccinated and developed shingles/ Suspected vaccination failure; Developed shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Shingles on her left foot).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The age at vaccination was not reported. After previous shingles on left foot resolved, the patient got 2 doses of Shingrix and then developed shingles on her right foot. This case was considered to be a suspected vaccination failure case, as the details regarding time to onset and laboratory confirmation for shingles were unknown. The reporter did not consented to follow up.
Mild symptoms Sore throat, congestion and fatigue. 2/8 At Home COVID-19 test positive. Televisit with doctor, who proscribed Paxlovid. Recommended also stopping the Lipitor for 2 weeks. The symptoms disappeared by the end of the course of Paxlovid. Symptoms returned on about 2/19 but were gone by 2/21.
Pt was given Tripedia U2397BA instead of Td with pertussis. No adverse event reaction. Adverse reporting notified.  Physician states that re-vaccination was not required.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 1:22 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 1:22 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 39.11.  Concomitant products were not provided.  On 13-Feb-2021, , Excursion time was 9 Am and the temperature was 32, total doses given for the day was 152. Condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Feb-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
(Moderna COVID-19 Vaccine EUA). EVENT: Fever. SYMPTOMS: chills, overall weakness, body aches and pain (stomach, head, muscles, leg soreness/aches), mild to moderate congestion, little to no appetite nausea, dizziness. SIGNS: gradual development of mild to severe chills and overall body ache, nausea and dizziness at moving or walking. TIME COURSE: 4-5 Days. TREATMENT (Personal-no health insurance): Bed rest and sleep, at-home remedies, elderberry, otc medications (robitussin and alka seltzer),  more rest. OUTCOME: weakness and no appetite, constant inability to get up or walk even for simple tasks, little to no energy, slow movements; faster recovery began on the 4th day with over-the counter medications.
Case number PHEH2014US000649 is an initial spontaneous report received from a pharmacist on 06 Jan 2014 and a follow up report received from the pharmacist on 18 Jan 2014: This report refers to an 11-year-old male patient who was inadvertently vaccinated with 0.5 ml of FLUCELVAX (batch number: 010031A) intramuscularly in the left deltoid on 02 Jan 2014. No adverse event was reported following this administration error. Follow up report received from the pharmacist on 18 Jan 2014: FLUCELVAX vaccination site and batch number were updated. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 18 Jan 2014: BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug use in unapproved population".
Fever of 105.0 body aches sore throat lethargic dizzy clammy
72 hours...exhaustion, super hot/icy cold within minutes, continued headache, diarrhea, nausea, could not eat for 2 days, 3rd day lost sense of taste and smell, 3rd day rash on arms and chest (4 hours), difficult to sleep soundly but needed to stay in bed or rest for the most part.  3/16 woke up feeling much better and able to eat, smell and taste about 75%.  Spoke via text with  doctors office personnel for advice 3/14 and 3/15...very supportive!
Fatigue, mild fever (99.5) Onset of fatigue early in the morning, fever around midday.
Feeling bad; Tiredness; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad), FATIGUE (Tiredness) and PYREXIA (Feverish) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    There was no reported medical history.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling bad), FATIGUE (Tiredness) and PYREXIA (Feverish). At the time of the report, FEELING ABNORMAL (Feeling bad), FATIGUE (Tiredness) and PYREXIA (Feverish) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.  No concomitant medication reported. No treatment medication reported.  It was unknown if patient was enrolled in the COVID-19 Vaccine trail.  Primary reporter contact for lot number information was unsuccessful.  The reporter causality for the events feeling bad, tired and feverish with the co-suspect of Humira was reported as no reasonable possibility.
Patient was scheduled for Pfizer Bivalent but was given Pfizer Monovalent in error.  Patient did not report any adverse reactions.
Patient received Moderna Booster shot Friday and experienced swelling on right side of neck (shot administered in right arm) the following day, Saturday.  Also experienced bruising in right leg -describing it as comparable to a varicose vein. Patient worked Saturday and Sunday (12 hour shifts).  We have not seen actual swelling on neck or leg.  Have asked patient to send us pictures or come by. Patient states today, swelling has gone down but not completely resolved.
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like having the flu), HYPERHIDROSIS (The sweats) and MYALGIA (Body aches) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported.).   On 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like having the flu), HYPERHIDROSIS (The sweats) and MYALGIA (Body aches). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like having the flu), HYPERHIDROSIS (The sweats) and MYALGIA (Body aches) outcome was unknown.            No treatment information was provided.No relevant concomitant medications were reported.  Action taken with mRNA -123 is not applicable.
Generalized malaise; warmth at the injection site; chills; Muscle Pain; Headache; joint Pain; Tenderness at the injection site; swelling at the injection site; large red spot at the injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Generalized malaise), VACCINATION SITE WARMTH (warmth at the injection site), CHILLS (chills), MYALGIA (Muscle Pain) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] from 2018 to an unknown date for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced FATIGUE (fatigue). On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warmth at the injection site), CHILLS (chills), MYALGIA (Muscle Pain), HEADACHE (Headache), ARTHRALGIA (joint Pain), VACCINATION SITE PAIN (Tenderness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (large red spot at the injection site). On an unknown date, the patient experienced MALAISE (Generalized malaise). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 28-Jan-2021, FATIGUE (fatigue) had resolved. At the time of the report, MALAISE (Generalized malaise), VACCINATION SITE WARMTH (warmth at the injection site), CHILLS (chills), MYALGIA (Muscle Pain), HEADACHE (Headache), ARTHRALGIA (joint Pain), VACCINATION SITE PAIN (Tenderness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (large red spot at the injection site) outcome was unknown.            The action taken with mRNA with the events was considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received on 29-APR-2021 .Reporters e-mail address updated On 15-Jul-2021: Follow-up received on 15-JULY2021  and concomitant medications and events were added.
This spontaneous report was received from an approximately 65 year old male physician (patient) regarding himself. There was no pertinent medical history. Concurrent condition of the patient included allergy to inhalants - not drug related. On an unknown date in the summer of 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included AVODART, HYTRIN and aspirin (reported as baby aspirin). Approximately on an unknown date in June 2013 (reported as 2 months ago), the patient developed shingles. The patient sought medical attention. He was treated with VALTREX. No lab tests were performed. The patient recovered by 30-JUN-2013 (also reported as the exact date of recovery was unknown). The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
employee received second dose as Moderna, her first dose was Pfizer on 1/28/2021
Approximately 48 hours following shot area red raised area developed around the site of the shot similar to bug bite. Tender to touch.
chest pain, dizziness, shortness in breath.  Has non-ST elevation myocardial infarction
09/08/2021 Chills, body ache. Sleep 09/09/2021  Loss of hearing in my left ear 09/10/2021  EENT- prednisone  09/10/2021 ER- disoriented, confused, vomiting, dizzy- 6 hrs
Severe headache. Restricted neck movement. Fever. Body aches x 2 days
Pt diagnosed with rash 24 hours after vaccine given, with local reaction at injection site. Viral exanthem possible etiology, however must consider vaccine.
he had the same problems; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (he had the same problems) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (he had the same problems). At the time of the report, DISCOMFORT (he had the same problems) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No treatment medication was provided.  No concomitant medication was provided.
Under the armpit it feels tender; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Under the armpit it feels tender) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 040A20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 17-Feb-2021 at 5:50 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021 at 5:50 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AXILLARY PAIN (Under the armpit it feels tender). At the time of the report, AXILLARY PAIN (Under the armpit it feels tender) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment details not provided by the reporter.  The tenderness started a couple  of days after the first dose and was gone approximately 4 to 5 days later.    Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Reporter details updated, patient's demographics updated, second dose vaccine information added and outcome of the event was updated from unknown to recovered.
Legs began to throb and hurt all night excruciating pain in my thighs and legs couldn't walk sit or walk down steps for 4 days and still my legs have pain and feel different.. I still have prob sitting like normal and walking down steps
tender, swollen lt arm from tetanus shot;seen 5/10/99 pink, raised area;
This spontaneous report as received from a registered nurse refers to a 40 year old female patient with no drug reactions or allergies. On an unknown date in 2013 (also reported as "about one year ago") the patient was vaccinated with the first dose of M-M-R II (route, dose and lot # not reported). On 17-JUL-2014 the patient was vaccinated subcutaneously with the second 0.5 ml dose of M-M-R II (lot # J000201, expiration date 09-JAN-2015). There was no concomitant medications reported. The registered nurse reported that on 12-AUG-2014 serologic testing was conducted (also reported as MMR II titers) and results showed that the patient's titer to measles was negative - less than 5 (units not provided). There was no treatment given for the event. The outcome of the event and relatedness between the event and M-M-R II was not reported. The patient did not seek medical attention. Additional information has been requested.
1st dose on 2020, didnt get the 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received on 12 December 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment:  The consumer reported that the patient received the first dose. The patient did not receive the second dose. The patient was asking should he/she still get the second dose or start over. The patient was asking that could there be possible adverse reaction and what could that be because primary care physician could not tell any more than GlaxoSmithKline have. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Severe hives, itching and welts. Skins swells and extremely itchy. Severe itching of hands, feet, hair, stomach and entire torso.
Flu-like symptoms: Headache, Body aches, Chills, Low grade fever, Muscle pain, Tiredness.