chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion/ABOVE 46F (46.73F) for 46 hours 5 minutes and 0 seconds; No additional AE/PQC reported at this time.; This spontaneous report was received from a nurse practitioner and refers to a 12-month-old patient of unknown gender.  The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant human albumin) (M-M-R II) subcutaneous injection (lot number S039319 and expiration date 04-DEC-2021 were verified as valid) (dose and vaccination scheme frequency were unknown; route and anatomical location of vaccination were not reported) for prophylaxis. It was reported that this was the first dose of the vaccine administered to the patient. The vaccine was exposed to a temperature excursion as it was improperly stored at 46.73 Fahrenheit degrees for 46 hours, 5 minutes (product storage error), which was detected by digital data logger. The recommended range temperature was minus 58 Fahrenheit degrees to 46 Fahrenheit degrees. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA002043: US-009507513-2104USA002045: US-009507513-2104USA002042: US-009507513-2104USA002044: US-009507513-2104USA002041:
Severe chills, all over body  aches, severe fatigue, nausea, severe headache, chest pain. Dificulty getting out  of bed.  Symptoms started Dec 10 and lasted Dec 14 evening
Second dose administered >42 days after the first dose/received the first dose of Moderna 6 months ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose administered >42 days after the first dose/received the first dose of Moderna 6 months ago) 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.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose administered >42 days after the first dose/received the first dose of Moderna 6 months ago). In 2021, PRODUCT DOSE OMISSION ISSUE (Second dose administered >42 days after the first dose/received the first dose of Moderna 6 months ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment information was not provided.  The patient was scheduled for the second dose on 30-AUG-2021.
Extreme left arm pain,  left arm burning pain, traveling pain up to the neck, headache, low grade temperature for 3 day..left arm still very sore on day 4
Leg pain and numbness. Patient reports pain in his legs as severe. He states that it was as if his leg were asleep with muscle aches and cramps. Lasting two days.
Entire (R) thigh red/warm swollen with itching within 24 hours of vaccines given.
Information has been received from a pharmacist concerning an approximately 14 week old male who in October 2006 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). Additional suspect therapy included a dose of Hib con j vaccine (OMPC) (MSD). Subsequently, two weeks later, the patient was passing blood in his stool. Unspecified medical attention was sought. There was no product quality complaint involved. The patient's sibling (WAES # 0611USA04780) had a similar experience after vaccination.
17-year-old patient received the 1st Moderna vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient received the 1st Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient received the 1st Moderna vaccine). On 11-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient received the 1st Moderna vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information, if any, was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-075042, US-MODERNATX, INC.-MOD-2021-074958 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075042:Same reporter US-MODERNATX, INC.-MOD-2021-074958:Same reporter
pt recv vax 12SEP96 & 13SEP96 pt exp a fever of 102 for 5 days;pt recovered;
Approximately 38 hours post vax, the pt had difficulty breathing and was very fussy. The pt sounded like she was grunting. This lasted approximately 1 hour.
Patient was administered a covid vaccine on 3/17/23 that was dated to expired on 03/14/2023. Pfizer and CDC was contacted and per Pfizer the vaccine stability data supports the storage between 2 to 8 . C for up to 75 days (ON  OR BEFORE 3/19/23). No adverse event was reported from the patient.
SOB, ended up sitting up; Little cloudiness in the head; Felt like weight in lungs; Little bit of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (SOB, ended up sitting up), FEELING ABNORMAL (Little cloudiness in the head), CHEST DISCOMFORT (Felt like weight in lungs) and FATIGUE (Little bit of fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma chronic. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (MUCINEX D), LORATADINE, LEVOTHYROXINE, OMEPRAZOLE, FOLIC ACID and FENOFIBRATE for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DYSPNOEA (SOB, ended up sitting up), FEELING ABNORMAL (Little cloudiness in the head), CHEST DISCOMFORT (Felt like weight in lungs) and FATIGUE (Little bit of fatigue). On 11-Feb-2021, DYSPNOEA (SOB, ended up sitting up), FEELING ABNORMAL (Little cloudiness in the head), CHEST DISCOMFORT (Felt like weight in lungs) and FATIGUE (Little bit of fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Herpes zoster without complication  (primary encounter diagnosis), Nausea Fatigue, minor indigestion, and reduced appetite Plan: valACYclovir (VALTREX) 1000mg Tab,        amitriptyline (ELAVIL) 10mg Tab   Expected course current illness and recovery discussed at length, patient advised that the nausea is likely from the shingles. Return to clinic for any increased or persistent symptoms as outlined during discussion.  Patient started on Valtrex, along with Elavil at night.  Patient given educational handout on shingles and the information in the handout reviewed with the patient
Chest pain, shortness of breath, blurred vision, dizziness.  Patient taken to the ER the same day as receiving the vaccination, given a full cardiac workup, and released.  He is now followed by cardiology and pulmonology, and has not shown improvement in symptoms despite prescription of anti-inflammatory medication and an inhaler.
Woke up at 2:30 AM with chills, perhaps a fever, body aches. Took one 200 mg Ibuprofen and fell asleep.  much better now.
Small bumps/mild rash on chest and a little itchy (but I?m also on Zyrtec)
Administered Moderna vaccine at 17 years old, and vaccine should be administered 18 and over for the vaccine. Called health department Nurse - County Nurse Manager to let her know what have happened and stated that booster shot of COVID is still considered valid and good. Explained to her that child is going to country end of June, and clarified if Moderna booster shot is still valid for her trip, and stated yes. Will talk to mom and let her know of situation and that we have talked to the health department to confirm.
Sore arm, headache, fever, chills, ( Started 4/2/21) bumpy rash on right forearm S(Started 4/3/21)
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No pertinent medical history, drug reactions/ allergies or concurrent were reported. On approximately 15-JUN-2016 (reported as "about 7 days ago"), the patient was vaccinated with ZOSTAVAX, subcutaneously (the dose, dosage number, anatomical location, lot # and expiration date were unknown). No concomitant medications were reported. The patient stated that, on the same day as the day of the vaccination, she developed shingles. No information was provided regarding whether the patient sought any treatment for this event. Moreover, at the time of reporting, the outcome of the event was unknown. The reporter also failed to provided a causality assessment between the event was unknown. The reporter also failed to provide a causality assessment between the event and the vaccination with ZOSTAVAX. Additional information has been requested.
Around 8:45 pm on March 20th, I noticed my right arm was a little sore again at the injection site because my boyfriend started to lay his head on that arm. In addition to the light soreness, there was a slightly ovular light red mark on my arm, similar to what others have dubbed "COVID arm". Soreness and the red patch lasted about 46 ish hours in total.
Patient was given the wrong age Pfizer 5-11yr bivalent lot GK1657 exp 01/31/24, and the patient is 12 years old.  we went ahead and gave him the 12 yr booster GJ3270 exp 01/31/24 for his age. Guardian was ok with getting the vaccine.
few dots of blood on the Band Aid; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (few dots of blood on the Band Aid.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (few dots of blood on the Band Aid.).        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.
A week after the vaccine I developed a UTI which was treated with antibiotics and resolved within 5 days after.
The patient passed out on the street shortly after receiving her COVID vaccine. EMS was activated by bystanders and they treated her for Hypoglycemia.
headache, nausea shooting pain from back through neck up through back of my head, blurred vision, lightheaded and dizziness
PATIENT REPORTED TO PHARMACY ON 1/23/2023 STATING SHE HAD A REACTION TO HER THIRD BOOSTER WHICH SHE RECEIVED THURSDAY. SHE REPORTS FEELING DIZZY WHILE DRYING HER CAR AT A CAR WASH AND THEN WOKE UP IN THE ER. SHE REPORTS THAT A BYSTANDER SAW HER AND SHE HAD A SEIZURE FOR ~ 6 MINUTES. SHE REPORTS HER BOTTOM LIP BEING NUMB (AND STILL IS). SHE REPORTED A WARM SENSATION TO TOUCH ON THE ARM AFTER ADMINISTRATION.
1 hour after vaccine developed HA, 6 hours after vaccine Chills, fever, nausea, dry heaves, weakness, dizziness, chest tightness
Mom reported swelling & redness at injection site, fever ( Max 103) , decreased appetite and fussiness
Fever of 101.3 F; Feeling tired, went to sleep again; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.3 F) and FATIGUE (Feeling tired, went to sleep again) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PYREXIA (Fever of 101.3 F) and FATIGUE (Feeling tired, went to sleep again). At the time of the report, PYREXIA (Fever of 101.3 F) and FATIGUE (Feeling tired, went to sleep again) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.3 (High) 100.3F.            No concomitant medications were reported. No treatment medication were reported. Action taken with m-RNA 1273 was not applicable.
Approximately 1 week after receiving booster, I started to experience severe headaches and loss of peripheral vision. I went to an Optometrist on 12/17 as symptoms continued to grt worse, who took images of my eyes and identified papilledema and sent me to Urgent Care. I was then taken by ambulance to the ER due to high blood pressure and heart rate. An MRV, CT Scan of my brain, and spinal tap indicated I had very high pressure on my brain. I was disgnosed with Ideopathic Intracranial Hypertension. I have had many follow up appointments, scans, and labs since 12/17. My vision has still not returned to normal, but we are seeing improvement as the pressure seems right be reducing. I am on 500 MG of Acetazolamide daily and 25 MG of Losaetan daily as a treatment plan.
weakness; Pain in the upper arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ASTHENIA (weakness) and PAIN IN EXTREMITY (Pain in the upper arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A, 031A21A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Golfer's elbow (he started with this issue before the pandemic, 3 years ago) in 2019. Concurrent medical conditions included Diabetes (1 year ago, Recent change in status such as improvement or worsening: no) since 2021, Blood pressure high (more than 10 years ago,Recent change in status such as improvement or worsening: no), High cholesterol (more than 10 years ago,Recent change in status such as improvement or worsening: no), Reaction to monosodium glutamate, Drug allergy (allergy to tramadol) and Drug allergy (allergy to chlorthalidone).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced ASTHENIA (weakness) and PAIN IN EXTREMITY (Pain in the upper arm). On 22-Nov-2021, ASTHENIA (weakness) and PAIN IN EXTREMITY (Pain in the upper arm) had resolved.            No concomitant products reported.  It was reported that patient did not experienced any adverse events after primary series, and only experienced pain in the upper arm and weakness during about 3 days after 1st booster, but no treatment was given. Patient was not able to take the 2nd regular booster at the right time since patient had elbow surgeries due to golfer's elbow. Patient was under a lot of medications but caller did not know names, she just know medications were for diabetes, high blood pressure and high cholesterol. Patient had no COVID positive test or diagnosis. Patient did not had any other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient visited a doctor. The patient did not experienced a similar event in the past.  No treatment products reported.
Swollen in the site of the shot again; Redness in the site of the shot /again; Itchiness in the site of the shot /again; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness in the site of the shot /again), INJECTION SITE PRURITUS (Itchiness in the site of the shot /again) and INJECTION SITE SWELLING (Swollen in the site of the shot again) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness in the site of the shot /again) and INJECTION SITE PRURITUS (Itchiness in the site of the shot /again). On 18-Feb-2021, the patient experienced INJECTION SITE SWELLING (Swollen in the site of the shot again). At the time of the report, INJECTION SITE ERYTHEMA (Redness in the site of the shot /again), INJECTION SITE PRURITUS (Itchiness in the site of the shot /again) and INJECTION SITE SWELLING (Swollen in the site of the shot again) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Tired,headache, neck ache, body ache, feeling unwell or flu-ish,fever,nausea, muscle aches, injection site sore, delayed menstration (cycle came later than usual), menstrual spotting, elongated bleeding time during menstrual cycle (bleeding for longer amount of days than normal)
This spontaneous report as received from a nurse refers to a 12 month old female patient. The patient did not have any drug reactions and allergies. On 30-JUN-2015, the patient was vaccinated with the first dose of VARIVAX (Merck) Lot# L004650, expiry date: 11-FEB-2017 (dose and route were not reported) and the first dose of M-M-R II Lot# L004658, expiry date: 05-FEB-2017 (dose and route were not reported). The patient did not take any concomitant medication. On 30-JUN-2015, less than a minute after vaccines administration, the patient experienced seizure. She was administered an oxygen and was taken by ambulance to the hospital. The patient was admitted to the hospital on 30-JUN-2015 and still remained there at the time of this report. The outcome of seizure was reported as recovering. Causality assessment was not provided. The reporting nurse considered the seizure as life threatening, disabling and medically significant as it required oxygen administration. Additional information has been requested.
Information has been received from a physician concerning a female nurse in his office who was vaccinated IM with a first dose of Gardasil. The patient experienced "nausea" within 24 hours of receiving the first dose of Gardasil. Unspecified medical attention was sought. The patient was recovering. The physician reported that two other patients experienced nausea after receiving Gardasil. Additional information has been requested.
Patient presents with a rash which first appeared two days after receiving the Shringrix vaccine. It is gradually getting worse. There are islands of erythema with clear and opaque vesicles embedded. The rash is tender but not painful. The distribution is on the left jaw, left lateral neck and left posterior neck (V3 and C2 dermatomes). No exposures could be elicited which would indicate a delayed hypersensitivity reaction such as poison oak.  Viral culture sent and patient started on valacyclovir for 7 days. Shingrix is an inactivated vaccine so I searched high and low for another cause for his cutaneous vesicular rash but non could be identified. I came to the conclusion that somehow the patient got shingles from Shingrix. If the viral culture comes back positive, I plan to request a consultation with concern that the batch of vaccines may not be completely inactive.
pt recv vax & has been having pain in rt arm especially in area above & below elbow area has been unable to extend arm fully;weak grasp;hgb 11.3 & EOS elevated;
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jul2022 at 17:00, outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (01Jul2022) Positive. If treatment ae No. No Other medication in 2 weeks. The patient previously received a COVID-19 Vaccine Yes. Device date: 01Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fatigue,; very bad chills after 24 hours after first dose; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er8764) via an unspecified route of administration on 31Mar2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 01Apr2021 (reported as 31Mar2021) (after 24 hours of first dose), the patient experienced fatigue and very bad chills. It was unknown if the patient received any treatment for the reported event. On 08Oct2020, the patient had nasal swab for COVID-19 test and resulted positive. On an unknown date, the patient had nasal swab and resulted negative (reported as thrice). The clinical outcome of events fatigue and very bad chills were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
No adverse events have taken place, vaccine was given too early. PT is 16, and moderna is approved for 18 and up.
Information has been received from a registered nurse concerning a patient who on 12-APR-2006 (Lot # 651494/0504R), 19-JUL-2006 (Lot # 651464/0504R), and 19-OCT-2006 (Lot # 650889/0143R) was vaccinated with the first, second, and third doses of RECOMBIVAX HB. Subsequently, the patient's titers were negative. Dates for the titers were not provided, but it was noted that a titer was done "recently." No further information available. There was no product quality complaint. It was noted that the reporter "would like a trace for the lot numbers provided". A standard lot check investigation was performed for Lot # 651494/0505R and Lot # 650889/0143R. All in-process quality checks for the lot numbers in question were satisfactory. The lots met the requirements of the Center for Biologics Evaluation and Research and were released. Additional information has been requested.
Reporting a breakthrough with vaccination.  Resident tested 10/29/2020 - positive for COVID 19 01/28/2021 - negative for COVID 19 2/4/2021 - negative for COVID-19 2/11/2021 - negative for COVID-19 2/18/2021 - positive for COVID-19   Was vaccinated for COVID -19 on 12/28/2020 and 01/25/2021