chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; 16 patients were administered pediatric monovalent vaccines instead of bivalent boosters; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters).    This case contains information for the 3rd of 16 adult patients described by the reporter No concomitant information was reported. Patient was administered pediatric monovalent vaccine instead of bivalent booster on 21DEC2022. No symptoms reported. No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-692175:Master
Information has been received from a pharmacist concerning an adult female who in approximately September 2004 was vaccinated with a dose of hepatitis A virus vaccine inactivated (manufacturer unknown). Subsequently the patient was exposed to someone with hepatitis A. A serology test showed that the patient was positive for hepatitis A and her liver function test was elevated. The patient sought unspecified medical attention. There was no produce quality complaint involved.  Additional information has been requested.
liquid dripped out during administration; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect dose administered in a 84-year-old male patient who received Herpes zoster (Shingrix) (batch number K7T79, expiry date 14th April 2023) for prophylaxis.   On 25th November 2021, the patient received the 1st dose of Shingrix. On 25th November 2021, unknown after receiving Shingrix, the patient experienced incorrect dose administered. On an unknown date, the outcome of the incorrect dose administered was unknown.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The reporter stated that, some of the vaccine liquid dripped out during administration and the reporter not sure if the patient received the full dose of Shingrix, which led to incorrect dose administered. The reporter did not consent to follow up.
flu; headache; muscle ache; fever; Initial information received on 17-Nov-2020 regarding an unsolicited valid non-serious case received from a social media consumer.  This case involves patient (unknown demographics) who experienced flu (influenza), headache, muscle ache (myalgia) and fever (pyrexia) while he/she received vaccine INFLUENZA VACCINE.  Past vaccination included every year INFLUENZA VACCIN and who experienced year headaches, muscle aches, fever and flu.  Medical history, medical treatment, 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 and expiry date: 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), headache, muscle ache (myalgia) and fever (pyrexia) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were not reported.  There will be no information available on the batch number for this case.
PATIENT'S LEFT ARM SWELLED OVER A LARGE AREA - HER DOCTOR (WHICH ONE HER DAUGHTER WASN'T SURE) INSTRUCTED HER TO APPLY ICE AND TAKE TYLENOL. OVER A WEEK LATER SHE IS STILL SWOLLEN BUT CONSIDERABLY BETTER.
This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation aggravated in a 90-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included atrial fibrillation (lasted one day and then resolve). In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced atrial fibrillation aggravated (serious criteria GSK medically significant), pain in arm, heart rate increased and heartbeats irregular. On an unknown date, the outcome of the atrial fibrillation aggravated, pain in arm, heart rate increased and heartbeats irregular were recovered/resolved. It was unknown if the reporter considered the atrial fibrillation aggravated, pain in arm, heart rate increased and heartbeats irregular to be related to SHINGRIX. Additional details were provided as follows: After vaccination, the patient experienced atrial fibrillation was worse for a few days which was included a rapid heart rate and an irregular heartbeat. The patient did not have to be seen by a physician. The reporter did not consent to follow-up. Lab Comments: On an unknown date, the patient's heart rate was rapid and irregular.
Lt leg "huge ball"/red size, took to Urgent Care - told to ice, MOTRIN, if worse to call PCP for abx. *Rt leg "smaller" lump/red.
Arm and neck pain; Neck pain; Fever; Chills; Nausea; This is a spontaneous case received from a contactable consumer (patient). This is the first of two reports. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the right arm on 09Mar2021 at 12:00 PM (at the age of 42-year-old), as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included one kidney, lost left kidney to cancer, mitral valve prolapse and left ventricle blockage on heart. Concomitant medications included ibuprofen (ADVIL) from an unknown date for an unknown indication. The patient previously took tetracycline on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021 at 12:00, the patient experienced arm and neck pain instantly after first shot. On an unknown date in Mar2021, the patient experienced fever, chills and nausea. It was unknown whether any therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021413382 same patient, different drug(dose)/events
Progressive and fluctuating hives and red rash on the shoulders, chest, abdomen, back, and upper thighs. Began on December 25 in the afternoon lasting about 30 hours, waxing and waning until a final flare-up in the PM in December 26. No more symptoms Dec. 27
In the evening, I had body aches and my back was sore. I went to sleep and woke up the next morning with dark urine. I thought I was dehydrated so I drank lots of water, but it did not help. I had some abdominal pain as well. I went to my doctor who determined it was a UTI. I was given antibiotics and took those. Within 24 hours, it had resolved.
Pain from shoulders to fingers; Pain from top of legs to toes; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CN6202) via an unspecified route of administration in the right arm on 26Feb2021 at 09:45 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included Atrial Fibrillation (AFib), depression and osteoarthritis. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FL9269) via an unspecified route of administration in the right arm on 05Feb2021 at 09:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. On 26Feb2021 at 18:00, the patient experienced pain from shoulders to fingers and pain from top of legs to toes. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain from shoulders to fingers and pain from top of legs to toes was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
muscle aches, confusion, fatigue, lymph nodes tenderness in underarms and jaw 1/7/20
Acute lacunar infarction; suffered a mini stroke; This is a spontaneous report from a contactable consumer (patient).   A 62-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm Left on 10Apr2021 13:00 (Batch/Lot Number: EW0151) at the age of 61-years-old as DOSE 2, SINGLE for COVID-19 immunization at the Pharmacy or Drug Store.  Medical history included asthma and arthritis. Concomitant medications included gliclazide (CLARITIN); mometasone furoate (ASMANEX); and assorted vitamin Cs all taken for unspecified indications and therapy dates. The patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) on 20Mar2021 at 03:00 PM (Batch/Lot No: ED6955) at the age of 61-years-old administered on the Arm Left for COVID-19 immunization. Then, received the 2nd dose on 10Apr2021 13:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Aug2021 10:30, the patient suffered a mini stroke as he had acute lacunar infarction. The event required Emergency room/department or urgent care visit and later admitted in the hospital in 2021. The patient received metoprolol and atorvastatin as treatment. The patient also had negative nasal swab on 08Aug2021.  The patient was discharged and recovered from the event in 2021  Follow-up attempts are completed. No further information is expected.
Patient called pharmacy around 8 pm Mon 1/22. She stated that she received 2 immunizations on Saturday, 1/20, the influenza and pneumonia vaccines. Patient stated that a female pharmacist gave her the immunizations and counseled her that she would not develop any side effects such as feeling "sick" or any soreness/redness at the site of injection. Patient states that all day Sunday she felt very ill and had a fever of 104. She also stated that she could not feel her arm and she had redness and swelling at the site of injection. On Mon 1/22, she states that her fever and symptoms of feeling ill subsided, but her arm was even more red and swollen, and she was experiencing numbness/tingling in her fingertips of the same arm. She then stated that her mom had been drawing circles around the area of redness and the circles had "gotten bigger," and the redness was now spreading up onto her shoulder and chest area. It was at that time she was instructed to go to the emergency room.
Patient experienced headaches, seizure in head such as head shaking and involuntary movement.  She also experienced leg jerking or shooting movement (involuntary movement). Still has ongoing headache.
This spontaneous report has been received from a a physician via a company representative, referring to a 59 years old male patient. The patient's medical history, drug and allergy history and current conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose number, route, anatomical location, lot number and expiration date were not reported) for prevention of pneumococcal disease.  The patient's concomitant therapies were not provided. It was reported that on an unknown date, the patient developed an itchy rash in an unknown location for an unknown amount of time after receiving PNEUMOVAX23, and as a treatment, the physician prescribed cetirizine hydrochloride (ZYRTEC). The patient's outcome was unknown at the time of reporting. The causality assessment between the event and PNEUMOVAX23 was unknown. Additional information is not expected because there was not consent to contact the reporter.
On the evening of 01/05/2023, I had a slight fever and continued the next day. By the afternoon on 01/07/2023, I was prescribed Paxlovid at the clinic. By the 01/09/2023 and 01/10/2023, I was feeling mostly normal.
depression is worse since getting the second dose; feeling really blah and on the weepy side; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depression is worse since getting the second dose) and CRYING (feeling really blah and on the weepy side) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 019B21a) for COVID-19 vaccination.     Previously administered products included for an unreported indication: . Concurrent medical conditions included Clinical depression. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) and METFORMIN for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, 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 DEPRESSION (depression is worse since getting the second dose) and CRYING (feeling really blah and on the weepy side). At the time of the report, DEPRESSION (depression is worse since getting the second dose) and CRYING (feeling really blah and on the weepy side) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. Treatment information was not provided.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (administered expired vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 013H21B) for COVID-19 immunization. No medical history reported. On Mar 30, 2022, at 11:00 am, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; .25 milliliter. On Mar 30, 2022, patient administered expired product (administered expired vaccine). At the time of the report, administered expired product (administered expired vaccine) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The vial initially stored in the refrigerator on Mar 1, 2022. The vial did not undergo any temperature excursions. The number of total doses: 17.
On the second day after the shot I had a fever of 102.5 around noon and  slept throughout the day.  Sometime during the night my fever broke. The next morning my temp was back down to normal.
30JUL97 presented w/fever 104, cranky;had been exposed to varicella 1wk prior;31JUL97 rash noted face & body, tiny red bumps;fever did not go below 101.5 alt Ibuprofen & APAP;not eating or drinking well;dx measles;dec activity
Headache that could choke a horse; Round raised circle; Red injection site; Itchy injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Round raised circle), VACCINATION SITE ERYTHEMA (Red injection site), VACCINATION SITE PRURITUS (Itchy injection site) and HEADACHE (Headache that could choke a horse) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-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 INJECTION SITE SWELLING (Round raised circle), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE PRURITUS (Itchy injection site). On 27-Feb-2021, the patient experienced HEADACHE (Headache that could choke a horse). At the time of the report, INJECTION SITE SWELLING (Round raised circle), VACCINATION SITE ERYTHEMA (Red injection site), VACCINATION SITE PRURITUS (Itchy injection site) and HEADACHE (Headache that could choke a horse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment included Acetaminophen Q6H
I received the vaccine in the morning. Later in the evening, I felt short of breath. The next morning (24 hr after the vaccine), I woke up covered in hives all over my body. I took 180 mg Allegra, the hives diminished, and I went about my day. The next morning (48 hr after the vaccine),  I woke up covered in hives again, with swollen lips and an itchy throat. I reached out to my doctor, who prescribed prednisone (40 mg / 2x daily); Benadryl every 4-6 hours; Pepcid as needed; and continued use of Allegra (180 mg/day). I took all of these medications on that day. The itchiness in my throat and swelling in my lips went away. Throughout the following five days, I continued to take this combination of medications, but reduced Benadryl to once a day. The hives persisted throughout the week, but finally went away about seven days after the vaccine.
Student has Chediak-Higashi which is a blood disorder and is not supposed to receive any live vaccines. Received MMR. No reaction, but called Hematologist MD and sent immediately to hospital for infusion and evaluation.
Moderna vaccine given was Spikevax.  Symptoms started to occur after approximately 1 week and are as follows: Left chest area rash from breast area down 6-7 inches. Rash is itchy, red, non -blistering Left inner upper arm rash, rash is itchy, red , non-blistering Left inner forearm rash from wrist to elbow, rash is itchy, red, non-blistering Patient has been applying Benadryl spray to calm itch.  Patient had Dr. appointment today just advised to keep applying Benadryl spray and that rashes should subside within a couple weeks.
On 10/6/21 0845 COVID 19 Moderna vaccine doses were drawn up.  Vaccine labeled and staff notified that doses should be used by 1445 on 10/6/21.  At end of day on 10/6, Moderna vaccines were not wasted.  Later on 10/7, 38yr old patient presented to clinic for 2nd COVID 19 vaccine. CMA administered expired COVID-19 Moderna vaccine (lot # 004C21A) to patient on 10/7 1057.  NM notified. Follow up indicates that manufacturer contacted to clarify if patient needs another dose and pharmacy to follow up. Per manufacturer another dose is not required.  No patient harm noted.
At 6pm my left leg became slightly numb and tingling. I moved around a lot to increase circulation and tingling subsided after about 5 minutes. Severe head dizziness followed and is still active at 8:00pm. Leg numbness has transitioned to an ache/kind of a cramping feeling mostly in quad.. I feel like I'm spinning and very drunk. No alcohol has been consumed.
Narrative:  56 YO M with PMH gastritis, HTN, HLD, and mental health conditions reported sore arm for one day following first dose of COVID-19 vaccination on 1/26/2021 which resolved within 24 hours without intervention. On 2/2/2021, patient developed sharp, needle-prick pain on scalp with redness, which spread to face and neck with 8-9/10 pain on scalp, face, jaw, upper neck which is triggered by movement and contact. Also reports itching and "welts"; small vesicular lesions seen on examination (3/17/21). Most lesions resolved without intervention. Suspected shingles/zoster reactivation, carbamazepine and valacyclovir initiated 3/17/21, patient no longer taking. Symptoms improved as of 4/24/21 but not completely resolved. Follow-up ongoing, may require MRI imagine if flare returns.
Hives/welts inside of arms/thighs both sides went to ER given BENADRYL/Steroids and cleared up in 1/2 hour.
Fever 104F x 2 days; similar s&s in another pt receiving same vax, same day; 26SEP91 recovered w/o problem; appetite improved;
Mild swelling, redness and itchyness At injection site.; Mild swelling, redness and itchyness At injection site.; Mild swelling, redness and itchyness At injection site.; This is a spontaneous report from a contactable reporter. This reporter reported for a female consumer.  An 82-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EMn00n, Expiration date: unknown), via intramuscular, administered in right arm on 15Feb2021 07:15 (at the age of 82-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262, Expiration date: unknown), via unspecified route, administered on 25Jan2021 07:30 AM (at the age of 82-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Congestive heart failure and Adhesive tape allergy with unknown onset and unknown ongoing and concomitant medications include Apixaban (ELIQUIS), Furosemide (LASIX SPECIAL) and Metformin. On 19Feb2021 04:00 PM, 04 days after the vaccination, the patient experienced mild swelling, redness and itchiness at injection site. Patient took no other vaccine in four weeks; patient was not diagnosed with covid prior vaccination. Patient was not tested with covid post vaccination. The outcome of the events was not recovered at the time of this report.  No follow-up attempts possible. No further information expected.
I had a sore arm, headache and tired after receiving the vaccine. I tested positive for COVID-19 with a home test on 10/03/2022. I did not have symptoms prior to testing. I contacted my doctor and was given prescription for PAXLOVID. I gradually started to feel better. Sixteen days later, I tested negative for COVID-19. I had a cough. Felt lethargic and had a headache. As of today, I still feel tired.
Today around 6am I started having sudden onset of chest pain and SOB, never experienced chest pain before.  Pain is sharp and tight. Just want to get this documented in case it is related to the Covid vaccination I received 10-11 days ago. No cardiac history.