chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Delayed menstrual cycle (7) days total; Severe cramping -more than usual; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7488) via an unspecified route of administration in the left arm on 28Jul2021 at 13:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 07Jul2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced delayed menstrual cycle (7) days total and severe cramping - more than usual when it started. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events delayed menstrual cycle (7) days total and severe cramping - more than usual was unknown at the time of this report.
rash developed on upper arm around the site of the vaccination.  Heat, itchiness, swelling around the area for 3 days.  Also some discomfort or aching at the site
I am in the beginning stages of menopause, so it is never normal for me to have more than one period in the same month. It started almost immediately after the vaccination (only one week after my last one ended) and I am old enough to tell that my body was not prepared for it at all. In a time of life where heart palpitations are normal, an unexpected side effect that has not studied, was disappointing. I have had several vaccines for travel and was not expecting to have such a reaction to this one. Also, I started my period a week early the following month and because of timing, I couldn't risk it a second time and ended up having to cancel the second dose.
Patient presented with weakness, dizziness, and light-headedness.  Patient does not have any respiratory symptoms and is being treated for community acquired pneumonia (CAP).  Patient was started on Azithromycin and Ceftriaxone to treat his CAP, as well as other supportive care. Patient status improved and he was discharged.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Mar2021 at 11:00 as dose 1, single (Lot number: EN6202), in left arm, on 01Apr2021 at 11:00 as dose 2, single (Lot number: EV0151), in left arm, on 11Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 08Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostrate Cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, patient was treated with Paxlovid.
Patient began to feel "lump in throat" and was getting worse. Epi pen was given.
Severe diarrhea; This is a spontaneous report from a contactable consumer (patient herself).   A 61-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL 9265), via an unspecified route of administration in arm right on 05Feb2021 at 15:00 (at the age of 61-years-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history was reported as none. The patient was not pregnant at time of vaccination. Allergies to medications, food or other products was reported as no. The patient's concomitant medications within 2 weeks of vaccination was reported as none. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 07Feb2021 at 08:00 AM, the patient experienced severe diarrhea. The reporter considered the event as non-serious. Treatment was not received for the event. The outcome of the events was resolved on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Patient was administered  Pfizer  booster instead of Modern as  requested .  Technician did not inform patient of name of vaccine before injecting.  She admitted she should have checked first.  Of note, upon scheduling, patient was told to stick to same vaccine that he received on Shot 1 and 2.
Patient called in stating his arm and top of shoulder are swollen and "bruised" from vaccine, no arm/back pain, felt like his blood pressure was raised and slight fever. Just discovered today that his back looks "bruised". Denied emergency symptoms, but states wants to be seen in person. Offered urgent care provider appointment 5/30/21, but declined, wants to go to emergency room to be seen in person.
in the middle of the night night he developed a terrible nosebleed. Every since then he continues to have the nosebleeds in the middle of the night once, twice or more a week / now it is in the middle of the day; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (in the middle of the night night he developed a terrible nosebleed. Every since then he continues to have the nosebleeds in the middle of the night once, twice or more a week / now it is in the middle of the day) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced EPISTAXIS (in the middle of the night night he developed a terrible nosebleed. Every since then he continues to have the nosebleeds in the middle of the night once, twice or more a week / now it is in the middle of the day). At the time of the report, EPISTAXIS (in the middle of the night night he developed a terrible nosebleed. Every since then he continues to have the nosebleeds in the middle of the night once, twice or more a week / now it is in the middle of the day) outcome was unknown.        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.
2/22/2021 10:09 pm resident reported 1 episode of being nauseous and having dry heaves, no temperature, MD notified and nurse was told to continue to monitor, no new orders, daughter made aware. Vital signs being done every 4 hours. 2/23/2021    3:04am resident complains of nausea, scant BM amount x 2, MD notified and no new orders, continue to monitor and encourage fluids, vital signs continue every 4 hours.
expired dose that was given inadvertently; The Pfizer vaccine was diluted #19:15 yesterday and left out next to the computer and given to a patient today #13:00. The dose was left in the syringe for longer than 6 hours; The Pfizer vaccine was diluted #19:15 yesterday and left out next to the computer and given to a patient today #13:00. The dose was left in the syringe for longer than 6 hours; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 37 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 13:00 (Lot number: FC3182, Expiration Date: 30Aug2021) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1 , Lot:  FC3180 Exp: Oct 2021), when the patient was 37 years old, for COVID-19 immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 31Aug2021 13:00, outcome "unknown", described as "expired dose that was given inadvertently"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 31Aug2021 13:00, outcome "unknown" and all described as "The Pfizer vaccine was diluted #19:15 yesterday and left out next to the computer and given to a patient today #13:00. The dose was left in the syringe for longer than 6 hours".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101138103 Same reporter/event , different  patient
Weakness in one leg; Muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in one leg) and MYALGIA (Muscle soreness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sciatic nerve lesion NOS (in one leg). Concomitant products included VITAMIN D [VITAMIN D NOS], ZINC and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 01-Apr-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 10-Apr-2021, the patient experienced MUSCULAR WEAKNESS (Weakness in one leg) and MYALGIA (Muscle soreness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 19-Apr-2021, MUSCULAR WEAKNESS (Weakness in one leg) and MYALGIA (Muscle soreness) had resolved.            Patient reported that she experienced weakness in leg in which she had sciatic issues. Patient received 2nd vaccine on either 28 Apr 2021 or  29 Apr 2021 with no AEs at all. Patient had nothing further to report.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant follow up received: second dose information added and action taken with suspect product was updated accordingly.
Upon administration of vaccine, patient became unresponsive with regards to decreased speech and alertness. Patient did not faint/pass out, but experienced sweating, feeling hot and pallor appearance.  No treatment necessary as patient slowly regained responsiveness.
8 x 5 cm erythema & induration to (Lt) outer thigh; low grade fever (100.5 F). Tx: ibuprofen, heat, monitor for increased edema/redness & C/PRN.
Kidney infection; Chest cold; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (Kidney infection) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced KIDNEY INFECTION (Kidney infection) (seriousness criterion medically significant), LOWER RESPIRATORY TRACT INFECTION (Chest cold) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, KIDNEY INFECTION (Kidney infection) and LOWER RESPIRATORY TRACT INFECTION (Chest cold) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome 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 information was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.  The formulation for co-suspect product Humira was reported as "Solution for injection in pre-filled pen". The reporter's causality for the event(s) of KIDNEY INFECTION and CHEST COLD with respect to Humira was not provided. Company Comment: This is a Spontaneous case reported by a consumer, concerning an elderly female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Kidney infection, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalamumab for an unknown indication. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning an elderly female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Kidney infection, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalamumab for an unknown indication. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
On January 3rd after receiving my 4th dose, I had a huge lump on head on it was itching and burning. I awoke the next morning , !was starting to see hives spread all over my body.  It was all my hips and legs they were the size of tennis balls. It was all over my chest back shoulders. They were stinging and itching, it was so bad I felt i was dying of it.  They last about half a day and kind of go away. It wasn?t just in one spot, It was spreading on my eyebrow and my eye would swell up. And for half a day it was there then go away it was crazy. I contacted my doctor and he said I had the Hives. There was nothing I had changed. On the 17th he had prescribed Cetirizine for the itching. I went in and I an injection Triamcinolone Acetone on the 21st. On the 24th I called him back; it was worse he the prescribed Hydroxyzine cream. The on the next day he prescribed Prednisone and the on February 7th he gave me a injection of Methylprednisolone Acetate. By this time, it was bad and should him my hips and things. He sent me to a dermatologist Dr. ant the same facility. On February 11th, Dr. prescribed Montelukast and Claritin, he had me to continue for a month. It would be for a day or two they would come back in a big wave. Then I went back, and he prescribed Cyclosporine 100mg. I had so many side effects from that on February he added Magnesium and Vitamin D and lowered the dose. I was to have a blood draw before every visit of my next appointments. The hives were way smaller and not coming in huge spots anymore. On July 6th, I met with him and he said I should see a neurologist on August 17,2021 I had a Biopsy on the large Hive on the back of my head, to see if was cancerous or any clue. The test came back as nothing but Hives. I had to wait to see another Dr.  I was put on a injection called Zolair in November, it less and less. I haven?t had any hives since December 23rd.
This spontaneous report as received from a 59 years old female consumer refers to herself with no pertinent medical history and no drug reactions or allergies. On 30-DEC-2012 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported). There was no concomitant medication. It was reported that she received a dose of PNEUMOVAX 23 on 30-DEC-2012. Consumer reported that on 01-JAN-2013 she developed a fever of 101 degrees Fahrenheit, that her arm was very sore and swollen, and felt "as if a baseball had hit it". Consumer reported that a large knot, the size of a grapefruit developed three inches below the injection site on the back of the arm, approximately 3 inches above the elbow. Consumer reported that the soreness and fever persisted through Thursday, 03-JAN-2013. Consumer reported that the large knot had now (by the time of the call on 01/10/2013) shrunk to the size of a silver dollar. No treatment was given for the events. The patient did not seek medical attention. The outcome of all the events was reported as not recovered. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2022 as dose 4 (booster), single (Lot number: EW0178) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Sulfa, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (non-serious), outcome "recovering" and all described as "COVID 19". Recurrent symptoms included congestion, runny nose, fatigue on 29May2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive. Patient received oral Anti-viral product (Pfizer) as COVID 19 treatment from 16May2022 to 20May2022.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events Drug ineffective  ,covid 19 cannot be completely excluded based on temporal association.
Bell's Palsy, right sided moderate  facial paralysis, acute onset Started on prednisone 80mg x 7 days, valacyclovir 1g TID x 7 days, and acupuncture
Influenza vaccine administered 1500 (L) delt. 1510 Returned to clinic area stating "felt like bugs crawling over me. Lips tingle, eyes itch, hand itch and injection site: no redness, no swelling, no hives. Administer BENADRYL 25mg PO 1510. Instructed to return to clinic area after 30 min. Returned to work station. Follow up clinic area visit 1555; continues to state "itch all over", hives noted on clients back. Second dose BENADRYL 25mg PO adm. Client alert, oriented. No respiratory distress. Work day ends 1600 - instructed to see local primary care provider. Tele call 10-2-12 AM "all ok. Itching resolved.
approx 3-4 weeks after vaccine, very fatigued and off and on slight fever. my heart at times would have a irregular beat and became short of breath, couldn't walk without almost passing out, elevated heart beat. on 06/12/2021 went to the emergency room for these symptoms. found blood clots in my lungs, enlarged heart--infection, heart failure and  pneumonia.  put into the ICU for 5days and released after a week in the hospital. put on blood thinners, heart failure meds, high blood pressure  meds, and at home oxygen. there is no complete outcome from this yet, returned to the er on November 25 for irregular heart beat
Do not have information on three previous MODERNA Vaccines he received but this was his fourth and it was Pfizer as noted above Awoke with chest pain 1/14/2023 and has now developed acute pericarditis with moderate pericardial effusion confirmed by cardiac MRI 3/9/2023
Information has been received from a physician concerning an 18 year old female who on 27-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 29-JUL-2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). After receiving the second dose, the patient experienced fever, stomach pain, nausea, a fast heart rate and high blood pressure. Additional information has been requested.
MOP states that the patient started experiencing redness and swelling localized to the injection site. MOP state the patient followed up w/ her PCM and was advised to use OTC Benadryl PRN. MOP states the patient has not experienced difficulty breathing, hives, or any other signs of allergic reaction. MOP states the patient had redness local to the injection site with her first dose at 12 months but stated it was mild.
Headache- severe x 4 days High Fever (103) (6 hours post injection begain, lasted 1. 5 days) Myalgia  Pain - bone, and  muscle Vomiting Nausea Agitation Diarrhea Inflammation, edema, heat firm induration at injection site
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (experienced repeated outbreaks of Shingles). Previously administered products included Shingles vaccine (Shingles vaccine 7 years ago). On 25th February 2019, the patient received the 1st dose of SHINGRIX. In March 2019, 7 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced injection site erythema. The patient was treated with acyclovir, Valacyclovir and ZOVIRAX Cream. On an unknown date, the outcome of the shingles and injection site erythema were recovered/resolved. It was unknown if the reporter considered the shingles and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient states that before receiving his 1st dose of SHINGRIX he was experiencing repeated outbreaks of Shingles. Patient took acyclovir, valacyclovir and ZOVIRAX cream. The patient stated that he did not have any Shingles outbreak for approximately 10 days so he decided to go ahead and get the 1st dose of ZOVIRAX in the left arm. The patient experienced redness at the injection site following the dose and that this redness resolved within a couple of days. The patient stated that approximately 7 to 10 days after receiving the ZOVIRAX vaccine, he had another Shingles outbreak. The patient stated that he had a Shingles outbreak on the top of both feet and this outbreak took approximately 1 week to resolve. The patient stated that since getting the vaccine, the Shingles outbreaks were more numerous and more frequent. Emergency room visit required. The patient stated that the ZOVIRAX ointment and Valacyclovir were not as effective anymore. The reporter consented to follow up.