chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My period came a week earlier than it was supposed to, 3 weeks after my first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 13:45 (Lot number: EP6955) at the age of 20 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergies: Peanuts" (unspecified if ongoing), notes: Known allergies: augmentin; "Known allergies: pistachios" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "Known allergies: augmentin". The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "recovered" (2021), described as "My period came a week earlier than it was supposed to, 3 weeks after my first shot". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: The patient took no other vaccine in four weeks, had no covid prior vaccination, was not covid tested post vaccination. The patient stated that she had period came a week earlier than it was supposed to, 3 weeks after first shot. It was usually consistent. 2 days after she received the second shot, felt intense pain in lower abdomen towards the right side. This lasted for over 24 hours, making it difficult to sleep. She took ibuprofen and tylenol around the clock, usually do not experience cramps while on period. It was usually the week before or after, she was not sure if it was connected to receiving the vaccine, but she thought her experience might be of interest.  No follow-up attempts are possible. No further information is expected.
Vaccine was given 25 minutes outside the 6 hour expiration window, manufacturer called, no advice given, no adverse events noted, pt educated of event that they received expired vaccine by 25 minutes and that efficacy of vaccine may not be as strong as if given within window of the 6 hour window time frame, given resources to report adverse events as well as to be considered for special circumstances for vaccine
Dizziness and persperation-10 minutes after vaccination.  Lollipop and glass of water given to the patient.  Felt okay after another 10 minutes, watched him for 30-40 minutes then sent home.
Blood pressure dropped from around 135/80 to 116/66 for several hours Tuesday afternoon. Today it is back to where it has been. Last night I woke at 2am with a 101.8 fever. (I'm normally 107.8) Today soreness at site of injection, Muscle aches, Slight fever, and shortness of breath.
After shot given waited 15 min after to see if any reaction, red splotchy noted to left arm where injection was given up to shoulder. 1) L hard.  Noted: Given Benadryl 12.5 mg im and Prelone 2 tsp po.
Pt recv vax on 4/19/99; min post vax pt exp muscle twitch in back & buttocks; on 4/20/99 pt exp lt arm pain & muscle spasm; on 4/22 pt exp muscle twitch of arms,legs, head, neck& decr coordination/ gait tx=Vicodin &Flexeril
body shakes; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of tremor in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 12th February 2020, 12 hrs after receiving Shingrix, the patient experienced tremor, chills and fever. On an unknown date, the outcome of the tremor, chills and fever were recovered/resolved.   It was unknown if the reporter considered the tremor, chills and fever to be related to Shingrix.  Additional case details were reported as follows: The patient experienced 12 hours after vaccination fever, chills, and body shakes. All events resolved within 24 hours after the injection. The reporter consent to follow up.
patient passed out in the elevator after receiving his first dose of GARDASIL 9.; This spontaneous report was received from a pharmacy technician referring to her grandchild, a 12-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient received his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date, route of administration, and anatomical location were not provided), administered for prophylaxis.   On an unknown date, after receiving the vaccine, the patient passed out in the elevator (Loss of consciousness). It was unknown if he completed the series. At the time of reporting, the patient recovered from the event.  The causal relationship between the event of loss of consciousness and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.   Upon internal review, the event of loss of consciousness was determined to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA007319:
Patient reports back 3 days after getting ZOSTAVAX with diffuse bruising, reported that the area was "hot and itchy".
He got his vaccine, his arm was barely sore to the touch.   He gets routine cancer check ups every 6 months, on 5/19/21 he had his usual CT scan of his chest, which showed a new pleural effusion and a new pericardial effusion.  Then there was a growth between his pericardial fat 2 cm x 2 cm that is not cancer as he had a PET scan afterwards that was negative for any highlighted areas.  His Houndsfield Units for the mass was 6.2 cm is 35-36 HU.  He then saw his results online and they want to do biopsies to see what is in the growth and in the effusion.    They have not figured out what to do yet for these symptoms. so he is going to be undergoing additional testing.    He did not have any of these symptoms or problems on his previous 6 month check up and is concerned that it is due to the vaccine itself.  He is in good health and exercises on a continual basis, does not smoke and never had, but does have a couple of drinks a day, but nothing to excess.
Nausea, feverish, throat tightness, itching, painful joint, arm swelling, flushed.
Tongue ulceration; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE ULCERATION (Tongue ulceration) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphoid leukemia.    No Medical History information was reported.   In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient experienced TONGUE ULCERATION (Tongue ulceration). At the time of the report, TONGUE ULCERATION (Tongue ulceration) had not resolved.            No concomitant medications was reported. No treatment medications was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 003B21A and 003B21A) for COVID-19 vaccination. The patient's past medical history included Edema legs (Edema right leg), Pain in arm (Pain in left arm), Shoulder pain, Fatty liver (Fatty liver disease), Impaired fasting glucose, Anal fissure, Onychomycosis, Hemorrhoids, Knee pain, Hyperlipidemia, Testosterone deficiency and Hypertriglyceridemia.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, General physical condition: results not provided General physical examination. On an unknown date, Liver function test: abnormal (abnormal) Liver function tests, Abnormal. On an unknown date, Physical examination: results not provided Physical exam  routine. On an unknown date, Serum ferritin increased: high (High) Ferritin elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. Other investigations include Observation and evaluation for suspected exposure to other biological agent, Gastrocnemius partial tear, Screening for prostate cancer, Screen skin cancer, Screen lung cancer, Screen Colon cancer. No Treatment information was reported.
Information has been received from a medical technologist concerning an 18 month old male who was vaccinated with ROTATEQ today.  There were no adverse effects reported.  Additional information has been requested.
After 8 hours of the vaccination, symptoms were vomiting, high temperature, and diarrhea.  Episodes lasted 48 hours.  Took a week to recover.
Itching of the injection site; Severe headache; Fever; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 16Apr2021 at 14:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 15:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation.  On 17Apr2021 at 00:00, the patient experienced itching of the injection site, severe headache, fever and body aches. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not 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 itching of the injection site, severe headache, fever, body aches were not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Localized swelling and erythema at site of injection, AND Shingles outbreak in one dermatome on the left mid chest and back with pain.
On November 1, 2021 I woke up with a bad headache around 07:00AM. I went to the Urgent Care. They tested me and told me I had COVID. I went on the 5th because I called my Pulmonologist and I spoke to the nurse and they told me to go to Urgent Care. I was so weak by the 5th and felt really sick. My Glucose level dropped 53 and Blood Pressure was 90/60. I do have Postural Hypotension. They sent me to the Hospital. I was treated with Remdesivir and Dexamethasone 6mg by IV. I was checked for blood clots and my heart rate. I had tachycardia that I often get when I get sick. My BP will dropped and HR goes up. I had a touched of Pneumonia but it wasn't bad. I did lose taste and smell. I am still haven't got full sense of taste and smell back. I also did loss my appetite. I do feel like I recovered but I still haven't got my sense of taste and smell back yet.
swollen, puffy face; pain; tiredness; This case was reported by a nurse via call center representative and described the occurrence of facial swelling in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th June 2022, the patient received Shingrix. On 27th June 2022, less than a day after receiving Shingrix, the patient experienced facial swelling, pain and tiredness. On an unknown date, the outcome of the facial swelling, pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the facial swelling, pain and tiredness to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: The nurse reported that the patient received a dose of Shingrix and developed swollen, puffy face, pain and tiredness. The reporter did not provide lot number and expiration date. The reporter consented to follow up.
Patient's mother reported that a couple of days after receiving the Covid vaccine, the patient developed itchy hives on her thighs and lower back. Patient was not seen by a provider. Mother messaged Dr. on 11/29/21 to inform us of this reaction and sent a photo. Mother stated that these hives went away after a couple of days. Mother reports there were no other changes in environmental factors.
multiple wheals around injection site, right shoulder area, and trunks. Hydrocortison cream and Loratadine given.
Approx. 5 mins after vaccine, client c/o itchiness on left shoulder and legs. Skin above injection site did appear to be red. Benadryl was offered and accepted by client (oral solution 25mg x 2). Vital signs WNL. Client left site unassisted and with steady gait, stating "not as itchy."
Swelling left side of face left side of nose left side of lips left eye swelled shut hives by 11/19/2015 facial pain facial nerve.
Vaccine was stored in refrigerator on 15-17 Aug-2022 and was administered on 19-Sep-2022; No Adverse event; given vaccine which was beyond the 30 day use by date; given vaccine which underwent temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-17 Aug-2022 and was administered on 19-Sep-2022), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperature excursion) and NO ADVERSE EVENT (No Adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperature excursion). On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-17 Aug-2022 and was administered on 19-Sep-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-17 Aug-2022 and was administered on 19-Sep-2022), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperature excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-17 Aug-2022 and was administered on 19-Sep-2022), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date) and PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperature excursion).    No concomitant products reported. It was reported that the lot number underwent temperature excursion on 15 to 17-Aug-2022 and was administered to the patient post temperature excursion.  No treatment products reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681465 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681465:
Moderna COVID-19 Vaccine EUA  mild nausea starting about 2 hours after shot, continuing the following morning
The same night that the immunizations were given mom thinks that was when symptoms started and then child confronted mom the next day and his arm was red, triple in size, warm to touch, itches, and hard knot. Mom states that whole top arm is huge, hard and swollen. Mom has been given Benadryl and Ibuprofen and ice packs.
Since taking the TDAP shot back in Dec 14, 2017, I have experienced severe rash all over my body. Been prescribed medications from the Clinic/Pharmacy and the Hospital/Pharmacy starting in mid-Jan 2018 through 5 June 2018. Oral Meds include: Cetirizine, Prednisone, Hydroxyzine, Loratadine and a (corticosteroid) Clobetasol Propionate Cream. Only the Prednisone was effective which I started taking in April 2018 and completed in May 2018. However, after completing the Prednisone medication, the rash came back 3 weeks later and is now worse than before. Continuing to see doctor for more treatment as of June 5, 2018.
arm continues to be sore at the injection site and the surrounding area; Arm continues to be swollen at the injection site and the surrounding area; With some reduction in range of motion; Feeling tingling in feet, primarily left foot; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 13:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had known allergies to gluten. The patient did not receive any concomitant medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Mar2021, the patient arm continued to sore and swollen at the injection site and the surrounding area, with some reduction in her range of motion. The patient also reported that she felt tingling on her feet, primarily patient left foot where patient have never had that before, It was not debilitating but very annoying and not getting better. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore, swollen at the injection site, the surrounding area with some reduction in range of motion and felt tingling on feet, primarily left foot were not recovered at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
10 days after receiving the first dose of Engerix B the pts eyelashes and eyebrows fell out. Outcome resolved. 10 days subsequent to receiving the second dose of Engerix the pts eyelashes and eyebrows again fell out. Unspecified treatment was given three weeks post vax. As of 07/28/2000 the outcome of the event is unresolved.
08MAR was given the vaccine around noon. Started to develop throat tightness and pain within the next 4 hours. Shortly thereafter developed temp 100F, chills, body aches and fatigue all which resolved within 2 days. Throat pain continued (tightness resolved) and patient then began to develop post-nasal drip and productive cough. Symptoms are continuing to today, 3/15 now 7 days post-vaccine
This spontaneous report was received from a registered nurse and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not provided. On 28-MAR-2017, the patient was inadvertently vaccinated with a dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). No adverse reactions were reported. Product quality complaint was not involved. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 18-year-old male patient who received MENVEO for prophylaxis. On 27th July 2018, the patient received the 1st dose of MENVEO. On 27th July 2018, less than a day after receiving MENVEO, the patient experienced injection site pain. On 31st July 2018, the patient experienced tremor of hands, loose stools, fatigue and headache. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the tremor of hands and loose stools were unknown and the outcome of the fatigue was unchanged and the outcome of the headache was recovering/resolving. It was unknown if the reporter considered the injection site pain, tremor of hands, loose stools, fatigue and headache to be related to MENVEO. Additional details were provided as follows: This case was previously reported to physician. The patient received MENVEO on an unknown arm. The patient experienced pain at the injection site which resolved. About 4 to 5 days after receiving MENVEO, the patient began to experience fatigue, headache, loose stools, and hands trembling.
ON 10/12/23 PATIENT EXPERIENCED SHORTNESS OF BREATH, CT SCAN SHOWED MULTIPLE BILATERAL PULMONARY EMBOLISM
Information has been received from a health professional concerning a 44 yr old female who on an unk date was possibly vaccinated with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  in the past (lot number unk). The pt now has a negative titer for rubella. The pt sought unspecified medical attention. At the time of this report the outcome was unk. No further information available.
Reported local injection discomfort then went away, shoulder joint pain returned on 12/15. This has slowly improved, but pt still has limited range of motion to date.
This spontaneous report as received from a nurse refer to a patient (age, gender unknown). On an unknown date a patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot #, expiration date, dose, route not reported) for vaccination. No adverse event reported. Additional information is not expected.
Pt devel rash (vasculitis) on 2 occasions in 1990 & 1991 p/flu vax; dx dermatitis of unk etiology tx meds; 2 mos later rash cleared up & pt had low back pain; dx leukocytoclastic vasculitis; pt went to ER 1 wk later w/sacroiliac pain;