chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suddenly, 6 hours after receiving Dose 2 of the Moderna COVID-19 vaccine my injection site arm starting hurting.  I took 1000 mg Tylenol and went to bed.  For the next 48 hours I remained in bed with major flu like symptoms:  fever, chills, severe body aches every where, very bad headache and severe arm pain.  I suppose the nausea I felt was due to taking 1000 mg Tylenol every 5-6 hours for 48 hours.  Then as fast as all this came on it all seemed to go away after 48 hours.  It was a long two days since I had major difficulty getting out of bed or caring for myself.
I was administering the Pfizer vaccine to patient around 10:23am.  After given the vaccine, I asked patient to sit on the chair in front of pharmacy for 15 minutes post vaccination observation.  After few minute later I heard the loud sound "bang" like something hitting the floor.  Then I ran out to the front of the pharmacy, patient was lying on the floor facing down.  I kneel down, turn patient over and assess to see if patient is conscious and breathing.  Patient was alert oriented.  He was able to tell me he didn't know why he spaced out for a second and fell down during that second.  He said he fell so much better laying down on his back.  He said his breathing is normal.  He also tell me he didn't sleep well last night and he didn't know if maybe he feel sleepy.  When paramedic came, his blood pressure is 127/70, blood sugar is 157, oxygen 94.  They assessed him and said he doesn't have any sign of trauma from the fall.  However, patient decided to go with them to the hospital to check to see if there is any concussion from the fall.  At 4pm, I called patient, he sound fine over the phone.  He said he only spent about 30 minutes in the hospital.  He said they assess him and said he was having psychological issue which too much anxiety that was why he fainted (During screening, he didn't show or tell me he was severe nervous).  He said he was trying the hide his nervousness in front of me.  I ask patient in the future please tell any healthcare provider about this so we can be more caution and better monitoring post vaccination.
Patient began to seize less than 5 minutes after receiving vaccine. the seizure lasted less than 1 minute. registered nurse on site laid patient down and supported head and neck. EMS was called and patient was taken to hospital
Patient reported right arm at site of injection was tender, warm to touch, and formed a "lump" under the skin approximately 5 days AFTER immunization given. No local/topical treatment. Patient took ibuprofen with symptoms improvement. Examined by me today, 9/11/2007. Area with mild erythema, indurated 10x5 mm, mildly tender to
The spontaneous report as received from a physician via sales representative refers to a 71 year old female patient. The pertinent medical history includes hypertension, glaucoma. Concomitant therapies included hydrochlorothiazide, PRINZIDE, FLONASE and BETIMOL ESTRACE. Approximately on an unknown date in February 2008 the patient was vaccinated with ZOSTAVAX (route, dose not reported). The reporter stated that the patient was seen in the office on 12-MAY-2014 and was diagnosed with ophthalmic shingles which started on 09-MAY-2014. It was also reported that the patient was referred to an unspecified ophthalmologist and was prescribed VALTREX, Prednisone, and NEURONTIN. The outcome of ophthalmic shingles was reported as recovered/resolved on an unknown date with no vision loss. No product quality complaint was involved. Additional information has been requested.
Information has been received from a nurse practitioner concerning a male who was vaccinated with Pneumovax 23. Subsequently the patient experienced dramatic local reaction. The patient was seen in the office. Additional information has been requested.
Fever 102.4, severe fatigue, chills, aches, HA; Tylenol with reduced fever.  Fever for 24 hours, symptoms gradually resolved in 3 days from initiation.
Information has been received from a Nurse Practitioner student concerning a 15 year old female patient with chlamydial infection and bipolar disorder and with no known drug allergies, who on 01-MAR-2010 was vaccinated with a first dose of GARDASIL (intramuscular route, lot # 661764/0650X). Concomitant therapy included DEPO-PROVERA, lithium and SEROQUEL. The patient was seen by the nurse practitioner two weeks after she had received the vaccination, at that visit the patient's mother reported that "about two days after" receiving GARDASIL, on 03-MAR-2010, the patient developed viral like symptoms. The Nurse Practitioner reported that since approximately 06-MAR-2010, the patient experienced muscle aches, pain in the anterior thighs and generalized fatigue; the Nurse Practitioner also stated that at that time the patient had blood work drawn on that day to rule-out hepatitis and the patient's liver enzymes were elevated. The patient's CBC result was normal, SGOT was 184 and the SGTP was 279. The Nurse Practitioner reported that the Chlamydia infection had been treated with an antibiotic (unspecified) (also reported that the patient was treated with erythromycin for treatment of Chlamydia). The Nurse Practitioner did not know if the patient's "viral syndrome" was related to GARDASIL. The patient was seen again on 23-MAR-2010 because her viral symptoms had worsened and as of that date the patient had not recovered. Follow up information has been received from the Nurse Practitioner who reported that the patient tested positive for Cytomegalovirus and that the virus was self-limiting and there was no treatment. The Nurse Practitioner stated that the patient was clinically feeling better and that the patient did not have hepatitis. On 05-APR-2010, liver function blood studies were repeating with unspecified results. Additional information has been requested.
Information has been received from a registered nurse (RN) concerning a 9 week old healthy female with no allergies who on 10-JAN-2006 was inadvertently vaccinated with a 0.5 mL dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot# 649808/0488R). There was no concomitant therapy. The RN reported that on 10-JAN-2006, the patient became fussy which lasted for a few days. Unspecified medical attention was sought, but no laboratory/diagnostic tests were performed. At the time of this report, the patient was noted to be fine. Additional information is not expected.
STROKE; FELL DOWN; This spontaneous report received from a health care professional (patient's wife) concerned a 54 year old male of Hispanic or Latino other race. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes, and high cholesterol. The patient had no known allergies and was non smoker.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, administered on 16-MAR-2021 at 16:00 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. After vaccination, later on that evening her husband mentioned that he did not feel too good. He took a Tylenol and then went to bed. At around 3:00 that evening his wife woke up to go to the bathroom and noticed her husband was awake. When she asked he responded that he thought he might have suffered a stroke. On unspecified date he experienced fell down and unable to move the right side of his body. On 17-MAR-2021 at around 5:00 that morning, she took him to the emergency room (ER). There the ER department performed a computerized tomography (CAT) scan and confirmed that he indeed had a stroke and decided to transfer him to another hospital. On 22-MAR-2021, he was then discharged. He was hospitalized for 5 days. A few days later on 24 or 25-MAR-2021 she took him to her Doctor Of Medicine (MD.) where they had him do rehab which consisted of daily walking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and the outcome of fell down was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210515350-Covid-19 vaccine ad26.cov2.s- A 54- year- old male of Hispanic or Latino other race presents with Stroke. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
had a bad allergic reaction; This is a spontaneous report from a Pfizer from a contactable female consumer (patient). A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 26Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a bad allergic reaction. Her Doctor already told her she should not but she does not know what to do and mentioned she is stuck in a state where she will have to keep on wearing a mask because she was not fully vaccinated. The outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Initial report was received from a consumer on 23 January 2012. A female patient in her "late 60s possibly 70" had received an injection of FLUZONE, sanofi pasteur Inc., lot number UT433AA (site and route of administration not reported) in November 2011. On an unspecified date "immediately" after the vaccination, the patient developed general malaise and then developed difficulty walking and talking requiring her to use a wheelchair. The reporter stated the patient "had all kinds of test done, x-rays, CT scans and blood work and the doctors are baffled where this infection came from and the last thing she received was a flu shot." The reporter also stated that the patient "stopped breathing." At the time of the report the patient was in the ICU at a hospital. It was unknown if the patient had any illness at the time of vaccination. The reporter was unable to provide the patient's past medical history. The patient was concomitantly taking estrogen therapy. The patient had received influenza vaccines in previous years. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: None.
This patient had his 2nd dose of Hep B given on 01/08/01. Development of subjective fever, malaise. weakness, headache, sweating, decreased appetite, pain in arm, somnolence, influenza-like illness, with shortness of breath, and tachypnea with congestion. On 01/09/01 (most severe) lasting 4-5 days. The patient did not seek medical care.
Patient came in for a Moderna  booster (.25) but received  full dose(.5)
Passed away in home days after vaccine, was in perfect health as far as can be expected by 93 year old,  before vaccine.
Patient reported a metallic taste on vaccine administration, after ~ 10 mins reported a tongue tingling.  The patient was escorted to the emergency department for observation.  Patient was slightly hypertensive 140's/90's which is not normal for her.  Some of this could be attributed from the "white coat effect".  The patient had no visible angioedema, just a mild rash on her trunk/upper torso/chest.  The patient was treated with 50mg PO diphenhydramine and 40mg of Famotidine.  The patient's symptoms resolved within 30 minutes of medications administered.   Patient was discharged after ~ 2 hours in the ED.
1420 recieved vaccination. When arrived at post vaccination area, reported a very mild pins and needles sensation from L shoulder down to hand and pinky and ring finger.  1426: BP 128/90 HR 62. 1420: Reports upper arm has returned to normal feeling; sensation of pins and needles to hand, pinky, ring finger. Reports that sensation remains at same intensity.  Over time, reports that the pins and needles sensation leaves his lower arm until at 1440 when tingling has resolved and everything feels "back to normal."  Released from post vaccination area.
1) wheal and flare reaction 30 minutes after persisted for 5 days. 2) nausea, vomiting, diarrhea, chills, temp to 102, profound malaise for 5 days, body aches for 4 days, alternating hot and cold for 6 days.
Scattered/Diffuse Hives through the whole body. Red, elevated  small and large hives, itchy, and hot to touch. A large cluster of hives develops on one part of the body lasting 1-6 hours, then dissipate, and reappear in another part of the body. No respiratory symptoms, anaphylaxis or angioedema at this time. However, the hives spread over the neck, face and mouth superficially.  Time course, to date, is 4 days with no improvement and continues. Antihistamines including benadryl 25mg q4-6h and zyrtec 10mg q24h have had mild effect/relief of itchiness. But the hives continue. Prescribed Prednisone taper started at 50mg, today marks day 2 of 10, with mild effect.
This spontaneous report was received from a patient's mother via a company representative and refers to a 12 year old female patient. She did not have any pertinent medical history, drug reactions or allergies. On 17-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, site, dose and route of administration were not reported). Concomitant vaccines included an unspecified influenza virus vaccine, administered at the same time the patient received GARDASIL 9. On the same day, after vaccination, she felt dizzy and lightheaded. The patient sought medical attention, she was taken back to the physician's office and sat down until she recovered. No treatment was given for the event and no lab diagnostic studies were performed. The outcome of the event was recovered on 17-OCT-2016. The relatedness between the event and GARDASIL 9 was not reported. Additional information is not expected due to lack of the reporter's contact details.
Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates in 2015 ("after 17-NOV-2015"), the patients were vaccinated with doses of improper stored PROQUAD (Merck) (lot # L031602, expiration date 18-FEB-2017; lot # L034933, expiration date 11-MAR-2017) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial unsolicited report received from a consumer via other company (manufacturer report number 2016557662) on 09-FEB-2017. This case involves an 86-year-old female patient who was vaccinated with a dose of TETANUS TOXOID (TETANUS VACCINE) (batch number, expiry date, dose, dose in series, route and site of administration were not reported), on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had allergy to vaccine. Lab data and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
Patient received Pfizer COVID-19 vaccine on 1/14/2021. Presented for second dose on 2/2/2021 (Day +19) and was erroneously administered Moderna product.
Redness and warmth with edema to right side of  neck and under chin. Resident was on Hospice services  and expired on 1.1.21
COVID-19; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU, ASKU and ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced COVID-19 (COVID-19) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, COVID-19 (COVID-19) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Reported that patient is in first trimester and had received three shots of the Moderna. And she also had COVID.  Company Comment: This is a spontaneous case concerning an adult female patient (exact age unknown) with Maternal exposure during pregnancy and no reported medical history, who experienced the non-serious unexpected, event of COVID-19, which occurred related to the mRNA-1273 vaccination, patient received three doses. At the moment of the report the patient is in her first trimester. The outcome was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Mastitis - fever, chills, cold sweats, localized breast pain, clogged ducts
Child received IPV vaccine in lower left arm, developed redness, warmth, induration the next day, developed blistering on the 3rd day. Mom treated with Keflex, Motrin reduced in 1 week.
Facial swelling noticed about and hour and a half after shot.  Swelling is through entire face but more noted on right hand side.  Noted massive headache and dizzy spell twice lasting no more than a minute each time. Taken Benadryl every 6 hours after noticing facial swelling.
UNBEARABLE MIGRAINE; SORE ARM (JAB); CHILLS; FEVER; EXTREME FATIGUE; This spontaneous report received from a patient via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be  requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced unbearable migraine, sore arm (jab), chills, fever, and extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unbearable migraine, sore arm (jab), chills, fever, and extreme fatigue. This report was non-serious.
a large swollen gland in right armpit; tired; achey; This is a spontaneous report from a non-contactable consumer, the patient. A 30-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER 8733) via an unspecified route of administration on 27Mar2021 at 18:00 (at the age of 30-years-old) in right arm as a single dose for COVID-19 immunisation. The patient medical history included celiac, hashimotos diseases and allergies to food (gluten, mushrooms). Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), glucosamine (MANUFACTURER UNKNOWN), Lysine hydrochloride (LYSINE) and Levocetirizine dihydrochloride (XYZAL) all for unknown indications from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route in left arm on 06Mar2021 at 18:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. 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 was not tested for COVID-19. On 28Mar2021, 24 hours after the vaccine the patient experienced achey and tired but this resolved after 6 hours. On 29Mar2021 at 19:00 the patient had noticed 48 hours after the vaccine a large swollen gland in right armpit. It was soft and tender to the touch. The adverse event did not resulted in a visit to emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events of achey and tired was recovered on 28Mar2021. The clinical outcome of the events of a large swollen gland in right armpit was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
itching all over; inside her ears and head to toe; itching all over; inside her ears and head to toe; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.   A 58-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 15:00 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunization. Relevant medical history included: "severe allergic reactions in the past" (unspecified if ongoing), notes: severe allergic reactions in the past; "chronic adult parvo B19 or fifths disease" (unspecified if ongoing), notes: about two year ago and it gives you arthritis symptoms; "Fibromyalgia" (unspecified if ongoing), notes: from many years; "allergies" (unspecified if ongoing), notes: from years ago; "she has food allergies too" (unspecified if ongoing), notes: she has food allergies too; "she doesn't eat strawberries" (unspecified if ongoing), notes: she doesn't eat strawberries; "autoimmune issues" (unspecified if ongoing); "pollen allergy" (unspecified if ongoing); "Grass allergy" (unspecified if ongoing); "Allergy to trees" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Epinephrine shot (epinephrine shot), for severe allergic reactions; Cortisone shot (cortisone shot), for severe allergic reactions; Ppsd 23 (2nd dose, Caller reports she had the second dose of the PPSD 23 two weeks prior to the Pfizer COVID 19 vaccine, Vaccine Name:  PPSD 23, Manufacturer: unknown, Lot Number: unknown, Route, Anatomical Location: not provided, No. of Previous Doses: one), administration date: Aug2021, for immunization; Ppsd 23 (her previous dose of PPSD was 6 months earlier.), administration date: Feb2021, for immunization. The following information was reported: PRURITUS (non-serious), EAR PRURITUS (non-serious) all with onset 27Aug2021, outcome "recovering" and all described as "itching all over; inside her ears and head to toe". Therapeutic measures were taken as a result of pruritus, ear pruritus.   Additional information: The patient did not receive any previous immunization and did not receive any Additional Vaccines on Same Date of the Pfizer Suspect. The patient got the vaccination on Tuesday (24AUG2021). lot number as either IC3180 or FC3180; then on Friday night she started itching all over; inside her ears and head to toe and if she scratches, she has a whelph come up. Now the itching was on and off; she thinks it may be improved. PCP has given her hydroxyzine for itching and it helps when she takes it. Right now, she was not itching. The patient had itching like this years ago when she had a real bad allergy attack. she was allergic to everything, to all the outside, pollen, trees, grass. she has food allergies too and she doesn't eat strawberries. No lab tests were done.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme nausea vomiting  ,fever,  chills , muscle fatigue and swollen lymph node in my right arm pit