chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chronic migraines; she cannot hear out of her right eye; states she is having a migraine that makes her want to throw up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing), notes: She has had migraines since she was 30 years old, prior to vaccine. The patient's concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 09Apr2021, outcome "not recovered", described as "states she is having a migraine that makes her want to throw up"; MIGRAINE (non-serious), outcome "unknown", described as "chronic migraines"; EYE DISORDER (non-serious), outcome "unknown", described as "she cannot hear out of her right eye".  Additional information: The caller stated that she had an appointment scheduled for her second dose of the Pfizer COVID vaccine that day, stated she had chronic migraines and she was having one today that made her want to throw up and she was hoping to reschedule her second shot as soon as possible but cancel the one for that day. She stated that she cannot hear out of her right eye. She stated that migraines she has had since she was 30 years old, prior to vaccine, they were called chronic retractable, means it didn't respond, sometimes they made her throw up, sometimes they last 4 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, chills, headache, muscle ache -- very severe for the first 18 hours from onset lasting 36 hours.
Slept quite a bit and very good last night; Fatigue comes in waves; Pain in her arm; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept quite a bit and very good last night), PAIN IN EXTREMITY (Pain in her arm), HEADACHE (Slight headache) and FATIGUE (Fatigue comes in waves) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bipolar disorder and Epilepsy. Concomitant products included VITAMINS NOS, CARBAMAZEPINE and LEVETIRACETAM for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arm) and HEADACHE (Slight headache). On 21-Mar-2021, the patient experienced SOMNOLENCE (Slept quite a bit and very good last night) and FATIGUE (Fatigue comes in waves). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Slept quite a bit and very good last night), PAIN IN EXTREMITY (Pain in her arm), HEADACHE (Slight headache) and FATIGUE (Fatigue comes in waves) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up information received on 06 Jul 2021 contains Non significant information
About 2 hours after vaccination, started feeling lip tingling, burning and chapped. This got worse throughout the night. Woke up the following day and had swelling, redness, blisters and chapped around the lips. Also complains of pain around lips BENADRYL and DECADRON taken. Completely cleared by 11/14/2017. Denies any use of new products or medications.
Heart Rate Increased; Menstrual flow very heavy; Menstrual Flow very painful; Sweating; Feel like the flu; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Menstrual flow very heavy), DYSMENORRHOEA (Menstrual Flow very painful), HYPERHIDROSIS (Sweating), INFLUENZA (Feel like the flu) and NAUSEA (Nausea) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Menstrual flow very heavy), DYSMENORRHOEA (Menstrual Flow very painful), HYPERHIDROSIS (Sweating), INFLUENZA (Feel like the flu) and NAUSEA (Nausea). On 12-May-2021, the patient experienced TACHYCARDIA (Heart Rate Increased). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at a dose of 4 mg as necessary. On 08-May-2021, HEAVY MENSTRUAL BLEEDING (Menstrual flow very heavy), DYSMENORRHOEA (Menstrual Flow very painful), HYPERHIDROSIS (Sweating), INFLUENZA (Feel like the flu) and NAUSEA (Nausea) had resolved. On 16-May-2021, TACHYCARDIA (Heart Rate Increased) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient wanted to report the side effects after receiving the second dose of the Moderna COVID-19 Vaccination. Patient received the first dose of the Moderna COVID-19 Vaccination in her left arm muscle, Expiration date unknown.  Patient received her second dose of the Moderna COVID-19 Vaccine on 01May2021, in the right arm muscle; Lot number 046B21A, Expiration date  unknown.    On 03May2021 patient had her menstrual cycle and then later in the month again.  Each time the menstrual flow was very heavy and painful, increased heart rate, sweating, nausea, feel like the flu.  Was tested for the flu once and it was negative and was tested for COVID-19 twice and both came back negative.  Consent to follow up with her health care provider and Safety. Preferred communication is phone.
c/o stomach hurt & couldn't take deep breath;t102 per forehead;no vomiting or diarrhea;saw MD 16AUG who felt sx vax related;glands in neck swollen;mom states glands noticeably swollen;appetite poor;energy level low;t104 17AUG;ATB given
MELANOMA; This spontaneous report received from a patient concerned a 57 year old male, white, not hispanic or latino. The patient's height, and weight were not reported. The patient had no known drug allergies, no previous medical conditions, and no current medication usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 15-SEP-2021, the patient was diagnosed with melanoma and the stage was not reported. The action taken with covid-19 vaccine was not applicable. The outcome of melanoma was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210929761-covid-19 vaccine-Melanoma. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient developed high fever, 103+, (L) thigh became bright red and swollen.
Fever, body aches, site swelling, oral and vaginal blisters for 14 days.
Patient received vaccine at 11 am and started having pain in arm/shoulder around supper time. Also, patient reported a "silver dollar" sized red swollen area at injection site. The pain was waking patient up at night we recommended cold compress, ibuprofen, and to call MD. The pain has improved, but not yet resolved and patient still cannot "reach for items" 4 days later.
last noc started to have swelling & redness lt thigh;cont today possibly worse;pt acting fine, but tender to touch, warm, edema;dx cellulitis;
Second dose had not been administered at time of the call; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose at the end of 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The reporter called in regards of a late second dose of Shingrix and till the time of reporting, the patient had not been administered the 2nd dose, which led to incomplete course of vaccination. The reporter did not have the patient information since patient came by to ask and left, also no vaccine information available. The reporter did not consent to follow-up.
Information has been received from a 23 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 15-JAN-2009 was vaccinated with the third 0.5 ml dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). It was reported that the patient had itchy rash/hives after receiving GARDASIL. A skin test was performed (results not reported). It was reported that the patient had not recovered at the time of the report. The patient sought unspecified medical attention. No further information is available.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium
Immediately after the vaccine was administered, the patient stated that she felt sick and light headed. I instructed her to remove her mask, place her head between her legs and take some deep breaths. Before she had completely bent over she lost consciousness and began seizing. She remained in the chair for the duration of the event and until the paramedics took her out of the pharmacy. I made sure she did not injure herself or fall out of the chair and when the event was over I called ED. I continued to monitor the patient until she was taken by paramedics.
Extreme Nausea began about 12 hours after shot and continued for about 24 hours.  Only vomited once.  No diarrhea.  Was drinking water and about 200 mL of Pedialyte.  Hyponatremia (114) symptoms of confusion and disorientation began about 36 hours after the shot.
pt recvd vax & pt exp local inj site rxn; No further details were provided;
Pfizer Vaccine use for COVID-19 under Emergency Use Authorization (EUA): Elevated AST to 400 and ALT 100 ~2 weeks after second dose
This case was reported by a physician via other manufacturer and described the occurrence of injection site swelling in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that, on an unspecified date, an unspecified patient experienced severe reactions to SHINGRIX. The physician reported that swelling at the injection site, "was the size of a pear". No additional information was provided.
No adverse effects reported; Temperature: 6F up to 14F 14 hourd 10 minutes; 14F up to 46F (16.7F) for 5 hours 40 minutes; This spontaneous report has been received from a medical assistant and refers to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, previous drugs allergies or reactions were not reported. Concomitant medications included sterile diluent  (manufacturer unknown).   On 15-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) at a dose of 0.5 milliliter once, lot #W003820, expiration date: 02-FEB-2024 (vaccination scheme, route of administration, and indication were not provided) following a temperature excursion of 6 degrees Farenheit (F) up to 14 F for 14 hours 10 minutes, 14 F up to 46 F (16.7 F) for 5 hours 40 minutes, time frame reported 19 hours 50 minutes. there was stated that no previous temperature excursion occurred. No adverse effects was reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2208USA006387: US-009507513-2208USA006344: US-009507513-2208USA006265: US-009507513-2208USA006030: US-009507513-2208USA006344:
03/15/2021 I started having issues walking. Went to see a podiatrist. He did stuff with my shoes and it gradually got better over the summer. I woke up one morning and I could barely walk. The muscles in my legs were sore. I could hardly walk across the room. My knees also hurt. It got so bad so bad I was using a cane. I went to the doctor and he sent me to the ER to make sure I did not have a blood clot. I did not have a blood clot. About 3 weeks later, I had my 3rd shot. I was starting to get better and not having to use my cane. I still had soreness in my legs. I read about a person who had same type of problem. It has gotten better, am able to walk a couple of miles a day.
Sore, painful, swelling at the beginning (3 to 4 days) then bruise (arm) - around 10 days. Patient is being monitored by physician's office because patient takes blood thinner medication.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, and concomitant therapies were not reported. On unspecified dates, between 08-MAR-2017 and 29-JUN-2017, the patients were vaccinated with VARIVAX (lot # L034367, expiration date: 08-SEP-2017; and lot # M002063, expiration date: 12-JAN-2018) for prophylaxis. According to the reporter, VARIVAX was exposed to the following temperature excursions: 58 degrees Fahrenheit (F) for 10 hours (from 08-MAR-2017 to 10-MAR-2017), 20 F for 65 hours (from 16-APR-2017 to 19-APR-2017), 26 F for 420 hours (from 20-APR-2017 to 06-MAY-2017), 19 F for 94 hours (from 08-MAY-2017  to 12-MAY-2017), 25 F for 133 hours (from 17-MAY-2017 to 26-MAY-2017), and 20 F for 339 hours (from 30-MAY-2017 to 29-JUN-2017). No adverse symptoms were reported. A digital data logger was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA010754: US-009507513-1709USA010755: US-009507513-1709USA010569:
pt recvd vax; 4nov94 in th pm, fever, pain, redness at inject site; during noc 5nov94, cont fever, geveralized discomfort w/ red streaks down arm to elbow;
After the last vaccination given (Hep A), pt immediately sat down on chair and staged "he felt sick to his stomach." His face showed a noticeable "green color." Pt was told to lie down on floor and his legs were elevated for approximately 5-7 mins. Pt then sat back down on chair until evaluated by physician. Pt denied of any difficulty breathing, SOB, angio edema. Pt only complained of nausea which resolved. A/P early vasovagal syndrome. Will return for Hep A #2, meningococcal vaccine next visit.
Patient came into the clinic at a local Urgent Care to receive a COVID vaccine with his father, the patient received the adult dose of Pfizer  and he is only 10years of age, no known reaction for the patient
I had a migraine with an aura and soon after the migraine started my neck pain got really bad. The headache wouldn't go away. After 2 1/2 weeks of suffering from the headache, I went to see my PCP. She sent me to the hospital to have a CT scan and that came back negative. My headache cleared up 5 days later. I went on a run and after I returned, my headache with the aura came back. We have found that the running needs to halt. I am still having neck pains, but the migraine has not come back. I am experiencing mild/moderate headaches though. I am now going through physical therapy for my neck pain.
Low-grade fever, fatigue, dizzy.  Injection site = size of a grapefruit, swollen and red - painful. On 9/13, I spoke with nurse who suggested I take Tylenol for pain. The following week I was seen by my doctor as I continued to experience low-grade fevers and chills.  She noted in my medical file that I was allergic to the vaccine.
he states that she initially noticed a swollen rash around her right upper eyelid then developed same type of rash shortly after around her left upper eyelid yesterday afternoon.  Today, she reports symptoms got worse and felt like her whole face was swollen.  She denies mouth or lip swelling.  She reports itching all over her body started this afternoon without rash.  She took a total of 200 mg of Benadryl yesterday and 100 mg of Benadryl today.  She denies use of new soap, lotion or other products for personal hygiene.  She denies new medication.  She denies eating seafoods recently.  She received Moderna vaccine 12/30/2020.  She tells me that she has been taking CBD and has ordered it from the same company. She denies fever, chills, cough, sore throat, shortness of breath or wheezing, abdominal pain, nausea or vomiting.
Swollen lymp glands, fever, reactivating of EBV RESULTING IN MONONUCLEOSIS
flu like side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like side effects). At the time of the report, INFLUENZA LIKE ILLNESS (flu like side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Flushed / Sweating-Mild
3-4 weeks after his second Pfizer covid 19 vaccination, patient developed a spontaneous DVT in his right peroneal vein.  He was treated with Eliquis (current still taking this) and his pain has resolved. He will be seeing a hematologist.
Pt on vacation, developed shingles on (R) leg. Dx'ed in emergency room (this is 4-5th patient to develop shingles after vaccine).
Panic attacks, major depression, lumbar disc displacement, obesity, gout, hypertension, diabetes. 1/4/10 Faced an operation of extracting lesions on left forearm and in turn to be operated for a second one on the same left forearm. Pain in lower extremities being treated for diabetes which there is no family hisotry on such sickness plus vision problem, also being treated for a possible ear device for hearing to be included for treatment.
The 2 wks following the 2nd Moderna vaccine, I experienced frequent myocarditis incidents: days 3, 6, 7, 10, 14 (twice). This is five times more frequent than any point previously. On 6/9/2021, at 9:05 a.m. I fainted for the first time ever. At 2 p.m. I experienced a hemorrhage in my right eye from a torn retina.
Feels a lump under the skin in the place he had his injection; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 03May2021 (at the age of 30-years-old) (Batch/Lot Number: EW01770) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Batch/Lot Number: ER8737) for COVID-19 immunization. On May2021, the patient felt a lump under the skin in the place he had his injection. Patient mentioned that if you touch it, it's not painful, but it's a lump under the skin. Patient wanted to know if this was normal. Outcome of the event was not recovered.  No Follow-up attempts are needed. No further information is expected.
pt recvd vax JAN93 & 20 mins post vax pt exp dec BP & felt cold, clammy & faint;
About 1 minute after administration, the patient began to feel dizzy. A few minutes later, she fainted for less than 30 seconds, then woke up. She became pale, clammy, dizzy, and nauseous. 911 was called and they arrived about 10 minutes later. Her condition did not change during this time and she did not have another syncopal event. Her husband and her were interviewed by EMS and then taken to the hospital.
Five days after vaccine I broke out in hives on my arms, legs and feet. It lasted 4 days
Patient became very pale, with chills and weakness, some tingling in arms.  After calling doctor, patient ingested one Benadryl table, and within 30 minutes felt normal. As per follow up: There is no employee by that name. We have never completed a VAERS form.
had antibody titers done and he does not have detectable varicella antibodies; This spontaneous report was received from an employee referring to himself, a male patient of unknown age. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 24-AUG-1998 and 29-NOV-2007, the patient was vaccinated with two doses of varicella vaccine, unknown if it was varicella virus vaccine live (oka/merck) (VARIVAX) (strength, route, lot# and expiration date were not reported) for prophylaxis. The doses were 9 years apart.  On an unknown date (reported as recently), the patient had antibody titers done and he did not have detectable varicella antibodies and was going to get a booster vaccine (antibody test negative). The outcome of antibody test negative was not resolved.  The causality assessment between antibody test negative and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.
Exhaustion, headache, loss of appetite, nightmares, chills and fevers, profuse sweating, diarrhea, body aches.