chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7/21-allergic reaction,  hives and ear swelling. ER administered IV steroids and antihistamines. Discharged with oral steroids, famotidine, montelukast and advised to take zertec.  7/29- anaphylaxis with hives. Epi Pen used and went to urgent care. Urgent care administered another shot of epinephrine, steroids, Benadryl. Continued to worsen , discharged and sent to ER. ER followed anaphylaxis protocol, IV meds and double breathing treatment. Once discharged, same medications list above were issued and continued.  8/2- ER to admit. Cognitive and speech impairment. At times unable to speak. Extremely low heart rate. Feeling of chest and throat tightness. Extremely confused. IV meds same as above. CT of head and throat. Brain MRI. ENT scope. Chest X-rays. Discharged on 8/4 with same meds as listed above.  8/14- ER to admit. Allergic Reaction. Hives on head, neck, back. Epi pen used at home , no change, so went to ER. ER administered IV meds plus morphine for extremely painful headaches due  huge hives. Discharged on 8/16.   Continuing under doctors care and trying Xolair in hopes of being able to stop steroids with an allergic reaction or anaphylaxis.
Patient ran fever of 100-102 for 3 days. Treated successfully with Tylenol. Moderate rash appeared on day 5 after onset of initial fever. Rash covered trunk, limbs, and face, was red and spotty but not raised or weepy.
flu like symptoms for half a day; I had a breakthrough COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (I had a breakthrough COVID-19 infection) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), LOSARTAN and ATORVASTATIN for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced VACCINE BREAKTHROUGH INFECTION (I had a breakthrough COVID-19 infection) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms for half a day). At the time of the report, VACCINE BREAKTHROUGH INFECTION (I had a breakthrough COVID-19 infection) outcome was unknown and INFLUENZA LIKE ILLNESS (flu like symptoms for half a day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications was provided as Monoclonal Antibodies. The patient experienced flu like symptoms for half a day which was resolved and tested negative on 20-SEP-2021.; Sender's Comments: This case concerns a 60-year-old male patient, with no medical history reported, who experienced the serious (medically significant) unexpected event of vaccine breakthrough infection and a non-serious event of Influenza like illness. The event occurred 6 months 9 days after the 2nd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered not applicable. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
Initial literature report received on 05 Jul 2010: Authors described about adverse events after flu vaccination in two patients with Immune disorders. This polymedicated patient (first case) with medical history of eczema and allergic rhinitis was vaccinated with seasonal flu vaccine (manufacturer unknown) and pneumococcus vaccine (manufacturer vaccine) on 14 Nov 2009. The patient's eczema was in remission at the time of injection. One week later (date unspecified), the patient developed a skin rash that became progressively more severe, involving both upper limbs, both knees and right ankle. The patient's trunk was also itchy but no rash. The patient was on multiple other drugs also since several years without any side effect. When rash was most pronounced, there were two significant laboratory findings including an increase in eosinophil count from 3.8% in a previous test to 18.7% (reference value unspecified) and immunoglobulin E was 3435.1 ng/mL (reference level: 0.2-379.2 ng/mL). The patient was treated with topical steroids, oral anti-histamines, and suspension of other medications (unspecified) for a week resulted in improvement of condition. The author concluded that the both cases did not constitute irrefutable evidence of vaccine-related exacerbations of immune disorders, but such type of adverse events should be noted for future references and emphasized the recommendation of foreign medical regulators about contraindication of H1N1 flu vaccine in patients with serious autoimmune diseases.
a little bit achy/maybe a little bit achy; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "didn't feel a thing". The following information was reported: PAIN (non-serious), outcome "unknown", described as "a little bit achy/maybe a little bit achy".  Additional information: Second shot, didn't feel a thing and third shot, maybe a little bit achy nothing more so.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300063739 Same patient, same vaccine but different doses with different events;
Patient reports swelling, warmness to the touch, bumps/or blisters, and itching at injection site and for 2 days after injection.  All of the reaction is within 4 inches of the injection site. After talking to the patient, she was going to take some benadryl and ice her arm. I followed up with her the next day and it was going away.
ACHE; LUMP IN ARMPIT CLOSE TO BREAST; TINGLING IN FINGERTIPS; NUMBNESS IN FINGERTIPS; PAIN IN ARM WHEN MOVING; FATIGUE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced ache. On APR-2021, the subject experienced lump in armpit close to breast. On APR-2021, the subject experienced tingling in fingertips. On APR-2021, the subject experienced numbness in fingertips. On APR-2021, the subject experienced pain in arm when moving. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ache, fatigue, headache, fever, lump in armpit close to breast, tingling in fingertips, numbness in fingertips and pain in arm when moving was not reported. This report was non-serious.
she has been very sick since yesterday; This is a spontaneous report from a Pfizer- sponsored program. A contactable female consumer (patient) reported for herself that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Apr2021 single dose for COVID-19 immunization. Medical history included COVID positive before at around 05Jun2020. The patient had 1st dose of BNT162B2 on 18Mar2021 for COVID-19 immunization. The patent has been very sick since yesterday (10Apr2021). She said she was feeling this same symptom when she was a COVID-19 positive. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 58 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220309858, 20220309972, 20220310363, 20220310590, 20220310306, 20220310548 and 20220310631.
Pt was hospitalized with Covid 19  from 7/20-7/22/2022 Dose 1 given Pfizer 2/19/2021 Lot # EN6201
Initial and follow-up information has been received from a registered nurse for the pregnancy registry for Gardasil concerning a 25 year old black female with no medical history and no previous pregnancies who on unspecified dates was vaccinated with the first and second doses of Gardasil. On 01-JUN-2007, the patient was vaccinated with a third dose of Gardasil (lot # 653650/0702F, exp. 17-OCT-2008). Concomitant therapy included prenatal vitamins (DUET DH AEC). The nurse reported that the patient received the third dose during her first trimester of pregnancy. The patient's last menstrual period (LMP) was on 07-MAY-2007. On 25-JUN-2007, the patient had an ultrasound performed which was normal. On 23-JUL-2007, the patient had another ultrasound which was normal. During the pregnancy the patient had ultrasounds that were normal at 6 weeks, 10 weeks, 19 weeks, 33 weeks, and 36 weeks. Estimated date of delivery was reported as 13-FEB-2008. On unspecified dates during the pregnancy, the mother experienced oligohydramnios, increased blood pressure, and pruritic urticarial papules and plaque of pregnancy (PUPPS). There were no infections or illness during the pregnancy. On 23-JAN-2008, 37 weeks from LMP, the mother delivered a live normal female baby, weight 6 pounds and 6 ounces, length 19 inches, Apgar score 8/9, and head circumference 13 inches. There was no congenital anomalies. There were no complications during labor/delivery. The outcome of the increased blood pressure, and pruritic urticarial papules and plaque of pregnancy (PUPPS) was not reported. No additional information is expected.
Extreme fatigue and overwhelming sinus issues, extreme mucus and congestion that is not clearing up, diminished kidney function
According to onsite fire company client symptoms, 8:38 am-alert to name but couldn't recall year and date, confused, slow to react, slow speech, dilated pupils.  8:40 am-BP 145/78, pulse 78, O2 Sat 97%,.  8:42 am-Client verbalized feeling nauseous and dizzy but she was okay, pupils semi dilated, able to follow command.  8:43 am-Per paramedic client needs further evaluation.  8:45 am-BP 142/80, pulse 79, O2 sat 100%, Blood glucose 79.  9:01 am-rescue crew arrived on scene.  9:08 am-Client transfer to hospital for further evaluation due to in and out periods of confusion.
Varivax given 4/17/08. On 4/28/08 Patient had mild case of varicella.
Swelling of fingers; Rash on knee and elbows; Patient received BNT162B2 and FLU VACCINE VII on 18Nov2022; Patient received BNT162B2 and FLU VACCINE VII on 18Nov2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Dec2022 at 10:30 as dose 3 (booster), single (Lot number: GJ6738) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Peanut" (unspecified if ongoing), notes: Name of Drug as Reported: Peanut, tree nuts and shellfish , Reaction: Allergy; "Shellfish" (unspecified if ongoing), notes: Name of Drug as Reported: Peanut, tree nuts and shellfish , Reaction: Allergy; "Tree nuts" (unspecified if ongoing), notes: Name of Drug as Reported: Peanut, tree nuts and shellfish , Reaction: Allergy; "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: FLU VACCINE VII, on 18Nov2022 as dose 1, single; DOXYCYCLINE. Vaccination history included: comirnaty (DOSE 2, SINGLE; Lot number: FL3198), administration date: 27Dec2021, when the patient was 16-year-old, for COVID-19 immunization; comirnaty (DOSE 1, SINGLE; Lot number: EW0186), administration date: 09Jun2021, when the patient was 15-year-old, for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 18Dec2022 at 10:30, outcome "unknown" and all described as "Patient received BNT162B2 and FLU VACCINE VII on 18Nov2022"; RASH (non-serious) with onset 20Dec2022, outcome "not recovered", described as "Rash on knee and elbows"; PERIPHERAL SWELLING (non-serious) with onset 20Dec2022, outcome "not recovered", described as "Swelling of fingers". Therapeutic measures were taken as a result of peripheral swelling, rash.  Additional information: Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient was not been tested for COVID-19.
Menstrual Cycle is very regular after having both my children. 3 days after first dose, I have cramping and sense of heaviness in my abdomen and lower back. Currently spotting blood. Period is not due for another week. I never ?spot? and the only time I did was during and after child birth.
Pt presented to the Hospital with increased ataxia, tingling bilateral weakness, fever and neuropathy. Pt had bilateral and symmetrical weakness, and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistent with Guillain-Barre Syndrome.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported that he heard from an unspecified healthcare that the patient was vaccinated with two doses of ZOSTAVAX (lot #, expiration date, strength, dose were unknown). The doses were given approximately 3 to 6 months apart. No symptoms were reported. Additional information is not expected.
Patient have not received the second dose yet; feeling bad all day, during one day; headache, during one day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling bad all day, during one day), HEADACHE (headache, during one day) and PRODUCT DOSE OMISSION ISSUE (Patient have not received the second dose yet) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (High blood pressure) and Anxiety.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling bad all day, during one day), HEADACHE (headache, during one day) and PRODUCT DOSE OMISSION ISSUE (Patient have not received the second dose yet). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feeling bad all day, during one day), HEADACHE (headache, during one day) and PRODUCT DOSE OMISSION ISSUE (Patient have not received the second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took a low dose of a medication for high blood pressure and antianxiety medicine. She did not remember the medications names.  The patient received the first dose at the end of March 2021. The patient received the vaccine in right arm (non-dominant).  The patient wanted to know the most time between the first shot and the second shot and she wanted to know if she can receive the second dose or go back and receive the first dose again.
Dizziness, nausea, chills, extreme swelling at injection site, blanked out causing a fall due to extreme light-headedness, very low heart rate, extreme fatigue (sleeping 12 hrs at a time) and having no energy when awake.  It has been over 2 months and still experiencing light-headed mess.  Cardiologist did ekg, stress test, ecko cardiogram, heart monitor, and blood work and concluded that there is no problem with the heart.  GP who administered the vaccine said she never heard of having these side effects from the PNEUMOVAX 23 pneumonia vaccine but I felt perfectly fine prior to receiving the shot.
Took the flu shot 9/23 as I do every year, the following day 9/24 experienced severe itching all over parts of my body. It progressed to severe patches of hives all over my body. No fever, no trouble breathing or wheezing at all, just a skin reaction (the hives felt warm like a sunburn, but no fever or any other symptoms). Took Claritin, Benadryl, and used topical hydrocortisone/calamine lotion to relive itching. The following day on 9/25, the areas that I had hives on the previous day calmed down, and the areas of my body which previously were normal and didn?t have hives had hives on them as of 9/25. Continued Benadryl, Claritin and  the same topical creams and the hives subsided gradually. I called the nurse line both the first night and the following day, and they said to continue my home treatments and as long as I have no respiratory issues it should resolve in a few days, and to call back or go to urgent care/ER if anything gets worse or doesn?t go away
After receiving Fluzone first time, that afternoon started having fever, continued with fever for a day then got congested and 2 days later started coughing, also vomited. Required Albuterol treatments. Diagnosed with sinusitis and given Augmentin. Second, Fluzone, started vomiting and fever the following day, cough 3 days later. Congested since the following day, came into office diagnosed with cough and sinusitis.
COUGHING TREATMENT GIVEN XOPENEX .63 NEBULIZER TV, 1 TEASPOON BENADRYL.  PATIENT ADMITTED TO MEDICAL CENTER.  11/20/09:  Hospital records received for date of service 11/2/09 to 11/3/09.  Dx: Acute bronchospasm. Presented with persistent cough, observed overnight, improved and discharged in the am.
autoimmune disorder sero-positive rheumatoid arthritis; autoimmune disorder sero-positive rheumatoid arthritis; fibromyalgia; costochondritus; depression; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 2, single (Lot number: EN5318) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Covid-19 immunization Manufacturer unknown), for Covid-19 Immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant), RHEUMATOID ARTHRITIS (medically significant), outcome "unknown" and all described as "autoimmune disorder sero-positive rheumatoid arthritis"; FIBROMYALGIA (non-serious), outcome "unknown"; COSTOCHONDRITIS (non-serious), outcome "unknown", described as "costochondritus"; DEPRESSION (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Rheumatoid arthritis: Positive.  Clinical course: The patient had an adverse reaction to second Covid vaccine Pfizer EN5318, February 4, 2021. As a result, the patient had an autoimmune disorder sero-positive rheumatoid arthritis, fibromyalgia, costochondritus, depression, etc. A VAERS report was filed.
Started with fever the day after shots, had fever for 3 days. Very miserable, not sleeping well, very fatigued, loss of appetite, very fussy. Rash appeared on stomach, back, groin area, neck, behind ears, some on face and head on the 4th morning after shots were given.
5:00 pm chills and low grade fever 8:30 pm 1 advil fever 100.2 bad chills 4/21/21 2:00 am 1 advil fever 100.0 bad chills, aches, sweating - shirt was wet 3:00 pm 1 advil  4:00 pm Claritin - rash on left arm
Regular dose of Pfizer was given instead of 0.2 ml dose for 5-11 year olds.
I experienced pain in my left arm which resulted in a lock shoulder. It has not gotten better. I had to seek treatment with my PCP.   I underwent x-rays of my left shoulder and MRI as well.  I've had two different steroid injections to my left shoulder, oral dose of steroids, physical therapy and I am going to go back to see my orthopedic surgeon. They think the vaccine was given to high.
Patient received Moderna bivalent booster dose that had undergone a temperature excursion.; product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE ( Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE ( Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE ( Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided
Arm and back pain when she was first given vaccine. Patient is underage 15 years old.
since having gardasil shots my daughter has complained of frequent headaches, hair loss, and joint pain.
Fever of 99.2; Arm aches at injection site; She aches all over her body, on back of right shoulder and neck; Mild headache; Chills; A spontaneous report was received from a consumer concerning a 66-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Injection site pain, pain, headache, chills and pyrexia.     The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the events arm aches at injection site, she aches all over her body, On back of right shoulder and neck, mild headache, chills, fever of 99.2.  Treatment details included Aspirin.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of events, arm aches at injection site, she aches all over her body,on back of right shoulder and neck,mild headache,chills,fever of 99,2 was unknown.