chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had a period 10 days ago. Pt never has abnormal periods. PT takes birth control. Pt had vaccine 6 days after period. Pt had another period 2 days after vaccine. 2 periods in less than 2 weeks. PT also has severe RLQ pain and abd tenderness that started 4 days after the vaccine. Pt presented to the ER for both problems that occurred 2 and 4 days after vaccine with no prior history.
This case was reported by a nurse and described the occurrence of accidental overdose in a 13-year-old male patient who received HAVRIX adult (batch number PC527, expiry date 8th June 2015). On an unknown date, the patient received HAVRIX adult. On an unknown date, an unknown time after receiving HAVRIX adult, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. It was unknown if the reporter considered the accidental overdose to be related to HAVRIX adult.
This is a spontaneous report by a contactable consumer. This male consumer reported on behalf of his two month old daughter who received PREVNAR 13 single dose on thigh of the right leg on 12Sep2012. Relevant medical history was unknown. While administration the needle of the vaccine broke due to which only some of the vaccine was injected and the broken needle remained in her right thigh and her right leg was bleeding. The doctor wanted her to get a second dose, so a second dose was given. The nurse was rushing because my daughter was crying. As the needle was being put in the thigh, the nurse hit the needle with the pinky of her hand and broke off the needle. The needle was stuck in her leg. It was not an issue with they syringe. The reporter does not have the pack of PREVNAR 13 handy as the product was received in hospital, hence LOT #, expiration date, NDC # and other product complaint information was unknown. Outcome was unknown. Follow-up (08NOV212) Follow-up attempts completed. No further information expected.
A physician (allergist) reported that a 3 year old male received his 1st dose of Prevnar on an unspecified date. Concomitant vaccinations were unknown and his medical history was not provided. Two weeks, post vax, the pt experienced fever, swollen and purple joints and "bright red skin" "upon stroking". He was treated with unspecified steroids for several days. The reporting physician was concerned about the possibly of serum sickness. Follow-up info was received on 09/05/2001 from the pt's pediatrician. The pt had no pre-existing illness at the time of vaccination and had no previous adverse events with prior vaccination. Medical history included hypopituitarism and it was noted that the child had been induced prematurely. The date of vaccination with Prevnar was 06/19/2001 and the events occurred on 07/12/2001. The events now were noted to have included an urticarial rash and painful fingertips.
Patient presented to clinic for Pfizer Booster.  Her Pfizer #2 was administered on September 1, 2021.  I administered her booster on  January 10, 2021 ( 3 weeks early).  Patient observed in clinic for 20 minutes and no complaints.
3/20 had a red band that was about 6 inches long and  3inches wide on 3/21 arm swollen tight and red from top of shoulder to three inches above the elbow feverish painful and itches in spots
ocular shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced ocular shingles. On an unspecified date, the patient was treated by a healthcare provider for ocular shingles. The outcome of the event ocular shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Headache, Fever, chills, symptoms were worse when laying down Narrative:  Other Relevant History:
Headache, Fatigue -30 min after (gone at 37 hours)  Muscle Aches - 27 hrs after (gone at 37 hours)  Eyelid edema & swelling in fingers - 37 hours (gone 72 hours)
BELL'S PALSY RIGHT SIDE FEELING NUMB RIGHT SIDE OF FACE, THEN ASYMMETRY OF FACE FOLLOWED. NO FEVER, NO OTHER SIGNS OF ILLNESS. NO EAR PAIN, NO COUGH, NO COLD. PREDNISONE 50mg 1 TAB DAILY X 5 DAYS THEN 1/2 TAB DAILY X 5 DAYS.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-OCT-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # M011832, expiration date 25-JAN-2018 (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 32 and 35 degrees Fahrenheit (34.4F) for 15 minutes. A digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA012988: US-009507513-1711USA007834: US-009507513-1711USA007835.
COMPLETE LOSS OF USE OF LEFT ARM IMMEDIATELY FOLLOWING ADMINISTRATION. EXTEME PAIN, UNABLE TO MOVE ANY FINGERS OR DIGITS ON THE LEFT ARM. DEAD LEFT ARM. SAUGHT TREATMENT THROUGH PREDNISONE BY PCP. ARM FELT BETTER OVER A FEW MONTHS. THEN IN DECEMBER 2021, PARESTHESIA OF LEFT ARM HAS BEEN ON GOING CONTINUOUSLY. MY LEFT ARM FEELS DIFFERENT THAN MY RIGHT ARM EVER SINCE THIS VACCINE WAS ADMINISTERED.  I BELIEVE THE PERSON WHO ADMINISTERED THE VACCINE GAVE IT WRONG.
gave Imovax in the gluteal area, NO AE; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 54 year old male patient who was vaccinated with dose of RABIES (HDC) VACCINE [IMOVAX RABIES] in the gluteal area.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Sep-2019, the patient received a 1 ml first dose of suspect RABIES (HDC) VACCINE lot N1L13, exp date: Nov 14, 2019 via unknown route in the gluteal area due to bat exposure.  It was a case of actual medication error due to Vaccine administered at inappropriate site.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  List of documents held by the sender: none
Intense arm pain and weakness on injection site arm (left) around 10 or 11 pm (6 hours after injection). Then I took a dose of Tylenol and went to bed shortly after. May have had symptoms in the night, but I woke up around 7am due to intense nausea and chills. I took a dose of pepto bismol and went back to sleep. All throughout the next several hours I experienced chills, nausea, fever (100.3 degrees F) and fatigue. My fever broke and I was able to get out of bed and eat something around 6pm. I felt much better and was no longer nauseous. Still felt fatigued until the next day around 10am.
pt devel a little rash on rt thigh 2 days p/vax;1wk afterwards pt had rash on both legs, arms, stomach & lips of mouth;student was referred to PMD who dx systemic allergic rxn;
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with a dose of improperly stored GARDASIL 9  (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. It was reported that the temperatures had reached below recommended temperatures. Specific temperature excursion details were unavailable at the time. This case is linked to case number 1610USA011174 and 1610USA011175 via same reporter link. Additional information has been requested.
3/31 2:45am-chills 6am-nausea 7am-fever greater than 101, dry heaves, throwing up, body aches, weak, fatigue  Mid morning headache  All symptoms  continued and intensified through the day.  Symptoms gradually started to decrease after 9pm.  4/1-Headache was primary symptom which subsided early PM  4/18 Vertigo (first time ever) and fatigue
Adacel is a new vaccination intended for adults under 65, which should replace Td for tetanus booster and will increase immunity to Pertussis. Daptacel is one of many brand names of the vaccine which is intended for infant use. The component antigens are the same, but the relative amounts are much greater for the infant vaccination. The nomenclature DTaP and Tdap is confusing and a potential source of error, which is further compounded by the similarity in the brand names. We have identified instances where adults and one adolescent have received the inappropriate infant vaccine.
ITCH IN TONGUE AND BURNING SENSATION IN THROAT AFTER 4 EPISODES OF VOMITING.
Within a hour of receiving both sesonal and H1N1 injectable vaccines felt like lungs were on fire and difficulty breathing. Presented to ER and was given Epi and Benadryl. Received monitoring and IV fluids and discharged.
Leg pain. Went away after 2 weeks. Enough to keep me up at night.
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a Pfizer- sponsored program  received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID. The patient wanted to reschedule her appointment for the second dose, because she's been quarantined. The outcome of the event was unknown.  Information about lot/batch has been requested.
Chills, mild headache, muscle soreness, fatigue, malaise, pain at injection site, low grade fever (101 degrees), mostly lasting no more than 24 hours. Fatigue and pain at injection site lasted three days. Treated during first day only with aspirin and naproxin sodium.
Chills, joint and body aches, fever and migraine. Got the test on Friday and did not feel better until Tuesday morning.
Diarrhea; Abdominal Cramps; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal Cramps) and NAUSEA (Nausea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal Cramps) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal Cramps) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
10/5 Aching in arms. 10/6 Generalized weakness, muscle aches, fever, chills, rash. Went to the ED evening of 10/6 and subsequently admitted to the hospital 10/7.  Treatment IV fluids and steroids.
Positive COVID-19 test on 7/20/2021, despite being full vaccinated.
Minor pain discomfort directly across the chest below breast/Discomfort after the last 3 doses; Minor pain discomfort directly across the chest below breast/Band of minor pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Minor pain discomfort directly across the chest below breast/Discomfort after the last 3 doses) and CHEST PAIN (Minor pain discomfort directly across the chest below breast/Band of minor pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Adhesive tape allergy, Benign prostatic hyperplasia and Blood pressure high. Concomitant products included TAMSULOSIN for Benign prostatic hyperplasia, VALSARTAN for Blood pressure high, VITAMINS NOS (DAILY VITAMINS), L-CITRULLINE, L-ARGININE [ARGININE], CUCURBITA PEPO SEED, SERENOA REPENS FRUIT, SITOSTEROL, ZINC OXIDE (PROSTATE PLUS), CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), PYCNOGENOL, CORDYCEPS SINENSIS (CORDYCEPS) and VITAMIN B3 for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced CHEST DISCOMFORT (Minor pain discomfort directly across the chest below breast/Discomfort after the last 3 doses) and CHEST PAIN (Minor pain discomfort directly across the chest below breast/Band of minor pain). At the time of the report, CHEST DISCOMFORT (Minor pain discomfort directly across the chest below breast/Discomfort after the last 3 doses) and CHEST PAIN (Minor pain discomfort directly across the chest below breast/Band of minor pain) had not resolved.            It was reported that patient got symptoms about 2 days after the shot. Patient felt minor pain, discomfort 2 inches high straight across his chest and was more prominent on the right side. Pain was away from the side of heart, continued on a straight line across the chest and went directly under the heart side. Patient felt discomfort once in a while throughout the day but mostly felt it when he was cooking dinner. Patient told it took a day for an episode to start after vaccination and he could not remember how long they lasted for but patient was still experiencing. Patient had not gone to the doctor for labs or tests about myocarditis/pericarditis.  No treatment medication was reported.   This case was linked to MOD-2022-569121, MOD-2022-569123 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2022: Patient details, Reporter details, vaccine details, medical History and concomitant medications.
Administration error - 0.1mL administered. Patient was recalled and was administered 0.4mL on the same day.
elevated temp 101, rash occcurring 203hr p/vax;tx w/DPH as recommended by child's MD p/phone consult
pt has shortness of breath, palpitation and chest pain which began 1 day after Pfizer vaccine. symptoms are mild and fading but still present
Shortness of breath; flu like symptoms; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 45-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 19Apr2021 (age at vaccination was unknown) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included diagnosis of asthma as an adult in 2013 and has an Autoimmune condition, Sjogren's syndrome. Concomitant medications were not reported. The patient took first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date in Apr2021 (age at vaccination was 45 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The caller received both doses of the Pfizer vaccine in April. After the 2nd vaccine dose, 19Apr2021, she experienced flu like symptoms and on the 3rd day those symptoms resolved. The caller then developed SOB and went to the ED where tests were completed and she was discharged home. The caller followed up with a Pulmonologist. She was placed on various medications, including steroids and inhalers. Nothing has helped one month Later. The caller asked whether these symptoms had been reported by other people and whether there was more information about SOB lasting for weeks after the pfizer vaccine. The outcome of event flu like symptoms was resolved on 21Apr2021. The outcome of event shortness of breath was unknown.  Information about lot/batch has been requested.
7/10/09 Received vaccinations. 7/15/09 c/o aches/pains, dizziness, H/A bruise arm. No fever went to chiropractor 3 X after last 3 wks. 7/29/09 - Called our office with above complaints received eval by pcp ASAP.
Patient reported an allergic reaction (lower lip swelling) around 10:00pm last night. Patient took a dose of benadryl and swelling resolved. Patient did not report any other adverse or allergic reaction.
I developed a rash on my collarbone, between my breasts and all over my ribcage
15 months old received adult dose; 15 months old received adult dose; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 15-month-old female patient who received HAV (Havrix adult) (batch number J99R4, expiry date 20th May 2022) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 31-Mar-2022 Reporter's comments: Nurse Practitioner reported that 3 months old patient received a Havrix adult dose by error. Consent to follow up was reported. Additional Supportive Information: Three month old patient received adult dose of Havrix in error, which led to accidental overdose and adult product administered to child.
Subsequent to receiving first and second dose of varicella virus vaccine live laboratory evaluation revealed a lack of response. Pt received vaccination more than 3 months before becoming pregnant.
Quarter size Red circle surrounded by swollen area about 3 in. Over 12 days the red area grew to i compass the  3 in swollen area   The entire area was hot. With a hard darker red  area at injection site.  Probable infection diagnosed    Cephalexin prescribed.
Immediately after receiving ADACEL, pt reported numbness in the immunized arm around the injection site. Spoke to mom about 3 hrs later & arm no longer numb, just sore.
The patient received all 3 vaccinations at The hospital. We received a request from the to enter a VAERS for this patient who had the series repeated after it was interrupted by COVID-19 and monoclonal antibody treatment (Hospital).
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (puffy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027421A) for COVID-19 vaccination. Concomitant products included DESVENLAFAXINE SUCCINATE (PRISTIQ), STRESS B COMPLEX [AMINOBENZOIC ACID;ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CHOLINE BITARTRATE; CYANOCOBALAMIN; FOLIC ACID; INOSITOL; NICOTINIC ACID; PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;ROSA CANINA;THIAMINE MONONITRATE], CLONAZEPAM and APOAEQUORIN (PREVAGEN [APOAEQUORIN]) for an unknown indication. On 09-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 18-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (puffy). At the time of the report, PAIN IN EXTREMITY (arm was sore), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (puffy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Event outcome and treatment details were not reported.
VOMITING; SLEEPINESS; FEVER; NAUSEA; EXCESSIVELY TIRED; This spontaneous report received from a consumer concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type-2 diabetes, and thyroid issues. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included metformin for type-2 diabetes. On 20-MAY-2021, the subject experienced vomiting. On 20-MAY-2021, the subject experienced sleepiness. On 20-MAY-2021, the subject experienced fever. On 20-MAY-2021, the subject experienced nausea. On 20-MAY-2021, the subject experienced excessively tired. Treatment medications (dates unspecified) included: tramadol, and paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, nausea, vomiting, excessively tired, and sleepiness, and the outcome of sick was not reported. This report was non-serious.
Information has been received from a registered nurse concerning a 5 year old female who on 01-MAY-2003 was vaccinated with Varivax (Lot # 642991/0489M). On 25-JAN-2007 the patient developed chickenpox on her abdomen. Concomitant medication includes TYLENOL. The reporter did not know the exact number of lesions or if the patient had a fever. The patient had been exposed to a child with chickenpox at daycare. The patient is currently taking BENADRYL for itching. At the time of the report the patient was not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. additional information has been received from the registered nurse who stated that the mother of the child called on 25-JAN-2007 stating that the patient developed chickenpox. The patient was feeling itchy and so mother asked the medicine for that. The mother was recommended to give BENADRYL 1-1.5 tea spoon every 6 hours for itching. It was unknown about the patient's status. Additional information has been requested.
Four inch diameter red spot at injection site. Swelling of neck, arm, armpit, and torso on side of injection. Chills. These symptoms lasted four days. Headache: as of today the headache has not gone away. I talked to the pharmacist who told me to take Benadryl which I did. Ibuprofen and Tylenol for the headache.
Patient said it made her face go numb saying it started with her lips, then her nose, and spread from there; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A non-contactable female patient reported about herself of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9267), via an unspecified route of administration, on 26Feb2021, as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first CoVax on 26Feb2021. In 2021, patient said it made her face "go numb" saying it started with her lips, then her nose, and spread from there. Outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.