chrisvoncsefalvay/vaers-outcomes huggingface dataset:
18hrs after DTaP #4 and Hib #3 given, pt woke up from sleep in am crying.  W/in minutes, began retching and subsequently became listless and unresponsive, while maintaining spontaneous breathing. Duration was 15min, no seizure activity, + back arching, and + generalized pallor/grey appearance.  Self-resolved, w/ slow return to baseline activity level over several hours.
Extreme lower muscle weakness, retrospectively diagnosed as Guillain-Barre in 1/2011 (occurred approx 6wks after seasonal flu vaccine, 10-12-2010). I became aware on 2/26/11 when husband reported it to me.
Initial report received from nurse on 02 Dec 2009: The reporter stated that, this child who was younger than 4 years was given FLUVIRIN on 02 Dec 2009. No adverse event was reported.
2 days after receiving the vaccine my right great toe started hurting. I went to the doctor 10 days after symptoms first appeared, and he said it was inflamed but didn't understand the cause. He thinks possible tendon or nerve inflammation. He has started me on an NSAID but symptoms haven't improved
sore arm, mild fever for 3 days; today 3/19/21 woke up with large red raised bump on arm that's sore, spoke with pharmacist who advised its normal with moderna and to take ibuprofen and ice it
massive edema of entire arm & hand;vaccine given in arm of side where modified radical mastectomy preformed 18yr prior;
Fridge temp went out of range by 4 degrees overnight on Sunday due to storm. Vaccine was administered to patient
This non-valid spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient concurrent conditions, concomitant medications and medical history were not provided. On an unknown dates, the patient was vaccinated with improperly stored VARIVAX (lot# R002056, expiration date: 22-JAN-2020, lot# N034553 expiration date: 05-DEC-2019, lot# N031004, expiration date: 03-NOV-2019 and lot# N027000, expiration date: 28-SEP-2019) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT MRK) (lot# and expiration date were not reported). Dose and route of administration for all vaccines were not provided. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 9 Celsius degrees to 8 Celsius degrees for 5 hours 30 minutes. Data logger was involved. There were no previous excursions reported. No additional information has been provided. Follow up information was received from the certified medical assistant (C.M.A) on 28-SEP-2018. On 28-SEP-2018, a call was placed to the CMA. The CMA stated she would have her supervisor fax the requested patient identifiers and dates of vaccination.
No adverse effects; The patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date since 22-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R017768, expiration date: 21-JUN-2020 (dose, frequency and anatomical location were not provided), administered subcutaneously as prophylaxis. The vaccine underwent a temperature excursion from -9 Celsius degrees (°C) to 8°C (-7.4C) during a time frame of 55 minutes as recorded by digital data logger. No previous temperature excursion was reported as well as no adverse effects. The sterile diluent used to reconstitute the vaccine (lot # S000130, expiration date: 21-JUN-2020) was properly stored.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1905USA005506: US-009507513-1905USA005505: US-009507513-1905USA005504: US-009507513-1905USA005488: US-009507513-1905USA005503:
suspected vaccination failure; whooping cough; lose my breath; asthma; did not feel well; cough.; sick; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant), apnea (serious criteria GSK medically significant), asthma, sickness, malaise and cough. The patient was treated with anti-asthmatic (nos) (Asthma Medicines (Nos)). On an unknown date, the outcome of the vaccination failure, whooping cough, apnea and asthma were unknown and the outcome of the sickness and malaise were recovered/resolved and the outcome of the cough was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, whooping cough, apnea, asthma, sickness, malaise and cough to be related to Tdap Vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received TDAP vaccine in 2016. The patient experinced whooping cough two years ago from the day of reporting The patient had developed asthma after over whooping cough The patient had coughed every day for over two years The patient lose breath when talk a lot (which patient normally do not do). The patient waas sick for 5 months and I did not feel well until months after that. At the time of reporting felt better. The patient's pulmonologist upped the asthma medicine and still patient had cough.
Vague onset of malaise, fever, exertional dyspnea, chest pain that progressed approximately 1-2 weeks after the 2nd dose of the Pfizer vaccine. Led to development of pericardial effusion with cardiac tamponade physiology, atrial flutter, and subsegmental pulmonary embolism. Workup of other causes of pericardial effusion (e.g., infection, malignancy, autoimmune), and hypercoagulability were otherwise negative. 2nd dose of vaccine was on 1/4/2021 and pericardial effusion was diagnosed and evacuated on 2/14/2021. Patient hospitalized from 2/14/2021-2/17/2021. Patient is also healthcare provider.
patient reported getting very sick upon vaccination, that evening experienced vertigo, nausea, vomiting, fever greater than 101, worst headache of her life, her eyes became sensitive and her vision changed to the point she cannot read her cell phone.  She will she her eye doctor.  She is a nurse and mentioned reading about keratitis.
No adverse effects reported; One dose of improperly stored MMR II was inadvertently adminsitered to the one patient on 10/16/2019.; This spontaneous report was received from a medical assistant referring to 12-month-old patient. The patient medical history, concurrent conditions and concomitant medications were not reported.  On 16-OCT-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot #R028003 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and establish as 01-OCT-2020) (strength, dose, frequency and route of administration, were not provided).  The temperature of storage and time frame of the excursion were above 47°F (Fahrenheit) and 10 minutes. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect was reported.
Information had been received on 17-MAY-2017 from a field representative who was informed by a nurse, at a physician's office, that an 11 year old female patient was administered her second dose of GARDASIL 9 (lot# M035486, expiration 05-JUN-2019) intramuscular injection for prevention of HPV on 10-MAY-2017. On 10-MAY-2017, the patient experienced syncope. The nurse caught the patient as she fell forward. The patient recovered shortly thereafter. No further information available. Additional information has been requested.
Small raised bumps on the stomach, shoulder, back and the forearm; Scratching the bumps; Spontaneous report received on 17DEC2019.  A nurse reported that a female consumer had small raised bumps on the stomach, shoulder, back and the forearm (PT: Skin reaction) and she was scratching the bumps (PT: Pruritus), while being on oral Vivotif for typhoid fever prophylaxis. On 01DEC2019, the consumer started Vivotif and a week after completing Vivotif course she developed small raised bumps on the stomach, shoulder, back and the forearm. She started scratching the bumps that made it worse. She did not have such experience in the past. On 16DEC2019, she took one dose of Benadryl (diphenhydramine) for treatment that helped with itching and subsided some bumps. She did not eat new foods and not use any new detergent. Action taken with Vivotif with respect to the reported events was not applicable. She was recovering from the reported events at the time of report.  Medical history included eczema on her hands.  Allergy included reactions to vaccines where the reactions "were not visible but she could feel it in her body".  Company Comment: A consumer completed Vivotif course and after a week had had small raised bumps on the stomach, shoulder, back and the forearm (generalized skin reaction) with itching. The events were resolving with Benadryl treatment. Considering the potential of Vivotif to cause pruritus and skin reactions, the causality of both the events is assessed as possible with Vivotif.; Sender's Comments: A consumer completed Vivotif course and after a week had had small raised bumps on the stomach, shoulder, back and the forearm (generalized skin reaction) with itching. The events were resolving with Benadryl treatment. Considering the potential of Vivotif to cause pruritus and skin reactions, the causality of both the events is assessed as possible with Vivotif.
injection site swollen; injection site hard; swelling in lymph nodes in armpit; tenderness in armpit; feels bruised in armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling in lymph nodes in armpit), TENDERNESS (tenderness in armpit), CONTUSION (feels bruised in armpit), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE INDURATION (injection site hard) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced LYMPHADENOPATHY (swelling in lymph nodes in armpit), TENDERNESS (tenderness in armpit) and CONTUSION (feels bruised in armpit). On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE INDURATION (injection site hard). At the time of the report, LYMPHADENOPATHY (swelling in lymph nodes in armpit), TENDERNESS (tenderness in armpit), CONTUSION (feels bruised in armpit), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE INDURATION (injection site hard) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details were not reported.
4MAY t101, WBC7.0, lym 57; 6MAY t102, pale, grunting, hypotonia, poor eye contact; WBC 14.0, SEG51, BAND16, RSV neg; dx bronchialitis w/RUL atelectasis; hypotonia; Tx-meds, O2;
Pt's sxs started 01/01/2022 with SOB, cough and wheezing. Presented in ED 01/08/2022 with worsening SOB, cough and Chest Pain. Tested + for COVID 01/08/2022, and was admitted. Pt is fully vaccinated and received booster 11/03/2021.
23-month-old female inadvertently received expired Moderna (infant) at around 9:30 am 9/6/2022 for her 2nd dose. The vaccine vial expired 34 hours from the manufacturer recommendation date (expired 9/4/2022).
Headache, tired, lightheaded starting approx 24 hours after GARDASIL 9 administration.
Patient is 8 years old came with his parents to get the  Pfizer Pediatric COVID-19 vaccine, After administration, I asked them to have a seat for 15 minutes to monitor patient, after approximately 10 minutes, patient's parent came and said that their son doesn't feel good, he feels dizzy. Applied cold ice to patient hand and wrists, patient felt better and I asked the parents to stay for 30 minutes instead of 15 minutes. Patient felt better later and was okay to leave.
10 mins after vaccination pt tried to stand up from chair and fell. Upon questioning, pt mentioned she felt dizzy. We gave her orange juice. No allergic reaction. A few minutes later,  pt asked us to call ambulance. EMT arrived and checked vitals, everything normal. Still taken to hospital of pt choice.
PATIENT SAID THAT 4 DAYS LATER HE DEVELOPED A MILD RASH ON HIS RIGHT ARM, ALSO A MILD RASH ON THE RIGHT SIDE OF HIS TORSO. HE SAID IT BEGAN WITH BUMPS THAT MAY HAVE BEEN FLUID FILLED AND WAS A LITTLE ITCHY. HE SAID THAT HE WASN'T USING ANYTHING ON THE RASH BUT THAT IT WAS GETTING BETTER AS OF 8/4/17. HE COULD NOT CONFIRM IF THE RASH WAS OR WAS NOT FROM POISON IVY OR SOMETHING ELSE. HE ALSO SAID HE HADN'T SEEN THE DOCTOR AS OF YET BECAUSE IT WAS GETTING BETTER AND HE WANTED TO WAIT UNTIL MONDAY. IF IT WASN'T GONE BY THEN OR IF IT WAS GETTING WORSE HE WOULD CALL THE DR THEN.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX (batch number 4FS5N, expiry date 8th March 2021) for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, chills and localized erythema. On an unknown date, the outcome of the pain in arm, chills and localized erythema were recovered/resolved. It was unknown if the reporter considered the pain in arm, chills and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The patient reported chills, arm soreness, and significant localized redness expanding up to the shoulder. The symptoms resolved after a few days. This case was linked to the case US2018184659, reported by the same reporter for the different patient who also experienced same symptoms with the same lot number.
Information was received from a consumer on 26-Aug-2010. The male (initials and DOB unknown) was administered two doses of unspecified influenza vaccine (manufacturer unknown). Dates of administration are unknown. No adverse symptoms were reported. No further information is expected. Information was originally received to Merck & Co., Inc. (case# 1008USA03684). The company considered the event unassessable to the suspect drug influenza vaccine. Information derived from this AE report does not change the current safety profile of the product.
This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old female patient who received Influenza vaccine Quadrivalent unspecified season. Co-suspect products included ZOSTAVAX. The patient's past medical history included fibromyalgia, esophageal hernia, reflux esophagitis, esophageal dysphagia and esophageal stricture. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and ZOSTAVAX at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms, weakness, cough, fatigability generalized, polymyalgia and general body pain. On an unknown date, the outcome of the influenza-like symptoms, weakness, cough, fatigability generalized, polymyalgia and general body pain were unknown. It was unknown if the reporter considered the influenza-like symptoms, weakness, cough, fatigability generalized, polymyalgia and general body pain to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The reporter reported for a family member and had limited information as the patient was not under their care. The patient received flu vaccine a month ago and experienced flu like symptoms, severe general fatigue, generalized myalgia (aches all over, feels like flu), cough, weakness but no fever. All the events started several days after ZOSTAVAX (which was previously considered as shingles vaccine). HCP had a limited information as the patient was a family member and not a patient under their care. HCP was unsure of which flu vaccine the patient received and later clarified that the patient received ZOSTAVAX and not SHINGRIX at local pharmacy.
heart problems; extremely fatigued/ fatigued kept going and felt it even more during work out/ super exhausted/ feeling of exhaustion lasts throughout the day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "extremely fatigued/ fatigued kept going and felt it even more during work out/ super exhausted/ feeling of exhaustion lasts throughout the day"; CARDIAC DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "heart problems". The events "heart problems" and "extremely fatigued/ fatigued kept going and felt it even more during work out/ super exhausted/ feeling of exhaustion lasts throughout the day" required physician office visit.  Additional Information: It was reported that the patient would be requesting the doctor to be checked for heart problems. After receiving the vaccine, the patient felt extremely fatigued; the fatigue kept going and was felt even more when the patient worked out. The patient felt super exhausted when working out and that feeling of exhaustion lasted through out the day. The patient took the first dose on 01Mar2021 and went for the second dose on 23Mar2021. The patient asked the doctor questions regarding her symptoms and doctors dismissed them and said it was okay to get the 2nd dose. Patient has not received boosters.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound symptoms of COVID-19 and positive test 10 days after original positive test. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
UTI; weakness; neck pain; A spontaneous report was received  from a healthcare professional concerning an 85-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced UTI (urinary tract infection), weakness (asthenia) and neck pain.  The patient's medical history was not provided.  Concomitant medications were not reported.  On 26-Jan-2021, the patient received the second of two planned doses of mRNA-1273 (LOT/BATCH: 029K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 21-Feb-2021, the patient went to the hospital and was admitted for two days for UTI, weakness, and neck pain. Treatment for the events was not reported.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore action taken with the drug in response to the events is not applicable.   The outcome of the events, UTI, weakness and neck pain, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
(L) arm became hot and red, ice applied. Change in voice noted. Hives on chest. BENADRYL 50 mg IM given left arm, 0.5 mg. epinephrine given in (R) arm. EMS called and patient transported to hospital. Released from ER to home.
I feel really sleepy; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (I feel really sleepy) and FATIGUE (Tiredness) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (I feel really sleepy) and FATIGUE (Tiredness). At the time of the report, SOMNOLENCE (I feel really sleepy) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient informed us prior to vaccination that she is prone to fainting and this happens when she receives vaccine or gets blood draw.
Arm pain 12 hours after injection, serious skin reaction, acne-like lesions, burning, painful especially on left side. Not resolved yet.
COVID ARM. RASH, ITCHY, HOT TO TOUCH, SENISTIVE TO TOUCH. THE SYMPTOMS STARTED ON DAY 3. PATIENT HAS BEEN TAKING BENARYL. AS OF 08/17/2021 SHE STILL HAS SYMPTOMS BUT IT DOES SEEM TO BE IMPROVING.
Received the vaccine on 12/31/2020. Symptoms: -Soreness developed later on in the evening and remained very sore and tender for a couple days.  -A light headache occurred and went away within a few hours. - After 5 days on of having the vaccine on 1/05/2021 I developed a itching  sensation on my arm And developed a rash on my arm (deltoid) where the vaccine was administered. It is a square shaped rash on my left arm.