chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RN administered Pfizer 5-11 BV booster at 0927. Prior to administration, Mom reports patient fainted after first covid vaccine, but had received 2nd COVID dose and other vaccines since that incident and did not have another fainting episode. Mom and patient state they do not think she needs to lay down during administration. Patient remained seated for administration, received COVID booster in the R deltoid. Patient remain seated in same position post administration. She was well appearing and speaking encouraging words to her brother as he received his vaccines. Both patient and her brother were seated on the exam table. Mom was standing in front of both patients but had back turned to console brother. Approximately 3-4 minutes later, while Mom's back was turned to patient, Patient fell head first from her seated position, from the table onto the floor. Patient was initially unresponsive. RN called out for help to come to the room. Mom turned patient over. Patient was spontaneously breathing at this time. Patient's eyes were open but not focused. Patient stopped breathing, color change noted to face - eyes were wide open and fixed. RN called out for the code cart. RN was aggressively stimulating patient via sternal rub. Patient never lost pulse. Patient began to spontaneously breathe by the time code cart arrived.  Dr. at bedside with DINAMAP, BP cuff and pulse ox applied. Dr. came to bedside, patient's legs were raised. intimal BP was 124/ 68, HR 99, SPO2 was 98. BP cycled q2mins. Dr. called 911 at 0933. Dr. and RN sitting with patient on the floor. Blood noted in mouth, Dr. palpated mouth, no obvious injury noted at that time. Ice pack applied to patient's forehead. Patient began to slowly look around, moving only her eyes. She lowly started to answer questions - she knew she was at the doctors but could not remember event. She reported pain the her head. She appeared very dazed, staring straight ahead. Patient was pale and sweating. Paramedics arrived. orthostatic BP obtained. Patient slowly sat up independently, then was able to stand up with assistance. Patient was visibly swaying side to side. Patient walked with assistance to stretcher. Patient was taken to ED via ambulance with Mom. Family member came to pick up brother.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse concerning a male child, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 10-Mar-2010. On 17-Mar-2010, the patient received expired vaccine for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Normal symptoms of fever, body aches, and fatigue occurred the first 48 hours after vaccine was administered. Then and itchy, red, patchy rash appeared on patient's neck and spread over entire body over the course of several hours. The rash included patient's scalp, face, neck, thorax, abdomen, arms, legs, hands, and feet. The rash lasted approximately 48 hours. Benadryl and singulair were taken to help with symptoms. Patient ran a 100.7 degree fever for several hours about 24 hours after rash appeared.  Additional information: Patient did not have a rash after her 1st two Covid vaccines from Moderna. On difference was patient was on singulair daily when given 1st two vaccine doses & was not on singulair when 43rd dose was received.
Patient reported "golf ball sized" lump in arm at the injection site as well as redness, pain and warmth to the touch.
This spontaneous report as received from a nurse refers to an 12 years old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot #K004204, exp. date: 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
A nurse reported that a 43-year-old female had a decreased response to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The pt's medical history, concurrent conditions and concurrent medications were unknown. The pt received injections of Engerix-B on 06/30/1992, 07/30/1992 and 01/30/1993. On 01/29/2003, a hepatitis B titer measured less than 6. The reporting nurse considered the decreased therapeutic response to be possible related to Engerix-B administration. On 03/21/2003, the pt received her 4th injection of Engerix-B.
Pt states swelling and pain to left side of face, eye and ear started on 1/26/21 later in the evening then became itchy.  No prior history of reaction to vaccines. Patient saw her PCP and gave her Bactrim . NKDA and no history of cosmetic procedures.
Right arm red, warm, swollen and painful started evening of shot site worse next day, also nausea, Benadryl and Motrin recommended, Keflex 250 mg
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old patient who received SHINGRIX for prophylaxis. On 18th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, headache and joint pain. On an unknown date, the outcome of the influenza-like symptoms, fever, headache and joint pain were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, headache and joint pain to be related to SHINGRIX. Additional details were provided as follows: The patient wanted to know how long would flu like symptoms last.
I was experiencing serve pain , electrical shocks , twithcing and jerks throughout my body. My doctor recommended taking Advil and it was a stabbing shock in my ankle hooked up to a batter. The sensation lasted for 7hrs I went to the ER. I can not walk far distances without my joints or nerves being aggravated.
On 01/16/2019, pt presented to follow-up appt with heart failure clinical pharmacy specialist reporting increased swelling in left arm after receiving Hep B vaccine which he initially thought was related to fluid retention and his heart failure. Patient received Hep B vaccine on 12/17/2018 to left and right deltoids. He reports some fevers and chills around Christmas after injection in addition to left arm swelling that began 1 week after getting the Hep B vaccination. Per pt report, right arm had swelled up but only for 1 day whereas left arm continues to swell on daily basis. He states when he wakes up his left hand and arm is normal in size and as the day goes on it begins to swell but he denies numbness or tingling. Per nursing note dated 01/16/2019, "There is +2-3 swelling to his arm especially forearm. Radial pulse +2 able to feel the pulse. Capillary refill greater than 3 seconds and slightly cool to touch."
This is a spontaneous report from a Pfizer sponsored program from a contactable consumer reporting for him/herself. This patient of unknown age, gender and race/ethnicity received on 15Nov2015 a single dose of PREVNAR 13 for immunization. Concomitant medications and medical history were not reported. On an unspecified date the patient experienced double pneumonia for which was hospitalized in Aug2016. The patient commented that the vaccine did not work for him/her. Outcome was not reported.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced mild arm pain after dose 1 of SHINGRIX. The reporter did not consent to follow up.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a male patient of an unknown age 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 PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Initially when receiving the vaccination I was fatigued within a few hours and a very sore arm. After 24 hours I was super fatigued, had chills, and headache, and arm pain was so bad I could b as reply move it. I had a headache and very sore arm for the next 4-5 days. My symptoms subsided until almost 2 weeks later. The area of the injection became raised, hot, itchy, and sore again. It's now been 5 days out from symptom onset and the redness has spread to a large part of my upper arm. It is also still itchy and tender to the touch.
I felt very fatigued on 12/30/2020, and noticed my hearing was decreased by evening. I woke up on 12/31/2020, with total loss of hearing in my left ear and decreased hearing in my right ear.
Red rash on arm , started 9 days after injection . Started smaller , became larger . This is day 3  , arm is slightly swollen warm to the touch and red .
Reports sore throat, congestion on 10/29/09. Developed rash with itching from chest to toes on 10/31/09. To PCP-treated with prednisone x 6 days. Returned to PCP 11/09/09-rash returned-advised to take ZYRTEC.
Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021; vaccine administered past its 30-days expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 11:47 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 11:47 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that, vaccine was administered on 02-Apr-2022 at 11:47:25.  No treatment details were reported.
4/24/2021. Extensive bilateral pulmonary emboli with hypoxia:  Uncertain of the cause of the emboli.  Did have COVID-19 in January and also received his 1st COVID vaccine within the last week.  No recent surgeries in no recent travel.  CT chest PE protocol demonstrates extensive right more than left pulmonary emboli with evidence of right heart strain.  Small pulmonary infarct in the right posterior lower lobe.  Started on heparin drip with full bolus and will continue heparin drip per protocol.
patient stated she was not feeling well at the end of the day. patient had the chills. woke up in the middle of the night with 104 degree fever and went to urgent care.
Itching at the injection; Rash that is growing in size at the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection) and VACCINATION SITE RASH (Rash that is growing in size at the injection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     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 10-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection) and VACCINATION SITE RASH (Rash that is growing in size at the injection). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection) and VACCINATION SITE RASH (Rash that is growing in size at the injection) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
Pt was observed closing his eyes and becoming slightly lethargic approx. 5-10 min after receiving vaccine.  He removed in his chair and was evaluated.  Alert and oriented X3.  No trauma.  He stated that he "was afraid of needles and passed out".  Pulse 99. Resp rate 82. BP 130/80.  Responsive to commands.  able to follow finger with neuro assessment. He also stated that he had not had breakfast.  He was offered and accepted water and crackers.  He had planned to eat this morning but had food in his car.  Patient was observed for 30 more minutes and escorted to his car.  During this time, he called his wife to notify her that he was ok to drive home.  Pt released by his own measure @1:00 PM. Dx: Vasovagal response/Fainting
Started noticing some unsteadiness and lack of balance and that has been going on for at least four months - it may have started as soon as a month or may be two months after receiving the vaccine, I'm not completely sure. I have had headaches but that was after a fall when I hit my head. I started falling when I was in and didn't go to the doctor. I fell and hit my head on a cement floor - and broke me nose.  I did see the doctor after that and he said that I had had a concussion - that was my first fall that I had. The first fall was in May. The last fall was on August 24th and  I had second one on July 12th also - I miss judged my stairs in the dark and fell on head and neck. I went to the hospital ER - for the 2nd one. The doctors don't know the cause of my falls. I have seen the eye doctor yesterday and he said everything looked normal even though I had pain behind both of my eyes. I'm going to heart doctor end of this month. I am still having the unsteadiness and lack of balance at least once a day. I am still having the pain behind both of my eyes and I still have headaches.  No treatment at this time.
achiness; headache; fever; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (achiness), HEADACHE (headache) and PYREXIA (fever) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achiness), HEADACHE (headache) and PYREXIA (fever). At the time of the report, PAIN (achiness), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient stated that she had reactions like headache 1 hour after getting the vaccines and she would feel great and then it would come back. Patient also experienced the symptoms of normal fever and achiness. Patient worried about Covid-19 vaccination and opined that COVID-19 vaccine alters own body frequency and for those that have had Covid shots. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-744256 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2023: Live follow-up has been appended.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744256:Husband case
Swollen and painful left axillary and left supraclavicular lymph nodes along with headache, malaise, body/muscle aches and nausea. Seen by the NP on an already scheduled doctor visit.
injection site redness; injection site swelling; injection site itching; Injection site which is bruised; Nauseous; Headaches; Fatigue; Diarrhea; Rash on stomach, back , hip, and thigh; Slept for 3 days; Low grade fever; Delayed reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE BRUISING (Injection site which is bruised) and NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.   On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE BRUISING (Injection site which is bruised), NAUSEA (Nauseous), HEADACHE (Headaches), FATIGUE (Fatigue), DIARRHOEA (Diarrhea), RASH (Rash on stomach, back , hip, and thigh), SOMNOLENCE (Slept for 3 days), PYREXIA (Low grade fever) and SKIN REACTION (Delayed reaction).   The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) for Adverse event, at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE BRUISING (Injection site which is bruised), NAUSEA (Nauseous), HEADACHE (Headaches), FATIGUE (Fatigue), DIARRHOEA (Diarrhea), RASH (Rash on stomach, back , hip, and thigh), SOMNOLENCE (Slept for 3 days), PYREXIA (Low grade fever) and SKIN REACTION (Delayed reaction) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Negative. On an unknown date, Influenza: negative (Negative) Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Concomitant product use was not provided by the reporter.
Syncope immediately after administration of flu vaccine and GARDASIL vaccine. Observed in office x 1 and pt recovered.
Hives covering entire body that started 10/4/2022 around 5pm, I took benadryl 25mg PO Q6H around the clock but the hives progressively worsened until 0930 of 10/6/2022 when hives were now painfully itchy and on my face and around my ears and my tongue started to feel itchy so  I went to urgent care and got 10mg IM decadron injection and got prescription for 40mg PO prednisone x7 days and hives decreased around 1600 on 10/6/2022  but did not fully resolve until  10/12/2022.
red itchy hives all over body.  Mostly on back side; red itchy hives all over body.  Mostly on back side; red itchy hives all over body.  Mostly on back side; cold chills; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Feb2021 17:15 (at the age of 66-year-old) as a dose 2, single for COVID-19 immunization. The Medical history was not reported, and the concomitant medications were reported as no. The patient had known allergies to penicillin. The patient did not receive other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Feb2021 the patient experienced red, itchy, hives all over body mostly on back side and cold chills. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included treatment with antihistamine and CORTIZONE 10. The clinical outcomes of the events red, itchy, hives all over body and cold chills were not recovered at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information which included: Age at Vaccination update as 66 years, Start Date/Stop date' update as: 21-FEB-2021 17:15; 'Anatomical Location' select as: 'Arm Left', Narrative 'The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left (at the age of 65-year-old) as a single dose for COVID-19 immunization on an unknown date' deleted since not reported, 'Historical Vaccine' deleted.
102 fever chills body aches headache sleepy arm pain nausea  from 2/14/21 at 1 AM - fever broke at 4 PM, felt off the next day as well, but OK to work etc.
Shot administered on 12/10. Began as noticeable upper arm swelling on 12/12. On 12/13 the swelling continued and began seeing red splotchiness. On 12/14, swelling continued but redness had spread and looked like a sunburn. 12/15 bruising began on the interior of the left arm around the periphery of the redness and swelling. Swelling was also noted in the left arm pit. Pain only present with heavy pressure. Range of motion was intact.
PATIENT'S PARENT ADVISED TO PHARMACIST PATIENT HAD FAINTING/PASSING OUT SYMPTOMS IN PAST WITH AN HPV VACCINE. PHARMACIST HAD PATIENT REMAIN SITTING AFTER VACCINATION. WITHIN A COUPLE MINS, PATIENT'S MOM FLAGGED DOWN PHARMACIST, REPORTING EXTREME SWEATING, NAUSEA, TROUBLE SEEING. PHARMACIST CALLED 911 AND EMS ARRIVED WITHIN 10 MINUTES TO MONITOR VITALS. PATIENT WAS RELEASED FROM EMS CARE AND ABLE TO WALK/LEAVE PHARMACY WITHOUT AN ISSUE.
This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. On unspecified dates the patients received doses of improperly stored RECOMBIVAX HB (dose, route, lot number and expiry date were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.