chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in November 2018, between 02-NOV-2018 and 16-NOV-2018, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) subcutaneously (dose was not provided, lot# R017945, expiration date 24-JUN-2020) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effect. The digital data logger was involved. The vaccine experienced temperature excursion between 15 degrees Fahrenheit to 46 degrees Fahrenheit (15.1 degrees Fahrenheit) for 1 hour. There were no previous temperature excursions. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1811USA009254: US-009507513-1811USA009255: US-009507513-1811USA009256: US-009507513-1811USA009257: US-009507513-1811USA009258:US-009507513-1811USA009260: US-009507513-1811USA009261: US-009507513-1811USA009142.
After vaccine was administered patient stated the he was feeling light headed/dizzy, so we told him to rest his head and put it down, got an ice pack, vitals, (bp, pulse, O2). Told him to follow up with his primary physician.
Elevated heart rate, heart rate spiked to 178 for no reason (just normal grocery shopping).  Heart rate while making a sandwich 111 (on apple watch) normal heart rate while warming up in spin class is 99, with heart rate max during spin climb of 170.  Was feeling very fatigued, bad headache and night sweats 24 hours after vaccine.  Elevated heart rate at approximately 48 hours post vaccine.
In August 2021 my heart started racing so I went to the ER and they diagnosed me with a-flutter and SVTs. I am getting surgery on my heart to stop the tachycardia.
pt recvd vax & exp a crusty area @ inj site a couple mm in area;sx persist;reporting MD was not sure which inj was involved;addl reporting MD does not think the sx are related to Engerix-B;is not sure of temporal relationship between sx
This is a spontaneous report from a contactable nurse, via a Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site, after the use of the product on an unspecified date. The patient was reported as ok but the outcome of the event pain at the injection site was unknown.
No Adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    Patient was over 18 years of age. No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 23 Jun 2023, 3 doses were administered at administration site 2. No treatment medication reported.   This case was for the 31st patient out of 47 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received contains Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case (Patient 1)
Patient misunderstood follow up instructions and thought he should come back for his second COVID Vaccine in 3 days, instead of 3 weeks. He received first dose 4/14/2021 and second dose 4/19/2021.
Achy; Difficulty walking; This is a spontaneous report from a contactable consumer (reported for her husband). A 89-years-old male patient received bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 09Feb2021 as dose 2, single for covid-19 immunisation. Medical history included Immunoglobulins from 01Feb2021 to 01Feb2021 and chronic inflammatory demyelinating polyradiculoneuropathy from Dec2020 to an unknown date (Diagnosed with CIDP (Chronic Inflammatory Demyelinating Polyneuropathy), Diagnosed in Dec2020). The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 19Jan2021as dose 1, single for covid-19 immunisation and experienced no adverse events. On an unspecified date, the consumer reported that the patient was achy and had sharp pain on his left surgical leg 6 inches above the knee to the top of his groin, he had increased pain with walking causing him to have difficulty walking. Reporter asks if there is any information on timing of the Covid vaccine and receiving IVIG treatments or with people who have CIDP, Reporter reports that she already spoke with her husband's Neurologist and the Nurse who instructed her to call Pfizer.  Follow-up attempts are completed. No further information is expected.
Fully vaccinated patient who admitted through ED after a fall.  Upon admission was noted to be COVID positive.  Provider d/c note:  "Patient with three days of generalized weakness leading to a Fall at home from which he could not get himself up and was found on the floor by his son.  He had reported that his right leg ""gave out"" and when evaluated in emergency department he was felt to be weak about right hip flexor so he was evaluated for a stroke. He has a history of ischemic multifocal multiple vascular territories stroke noted in 2016 and  In 2018 had 3 cm right frontal lobe hematoma.  Unclear if his right leg weakness is a residual from these events.  His CT head and computed tomography angiogram head/neck negative for acute findings.  An MRI brain was requested but patient declined.  He has been improving with physical therapy and the patient is going to have further subacute rehab at an extended care facility.    He was incidentally was found to have a COVID-19 virus infection (a caregiver had tested positive).  The patient has been vaccinated and has no new respiratory symptoms (has chronic cough) and chest film without findings consistent with viral pneumonia though some finding noted in upper lung on CT neck..  He did complete a course of REMDESIVIR and DECADRON.  He was able to be weaned down to room air. "
Chills, fevers up to 101 degrees Fahrenheit, severe myalgias, loss of appetite
Pt walked away fine. Made it about 3 aisles before collapsing to floor. Hit head and was bleeding. EMS came and went away in stretcher. Was conscience when rolled away.
Two days after receiving vaccine, patient started to develop cold symptoms and swelling in her face that got progressively worse throughout the day.
This morning patient presented to the site as part of screening. At time 1000, patient received immunizations for Anthrax and Influenza. After receiving both immunizations, patient remained in a vaccination chair. She complained of nausea. Suddenly, she lost consciousness, falling forward, striking her left forehead on the Floor. There was no obvious bleeding, or significant visible abnormality. Patient then quickly resumed consciousness, was able to engage with medical providers. Due to the apparent syncope (fainting) with subsequent head injury, emergency services were initiated, and patient was transported to the MC ER by ambulance for observation.   SPC MEEKS was accompanied in the ambulance by her Unit battle buddy SPC AIKENS.  A patient safety report is being completed at the CRDAMC Patient Safety Office.
45 min later after receiving the vaccine I felt a lump in my throat. No other symptoms of an allergic reaction.  Took benadryl with improvement of symptoms. Had intermittent difficulties swallowing seven hours afterwards. Went to the ED and was prescribed  prednisone/ pepcid/benadryl. Symptoms improved but next day felt intermittent difficulty swallowing again. Returned to the ED and was given IV solumedrol and, IV pepdcid,  IV benadryl.
Headaches; sweating; fever; nausea; tremors-chest and body; fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Jan2022 18:00 (Lot number: FL3198) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "Stroke" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Brain stenosis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: TRINTELLIX; LOSARTAN taken for blood pressure measurement; ROSUVASTATIN taken for blood cholesterol; ASPIRIN; LAMICTAL. Past drug history included: Fosamax, reaction(s): "Known allergies: Fosamax"; Lipitor, reaction(s): "Known allergies: Lipitor"; Atorvastatin, reaction(s): "Known allergies: Atorvastatin". Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Route of Administration: Intramuscular, lot number=331308A,, administration time=10:30 AM,), administration date: 17Dec2021, when the patient was 56 years old, for COVID-19 Immunization; Flu (other vaccine 4weeks product=Pfizer,, other vaccine 4weeks vaccine date=17Dec2021,, other vaccine 4weeks lot number=331308A,, other vaccine 4weeks dose number=1,), administration date: 17Dec2021, when the patient was 56 years old, for Immunization. The following information was reported: HEADACHE (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "Headaches"; HYPERHIDROSIS (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "sweating"; PYREXIA (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "fever"; NAUSEA (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "nausea"; TREMOR (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "tremors-chest and body"; FATIGUE (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "fatigue". The events "headaches", "sweating", "fever", "nausea", "tremors-chest and body" and "fatigue" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, hyperhidrosis, pyrexia, nausea, tremor, fatigue.  No follow-up attempts are possible. No further information is expected.
she got the second shot she told the nurse her pain has increased; This is a spontaneous report from a contactable consumer. This consumer reported for a female pa-tient (sister) that, a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspeci-fied route of administration on an unspecified date as a DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included, back pain from an unknown date and unknown if ongoing. It was reported that her sister started having a pain, she had pain before on her leg but with the first shot it intensified. Then it got mild so she though it was related to her back pain and whatever. They took care of the back but she's still having the front. The patient's concomitant medications were not re-ported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for covid-19 immunisation. Post dose 1 she started having a pain. It was reported that, the patient got the second shot she told the nurse her pain has increased on an unspecified date. Reporter stated she was calling regarding the Pfizer shot, the first one, the Covid 19 vaccine. During report 1 about herself this reporter reported information about her sister who she reported also had the Pfizer shot. Reporter mentioned that her sister had the Pfizer Shot and had side effects. She would have to ask her sister who started getting sick but that was to be expected and then got better the next day. She was the only one except for this one sister who she thought was having a side effect. Reporter was the only one having side effects within she would say 2 weeks. Her sister started having a pain, she had pain before on her leg but with the first shot it intensified. Then it got mild so she though it was related to her back pain and whatever. They took care of the back but she was still having the front. So then when she got the second shot she told the nurse her pain has increased and she said now it was getting pretty, she had been putting ice and stuff like that she got her shots really early, this was like months later. Therapeutic measures were taken as a result of the event. Outcome of the event was unknown.  Information about lot/batch number has been requested.
chills; headache; achy pain; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (chills), HEADACHE (headache) and PAIN (achy pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), HEADACHE (headache) and PAIN (achy pain). At the time of the report, CHILLS (chills), HEADACHE (headache) and PAIN (achy pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Although I am on birth control and have a very regular menstrual cycle because of it, I have started my period today. I received my vaccine yesterday. I still have two days of hormones before the placebo pills and normally wouldn?t get my period for another week
Unaware that patient was pregnant.  She was immunized with Menactra vaccine on 07-13-2006, patient began having heavy vaginal bleeding.  Patient denied being pregnant and/or recent sexual activity.  Bleeding continued and was advised to go to emergency room went to urgent care. Positive pregnant test, outcome was miscarriage of pregnancy.
itchy rash on her stomach and back; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles prior to vaccination).   In December 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In February 2022, between 1 and 3 months after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received dose of Shingrix on left arm and about a week ago from the date of reporting, the patient experienced an itchy rash on her stomach and back. The patient had shingles prior to getting the vaccine and stated that it appeared to be similar to what she experienced with shingles. The reporter did not consent to follow up.
Pain through injection site arm all the way into middle finger. End of finger started swelling and turning purple. Remained this way until the next day.
expired dose of Infanrix was administered; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number 9BC23, expiry date 30th January 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st January 2022, the patient received Infanrix .5 ml and Infanrix Pre-Filled Syringe Device. On 31st January 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an expired dose of Infanrix, which led to expired vaccine used. The reporter (reporting nurse) was not the person administering the vaccine. The reporter was notified of the event and called GlaxoSmithKline to ask about the dose validity and timing to repeat the dose, if needed. The reporter did not have any patient details at the time of the call. The reporter stated that there was no reaction following the administration of expired vaccine. The reporter consented to follow-up.
I took 1 does 500 mg tylenol preventively before vaccination. AE started ~7hours after injection (9:30PM) with chills, mild fatigue and muscle aches in the back. Took 1 dose 500mg Tylenol to mitigate, then another before going to bed around 11PM. Woke up  6 hours later (4AM, 14 hours after the injection) with intense back pain and strong shakes/ tremors (it was difficult to stand and get to the bathroom) and general feeling of elevated temperature (didn't measure temperature at the time). Took 2 doses of Tylenol (1g), symptoms improved within ~15 minutes enough to fall asleep.  Next day, fatigue and muscle pain persisted in the morning, took another Tylenol at 9AM preventively. However chills started again around noon (22 hours post injection) and quickly evolved in 101.7F fever and additional symptom of tactile pain on the skin mostly on the arms and back (even t-shirt fabric felt painful to the skin). Having maxxed the amount of Tylenol per 24 hour, switched to aspirin, but fever did not respond to aspirin. Muscle pain in the back responded to topical application of CBD/THC cream (2.5mg per mL THC brand "Kind"). Took Tylenol when out of the 24 hour window (around 5PM) and fever/pain rescinded quickly thereafter. Day 2 after injection (03/06) I developed a  red rash close to the injection site, not itchy but a bit painful to the touch. And a egg-sized inflammation in the arm pit on injection site (inflammed lymph node). Took 1 Tylenol 500mg and 1 Ibuprofen 200mg to reduce inflammation. No more fever or muscle ache, no more painful skin to the touch. Overall feeling much better
Started feeling sore joints, fatigue, chills, loss of appetite on 8/10/21 (Tuesday following shot on Fri, 8/6/21). NOTE: On day after shot, 8/7/21,  began weed-eating front yard.  Received sudden yellow jacket bee sting to bare chest, lower right quadrant just under rib cage at approx. 11AM.  Removed bee stinger.  Area became hot, swollen, painful.  Area is still tender to touch today, 8/25/21.  Patient feels this bee sting may be exacerbating lingering adverse events of sore joints, fatigue, chills, loss of appetite.  No cold compress applied to sting site following removal of stinger.
Xerostomia dry mouth noticed two days after first shot and has continued until present. On recommendation of tele doctor I went to the urgent care and they drew blood for testing and the results were negative for any systemic cause
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:  1905USA005488: 1905USA005505: 1905USA005504: 1905USA005507: 1905USA005503: