chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; dizziness; chills; headache; weird hallucinations; sore arm; felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, Lot unknown, second dose) intramuscular in left arm on 28Jan2021 at 09:15 (at the age of 40-years-old) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Past drug history included allergies: cefazolin sodium (ANCEF). Historical vaccine included BNT162B2 (Lot unknown, first dose) for COVID-19 vaccination on 05Jan2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had a sore arm and felt groggy on Thursday night (28Jan2021). The patient was feverish (highest temp was 100.4 F) with dizziness and chills and headache all day Friday, on 29Jan2021. On Friday night (29Jan2021) the patient had weird hallucinations (I hallucinated?, I guess, I was awake and talking to my husband and he said I seemed awake? but that my bed was breaking in half and sinking into the floor, and I kept telling him I couldn't breathe but he said I was breathing normally). No treatment was provided for the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache. The outcome of the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache was recovered on 31Jan2021. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The reported event hallucination was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Approximately thirteen hours after I received my second dose of the vaccine I started having cramping in my abdomen.  The cramping got increasingly worse and I started to get really bad chills.  The cramping feeling turned into a stabbing pain and reached a threshold that I could no longer stand so my husband had to drive me to the ER.  I have never been in so much pain.  Once it the ER I received medicine for the pain and a CT scan that revealed that I had appendicitis and needed to have it removed with an appendectomy.
This is a spontaneous report from a contactable consumer. A 65-year-old female patient received PREVNAR 13; (batch number unknown), via an unspecified route of administration on 15Nov2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had put ice on her arm because of site pain on 15Nov2018. The patient had a colonoscopy on an unspecified date. The outcome of the event was not recovered. Information on the batch number has been requested.
Pt experienced severe abdominal pain, nausea, vomiting, and fever, lasting for 7 days.
Brief (1-2 minutes) tonic seizures with almost immediate between to normal LOC. No fever "looked pale". Not preceded by tantrum.
Patient indicates that she had painful redness and swelling, lasting about 7 days, starting shortly after receiving the vaccination.
103.2 temperature, sharp body aches, headache, chills, extreme arm pain, swollen lymph nodes
This report was received from GlaxoSmithKline and was assigned manufacturer report number A0972370A for PEDIARIX, concerning a 18 weeks old female patient with no relevant medical history and no history of adverse events following previous vaccinations who on 30-MAR-2012, was vaccinated with a dose of ROTATEQ (lot #, dose and route not reported). Secondary suspect vaccines received on the same day included the second dose of PEDIARIX in the left thigh (lot # AC21B323AA, dose and route not reported). There was no other concomitant medication. It was reported that on 31-MAR-2012, 1 day after vaccination the patient experienced poor oral feeding, severe hypotonia (weakness) and weak crying. The physician reported that these symptoms appeared to be severe and the child's decreased tone was to the point that intubation was being considered to protect the child's airway. Tests and work-up for possible metabolic and neurological causes were being performed (results pending). It was reported that the patient was hospitalized in the intensive care unit. At the time of the report the patient's events persisted. The physician considered poor oral feeding, severe hypotonia (weakness) decreased tone, and weak crying to be disabling, immediately life-threatening and clinically significant (or requiring intervention). This was originally reported by a health physician. Additional information is not expected.
Fast pounding heartbeat for 12 hours, left leg calf felt tingly,  felt like someone was squeezing my throat briefly twice. That Went away within 2 minutes
Headaches, nausea, blurry vision, wheezing - started a stuffy nose.
Fever/ had 101 temperature; Sick all night; He did not feel good; This is a spontaneous report from a contactable consumer (patient wife) reported for her husband. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date, NDC number, UPC number were unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number and Expiry date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unknown date, the reported stated that she just had a question her husband got second shot yesterday and he had fever, sick all night, moving around and he did not feel good, he had 101 temperature on an unspecified date. The clinical outcome of events was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
12/15 vaccination  1/1 4:30 started having  tingling and numbness in face, L side. Felt 'off'. My left arm started to tingle and numb. Didn't last very long. Would come and go. Laid down. Ate some dinner; queasy.  1/2 Still felt 'off' 1/3 Symptoms occurred again with the numbness; face down to arm.  HR was high for resting; 130's. BP 200/100.  ED - CTA head/neck EKG, blood panel Symptoms resolved in ED; vitals normal 1/7 Neurology. Normal exam.  MRI of brain; normal.  Referral to cardiologist.  Echocardiogram; normal Heart Monitor - waiting on results  COVID - negative  *DR/MGR of vaccine clinic
weakness; fever; sorness at sight; aches; nausea; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 06Apr2021 (Lot number: EW0150) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Unknown Lung infection contracted 1995", start date: 1995 (ongoing), notes: Contracted in (state-withheld) on vacation while staying with family in (city-withheld) outside of (city-withheld) Apt. was over active butcher shop (100s of years old) next to post office, Dont know address, fever onset then congestion in lungs, Cough was very productive, sticky green sum, at one point cough produced so much started to chore and had to use sink edge to push diaphragm and push sum forward before black out. Was over a cup of sum in one cough. Brother found me passed out and could not wake me. He said my ups were blue. I think I was unconscious around 10 hours. After I recovered and went back to (state-withheld) doctor said air sacs were damaged but could not say what illness was. Every morning cough up infection ever since. Concomitant medication(s) included: LISINOPRIL; HCTZ; B12 [CYANOCOBALAMIN]; FOLIC ACID; POTASSIUM; MAGNESIUM; D3; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: PAIN (non-serious) with onset 07Apr2021, outcome "recovered", described as "aches"; NAUSEA (non-serious) with onset 07Apr2021, outcome "recovered", described as "nausea"; HEADACHE (non-serious) with onset 07Apr2021, outcome "recovered", described as "headache"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; PYREXIA (non-serious), outcome "unknown", described as "fever"; MYALGIA (non-serious), outcome "unknown", described as "sorness at sight". Therapeutic measures were not taken as a result of pain, nausea, headache.  No follow-up attempts are possible. No further information is expected.
headache; at wrist, 4 little bumps coming up/ inflammation of the tendons.; The injection site is very tender; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (at wrist, 4 little bumps coming up/ inflammation of the tendons.), INJECTION SITE PAIN (The injection site is very tender) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE PAIN (The injection site is very tender). On 23-Jan-2021, the patient experienced TENDONITIS (at wrist, 4 little bumps coming up/ inflammation of the tendons.). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Jan-2021, INJECTION SITE PAIN (The injection site is very tender) had resolved. At the time of the report, TENDONITIS (at wrist, 4 little bumps coming up/ inflammation of the tendons.) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included Cholesterol. Treatment details also included ice.
Beginning symptoms were extreme nausea, fatigue, headache, vomiting, diarrhea, body aches which lasted over a week.  Progressive health problems since including chronic headaches, fatigue and weakness, pityriasis rosea, digestive issues, joint pain, abdominal pain, depression.
Swelling (L) arm, at injection site 10 cm area of erythema, swollen face, dyspnea, wheezing - taken to ER - given BENADRYL then saw me 10/8/2010.
Father called to state that the child had cold symptons the day following her H1N1 vaccination and also had a "crick" in her neck.
hotness; soreness; bump on arm; redness; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hotness), PAIN IN EXTREMITY (soreness), VACCINATION SITE SWELLING (bump on arm), VACCINATION SITE ERYTHEMA (redness) and HEADACHE (mild headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hotness), PAIN IN EXTREMITY (soreness), VACCINATION SITE SWELLING (bump on arm), VACCINATION SITE ERYTHEMA (redness) and HEADACHE (mild headache). At the time of the report, VACCINATION SITE WARMTH (hotness), PAIN IN EXTREMITY (soreness), VACCINATION SITE SWELLING (bump on arm), VACCINATION SITE ERYTHEMA (redness) and HEADACHE (mild headache) had not resolved.      Action taken with mRNA-1273 in response to the events was not applicable      Treatment included ice No concomitant medications information was reported    This case was linked to MOD-2021-221254 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Updated contact information  Email
Information has been received from a pharmacist referring to a 60 year old male patient with insomnia, high blood pressure and high cholesterol. The patient has no pertinent medical history and no drug allergies. On 03-NOV-2015 the patient was vaccinated with ZOSTAVAX (lot # L028282, expiration date 28-OCT-2016, 0.65 ml, subcutaneous). Concomitant therapies included zolpidem, unspecified medication to reduce blood pressure and unspecified medication to lower cholesterol. On 10-NOV-2015 the patient had rash on both of his lower legs. On the same day, the patient came to the pharmacy to seek medical attention and the reporter stated that the rash "looked like scabbed over pustules". No lab diagnostics studies were performed and no treatment was given for the events. Outocme of the events was not recovered. Causality assessment was not reported. Aditional information has been requested.
Tinnitus after the 1st dose; Ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus after the 1st dose) and TINNITUS (Ringing in ears) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011a21a) for COVID-19 vaccination.     The patient's past medical history included Tinnitus (she has had it off and on over the last 8 years) since an unknown date.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus after the 1st dose) and TINNITUS (Ringing in ears). The patient was treated with CLONAZEPAM (KLONOPIN) for Anxiety, at an unspecified dose and frequency. At the time of the report, TINNITUS (Tinnitus after the 1st dose) and TINNITUS (Ringing in ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications are provided.
This spontaneous report was received from a medical assistant concerning an unspecified number of patients (demographics unknown). On unspecified dates since 29-JUN-2015, the patients were vaccinated with doses of improperly stored VAQTA (dose, route and lot# not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a certified medical assistant (also reported as healthcare worker) and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 21-MAR-2016 the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # L040413, expiration date 13-APR-2017, dose and route not specified). The vaccine was stored at 10 F for 45 minutes. No adverse events reported. This is one of several reports received from the same source. Additional information has been requested.
Increased pain left upper arm and shoulder with movement of arm. No redness or swelling. Patient thinks injection given too high.
Patient admitted to the hospital on 5/10/2021 with bilateral facial nerve palsies, followed by numbness and tingling of both arms and legs.  Symptoms starting to resolve.
4/9/14 Pt had stuffy nose from allergies in morning and otherwise felt fine. Had immunizations at 10 am. Felt fine until 5 pm when she felt tired and weak. Temp was 101 around 7 pm. Left arm throbbing and numbing at around 7 pm, resolved in 30 minutes. Fever peaked at 102.3 at 9 pm. Took Advil. Woke up at 2 a.m. with 102 temp and chills and took more Advil. 4/10/14 Temp 8:30 am  101. Took Advil 400 mg. Seen by MD at 9:30 am. Feels tired, slightly achy. Temp 102.4. Left arm sore to raise arm and to palpate but not painful at rest. WBC 13.9 with neutrophilia, no bands. Mild tenderness and induration for 3-4 cm around left deltoid injection site. Took Advil alternating with Tylenol at 2pm, 6 pm and at 12 midnight. 4/11/14 Temp reported by patient: 101.6 Took Tylenol. Left deltoid: 10 cm erythema and warmth, tenderness, no streaking. This is location of pneumococcal vaccine. Due to progression of erythema around injection site, and leukocytosis and continued fever, will treat for possibility of injection site infection. Start Keflex TID. 4/12/14  L upper arm with 8 x 7 cm area of induration deltoid area. 3 blotchy areas of redness over lower deltoid extending to 10 cm above elbow ( 8 x 5, 7 x 4 and 7 x 5 cm each). Entire area mod tender and mod warm to touch. 4 cm area of ecchymosis just distal to area of erythema. 4/15/14  Left arm discoloration has stopped advancing and started fading. No paresthesias or numbness.  Presumed cellulitis after pneumococcal vaccine vs severe immunologic reaction causing severe local and also systemic sx (fever, malaise, headache, nausea, leukocytosis). All sx resolving.
After I received the vaccine I felt fine for the first week.  However, I started to have post-menopausal bleeding within the second week after receiving the vaccine.  I had cramping, bloating, and bleeding.  I was shocked since I haven't had a period in about 20 months.  The bleeding lasted about a week and a half and has now ended.  I decided not to receive the second dose as I am afraid of any further bleeding.
8/26/04 mom called to report temp of 100.2 c/o severe abdominal pain which started around midnight. No N/V. Does have local soreness of injection site. Advised to call family physician as this pain is not associated with either vaccine. 8/27/04 client saw family Dr was told she had flu. Feeling much better today.
pt fainted post vaccination- caught by paramedic.  treated and monitored by paramedic.  BS 70, BP 99/40, HR 52.  given ginger ale and H20, assessed and monitored by  paramedic- helped to sit/stand- initially felt well then dizzy and helped to sit, HR dipped to 40s/50s after each time of sit/stand attempt-  pt was advised on benefit of further eval @ ER- he agreed and ambulance was called.
Information has been received from a Licensed practical nurse, via a company representative, concerning a 15 year old female patient. On 29-MAR-2013, the patient was vaccinated with the first dose of GARDASIL (dose, route and frequency were not reported) (lot # AE0131; Expiration date was not reported). On 13-SEP-2012, the patient received the second dose of GARDASIL (dose, route and frequency were not reported) (lot # AE0131; Expiration date was not reported), and on 29-MAR-2013, the patient received the third dose of GARDASIL (dose, route and frequency were not reported) (lot #: H015555; Expiration date was not reported). It was reported that in April 2013, shortly after receiving the third dose of GARDASIL, the patient experienced significantly abdominal pain and nausea. The patient sought medical attention through doctor's appointment, and it was determined that the patient would need to have her gallbladder removed. It was reported that surgery was planned at an unspecified time. Also it was reported that the patient discontinued GARDASIL therapy on 29-MAR-2013. It was also reported that the events did not cause significant disability or incapacity. In April 2013, the patient died. It was unknown if autopsy was performed. Cause of death was unknown. At the time of the report, the patient's outcome for abdominal pain, gallbladder disorder and nausea was unknown. Additional information has been requested.
Client was vaccinated at a community event.  Twenty minutes after receiving the vaccination she began complaining of chest pain and difficulty swallowing.  Her VS remained stable, however, she reported difficulty breathing and at that time emergency responders was called.  She remained alert and responsive for the 23 minutes between symptom onset and EMS arrival.  She was transported out of the facility.
PATIENT EXPERIENCED PAIN IN HER ARM THAT STARTED AFTER RECEIVING THE VACCINE AND CONTINUED. PATIENT WENT TO MD ON 10/12/23 AND WAS DIAGNOSED WITH BURSITIS.
COVID-19; coughing; Nausea; vomiting; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), COUGH (coughing), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concurrent medical conditions included Fatigue (Prior to the vaccination due to working a lot).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced COVID-19 (COVID-19), COUGH (coughing), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (headache). At the time of the report, COVID-19 (COVID-19), COUGH (coughing) and HEADACHE (headache) had not resolved and NAUSEA (Nausea) and VOMITING (vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
heart surgery; This serious case was reported by a pharmacist via call center representative and described the occurrence of cardiac operation in a male patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced cardiac operation (Verbatim: heart surgery) (serious criteria clinically significant/intervention required). The outcome of the cardiac operation was unknown.   It was unknown if the reporter considered the cardiac operation to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     It was unknown if the company considered the cardiac operation to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 8-Nov-2023 Pharmacist reported that a patient received 2 doses of Twinrix and had heart surgery sometime after that. Reporting out of obligation, most likely not related, the reporter had to get off phone and could not give any details when agent tried to collect them, mailing address of Pharmacy in health care professional's details.
moderna booster 0.25 ml administered to patient inadvertantly due to rph grabbing wrong tote, no symptoms within first 4 hours after administration, will follow up with family to monitor progress, physician notified shortly after occurence
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.