chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numb feeling from head all the way to nose; Headache; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration, injection in upper left arm, on 20Jan2021 at 10:45 at single dose for COVID-19 immunization; administered in a clinic, like the county clinic. The patient's medical history included ongoing over weight (stated she is 100 pounds over weight), ongoing slight heart disease, ongoing thyroid issue, ongoing blood pressure, and feeling like claustrophobic with the mask. The patient previously received swine flu shot in 1976 and experienced odd headache, and received flu shot two months ago (Nov2020). She mentioned that in 1976 she was in the military and had the Swine Flu Shot. The president made it mandatory they get it because they were afraid there was going to be an attack and they all had to get this vaccine. After getting this vaccine she had an odd headache. She also had a headache after getting the COVID 19 Vaccine, but it was not as bad. She had a little headache with the numbness after she got the COVID 19 Vaccine. While in the military when she got the Swine Flu shot they administered it with an air gun. She does not have any details to provide a lot/exp/NDC. They were just hurrying up to administer because afraid of possible biologic attack. She mentioned a lot of people have had bad reactions to the swine flu shot, but no additional details provided. Concomitant medication included metoprolol and ongoing lisinopril; both for blood pressure. There were no additional vaccines administered on same date of BNT162B2, and there were no prior vaccinations within 4 weeks. The patient experienced numb feeling from head all the way to nose on 20Jan2021 10:46, and headache on 20Jan2021. The patient called to report minor adverse reactions that occurred after getting the vaccine. She did not want her HCP contacted because she wants to ensure she gets the second shot. She clarified the reaction was odd. She had her face mask on when she got the shot. Normally she has the feeling like claustrophobic with the mask on which also occurred after she got the shot. After she got the vaccine, she also started to feel numb from her head all the way to her nose. It lasted 45 minutes. She started to feel this numb feeling 1 minute after getting the vaccine. She could tell something was not right. She thought at first it was the face mask, but after she took the mask off after waiting the 15 minutes under observation, she still had the numb feeling as it had not gone away yet. She could touch her face and could feel the numb feeling. The numb feeling was like getting a tooth filled, not that bad, but something like that. The outcome of the event numb feeling from head all the way to nose was recovered on 20Jan2021 at 11:31, and the outcome of the event headache was unknown. She mentioned she has some friends who have passed away from COVID and who were hospitalized from COVID. That is why she is so grateful for the vaccine and putting it out there.
heart rate 180+/min 2 wk; neurological, vertigo, dizziness;
Headache  Fiver(100 F) Pain in all body Shiver Sore throat Vertigo Nausea
Recipient reported having chills overnight and reported to work today with left arm to left flank soreness. She took Motrin
a few min p/vax pt c/o throat hurt & eyes itched;devel swelling around both eyes w/redness & itchy rash on inner aspect of both wrists;epi given SQ paramedic summoned & taken to ER;
Cellulitis left thigh. Fever, swollen/red at injection x 2d. Vomiting. c/o L left swollen, redness, warm to the touch. After receiving vaccinations on Friday.
Patient tested positive for COVID after first dose; Patient tested positive for COVID after first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number/expiration date unknown) via an unspecified route of administration on 22-Dec-2020 (19 days before 10-Jan-2021)  at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient tested positive for COVID after first dose. Reporter would like to know how he should proceed for second dose. The outcome of the events was unknown.   Information on lot/batch number has been requested.
Swelling on left side of Face; A Spontaneous report was received from a Consumer concerning 78 years old, female patient who experienced swelling of face.  The patient's medical history was not reported.   No Concomitant medicines were reported. Lab details were unknown.  On 02 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On unspecified date, the patient experienced swelling of face. Treatment for the event included: Zyrtec, Benadryl, and Nasal Spray Action taken with mRNA-1273 in response to the events unknown. The outcome of the event was reported as Not Recovered / Not Recovered. Consent was given for follow up from Safety.
Developed fever to over 106F, taken to ER and admitted. Workup completely negative. No prior reactions to vaccines. First time receiving flu vaccine.
It was my third dose the booster shot; I am having reactions to it. I am having seizures in my brain; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 61 years old, dose 3 intramuscular on 09Nov2021 12:00 (Batch/Lot Number: 30155BA) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history was not reported. Patient was not taking any medication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 Immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 Immunization on 04Mar2021 at age of 61 years old. Patient took the vaccine yesterday at 12 noon. It was her third dose the booster shot and she was having reactions to it. She was having seizures in her brain (09Nov2021) and she was currently at the ER. Anatomical site of vaccination was left. No treatment was received. The outcomes of events were unknown.   Follow-up attempts are completed. No further information is expected.
Developed rash on the 24th of March went to urgent care on 29th of March and was told it was shingles; This is a spontaneous report from a contactable consumer, the patient. An 88-year-old non-pregnant female received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 20Mar2021 at 12:15 (at the age of 88-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 27Feb2021 at 12:00 (at the age of 88-years-old), as a single dose for COVID-19 immunisation. The patient did not have any allergies to food, medications, or other products. Prior to 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 COVID vaccine. On 24Mar2021, the patient developed rash. On 29Mar2021, the patient went to urgent care and was told that it was shingles. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures included treatment with famciclovir (MANUFACTURER UNKNOWN) for the event of shingles. The clinical outcome of the event shingles was recovering at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Then after second dose had axillary and cervical nodes tender 10-14 days later and then recovered in 2-3 days; Lymphadenopathy; This is a spontaneous report received from contactable reporter(s) (Physician).  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 19Mar2021 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: FENOFIBRATE taken for hyperlipidaemia, start date: 2018 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular), administration date: 26Feb2021, when the patient was 52 years old, for COVID-19 immunisation, reaction(s): "Lymphadenopathy-Lymph node pain around left clavicle", "Lymphadenopathy-Lymph Node Pain/tenderness on right side- near the axilla, underneath the arm next to the chest", "arm pain", "Also reports joint stiffness around neck and shoulder". The following information was reported: TENDERNESS (non-serious), outcome "recovered", described as "Then after second dose had axillary and cervical nodes tender 10-14 days later and then recovered in 2-3 days"; LYMPHADENOPATHY (non-serious) with onset 19Mar2021, outcome "recovered" (2021), described as "Lymphadenopathy". The event "lymphadenopathy" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: It was reported that the patient provides information regarding the reported adverse event(s) with the use of the product and no Pfizer product had a causal effect to the adverse event. There was no Relevant Tests reported. No Prior Vaccinations (within 4 weeks). Vaccination facility type was reported as Hospital. No Vaccine Administered at Military Facility. Patient had axillary nodes tender after first dose after left arm but recovered. Then after Second dose had axillary and cervical nodes tender 10-14 days later and then recovered in in 2-3 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of throat swelling in a 56-year-old female patient who received ENGERIX B adult (batch number 9T25S, expiry date 3rd April 2020). Co-suspect products included HAVRIX (batch number 3PJ73, expiry date 27th February 2020). On 6th March 2018, the patient received the 1st dose of ENGERIX B adult (intramuscular) 1 ml and the 1st dose of HAVRIX (intramuscular) 1 m. On 6th March 2018, less than an hour after receiving ENGERIX B adult and HAVRIX, the patient experienced throat swelling and chest heaviness. The patient was treated with epinephrine. On an unknown date, the outcome of the throat swelling and chest heaviness were unknown. It was unknown if the reporter considered the throat swelling and chest heaviness to be related to ENGERIX B adult and HAVRIX. Additional information was received as follows: At 14:15, the patient received ENGERIX B in the left deltoid and HAVRIX in the right deltoid. Within 30 to 45 minutes of ENGERIX B and HAVRIX vaccination, the patient experienced throat swelling and chest heaviness. The patient was administered a dose of epinephrine and taken to the Emergency Room (ER). It was noted that the patient experienced immediate relief after receiving Epinephrine. Reporter was unable to provide any additional information. They had not received information at the reporting time as to the result of the patient's ER visit.
Pt received vaccine at 6:30pm. Patient felt pressure on her heart, fast heart rate (over 100) and dizziness when first reporting symptoms at 6:35pm. 6:59pm patients symptoms have reduced significantly. Pt was advised to lay down. BP 160 (high) at around 6:40. Heart rate at 70 at 6:55pm. BP was taken again at 7:03pm 130/80. Pt was advised to f/u with primary care.
Shot was placed into tendon in extreme upper arm.  Significant pain in shoulder and neck area ensued.  After separate visits to chiropractor, message therapist, and D.O. physician, most pain has subsided.
1.6 inch x 2.25 inch area of redness surrounding injection site on top of leg (RVL) that began at 9 pm on 04/08/2015. 4 cm area of redness on side of leg (RALT) that began at noon on 04/08/2015.
Patient was diagnosed with both acute pulmonary embolism and Left leg DVT on 12/6/2021 4 days after receiving Pfizer COVID booster. -CT chest had already been scheduled as routine followup for Hx Merkle cell tumor chest wall (in remission) and two right sided acute PEs found. -Pt also developed left leg swelling on that same day (12/6/2021) and DVT confirmed with venous US.
suspected GBS;2-3 days p/vax pt began exp numbness in arms & legs which then progressed over entire body including tongue & mouth;also had bifrontal h/a & pain which radiated up & down spine & legs;epigastric soreness;adm to ICU;
Patient reported chills, nasal congestion, lethargy and coughing starting 10/05/2011 and did not resolve within two weeks. Patient evaluated and appears to have viral illness. Patient has reported that she feels viral illness is related to vaccine.
Feeling of impending doom, pale, diaphoretic, shaky, lightheaded, red raised welts on face and right arm.  Burning sensation on right arm, and shortness of breath.  Also racing heart rate (tachycardic).
SHAKEN; UNABLE TO REST; HEART RACING; HEAVY HEAD; A LITTLE DIFFICULTY IN BREATHING; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced tiredness. On 19-MAR-2021, the subject experienced heart racing. On 19-MAR-2021, the subject experienced heavy head. On 19-MAR-2021, the subject experienced a little difficulty in breathing. On an unspecified date, the subject experienced shaken, and unable to rest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart racing, heavy head, tiredness, and a little difficulty in breathing, and the outcome of shaken and unable to rest was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Headache, muscle aches, sinus congestion, fever, chills. Headache and muscle aches began at 3 AM on March 23. Sinus congestion began at approximately 9 AM on March 23. Fever and chills began after 5 PM on March 23. All symptoms persisted until approximately 9 AM on March 25. Fully recovered by March 26.
Unable to get warm, severe aches in all muscles and joints, dry heaves (did not eat), headache worse than any migraine I?ve ever had, and an inability to maintain a standing position.  My brain felt like jelly.  This happened again on the two following days but has not come back since.
Pt had 3 shots on 09/14/2001 she developed papular rash around all 3 sites of injection with diffuse local swelling and redness. Advised Benadryl.
Subject in pneumococcal vaccine trial (not blinded) was hospitalized with a COPD exacerbation and had 2 seizures while in hospital. Vaccination took place on 9/19/07 and hospital admission was 10/7/07.  Relationship to study treatment is 'Unlikely'. We would be happy to forward the Study's SAE form upon request. Subject ID number is A100099.11/30/07-records received for DOS 10/7-10/11/07-SAE report  Presented to ED with COPD exacerbation, while in ED had a seizure. Admitted to MICU where second seizure occurred.  The SAE occurred approximately 1.5 weeks before the CO2 visit. Relationship to study vaccine unlikely.
02/23/23 I was sweeping snow and my head started hurting I called 911 because it did not feel right. I went unconscious and woke in ICU after several days. I was diagnosed with a brain aneurysm and spent an additional 2 weeks in ICU. I was discharged on 03/11/2023. And sent home with nimodipine, TYLENOL PRN, oxycodone (did not take) and a stool softener. I'm currently getting better day by day.
Initial case was received from a consumer on 09 October 2009. A 29-year-old female patient experienced muscle cramping, generalized weakness, fatigue, and malaise after receiving an intramuscular deltoid injection of FLUZONE (lot not reported) on 08 October 2009. The patient had a history of high blood pressure, and was taking DIOVAN 80mg concomitantly. Approximately seven hours post-vaccination, the patient experienced muscle cramps in both hamstring muscles when she attempted to exercise. She also complained of generalized weakness, fatigue, and malaise. At the time of the report, the events had not yet resolved. The patient reported that she received an influenza vaccine annually. Documents held by sender: None.
Nausea, blurry vision. BP 142/104 (pulse 82).
We had an employee get their 2nd booster on Friday and had a reaction. She stated the shot hurt very badly during administration which she had never experienced before. Then that night she had a raised knot appear at the injection site. She stated that the raised knot could be seen through a shirt and that it was very painful and had ?fever.? She took Tylenol throughout the weekend to help. Today I looked at it and the knot is gone but there is still a still a  red circular area where the injection was given and it is still warm to touch.
Rapid heart rate; Elevated blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "Rapid heart rate"; HYPERTENSION (non-serious), outcome "unknown", described as "Elevated blood pressure". Additional information- It was reported that My adult daughter received her 1st dose of the Pfizer Vaccine and the next day she began to develop a rapid heart rate elevated blood pressure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Constant throbbing above my left elbow on my arm. The pain has not stopped for days, and neither does the throbbing.
Dose injected 2 days after beyond use date. Moderna confirmed that the dose was still viable.
pt had 4-6 hrs p/vax prolonged screaming for days, 6 wks of fussiness, poor sleep, anorexia, cold sx, emesis & diarrhea;
This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 09 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Information has been received from a healthcare worker referring to an unspecified patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On an unknown date, the patient was administered with improperly stored VAQTA (lot # R017644, expiration date: 09-AUG-2019, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effect reported. The stored temperature was 32 -35 (33.6) Fahrenheit (F). The time frame was 220 minutes. There was no previous temperature excursion. The call was because of a data logger. The outcome of the events was unknown. The causality assessment was not provided by the reporter.
Chill, fever, insomnia, body aches, migraine, pain at site of injection, tiredness, auditory anomalies, swollen injection site
COVID-19; COVID-19; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for 28 patients. This is one of 28 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date. The reporter stated that 28 people from a certain University tested positive.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101237061 Same reporter/product/events, different patient
Started with the lower right leg and foot being itchy and red 7 days post vaccine. It then progressed to the right lower leg. After a few hours, the upper legs became red and itchy. It then affected my right arm, a little on my abdomen, and then the right elbow area. Benadryl, a cold shower, and icing the areas made the symptoms go away for several hours, but they returned over night at 3am.  Day 8, the symptoms were gone most of the day, but returned in the evening around 8pm. Benadryl taken and iced down the arms and legs.  Symptoms subsided.  They returned again at 3am and woke me from sleeping. It affected both feet, both legs, both arms, a little on my back and sides.
Started with a Cough around 8pm, progressed to Wheezing and tightness of chest. Patient used her QVAR inhaler to some relief and took Benadryl around 8:30pm and went to bed.  Morning of 8/31/2011 woke up with a little throat irritation persisting, but other than that she was fine.
10 minutes, post vax, the pt reported vision changes, weakness, shakiness but was coherent and oriented. He then became diaphoretic, pale and required assistance from local EMT's. He was transported to the local hospital and given fluids. He recovered.
pt recvd vax;rash started w/in 12 hrs of vax;hands & feet swollen,maculopapular rash from head down;
severe swelling rt deltoid <12hr p/vax;red fine bumps around the edges lasting 2-2 1/2days;
Severe body aches, fatigue, fever of 101.3  after given extra strength Tylenol
Hives rash just below armpits under each arm.  Areas were 2 inches square.
Mother called into the office two days after vaccine was administered and stated that the child's right thigh is red and that he is complaining of pain.