chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rapid heart rate; Elevated blood pressure; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number; ER2613) via an unspecified route of administration on 27Mar2021 at 16:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included losartan potassium (MANUFACTURER UNKNOWN) from an unknown date and for an unknown indication. 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 27Mar2021 at 16:00, the patient experienced rapid heart rate and elevated blood pressure. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events rapid heart rate and elevated blood pressure was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Awoke with severe double vision, determined by E.R. Doctors to be a Transient Ischemic Attack
canker sore on side of tongue; sore arm; fever; muscle aches; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A 40-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in on an unknown date as single dose for COVID-19 immunization after which patient experienced sore arm for approximately 48 hours, fatigue lasting 4 days. On an unspecified date in 2021, after second dose patient experienced sore arm (for approximately 48 hours), fever and muscle aches (approximately 15 hours post vaccination continuing for about 24 hours) and experienced canker sore on side of tongue about 3 days post vaccination. Outcome for the events were unknown.   No follow-up attempts are needed. No further information is expected.
No additional AEs; The healthcare worker is reporting that unknown number of patients received improperly stored vaccines.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX ( x010534   4/11/2025); This spontaneous report was received from a health professional and referred to unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant therapies or drug reactions/allergies were not reported.  On an unknown date, the patients were vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X010534, expiration date: 11-APR-2025, lot #W022293, expiration date: 13-JUL-2024 administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided). Temperature excursion occurred and it showed 11.4 degree Fahrenheit for 1 hour (product storage error). No additional adverse events were reported (no adverse event).  This case is non-valid due to unidentifiable and unquantifiable patients.  Follow-up information has been received on 17-OCT-2023. The patient's identifiers were updated. On 10-SEP-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot# was reported as X012248, but upon internal validation indicated as an invalid number) administered subcutaneously (SQ) on the left thigh by a trained healthcare professional. The vaccine administered was stored in a freezer. The excursion was not reported until the following day until the staff noticed it.
Received the anthrax vaccine on 28 Nov 02 and 5 May 03 that contained squalene.  Developed numerous symptoms, resulting in the eventual diagnosis of Celiac Disease and currently experiencing other symptoms that have not been diagnosed.
Information has been received from a physician referring to a 38 year old female patient with asthma, rhinitis, allergic to penicillin, cefdinir, azithromycin and clarithromycin. On 14-APR-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, lot# K020215, expiration date 15-MAR-2016, due to "having low protective strept pneumo titers". Concomitant therapies included FLOVENT, azelastine hydrochloride, DYMISTA and ZYRTEC. On 16-APR-2015, the patient experienced "diffused" myalgia. On 17-APR-2015, the patient experienced shortness of breath. On 18-APR-2015 the patient experienced "possible" tongue swelling. No lab diagnostics studies were performed. The patient was seen by the physician on 20-APR-2015. The physician prescribed the patient a "5 day course" of prednisone and increased the patient's FLOVENT to an unspecified amount due to the shortness of breath. The outcome of the events was reported as recovering. Additional information has been requested.
Child received TIV on 11-10-2010 and 12-27-2010 and 1 week after each TIV was administered the child vomited 6 - 7 times. Was afebrile no other symptoms.  Lot # to TIV received on 12-27-10 was U3784AA, into right thigh, IM.
immediate burning painful feeling in arm, brief and mild; burning and numbness in the arm between the shoulder and her elbow; burning and numbness in the arm between the shoulder and her elbow; allergic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 16May2021 (Lot number: EN0185) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16May2021, outcome "recovered" (16May2021), described as "immediate burning painful feeling in arm, brief and mild"; HYPOAESTHESIA (non-serious), BURNING SENSATION (non-serious) all with onset 16May2021, outcome "recovered" (16May2021) and all described as "burning and numbness in the arm between the shoulder and her elbow"; HYPERSENSITIVITY (non-serious) with onset May2021, outcome "unknown", described as "allergic reaction". Therapeutic measures were not taken as a result of pain in extremity, hypoaesthesia, burning sensation.  Additional information:Caller received a callback from Colleague (Name withheld), INT #. Saying she had additional information for her. During transfer, Caller mentioned that her daughter received primary first and second dose in may and june of the Adult Pfizer covid 19vaccine. After the first dose, she experienced a bit of burning and numb sensation in the arm where she received the vaccin, between her shoulder and elbow, and for the next dose a month later, she experienced a much stronger, but similar sensation. It started immediately after the administration of the vaccin. 30 minutes after, when she got home, it got worse, and it got briefly to her head. It was frightening and she was crying. Her heart was pounding, then the burning sensation numbness came all through her arms, fingers and other parts of her body. 40 minutes after the dose it started to subside and patient wasn't taken to ER. weigts 109 pounds, heights 5. 6 Caller wanted to know if her 13 years old can take the booster. She also read that this kind of symptoms happen to people who react to ingredients of the vaccine. She wanted to talk to staff to receive the additional information she found on this questions. Potential EA duplicated. Transmitted to safety. No visit to Emergency Room and Physician Office. No Prior Vaccinations (within 4 weeks).
About 15 minutes after receiving vaccine, she got in her car and noticed a rash, started having light headed.  Thought she needed food, then got the headache and chills.  For the entire night she did have the cold chills.  She went to work the following day and her skin started feeling tingly.  By the time she got home on 2/3/21 she felt nauseous, had temp of 101.8.  The whole night she pretty much swim in sweat.  She went to work and was sent home due to the fever, nonstop sweating, and fatigue feeling like she was going to pass out.  Around 12:00 PM on 2/4/21 she couldn't keep anything down, she lost 5# since this vaccine.   She took an Ibuprofen 800 which didn't do much.  She took Pepto-Bismol, Advil and could not hold anything down.   The brain pounding headache that didn't want to go away yesterday.  She is still having a headache, she feels like every step she takes she has to use the restroom due to diarrhea episodes.  She has been at home trying to sleep through the symptoms and has not seen a doctor as when she called with her first vaccine reactions they did not have any information to tell her since the side effects are so new.  She only gets up today only when she has to use the restroom.  She has been in the bed since she went home on 2/3/21.
Tested positive for COVID; Nosebleed after the first dose; Severe pain in eyes, back, and neck; Severe pain in eyes, back, and neck; Severe pain in eyes, back, and neck; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot no: EL8299, Expiration date: 31Aug2021 or 31May2021), via an unspecified route of administration in left arm, on 05Feb2021 at 12:05 as single dose for COVID-19 immunization. Medical history included Hypertension, Nosebleed, Cardiac failure, Diabetes mellitus, Obesity, Heart trouble, Asthma, Cholesterol, Diabetes, places under tongue for heart and Blood pressure. Historical Vaccine included flu shot either 1994 or 1999, she cannot remember. Concomitant medication included Metoprolol for blood pressure, Isosorbide, Nitroglycerin for places under tongue for heart, Aspirin for Cholesterol, Metformin for diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 05Feb201, the patient experienced nosebleed. On 15Feb2021, the patient tested positive for Covid-19. In Feb2021, the patient experienced severe pain in eyes, back, and neck. The events did not result in a visit to emergency room. The outcome of the events COVID-19 and nosebleed was unknown whereas of other events it was not recovered.   No follow-up attempts are possible. No further information is expected.
After my first dose Moderna vaccine, I experienced soreness to my left arm. I also experienced diarrhea, abdominal cramps that came and went, low grade fever, chills and muscle aches and flu-like symptoms. I felt tired throughout the days and my left arm swelled up. I went to an urgent care facility and saw a doctor who prescribed medication. About one week later, my symptoms started to go away. Then after one week and a half, my left arm again swelled up and I could not lift my left arm up or carry anything heavy, it was also  tender to touch. Today I still have a minor cold  and stuffy nose that comes and goes and this has been happening since the vaccine.
Burning sensation on the right hand; Sudden rash on the right hand; Itching sensations on the right hand; This is a spontaneous report received from a contactable healthcare professional, the nurse. A 42-years-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot number: EP6955) via intramuscular route in left arm on 19Mar2021 at 11:45(at the age of 42 years) as single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. Medical history reported as none. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not received any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medication within two weeks prior to the vaccination. The patient experienced burning sensation on the right hand, sudden rash on the right hand, and itching sensations on the right hand on 20Mar2021 at 02:00. The events didn't resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events burning sensation, rash and pruritus was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Medical history captured as None in patient tab; patient age updated as 42 years old per source; facility name captured.Verbatim updated as "Since the vaccination, the patient had not been tested for COVID-19" in narrative.
12-03-07 patient came to health department 1:00 pm and complained of severe itching at site of injection.  5x5cm circular area of erythema present.  Advised it appeared to be norma reaction.  On 12-11-07 patient called health department and said the area had gotten larger, intense itching and burning and felt hot to touch.  Was given Keflex and stopped due to nausea.  Was then given Amoxicillin 500mg for 10 days.  Started improving in 2-3 days.  Totally normal now.
Rash from site of injection on left arm down to the elbow.  Raised rash.
Prickles all over, which developed into shooting pain. No rash. Lasted about 5 days. Continue to have discomfort in the area, serious discomfort for about an hour 2/10/2010, morning. Visit to urgent care, Benadryl.
Pt received MCV4. Bexsero and HPV9. 3-4 Minutes after vaccination pt stated she was feeling dizzy and proceeded to pass out.  Pt had LOC for about 5-10 seconds.  Dad and nurse supported patient in her chair until she regained consciousness and then was lowered down to the floor with feet up.  Pt stated she was feeling back to normal after just a few minutes.  Pt stayed in lying position for about 5 minutes and was given a juice box and alcohol pad to sniff.  After about 5 minutes patient slowly moved to the sitting position/ standing  Pt stayed in clinic for 20-25 minutes after incident and stated feeling completely normal before leaving with parent. No Nausea reports.
fever spiked (103.5), triggering seizure; This is a spontaneous report received from contactable healthcare professional from a representative.  An 8 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number: unknown) as second, single dose for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included BNT162B2 (dose 1, single), for Covid-19 immunization.  The following information was reported Febrile convulsion (non-serious), outcome unknown, triggering seizure. Relevant laboratory tests and procedures are available in the appropriate section.  After the second dose, the 8 year had fever spiked (103.5), triggering seizure. The patient was taken to a hospital.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Patient diagnosed with Sixth Cranial Palsy to the left eye. Blurred vision , double vision , tunnel vision ,light sensitivity, dizzy , in slammed , confusion .
Immediate and localized erythema and swelling at and around injection sites. Warm and firm to touch. Dr. notified at time of incident.  Benadryl given, which resulted in reduced redness and swelling approximately 15 minutes later.
Numbness and tingling in face ~45 min after shot, started with left side, then included mouth, went away after ~15 min, and came back off and on a few times over next few days; extremely swollen lymph node on left side, noticed ~45 min after shot, went away by next day; headache, minor aches in joints for 1 night
Information has been received from a pharmacist referring to an adult patient of unknown age and gender. There was no medical history or concurrent condition reported. On an unknown date the patient was vaccinated with an initial adult dose of VAQTA (1.0 ml, lot# and route were unknown). Then, on 27-OCT-2015, the patient inadvertently administered a pediatric dose of VAQTA (0.5 ml, lot# and route were unknown) (accidentally underdose). No concomitant medication was provided. No adverse effect was reported. Additional information has been requested.
Diarrhea 32 hours. Upset stomach 48 hours (including the 32 hours with diarrhea).
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
very nauseous; pain in underarm; hurt a little at injection site; This is a spontaneous report from a contactable Consumer(patient). A 68-year-old female received first dose of BNT162b2 (BNT162b2, solution for injection; Lot number: EL9263, Expiration date: Unknown), via unspecified route of administration in the left arm on 25Jan2021 (patient was 68-year-old at the time of vaccination), at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 25Jan2021, the patient experienced hurt a little at injection site. On 26Jan2021, the next day patient experienced very nauseous and had pain in her underarm. The patient still having pain under her underarm. She has been looking up information. She doesn't know if it is because it is in a lymph node or what. The arm pain she noticed 1-2 hours after the shot. It was just sore to the touch. She got the vaccine in her left arm. She got it to be able to see her grandchildren and start living again. Patient got the first shot on 25Jan2021. The Patient was heard that vaccine was supposed to be given 3 weeks later, but they got appointments for 4 weeks later. The outcome of the event injection site pain is recovered on 26Jan2021. The outcome of the event Nausea was Recovering, and Axillary pain was not recovered.   Follow-up attempts completed. No further information expected.
First day- dizziness, hot feeling, chest tightness, pain in right arm Days 2-4- dizziness, fever of 101, chest tightness, chest pressure, shortness of breath, heart palpitations, fatigue, elevated resting pulse Days 5-6- chest tightness, chest pressure, shortness of breath, heart palpitations, fatigue, Day 7- pain in my arm returned, arm was hot, less chest pressure and tightness, fatigue  Medicated with ibuprofen
July 22  1st dose No symptoms   July 25 Warmth in body. Slight congestion behind nose  July 26 Warmth  Tingling in arms, hands, feet and lower leg. Slight congestion behind nose  July 27-29 Warmth  More Tingling in arms, hands, feet and lower leg. Slight congestion behind nose  July 30 Warmth Most Tingling in arms, hands, feet and lower leg yet. Slight congestion behind nose  Throat felt like was closing. Sweaty palms. Breathing labored. I took a pulse aux 98% saturation 57bpm at the fire station around 845am  At bedtime my condition worsened again. Not as bad at morning. I ate a bar with peanut butter. Took Benadryl before bed.   July 31  Woke up feeling good. Not much tingling. But there. Light. Ate a perfect bar around 9am. Felt my tingles come back, light subtle tight throat. Did the first dose intensify an allergy?  Or create one?    1030am feeling better. Monitoring  1330 did a workout and the tingling/pins and needle feeling in my body worsened.
Later that day - blinding headache that lasted for 5 days, utter fatigue (3 days); nausea; joint pain, stiffness and aching (5 days); sore arm (unable to raise - 3 days, discomfort lasted 5-6 days). May 8 - Telephone appt with physician at 9:30am re - severe shortness of breath, ankles swollen, prolonged 'fluttering' in left leg from knee to ankle. Expressed concern re thrombosis and urge immediate visit to emergency or medical clinic. Phoned emergency number and attended by Nurse around 1130. Pulse very low ( 44) concern re angina, hypothyroidism, blood clots.  Saw DR on May 11 - (pulse 60). Follow-up visit May 27 - B12 level low, all other results normal.
Migraines, body aches, chills, no appetite swollen lymph nodes in neck, low grade fevers. Redness swelling of injection site as well as heat No treatment  given.
Following my 2nd dose of the Shingles vaccine (Shingrix), I initially experienced a mild reaction, including fatigue and low grade fever.  Late in the day two days after I received the vaccine, I felt considerably worse, reaching a high fever by that evening with severe stomach pain, nausea, vomiting/diarrhea.  For the next 4 days, my stomach pain was severe, but moved from my upper to lower GI area.  A low grade fever continued. Today, 7 days after the vaccine, I still have trouble eating, and I am more tired than usual, but it seems to be winding down.
A 10 year old patient was administered the flublok, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (MI) (Reference number- 00333645) and transmitted to Sanofi on 27-Oct-2020.   This case involves a 10 years old male patient who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2039, expiry date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination on 05-Oct-2020 (product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given that day.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Injection site pain. Severe chills, nausea, fatigue, muscle and joint pain, headache. Severe symptoms for 6 hours. Treated with rest, hydration, and acetaminophen. Prolonged fatigue and headache for 3 days.