chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BS shot! Was fine since the early 90's. Had to get one on 2019. I got the flu. Never again!; Initial information was received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown age and gender patient who had got flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in 2019, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, expiry date unknown) via unknown route in unknown administration site prophylactic vaccination. Information for batch was requested.  On an unknown date the patient had got the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Initial report received from a health care professional on 22 October 2013. The two patients whose age, gender, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number, expiry date, route and site of administration was unknown) on 21 October 2013. On 22 October 2013, the patient's complaints of a 3 inch red raised area at the injection site of FLUZONE ID. The outcome of the event was not resolved. List of documents held by sender: none
This is a spontaneous report from a contactable consumer (patient). A 20-year-old patient, of unspecified gender, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, lot# EN6201, expiry date: unknown), at vaccination age of 20, via unspecified route of administration, right arm, on Feb 9, 2021, at 17:00, single dose, for COVID-19 immunisation. Historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, lot# and expiry date: unknown), via unspecified route of administration, on unspecified date, single dose, for COVID-19 immunisation. Facility type vaccine was other. Medical history included peanut allergy, from an unspecified date and unknown if ongoing. Concomitant medications: none. There was no other vaccine in four weeks and no other medications in two weeks. On Feb 9, 2021, at 20:00, patient experienced rash over entire body. AE resulted in doctor or other healthcare professional office/clinic visit. AE treatment given: Benadryl. Patient did not have COVID-19 prior vaccination, and was not tested for COVID-19 post vaccination. The outcome of event: recovering. Follow-up (May 12, 2021): Follow-up attempts completed. No further information expected.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Rash Generalized-Mild, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Severe, Systemic: Weakness-Mild, Additional Details: Patient recieved vaccination. 15 minutes later patient stated she wanted to stay a little longer with a feeling of uneasiness and muscle trembling/shaking and feeling cold. 27 minutes later patient stated she felt a sudden tightness in her chest and a shortness of breathing. Patient requested to get an epi-pen injection due to the difficulty in breathing. Patient had epi-pen injected into left thigh at 4:46 pm .
pt recv vax 5JUN98 & 10JUN no sx;11JUN had itching, redness 2" diameter & swelling inc 1/2";had white spots where needle went in;no pus or  drainage;no rash;12JUN98 white spot no longer there redness & swelling down;
The patient was found unresponsive in shelter and reportedly had witnessed seizure activity.  He was intubated for altered mental status with hypercarbia and admitted to ICU.
I have developed active Crohns ileitis after 4 years of remission. GI symptoms (diarrhea, constipation, stomach pain) started approximately one month after the first vaccination.  At the time of vaccination I was not informed that "people with autoimmune conditions may receive a COVID-19 vaccine. However, they should be aware that no data are currently available on the safety of COVID-19 vaccines for people with autoimmune conditions." I do not think that is in line with informed consent care standards.
pt recvd vax; rash, swelling & erythema at site of inject;time course- uncertain but w/in 1 day of inject; tx dph, sent home; no sequalae;
Initial information received from a consumer on 21 September 2012. A 46-year-old male patient received IMOVAX Rabies (batch number: not reported) intramuscularly in the left arm on 05 September 2012. On 12 September 2012, the patient received next dose of IMOVAX rabies intramuscularly in the left arm (batch number: not reported). He had also received RABAVERT (other manufacturer vaccine, intramuscular in the left arm, batch number: not reported), Tetanus (other MFR, intramuscular in the right arm, Batch number: not reported), RIG (other MFR, intramuscular in the gluteus and arm, batch number not reported) on 29 August 2012. On 01 September 2012, the patient received second dose of RABAVERT intramuscularly in the right arm. Medical history included hypertension. Ongoing illness at the time of vaccination included bat bite on left side of the collarbone. Concomitant medications not reported. On 16 September 2012, after completion of post exposure series the patient had fever 99-101, decreased appetite, night sweats and general malaise. On an unspecified date WBC and lymphocytes were elevated and blood work was done. Treatment medications were not reported. At the time of this report, the events were continued. Documents held by sender: none.
Headache, nausea, dizziness, fever, muscle ache, chills, swelling of injection site, redness injection site, itching injection site.
After injection child began crying hysterically and saying the shot was burning her arm and then started hyperventilating. She then stated she could feel the medicine shooting through her body and that her legs wouldn't work. Pt insisted on leaving and walked to the car on her own.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 25-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Mother brought the child back to the clinic at 17:00 with a red rash (hives) that appeared on his face and neck. No respiratory distress; BBS-clear; BP 92/60; Temperature 98.2F (ax). City health officer notified; child to take Benadryl for the reaction. Mother is told this through a Spanish speaking interpreter.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Visual Changes/Disturbances-Medium
gastroparesis; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED GASTRIC EMPTYING (gastroparesis) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced IMPAIRED GASTRIC EMPTYING (gastroparesis) (seriousness criterion medically significant). At the time of the report, IMPAIRED GASTRIC EMPTYING (gastroparesis) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.     The patient received the initial booster dose of Moderna COVID-19 vaccine, Bivalent. It was reported that the patient had had Moderna COVID-19 Vaccine and had no previous history of gastric problems but ended up with Gastroparesis.  No treatment medications were reported.  Company comment This spontaneous case concerns an adult male patient with no medical history reported, especially no previous history of gastric problems, who received the initial booster dose of bivalent mRNA-1273.222 (BA.4/BA.5) vaccine and experienced the serious, medically significant, unexpected event of impaired gastric emptying, reported as gastroparesis. The events´ onset and the vaccination dates were not provided, thus, exact latency between vaccination and onset of the events could not be assessed. There is no further clinical information provided for medical review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) vaccine is not affected by this report.   Reporter did not allow further contact
After next day after receiving vacc. pt. got red rash and swelling in her arm. Went to Dr. visit and had to take BENADRYL for 3 days.
Left deltoid area presented with, edematous, warm to touch, erythema to the skin area.
Information has been received on 17-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 07-FEB-2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 19-JUN-2012, the patient was treated by a nurse practitioner at a physician's office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. The patient has been prescribed VALTREX, gabapentin and EMLA cream for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Extreme dizziness; nausea; headache; injection site reaction to include red, hot to touch, itchy welt; injection site reaction to include red, hot to touch, itchy welt; injection site reaction to include red, hot to touch, itchy welt; injection site reaction to include red, hot to touch, itchy welt; This is a spontaneous report from a non contactable other HCP. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular on right arm on 18Dec2020 15:30 at first single dose for covid-19 immunization. Medical history included Type II diabetes, migraines, solitary kidney status post (s/p) left nephrectomy in 2006. Concomitant medication included metformin, amitriptyline, propranolol. Known allergies included morphine, septra. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme dizziness, nausea, headache as well as injection site reaction to include red, hot to touch, itchy welt, all on 21Dec2020 05:00. The events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the events. Outcome of the events was recovered.  No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
12/06 8pm: Developed chills, fever, headache, muscle soreness, skin sensitivity, joint pain, and sweating which worsened overnight and into morning/early afternoon of 12/07. 12/07 1:15pm: Arms and legs began pins and needles tingling, progressed to numbness in all limbs, further progressed to intense muscle contractions and paralysis lasting 1hr.  Regained full control of limbs and hands by 3pm.
Headache & fatigue - 6pm (3 hours after vaccine)  Nausea, dizziness, body aches - 6am (15 hours after vaccine)
Booster 10/12 at about 3 pm.  Just had some arm soreness that evening.  She was restless going to sleep.  She woke up about 3 am with chills, diaphoresis, headache and tinnitus, and passed out--ended up on the floor.  She woke up at 0630 with nausea, dry heaves, watery diarrhea.  She felt "crappy:" the rest of the day with a "low grade headache".  She noted that there were things moved around in her bathroom and realized that she must have been disoriented during the middle of the night.  She has a scratch on her ankle and nose and a knot on her head.  She was able to shower later in the morning and didn't eat anything other than crackers yesterday due to nausea.  She had water.  She feels better today.  Not taking aspirin.
Itching hives welts red like a lobster almost immediately after I waited for the  30 mins and even told EMS they said it?s normal
Incidental finding. 5/28/21. EKG right bundle branch block.Normal sinus rhythm before Pfizer vacination FYI: 3 other friends (in 70's) have palpitations, one dx: paroxymal atrial fib.
Presented to Labor and delivery on 1/27/22. COVID positive on 1/16/22. gravida 4, para 2-0-1-2, She was  admitted to Labor and Delivery in latent labor with rupture of membranes,  which happened at home and she progressed to have a normal spontaneous vaginal  delivery of a live male infant weighing 8 pounds 3 ounces and the Apgars  given were 8 and 8 at 1 and 5 minutes.  She is being discharged home on  January 29, 2022 in stable condition.
headache, nausea, weakness, exhaustion, fever, chills, body aches, swollen lymph node in armpit of arm that received the injection.
The patient's mother stated 2 days after the first vaccine, patient began to have distortion of taste. She described it as things tasting like garbage or vomit (sour). She added protein tasted the worst. The patient was seen by her PCP, who diagnosed her with "parosmia." The patient has no other adverse effects but the bad taste when eating. The patient's mother did want her to receive the second dose, which she received today (2/19/2022). Today's vaccine appointment is when the mother notified us about the distorted taste.
Facial numbness/tingling; Facial numbness/tingling; This is a spontaneous report from a contactable other hcp (Patient).  A adult female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization.  Medical history included asthma, Known allergies: Sulphur drugs and adhesive sensitivity.  The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient experienced facial numbness/tingling on 16Dec2020 with outcome of recovered on unknown date. The patient did not receive any treatment. Information on Lot/Batch number has been requested.
As stated above. He was sick after every round of vaccines. He would get an upper respiratory infection. Ear infections, colicky, sensitivity to sounds, night terrors, he has been having severe tantrums and high pitch screaming since before he was 6 months old. He would either have constipation or explosive diarrhea. His stool is still not solid. He had reflux until he started eating solid foods. He will only eat carbohydrates now and fruit. He has repetitive behaviors, OCD, severe  behavioral tantrums and is  very defiant. After the vaccines on 10/20/2016 he no longer said words until after 2 years with help from natural remedies. He stopped listening to his name after the 10/20/2016 vaccinations. With the help of natural remedies he is now listening to his name. He still does not sleep through the night. He definitely has issues with attention. He has not played with toys like a normal child since 6 months old. He started flapping his hands around a yr old after the 1/20/2017 adverse reaction. The night of the event we heard loud high pitch screaming. He was inconsolable and having convulsions. He had a high fever over 104 that persisted for days. He then started banging his head in his crib. The head banging continued for 9 months when he would be frustrated or upset. After the adverse reaction on 1/20/2017, He came down with another severe upper respiratory infection, what seemed to be whooping cough and was sick until the week of March 26, 2017. I called his pediatricians office, to report the incident the following day. I was told by the nurse there was no way it was the vaccine. I did not return to their office.
Mild allergic response to vaccine (Tdap or Menactra) vs. early cellulitis.  Advised to monitor clinically and start cephalexin if symptoms worsen (increase in size or streaking of red area, fever, other)  Can use Tylenol or ibuprofen prn for pain.
HSV Keratitis; This case was reported by a other health professional via sales rep and described the occurrence of herpes simplex keratitis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 17 days 12 hrs after receiving Shingrix, the patient experienced herpes simplex keratitis (serious criteria GSK medically significant). On an unknown date, the outcome of the herpes simplex keratitis was unknown.   It was unknown if the reporter considered the herpes simplex keratitis to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient developed herpes simplex virus (HSV) keratitis in one eye with no trauma. The patient has seen ophthalmologist and was now in consultation with her primary care physician. No further details were provided.
Red hive around 2?x3? appeared on arm about a week after vaccination. Itching, mild soreness, pain under arm. Swelling is getting worse every day.
Patient reported lump in neck and burnt tongue feeling. States that she noticed symptoms about 4 days later after receiving the vaccine and today 3/30/21 still notices symptoms. Recommended patient contact primary care physician for further evaluation.
Received second dose of vaccine 5/13/21. Reportedly noticed bilateral lower extremity swelling Saturday 5/15/21, and mild to moderate chest pressure 5/17/21. Noticed swelling of the extremities worsening 5/22/21. Came to the emergency room for evaluation 5/24/21.
Problem with my stomach; Colour of my bowl now just like green grass it got me to smell like a cow; bowl is a hard it is no more a soft, it is less running; Bowel run like diarrhea; Colour of my bowl now just like green grass it got me to smell like a cow; bowl is a hard it is no more a soft, it is less running; Colour of my bowl now just like green grass; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 09:05 (Lot number: EP6955) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; ATORVASTATIN taken for blood cholesterol; METFORMIN; GABAPENTIN. Vaccination history included: Bnt162b2 (1st dose, Batch/lot number: FN6215, Anatomical injection: right arm injection, Time the Vaccination: 09:15), administration date: 04Mar2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: ABNORMAL FAECES (non-serious), FAECES HARD (non-serious) all with onset Apr2021, outcome "unknown" and all described as "Colour of my bowl now just like green grass it got me to smell like a cow; bowl is a hard it is no more a soft, it is less running"; FAECES DISCOLOURED (non-serious) with onset Apr2021, outcome "unknown", described as "Colour of my bowl now just like green grass"; ABDOMINAL DISCOMFORT (non-serious), outcome "not recovered", described as "Problem with my stomach"; DIARRHOEA (non-serious) with onset Apr2021, outcome "not recovered", described as "Bowel run like diarrhoea". The event "bowel run like diarrhoea" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of abnormal faeces, faeces discoloured, abdominal discomfort, faeces hard. Therapeutic measures were taken as a result of diarrhoea.  Additional Information: It was reported that History of all previous immunization with the Pfizer vaccine considered as suspect was reported was not reported. Family Medical History Relevant to AE(s) was not reported. The patient did not administer additional vaccines. The patient had no prior vaccinations (within 4 weeks) and no AE(s) following prior vaccinations. The foot got an Antigout. There was a burning in patient foot. The patient took some sugar pills to that Metformin. The patient had problem with stomach. It was not worsened but its same as every day, had this problem 3-4 times a day. The patient stated the second dose was received in his right arm as an injection on 25Mar2021. Patient stated he went to the doctor yesterday and his doctor told him to take Imodium for diarrhoea.  No follow-up attempts are possible. No further information is expected.