chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a noncontactable consumer (patient). A 38-year-old patient, of an unspecified gender, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Patient previously received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. After the first shot, patient experienced depression and brain fog (contributed to a car accident). On unspecified date, patient had lessened depression, then after he received second shot, depression and brain fog returned significantly worse. Anxiety also heightened. Patient still has large swelling at the injection site 3 days post-shot. Outcome of the events: not recovered. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up.
Fever, myalgia, headache, photophobia with in 12 hours of vaccine administration.
Symptoms: pain at the injection site, aching body, fever, feeling cold, feeling tired, and sensitive skin.   Time course: about three days.   Treatment: acetaminophen.   Outcome: I feel fine now.
I spoke with pt prior to injection today in the clinic: Pt had a reaction to potentially varicella vaccine as a child but not completely sure which vaccine...She was told she broke out in hives per mother but unsure. Discussed risks of getting vaccine and she should have done at a facility equipped for emergencies and pt verbalized understanding and wanted to move forward with vaccine. Pt tried to have vaccine done at clinic but was told they won?t give the vaccine to her. I told her I have Epi on standby and she would need to stay in the clinic for 30 minutes to watch for adverse reactions. Also counseled her on delayed reactions and being aware of her body and watching for reactions when she leaves the facility. If she does have a reaction after leaving clinic such as difficulty breathing/color changes to seek medical attention immediately and she verbalized understanding. Discussed not to have any other live vaccines or TB skin tests for the next month. She expressed she had not had any live vaccines or TB skin test in the last month either.  Pt had a possible reaction to varicella vaccine today. After about 10 minutes of observation, pt complained of lightheadedness and difficulty breathing. 1 dose of epi administered, and emergency services notified. Pt taken to ER by paramedics for further evaluation.
Upset stomach, mild fever, shivering. Mild swelling, redness and tenderness/pain at injection site.
a few weeks ago we both contracted the virus; a few weeks ago we both contracted the virus; This is a spontaneous report from a contactable consumer (reporter's wife) A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient a few weeks ago "we both contracted the virus" in 2021 with outcome of unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101426769 same reporter and event, different patient.
Immediately after immunizations, patient became nauseated, pale, diaphoretic and c/o being hot. Emesis. Small amount of clear phlegm. Cool cloth applied. Denies dizziness or light headedness. Mother in room Dr and H2O. Stayed x 20 min for evaluation with no further issues. Left facility without issues. Starting Hep B series over Dr dif negative titer.
Erythema at injection site approx. 5 cm in diameter per MD, painful and warm getting larger per pt. Prescribed clindamycin and BACTRIM for precaution, pt doing well and no other complications.
Patient reported he felt a sensation that traveled from his left arm to his neck. Denies shortness of breath, closing of throat, swelling tongue. No rash or hives noted. Initially 72/35, 68, O2 sat 97% and last reading 112/58, 63 and O2 saturatyon 99%. Patient drank 4 small bottles of water ( 8 oz each bottle). Patient tolerated well.  Patient was administered 20ml of childrens benadryl 50mg dose. Patient tolerated it well. Patient left approximately 25 minutes later with mother whom is a nurse and she decided to leave. Patient appeared in no distress and advised mother of patient if patient worsens go to urgent care.
Large red spot at injection site, paint, redness and warmth. Patient took Ibuprofen. Recommended icing and elevating arm and to take Tylenol or Ibuprofen for pain/swelling.
This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose). On 22-Jan-2022, ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Three patients received the booster dose of the Moderna vaccine instead of their full first dose of the Moderna vaccine. Patients received half dose from Lot no: 041J21A.
About 15 minutes after receiving the vaccine, teammate went to stand up  and got dizzy. Pt advised to sit back down and wait a bit. RN out to assess pt and again pt was ok sitting but upon standing noted wobbly and asked to sit back down. She did complain of dizziness at this time with some slight shortness of breath. BP noted in 120's with several checks, diastolic BP noted in 70's with heart rate noted 90-110 which per pt elevated HR normal for pt. At this time she did state that she was having some cardiac workup completed and just had  on that was removed on 23rd March. At this time pt was brought back to treatment floor for further evaluation with ambulation assistance by RN. Pt was placed on oxygen 2 liters. BP's remained normal in 120's and HR as well between 90-100. Each time pt felt ok and went to stand she became dizzy and noted wobbly thus asked to sit but BP's remained normal. Pt states she ate some cucumbers and another fruit prior to coming. Pt at 1230 up to restroom with noted vomiting. After vomiting pt stated she was feeling much better. BP noted  124/84 temp 98.1 with c/o of n/v but no other symptoms while in restroom. Left arm noted some patchy redness after pt was itching the arm. At this time pt was given Benadryl 25 mg 2 tablets PO. Continued to monitor pt for about 30 minutes with redness subsiding on her arm, while all vitals remained stable. At this time pt was eager to leave and head home. at 1300 BP noted at 119/73 HR at 100. All symptoms subsided and while pt was standing no wobbling noted. Dr. was phoned and notified of the event as he is the medical director. Pt was given RN number to call when she arrived home.
severe hip right hip and lower back pain; severe hip right hip and lower back pain; Chills; body aches; fever of 100.4; This is a spontaneous report from a contactable Other HCP (patient herself). A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, in left arm on 20Aug2021 17:30 (age at vaccination: 33-years) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Medical history included asthma, heart murmurs, prediabetes, high blood pressure, pcos, known allergies: Avocados, from an unspecified date and unknown if ongoing. Other medications the patient received within 2 weeks of vaccination was multivitamin, hydrochlorothiazide, metformin, which were concomitant medications, taken for unspecified indication, start and stop date not reported. On 21Aug2021 13:00, patient experienced chills, body aches, severe hip right hip and lower back pain, fever of 100.4. No treatment was received as a result of the adverse events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Device date was reported as 23Aug2021. The patient underwent lab test which included fever, with results: 100.4, on 21AUg2021. The outcome of event was recovering.   Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Cancer patient received half dose booster instead of 3rd full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Cancer patient received half dose booster instead of 3rd full dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Cancer.   On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Cancer patient received half dose booster instead of 3rd full dose). On 13-Dec-2021, ACCIDENTAL UNDERDOSE (Cancer patient received half dose booster instead of 3rd full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided. Reporter stated that this is not an error. Patient did not ask for the full dose at the time of vaccination.   Reporter did not allow further contact
had 1 poss febrile sz 2-3 days p/vax; seen by MD 12AUG93 for illness & reported above possible sz; pt is to have ped DT to complete immun;
Pt experienced generalized myalgia, fever (101.9) and frontal headache and generalized rash.
Patient reported warmness and redness around the injection site 2 days later. Patient described it as a few inches wide, but not itchy or too bothersome. Patient was instructed to: 1) If anaphylaxis occurs to call 911 2) If the reaction stayed the same, go to the doctor early next week. Patient went to the doctor the following week because no improvement was seen. Doctor assessed the area and saw improvement with the administration of Benadryl and diagnosed the patient with an allergic reaction. Patient called the pharmacy a few days later to update allergy list.
It was reported that immediately after vaccination the pt could taste the vaccine, had esophageal spasms and a burning and nasal sensation, no respiratory distress or anaphylaxis. These symptoms lasted about 1/2 hour. Pt took Benadryl and was also seen in the emergency room. Further information is requested.
lt upper arm swelling & redness involving whole area laterally & posteriorly; no vesicles; tenderness pos;
Swelling, rash/redness that covered half of his upper arm and the inside of his arm near the armpit.
Experienced headaches, chills and extreme fatigue approximately 9 hours after receiving the injection. The fatigue lasted approximately a day and a half. I was unable to perform normal daily activities due to the fatigue.
Light-headedness followed by eyes rolling back and passed out.  Later, feelings of weakness, insomnia, breathless during exercise.
Sudden onset of acute respiratory failure with hypoxia and hyperglycemia  Lungs filled with fluid, oxygen went down to low 80?s and coughing - could not breath.  911   Emergency to hospital.
Adverse reaction didn't begin until a full week after injection. First a knot appeared at the injection site with redness. Later in the day a rash appeared about 2 inches below the injection site. Rash is raised, red, hot to the touch, has a burning sensation, itchy, feels like a sunburn when touched. Rash doubled in size within 24 hours. Treated with diphenhydramine and ibuprofen. No change the next day -- present time.  Unknown if related to vaccine, but correlates with time period of adverse reaction development: Debilitating fatigue, worsened orthostatic intolerance, and a severe vasovagal episode.
Fever 101 degrees, nausea, fatigue, chills, no appetite.  Tylenol taken for fever.  Symptoms lasted for 48 hours with fatigue extending to 3rd day.
Information has been received from a medical assistant concerning a 20 year old female who on 31-OCT-2007 was vaccinated with PNEUMOVAX 23 (lot # 658451/0963U).  In approximately November 2007, the patient experienced an injection site reaction.  The patient was seen at the physician's office.  The patient had a 13 cm area of redness.  The injection site reaction was diagnosed as a bacterial infection.  The patient was treated with antibiotics.  At the time of reporting, the patient was recovering.  Additional information has been requested.
02/23/22 presents to ED for "shortness of breath". PMHx of "afib on ASA, CVA, HTN, pulmonary HTN, HFpEF (50% most recently), CAD s/p stents, COPD no home O2"
After receiving the flu vaccine patient fainted within 5 minutes and fell on the ground. Emergency service was called and patient was taken to the hospital.
Returned to office SOB, face swollen, nasal congestion, wheezing, HR = 98, B/P 100/48. Tx Orapred 30mg po stat. Xopenex 0.63 mg via neb stat, Rhinocort to both nostril - 911 for ambulance arrival. 20 minutes later - significant improvement noted and transported to ER - 1 hour observation - Benadryl and released.
No fever or aches after second dose, rashes start on 07/23 (Fri) evening  after second dose 07/21 (Wed). Rashes appeared on arms and thighs. Taken Zyrtec once in the morning and once at night. Went to Urgent Care on 07/26 (Mon) morning. Given PREDNISONE 10 mg oral tablet and TRIAMCINOLONE ACETONIDE 0.1% External Ointment. Rashes reappear on 08/13 after PREDNISONE had been completed. Went to PCP on 08/26 and was prescribed FAMOTIDINE 10 mg and TRIAMCINOLONE ACETONIDE 0.1% Cream.
Sunday, July 7, 2019 about 7:00 pm Left arm swelled all the way down to the wrist. Burning sensation in both wrists. About 9:00 pm Skin was hot and dry to the touch, but no fever. Nausea started around 9:00 pm, dry heaves and vomited once until about 2:30 am. Monday, July 8, did not go to work, was fatigued and nauseous most of the day. Tuesday, July 9, felt better, still a little nauseous and fatigued. Wednesday July 9, nausea returned in the evening, burning sensation in the wrists, skin was hot to the touch. Thursday July 10 feeling better for most of the day. Friday, July 11, was okay most of the day, but by evening had an upset stomach again and several very soft bowel movements in a 2 hour period. No nausea or other symptoms on Saturday or Sunday July 13 and 14.
Injection site pain for one week after vaccination Tiredness and Fatigue for one day after vaccination Nausea and Vomiting. Vomited 4 times over the course of 6 hours. Slept for 5 hours and felt better.  Swollen lymph nodes for 3 days after vaccination.
As I mentioned to the lady on the phone when she called. I am not so sure that this is directly related.  Right around January 5 of 2022, I began to have repeated but very intense series of vertigo and symptoms that appeared to mimic those of a minor stroke.  I was taken to the emergency room and was kept for observation due to the similarities of a minor stroke associated with my intense vertigo and loss of partial body control in some cases.  I continued to have repeated instances of sudden but very intense vertigo  for a few months at least having a case twice a week at varying levels of intensity.
This spontaneous report as received from a physician refers to a 20 month old (now 3 years old) male patient. The patient was intramuscularly vaccinated with 0.5 ml of MMR II (lot number unspecified) on 13-APR-2010. No other co-suspects or concomitant medications were reported. A couple of years after vaccination "within the last couple of weeks" approximately in July 2012, the patient had fever and facial swelling. The doctor further stated that immunoglobulin G (IGG) and immunoglobulin M (IGM) were drawn and that IGG came back negative. The patient had sought unspecified medical attention. Unspecified treatment was given. The outcome was unknown. Additional information has been requested.
Narrative:  COVID infections following completion of COVID vaccine series 02/20/21 COVID vaccine dose #1 03/15/2021 COVID vaccine dose #2 07/23/21 Pt reports cough, fatigue, runny nose, watery eyes, sore throat; COVID POSITIVE 07/24/21 Pt reports chills, headache, loss of taste/smell, muscle pain; rx given for acetaminophen, throat lozenge, DM/guaifenesin 07/25/21 Pt reports mild headache and continued symptoms; is stable 07/26/21 Pt reports nasal and chest congestion, fatigue, but is improving 07/27/21 Pt reports mild, infrequent productive cough, fatigue, mild chest congestion and shortness of breath 07/28/21 Pt reports shortness of breath with activity 07/30/21 Pt reports fatigue, loss of taste/smell, muscle pain, and improving cough 07/31/21 Pt reports fatigue, runny nose; met CDC guidelines for stopping isolation 08/03/21 Pt presents to annual visit reporting mild chest congestion, cough, but feels much better; rx given for DM/guiafenesin
First dose / in 2019 / second dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received on 13th November 2019, from batch number 49Y35 and expiry date 22nd October 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up. This is1 of the 2 cases reported, by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021134481:Same reporter. Patient 2 of 2.
This spontaneous report as received from a female consumer of unknown age reporting on herself. The patient was vaccinated with ZOSTAVAX (lot #, dose and route not reported) on 10-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced a temperature and rash at the injection site. No treatment information was reported. It was unknown if the patient sought medical attention. The outcome of experienced a temperature and rash at the injection site was unknown. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Armpit swelling; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 15:00 (Lot number: EWO173) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: SWELLING (non-serious) with onset 20Aug2021 15:00, outcome "unknown", described as "Armpit swelling". The event "armpit swelling" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling.  Additional information: Patient had no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient complained of shortness of breath, chest tightness and inability to breath. Patient was given benadryl IV, IV fluids and placed on monitors and then transferred to a higher level of care.  This all happened starting about 7-8 minutes after vaccination. Patient was tachycardic, hypertensive
Initial misuse report received from a healthcare professional on 09 August 2013. A child was administered only DTaP/IPV component of PENTACEL vaccine without ACTHIB component. No more information was provided. No adverse event was reported. List of documents held by sender: none.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical Information: No other medication in 2 weeks. It was reported that patient rebound Covid after taking Plaxovid.The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.