chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On March 3, 2021, a eligible vaccine recipient, patient, received her first dose of Pfizer Covid 19 vaccine at approximately 9:00am.  After a 15 minute observation period, patient was driving home at approximately 9:20am when she began to feel tingling and numbness in her mouth and tightening of the throat.  Patient returned to clinic and informed clinic staff she was having a reaction to the vaccine.  A cardiologist volunteering in the post-immunization observation met with the patient and evaluated her.  The cardiologist was informed by patient that she had a history of allergic reactions to vaccines and carries an EpiPen, but had not used it yet.  Patient's vitals were normal. She was given diphenhydramine for her symptoms, which did not improve.  The Emergency Department was consulted, who advised that patient should be transported to the ED and monitored for 4 hours.  The cardiologist transported patient to ED via wheelchair.  The following day, patient reported she was released from the ED after 4 hours of observation.  All of the symptoms had subsided at the time of release from the ED, and she was back to baseline on 3/4/21.    The patient was referred to an allergist for consultation and clearance prior to receiving a second dose of Pfizer vaccine. Also of note, upon review of the patient's vaccine consent form, she did not acknowledge that she had previous anaphylactic reactions to other vaccines, nor was this information relayed to the vaccinator who administered the vaccine.  Upon return to clinic, the patient reported she was 5-6 weeks pregnant.
3/14: fatigue and nausea 3/15: severe headache (alleviated with Tylenol) and fatigue/flu like symptoms
Vial of pediatric vaccine was not diluted before administration so a larger than recommended dose was given
Got Covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got Covid 19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced COVID-19 (Got Covid 19). At the time of the report, COVID-19 (Got Covid 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.  It was reported that patient had Covid 19 after on 09/21 and Covid 19 results were positive and then again on 09/05 patient second dosage was schedule for 09/11.  Patient still COVID Positive as of today.   Reporter did not allow further contact
Have had headaches and mild heart pains since getting the first shot 24 days ago. I have never had heart pains before this. Went to doctor today and had an abnormal EKG and awaiting other test results.
Info has been received from a health prof'l concerning a female school employee who was vax'd w/Hep B vax recombinant. Subsequently, 1.5 hrs later the PT experienced lightheadedness and pressure in her ears. Add'l info. has been requested.
I was vomiting from 1am-5am the night after vaccination; I had diarrhea, after every vomit; I would feel immediately better but then shook uncontrollably; Then I did not have any appetite for 3 or 4 days after; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 06Jul2021 at 14:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient previously took brompheniramine; pseudoephedrine (DIMETAPP) and doxycycline (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was vomiting from 01:00 to 05:00, the night after vaccination on 07Jul2021. The patient had diarrhea, after every vomit and would feel immediately better but then shook uncontrollably. Then she did not have any appetite for 3 or 4 days after. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events was vomiting from 01:00 to 05:00, the night after vaccination was resolved on 07Jul2021 at 05:00, while that of had diarrhea, after every vomit and would feel immediately better but then shook uncontrollably, then did not have any appetite for 3 or 4 days after was resolved on an unknown date in Jul2021.  No follow-up attempts are possible. No further information is expected.
prickly heat rash; itchy rash; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date in Mar2021 as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient asked if she should receive the 2nd dose if she had an itchy rash all over her body 8 days after the 1st dose on 11Mar2021. She had an extremely itchy rash all over her body. It came on suddenly. It occurred 8 days after the 1st dose. It looked exactly like a prickly heat rash. She called her doctor, but he said they have nothing to do with the vaccine declined to offer any management. She took diphenhydramine (BENADRYL) and used a DOMEBORO compress. The side effect did go away. This started the day before the present report in the afternoon (11Mar2021). It worsened throughout the night. The case was reported as non-serious. The outcome of the events was resolved.  No follow-up attempts are needed; information about lot/batch number cannot been obtained.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, since 03-NOV-2016, the patients were vaccinated with the improperly stored (above 8 degrees Celsius but below 25 degrees Celsius (9.7 degrees Celsius) for 32 hours and 30 minutes) doses of VAQTA (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse experiences and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA014195: US-009507513-1702USA004090: US-009507513-1702USA004088: US-009507513-1702USA004089.
This spontaneous report was received from a nurse and refers to an multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (dose, lot # and expiration date were not reported). Other improperly stored vaccination was PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 50.4 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Woke up with left side of mouth swollen significantly. Normal injection site, no heat, or swelling was observed. He was concerned that the vaccine did it. The only other thing he did per his report was mow the lawn. After 2 hours, he did state it seemed to be going down.
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 70 year-old male patient. On 06-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Information was received from the territory manager from Pfizer and was assigned manufacturer report number (W2015198854) for PREVNAR. This was originally reported by a consumer or non health professional concerning to a patient of unknown age and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unspecified date approximately in 2013, "two years ago" the patient was vaccinated with PNEUMOVAX 23 (route, anatomical location, lot# and expiration date were not reported). There was no concomitant therapy reported. On an unknown date, the patient experienced swelling and pain. The outcome of swelling and pain were unknown. The territory manager mentioned that an unspecified doctor wanted to know if PREVNAR could be given to the patient or not due to prior adverse events. Additional information is not expected because the reporter details were not provided.
PATIENT SAID RED AND SORE, REDNESS LARGER THAN EXPECTED, SWELLING.
Received a vaccine expire 10 days before the vaccination; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXAA1EZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 10th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received a dose of Bexsero, which was expired 10 days before the vaccination, which led to expired vaccine used. The reporter consented to follow up.
Pt. states that after receiving the 2nd dose of Moderna 03/13/2021, started experiencing symptoms 03/19/2021 of inside of the mouth blistered (2 weeks) treated by physician with "Canker sore Mouthwash" 1x day, achy muscles throughout forearms and shoulders lasting 3 months. No other side effects noted.
My right hand was itchy; raised bumps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "not recovered", described as "My right hand was itchy"; MASS (non-serious) with onset 2021, outcome "not recovered", described as "raised bumps". Therapeutic measures were not taken as a result of pruritus, mass.  Additional information: No covid prior vaccination and no covid tested post vaccination. There was other medical history. There was other medications in two weeks and no other vaccine in four weeks.  Follow-up attempts completed. No further information is expected.
Had shot had shingles/ suspected vaccination failure; Shingles; Burned; Itched; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shot had shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), burning sensation (Verbatim: Burned) and pruritus (Verbatim: Itched). The outcome of the vaccination failure was unknown and the outcome of the shingles, burning sensation and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, burning sensation and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-MAR-2023/ 27-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced shingles twice. The patient stated that the shingles were not as bad and did not blister it was just burned and itched. The patient stated that you can experience shingles more than once even after received Shingles vaccine years ago. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unspecified dates after 01-JUN-2015, the patients were vaccinated with doses of GARDASIL 9 (dose, frequency and lot# were not reported) which was improperly stored. No adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Several days of shortness of breath. Culminating in heart rate over 300 and a trip by ambulance to Hospital. Spent 4 days in ICU. Diagnosed with severe atrial flutter. Underwent cardio version to stop flutter. A month later underwent heart ablation.
Irreparable Damage/brain injury; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN INJURY (medically significant), outcome "not recovered", described as "Irreparable Damage/brain injury".   The lot number for bnt162b2 was not provided and will be requested during follow up.
03/21/22 presents to ED for "Abdominal pain". PMHx of "HTN"
Adverse reaction to Spikevax covid age12+ vaccine 12 hours after the shot had, fever, difficulty breathing, headache, chills, very sore arm, some palpitations.
Right hip pain (moderate); Fatigue (moderate); Chest tightness (mild); Left arm soreness (mild); This is a spontaneous report from a contactable nurse (patient). A 58-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration, administered in Arm Left on 04May2021 13:45 (Lot Number: EW0179) as DOSE 2, SINGLE (at the age of 58-year-old) for covid-19 immunisation. Medical history included Endometriosis, eczema. Known allergies reported as Mold, dust, seasonal allergies. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729) via an unspecified route of administration at left arm as dose 1, single on 13Apr2021 11:30 (at the age of 58-year-old) for covid-19 immunisation. Concomitant medication(s) included estradiol, norethisterone acetate (COMBIPATCH). No other vaccine in four weeks. The patient experienced fatigue, chest tightness, left arm soreness on 05May2021, right hip pain on 06May2021. No treatment received. No covid prior vaccination. No covid tested post vaccination. The outcome of the event for Fatigue was recovered on 10May2021, Chest tightness (mild) was recovered on 06May2021, Left arm soreness (mild) was recovered on 07May2021, Right hip pain (moderate) was recovered on 03Jun2021.  Follow-up attempts are completed. No further information is expected.
Autoimmune response involving all previous symptoms of PTLDS especially dizziness, multiple joint pain especially spine, shoulders and hands along with uncomfortable stomach pain and severe headache. Treatment -water, some pepto, and 2 ibuprofen.  Started previous evening with fatigue and hands, woke up around two AM  with tremors and cramping, all symotoms worsening to the mid afternoon. Unable to stand or walk with confidence or safely hold objects
Symptoms (auditory and visual hallucination, paranoid delusion) started on 8/8/21 (3 days after the date of vaccination). Parents brought her ED on Tuesday 9/7/21, where basic lab tests (CBC, CMP, UA, UTOX) were done and results were WNL. They did not do a COVID test or any imaging studies. Referred by the ED, the parents brought her to  us on Wednesday 9/8/21. Risperidone 0.5 mg QHS was started. Pt returned for follow-up today (Friday 9/10/21) and showed improvement. Plan: increase Risperidone to 1 mg QHS and return for follow-up on 9/17/21. also referred pt to PCP for further medical workup.
Fatigue; Arm sore where she got her first dose; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 64-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 (Lot number: EN6199) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Prediabetes" (ongoing); "Thyroid problem" (ongoing); "High blood pressure" (ongoing). Concomitant medications included: METFORMIN taken for glucose tolerance impaired (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); LOSARTAN taken for hypertension (ongoing); LOTENSIN [CAPTOPRIL] taken for hypertension (ongoing); TYLENOL taken for pyrexia, start date: 03Mar2021, stop date: 03Mar2021. Vaccination history included: Flu vaccine (She had flu shot before. On the first day, she had mild flu like symptoms but they went away the next day and she felt good. She got the flu vaccine last year, so it wasn't even close.), administration date: 2020, reaction: "Mild flu-like symptoms". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Arm sore where she got her first dose".  Additional Information: The patient received COVID-19 vaccine since she had prediabetes and wanted to make sure that she was covered because of underlying conditions. She made an appointment to see her doctor today at 1:00 PM (date unspecified). When she had her first dose, she did not have a lot of symptoms, just fatigue and her arm where she got the vaccine was very sore. She didn't take her medications the day of the vaccine and didn't eat anything either for both doses. She hydrated very much before. She checked with her primary doctor to see if it was advisable to take the vaccine and he said it was no problem. On the first day of the COVID vaccine, she took acetaminophen (TYLENOL) thinking in case she got a fever, she should take it then her daughter said taking it makes it less effective. She thought oh great, she didn't know that. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency room or physician office. The patient did not receive prior vaccinations within 4 weeks. The patient had no family medical history relevant to adverse events and had no relevant tests done.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335699 Same patient and drug; Different dose and events
administrated with engerix-b batch recall; administrated with engerix-b batch recall; This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:18-APR-2022 Reporter's comments: No patient's identifiers were provided.  The nurse reported that a patient was administrated with Engerix B batch recall for October.  The reporter had been on maternity leave and had just found out about it. No vaccination date was provided. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The nurse reported that a patient was administered with Engerix B batch recall, which led to recalled drug administered and drug dispensing error. The Vaccine Administration Facility is the same as primary reporter. This case is one of 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066344:Same reporter US-GLAXOSMITHKLINE-US2022AMR068023:Same reporter US-GLAXOSMITHKLINE-US2022AMR068022:Same reporter US-GLAXOSMITHKLINE-US2022AMR068026:Same reporter US-GLAXOSMITHKLINE-US2022AMR068024:Same reporter US-GLAXOSMITHKLINE-US2022AMR068025:Same reporter US-GLAXOSMITHKLINE-US2022AMR068021:Same reporter
pain in the injection site; joint pain in the hand of the same side; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as second dose, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) in Apr2021 for covid-19 immunisation and patient did not experience any reaction. The consumer reported that after the administration of the second dose she experienced pain in the injection site and joint pain in the hand of the same side on Mar2021. The consumer reported that she thinks of herself as a healthy patient. Seriousness of the events was reported as non-serious. The outcome of the events was unknown.   Follow-up attempts are needed; information about lot/batch number has been requested.
pt recv vax & 3mo later pt devel full blown chicken pox;MD reported 3 pt;