chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a red rash on my upper left arm where I had my vaccine; This is a spontaneous report from a contactable consumer (herself). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6203, Expiration Date: unknown) (at the age of 66-year-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included atorvastatin, calcium carbonate (CALTRATE 600), ubidecarenone (COQ-10) and Vitamins (unspecified) for unspecified indication. The patient reported that "she had a quick question, she got her first Pfizer Covid vaccine a week ago, Friday on the 26Feb2021 and (06Mar2021) yesterday, last night, she noticed that she had a red rash on my upper left arm where I had my vaccine. It didn't hurt, it didn't itch, it's red, little warm but that was day 8, (06Mar2021) yesterday was day 8." The patient stated that "she took her claritin and she put some hydrocortisone cream on it." The patient further reported, "Well she had one other question and she did not know if that's something you can answer or if the other people would answer. she got allergy injections (unspecified medications) every 3 weeks and she was supposed to get it last week, I get four of them, 2 in each arm and I did not get it last week because of getting the Covid vaccine. She wanted to wait. Now do you know how long you have to wait before you can get your allergy injections when you get these vaccines?" The outcome of the event was unknown   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a registered nurse via company representative regarding an unspecified patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with VAQTA dose 1 and after 2 months received dose 2 (inappropriate schedule of drug administration). No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. Additional information has been requested.
Loud Buzzing in left ear 10 days after vaccine.  Has lasted for 4 days.  Saw physician today and told it can last two weeks.
First time I gave her the HPV shot she fainted and had a small seizure for approx 5 sec. Today, I gave her the 2nd HPV shot, she was sitting this time, had a seizure for approx 5-8 sec, w/ no fainting and was aware this time of her surroundings.
Seizures; encephalopathy.  Nurse follow up on 07/08/04 states: "No new information."  Nurse follow up on 08/09/04 states: "no new information."
Information has been received from a nurse concerning herself who was vaccinated with a dose of Gardasil.  Subsequently the patient developed shingles with one lesion.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
It was reported that a pt (3 of 9) received a Tripedia vaccination the week of 3/23/01. Reportedly, sometime after the vaccination (date not specified), the pt developed a large local reaction at the injection site. From additional correspondence received on 5/16/01, additional pt, vaccine administrator and responsible physician information was provided.
Eyelids are swollen/ swollen eyelids; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 02Apr2021 at 15:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADD), asthma, depression, seizure, migraine and allergies. The patient had latex allergy and seasonal allergy. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the 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 vaccination. On 03Apr2021 at 06:00 the patient experienced swollen eyelids. She had seasonal allergies but have never experienced this with her seasonal allergies. The patient had the COVID-19 vaccine on Friday and woke up on Saturday morning with the swollen eyelids. The only other time she had experienced swollen eyelids is when she had an allergic reaction to latex. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if patient received any treatment for the event. The clinical outcome of the event eyelids was swollen was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
swelling at injection site after both vaccines; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at injection site after both vaccines) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at injection site after both vaccines). At the time of the report, VACCINATION SITE SWELLING (swelling at injection site after both vaccines) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   This case was linked to MOD-2021-067360 (Patient Link).
Probable flu with severe bronchitis started Thanksgiving Day 2022. Lasted 22 days. Unknown of related to covid shot.
Some time post vax, the pt experienced pain and paresthesias at the injection site. As of 9/6/00, the outcome was unknown. Additional information has been requested.  Follow up on 02/02/2001: "Concurrent medical conditions included allergic rhinitis.  Concurrent medications included immunotherapy (NOS).  The patient received an 'allergy shot' approximately one week prior to his last Lymerix injection.  On 04/23/1999 and 05/21/1999, the patient received his first and second Lymerix injections at dose 0.5cc's (respective lot numbers LY120F9 and LY123A9). He received his third Lymerix injection on 05/17/2000.  On 05/30/2000, the patient developed migrating paresthesias, noted as moderate.  He also experienced pain at the injection site.  The patient was not treated for the events.  Relevant laboratory tests included erythrocyte sedimentation rate of 5mm/minute, white blood cells 6.2mg/dl, hemoglobin 14.8mg/dl, platelets 198,000x1000/cu mm, mean corpuscular volume 91 fl, vitamin B12 714pg/ml, and folate >20ng/ml.  The physician felt the events were possibly reltated to Lymerix but also noted that the events may have been associated with immunotherapy.  Information received on 11/10/2000 reported that the events were ongoing.  The event of 'paresthesia' does not meet ICH serious criteria, but is being submitted as an expedited report by special request per the 06/28/2000 letter.  The initial section of this report was submitted  on 09/12/2000."
Missed periods (already 2 months) after vaccination; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration on an unknown date (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient had missed periods (already 2 months) after vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event missed periods (already 2 months) after vaccination was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient reports have bad muscle pain at deltoid after receiving 2 injections. Patient has requested FLUZONE and PNEUMOVAX on same arm so they were given 1 inch apart and appropriate techniques and policies were followed. Patient was observed for approximately 20 min after injections and reported no pain or adverse effect. Today almost one month later she came to pharmacy and reported arm pain not at joint but at muscle that makes it difficult to lift and is not helped by ice or oral pain medications she is currently taking. She was just seen by a doctor today but it was at a routine neurology appointment.
Mom states pt had shrill like cry that lasted for 3hrs; Mom states PMD was notified;
Fever of 102; Body aches; Headache; Weak; Tired; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was reported as none. The patient did not receive any concomitant medications. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the 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 vaccination. On 09Apr2021 at 00:00, the patient experienced fever of 102, body aches, headache, weak and tired. The events did not result in a visit to doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. The clinical outcome of the events fever, body aches, headache, weak and tired was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Broken out in a rash on the torso; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Broken out in a rash on the torso) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced RASH (Broken out in a rash on the torso). At the time of the report, RASH (Broken out in a rash on the torso) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment:Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Large area of erythema (5cm) and induration (3cm) left thigh following DTaP 4.
anxious, faint feeling. Observation, juice offered and symptoms improved. Patient discharged home.
Hives, shortness of breath, treated at emergency department with Epinehrine & steriods
Patient fully vaccinated with Pfizer. Second dose received 4/29/2021. Tested positive for COVID on 10/14/2021. Admitted to Hospital on 10/15/2021. Expired on 10/20/2021 while still hospitalized.
Information has been received from a registered nurse concerning a 63 year old male patient who on 9/12/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number 637094/0945K). The patient called the physician's office a day later because his arm was red. It was also reported that the patient developed an unduly injection site reaction described as very severe redness, swelling and hard lumps around the injection site. It was noted that this reaction persisted for several weeks. It was also reported that the lumps took several weeks to resolve. The patient never needed to go into the office for a visit and has since recovered. The nurse and a physician reported feeling strongly that the vial was contaminated. There were no cracks in the vial, the flip off cap was intact upon first use and the liquid remaining in the vial was clear. The office reported only using these three doses from the 5 dose vial. The reporter noted that they sent a sample for testing. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. It was also reported that two other patients were vaccinated with one dose of pneumococcal vaccine 23 polyvalent from the same lot (lot number 637094/0945K) and experienced similar events (WAES01104576 and WAES01113124). No further information is available.
she is "nervous" to take the second dose; pulsing in right ear; tinnitus in her right ear beginning 4-5 days post vaccination.tinnitus "gets worse" when she tries to sleep and has a "pulsing feeling; pain at injection site shooting pain to wrist; tender to touch; pain in her right arm lasting 8 days post injection; "shooting pain" down her entire arm post vaccine administration lasting 8 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TENDERNESS (tender to touch), PAIN IN EXTREMITY (pain in her right arm lasting 8 days post injection), PAIN ("shooting pain" down her entire arm post vaccine administration lasting 8 days), TINNITUS (tinnitus in her right ear beginning 4-5 days post vaccination.tinnitus "gets worse" when she tries to sleep and has a "pulsing feeling) and NERVOUSNESS (she is "nervous" to take the second dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027Az1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroiditis NOS. Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced TENDERNESS (tender to touch), PAIN IN EXTREMITY (pain in her right arm lasting 8 days post injection), PAIN ("shooting pain" down her entire arm post vaccine administration lasting 8 days) and VACCINATION SITE PAIN (pain at injection site shooting pain to wrist). On 30-Mar-2021, the patient experienced TINNITUS (tinnitus in her right ear beginning 4-5 days post vaccination.tinnitus "gets worse" when she tries to sleep and has a "pulsing feeling) and EAR DISCOMFORT (pulsing in right ear). On an unknown date, the patient experienced NERVOUSNESS (she is "nervous" to take the second dose). The patient was treated with Manual therapy (ice and heat on arm) for Vaccination site pain. On 03-Apr-2021, PAIN IN EXTREMITY (pain in her right arm lasting 8 days post injection) and PAIN ("shooting pain" down her entire arm post vaccine administration lasting 8 days) had resolved. At the time of the report, TENDERNESS (tender to touch), TINNITUS (tinnitus in her right ear beginning 4-5 days post vaccination.tinnitus "gets worse" when she tries to sleep and has a "pulsing feeling), EAR DISCOMFORT (pulsing in right ear) and VACCINATION SITE PAIN (pain at injection site shooting pain to wrist) had not resolved and NERVOUSNESS (she is "nervous" to take the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Tylenol Advil ENT visit   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Follow-up received included Reporters email ID, updated Concomitant medicines like Tylenol and Advil, Included some Adverse event and also treatment like Advil and ENT visit.
1. Severe Headache on day 2...lasting 3 days 2. Itchy raised rash on left forearm on day 2 after injection.  Still here on day 4 after injection.
Menstrual issues: excessive bleeding and cramps (more then ever experienced). Menstrual period lasted 3 days longer than typical. This has occurred in both cycles following the vaccine injection.
Patient developed itching, redness, warmth and induration in (R) deltoid region, approximately 1 hour after receiving the FLUBLOK vaccine. Symptoms have continued up to 48 hrs after receiving vaccine. She has taken ALLEGRA and BENADRYL with some help. Also C/O headache and nausea.
10/14/2008 11:10am shot in left arm. 11:50am discomfort in left arm. 1:00pm pain in lower back, tingling in hands and feet. 2:30pm symptoms increased intensity. 3:00pm went to doctor's office.  Vitals normal except for bp 170/67(?)  Doctor's diagnosis panic attack. Note:  I am husband and I received shot same time.  No problem.  My layman opinion is the panic attack was due to reaction to shot.  Her breathing was normal until we entered doctor's office.  6:00pm red rash appeared on upper left arm. The system would NOT let me submit without mfg info.  Help line told me to just pick one at random.
Pt got  dose of vaccine  Pfizer bionTech Lot # EL1283 with exp 10/22 and had an anaphylactic reaction with dizziness, tongue swelling and shortness of breath. Vaccine given in tent. Pt felt she was going to fall and was assisted down. She was diaphoretic and tongue swollen. Epi pen was administered. Pt with history of  sever allergic reaction as a child but has never used epi pen in adult life and sensitive to flu vaccine with eggs. Pt taken to ER.
expired dose of TENIVAC was inadvertently administered, with no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00375578) and transmitted to Sanofi on 30-Nov-2020.    This case involves a 37 years old male patient who received an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number U6101AA and expiry date 23-Oct-2020) via an Intramuscular route in an in the  Left Deltoid for prophylactic vaccination (Expired product administered).    The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.    This was an actual medication error case due to Expired vaccine used (latency same day) on 30-Nov-2020.    At the time of reporting, 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 holders 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.    There will be no information on the batch number for this case.
Information has been received from a pharmacist concerning a 61 year old female with diabetes and seasonal allergy who on 20-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) 0.65 ml by subcutaneous injection (lot number and injection site not reported). Concomitant therapy included insulin, unnamed thyroid medication and unnamed estrogens. On hour after the vaccination the patient called the reporter stating that her blood sugar was 400. This was tested on her home glucose monitor. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 08-JUL-2012, the patient was inoculated with the ZOSTAVAX, administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date later in 2012, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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.
CHIEF COMPLAINT:   Pt tested Covid+ yesterday. Only complaints are N/V. Pt was told to come here by PCP for antibody infusion. Pts heart rate at triage bouncing between 140-180's. Pt is 96% RA.   HISTORY OF PRESENT ILLNESS:     72 year old male with PMH of Diabetes, CAD (MI 2018 s/p quaduple bypass), s/p AVR 2018, HFrEF 35-40 (as of echo 7/2021) s/p ICD placement 2019, HTN, HLD, PVD. Presents to Hospital 11/13/21 with positive COVID test yesterday. Patient began feeling ill Monday 11/8. He has been vomiting since then, last vomited yesterday 11/11. Unable to report color or contents of vomit as his vision is impaired. He is vaccinated against covid x2. He presented to the hospital anticipating antibody infusion, however was found to have elevated HR in 140s-180s on triage. Patient reports mild headache, mild chest tightness in addition to nausea/vomiting, but otherwise no symptoms. He denies body aches, fever, chills, sob, abdominal pain, palpitations.