chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 09/10/2021, I was driving  late at night and I experienced this light sensitivity to headlights. Later, I experienced sharp pain to the center of my forehead, flashing lights in the left eye, headaches, ringing & fullness in the ears loss of balance, and had a feeling of impending doom. I felt foggy headed and I felt like I wasn't thinking clearly. There was pain and pressure in the base of my skull as well. I was prescribed migraine medication that was not effective. I've seen an ophthalmologist and an ENT. I have an appointment with a neurologist soon to do an MRI.
This case was reported by a health professional and described a 57 year old female subject who did not respond to immunization with hepatitis B vaccine recombinant Engerix B. Medical history included breast cancer, fatigue, muscle spasms, allergy to sulfa, and social alcohol use. Concurrent medications included tamoxifen to treat breast cancer, modafinil (Provigil) to treat fatigue and baclofen to treat muscle spasms. On 3/10/2004, 4/09/2004, and 09/10/2004, the subject received three doses of Engerix B (lot number not specified). Approximately eight months later, on 5/14/2005, a hepatitis B surface antibody titer was negative. On 6/03/2005, the subject received a booster dose of Engerix B (lot AHBVB005AA).
Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     Concurrent medical conditions included BP.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced SINUSITIS (Sinus infection). The patient was treated with AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICLAV) at an unspecified dose and frequency. At the time of the report, SINUSITIS (Sinus infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include three different BP medications.
This spontaneous report as received from a nurse refers to an unspecified number of patients. Demographic information was not provided. On 23-DEC-2013 the patients were vaccinated with a dose of RECOMBIVAX HB 10mcg/ml which had been exposed to -5 degrees Celsius for 20 minutes which was not supported. Route, dose and lot number not reported. No adverse effects were reported. This is 1 of 3 reports received from the same source (other case IDs 1312USA012120 and 1312USA012121. Additional information has been requested.
Approximately 6-7 hours post vaccination, eyelids on both eyes swelled up and became itchy. Swelling and itching persisted through the date of this report. Wore contact lenses every day for 6 years prior; unable to wear lenses post-vaccination. Purchased glasses as a result of this vaccination. So far, have attempted allergy eye drops, lubricant eye drops, and antibiotic eye drops to no avail.
This spontaneous report was received from a healthcare professional referring to an approximately 9 weeks old patient of unknown gender. Information about the patient's medical history or concurrent conditions were not reported. On 04-AUG-2015, the patient was vaccinated with hepatitis b vaccine (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided). Other suspect therapies included pneumococcal vaccine (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided) and ROTARIX, (dose, route of administration, lot#, expiration date and indication were not provided, all vaccinations administered on the same date. Concomitant medication was not reported. On an unknown date, in 2015, the patient experienced an adverse event, described as "vaccine adverse experience" At the time of reporting, the outcome of vaccine adverse experience was unknown. The causal relationship between the adverse event and the suspect therapies was not reported. Additional information has been requested.
Information has been received from a 49 year old female registered nurse with no known allergies and history of cataract surgery performed four years ago who on 28-OCT-2009 was administering MMR II (Lot No. 663798/0357Y) to a patient and the child moved and some of the solution splashed into the nurse's eye. The nurse flushed her eye with cool water. There was a little mucous present. Concomitant medication included SYNTHROID. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was not recovered. This is one of two reports received from the same source. No further information is available.
Next day noticed itching at site of vaccination. Mild tenderness, seen at clinic 3/27. 6X5 cm warm pink area surrounding 2.5 cm area darker pink + mild induration.
knot on her left arm where she had been getting the Pfizer Covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (ongoing); "Anemic" (ongoing), notes: she has always been anemic.; "Allergies" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension, start date: 06Oct2022 (ongoing); FERROUS SULFATE taken for anaemia, start date: 2022 (ongoing); FEXOFENADINE HYDROCHLORIDE taken for hypersensitivity (ongoing); FLUTICASONE PROPIONATE nasal taken for hypersensitivity (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EW0161, Anatomical location: Left arm), administration date: 15Apr2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "All of those doses were administered into her left arm. She noticed a knot on her left arm"; BNT162b2 (DOSE 2, SINGLE; Lot number: EW0167, Anatomical location; Left arm), administration date: 03May2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "All of those doses were administered into her left arm. She noticed a knot on her left arm". The following information was reported: VACCINATION SITE MASS (non-serious) with onset Nov2022, outcome "not recovered", described as "knot on her left arm where she had been getting the Pfizer Covid-19 vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site mass.  Additional information: Reporter thought he was concerned because she hadn't been to him in a minute. On 08Sep2022 when she saw him her blood pressure was high. He wanted her to go get a blood pressure reading, but she couldn't so then they just went up to 10mg of Amlodipine. She couldn't find nowhere because they shut the blood pressure cuffs down. She needs to get a blood pressure cuff for her home. Patient receiving concomitant medication One-A-Day Vitamin. All of those doses were administered into her left arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201309901 Same patient and drug, event separated in time;US-PFIZER INC-202201309902 Same patient and drug, event separated in time;US-PFIZER INC-202201309903 Same patient, different drug/event;
the patient was given 6 dose's of vaccine, the .3ml of undiluted vaccine was diluted in the syringe with .3ml of diluent and administered to the patient.
After vaccine the patient tried to stand up and passed out. 911 was called and an EPIPEN was administered to the patient. She recovered after the administration of the EPIPEN. The ambulance arrived and took the patient to the hospital.
Pt recvd 1st dose of vax w/no noted problem; pt recvd 2nd dose of vax 18AUG92 w/in an hr following the vax, pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs;
Swallowing dysfxn and annuciation difficulties, for 3-5 days post INFLUENZA vaccination.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 05-JUN-2013, the patient was vaccinated with a dose of VAQTA (lot # 0100AE, expiry date OCT-2014), with the same lot of improperly stored VAQTA. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Injection in left arm on Sunday, 3/28 - 4PM. By Tuesday, 3/30 - I stared feeling  unusually / more than normal tired. By Thursday, April 1, 2021, symptoms of headache, body aches, extreme tiredness where all I wanted to do is sleep, depression, a bit of nausea continued and by 4/1 I had to go home from work. My lower calves (both legs) and ankles and feet were swollen, throbbing and felt like there were pin pricks / tingly sensation in my legs. I stayed home from work on that Friday, April 2, slept and slept. I tried to do minimal tasks that exhausted me - like wash dishes. I took aspirin - drank a ton of water and had lay with both legs elevated. By Sunday I was fine.
This case was reported by a consumer and described the occurrence of adverse event in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporter stated that, he advised the person with the question. The patient had all the side effects.
Fever, chills, myalgias, dizziness, fatigue, loss of balance, Fall, sustained concussion
Swelling, redness, warm to touch, itchy. Low grade fever on 1st day, slight pain.
Pt vaccinated with Engerix-B developed diarrhea, dizziness, nausea, neck pain, weak, aches, cramping for 12 hrs.
That night I had severe body aches and muscle spasms and during the night developed tender/swollen LEFT axillary lymph nodes.  FYI: I've never had cosmetic fillers before. Tuesday during the day I felt feverish with chills (although had a normal temperature), worsening swelling to LEFT axillary lymph nodes, and night sweats. Wednesday, I continued to be achy, have tender/swollen lymph nodes and night sweats, and also developed petechiae on my face.   Today on Thursday, I developed cold sore on my lip.
When I woke up on 12/5/21 I noticed a rash on my forearm, tiny red dots. It wasn't itchy until later that day. The next Day I went to the doctor and by then the tiny red dot had changed to be red, swollen and very itchy like a sunburn. The doctor thought it was a stress hive and gave me prednisone. I would never have known it was Covid until I took a test later and tested positive for Covid. my husband had Covid. when i look back to the week of 12/6 it was a busy week at work, I did have extreme fatigue, brain fog, slightly elevated temperature (my temp usually runs low), but I thought it was from work. My nose might have been a little runny but that's not unusual because I work in an old building. Every day I felt disoriented and dizzy and extremely tired at the time. The itchy rash went away in about a week. Brain fog and fatigue went on for 2 weeks.
heart palpitations; shortness of breath; headaches; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (Patient) from a Pfizer sponsored program regulatory authority.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. It was reported by the patient that it has been over two weeks since his/her second dose of the Covid 19 vaccination and from an unspecified date he/she continued to have heart palpitations, headaches and fatigue as well as shortness of breath. Patient was concerned that these side effects are lasting so long and wanted advise. The outcome of all the events was not recovered.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Pain and a heavy feel to left arm.  A headache came on around 12 PM.  I am usually an energetic individual.  But around the same time as the headache, I felt fatigued and stayed home and rested.
Initial misuse report received from a healthcare professional on 09 OCTOBER 2014. A female patient had received a dose of FLUZONE QIV (batch number UT171AB, dose in series, route and site of vaccination not reported) on unspecified date. It was reported that the patient received a laceration on her thumb when plunger fell out of FLUZONE QIV prefilled syringe barrel. The patient had administered vaccine and when she went to discard the prefilled syringe, the plunger "fell out" of the syringe barrel and cut her thumb of  her right hand. Reported that the part of the plunger that cut her thumb was the area around the plunger end that is inside the syringe barrel next to the barrel stopper. Stated her thumb did bleed, but cleansed the area and was put on a band aid and bleeding had stopped. Product complaint no 268663 was completed for the FLUZONE QIV prefilled syringe. List of documents held by sender: none.
Patient presented to clinic on 8/6/10 for allergy injections. Patient noted swelling on left deltoid where he received an immunization on 8/4/10. Swelling was approximately 4" X 3", raised 1/2". Patient reported tenderness in the area. No redness or warmth noted.
Headache, Myalgia, Fever & Nausea Vomiting Narrative:
started w/headache & light headedness about 5 hours after.  6 hours later I had extreme gastro issues- diarrhea & vomiting which lasted for hours, severe stomach pain, shaking almost to the point of seizure , still saving stomach issues almost 4 weeks later
This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a 62-year-old male patient who received SHINGRIX for prophylaxis. On 11th July 2018 14:15, the patient received the 1st dose of SHINGRIX (intramuscular). In July 2018, 2 days after receiving SHINGRIX, the patient experienced fatigue, nausea, shivering, headache, chest pressure and difficulty breathing. On an unknown date, the outcome of the fatigue, nausea, shivering, headache, chest pressure and difficulty breathing were recovered/resolved. It was unknown if the reporter considered the fatigue, nausea, shivering, headache, chest pressure and difficulty breathing to be related to SHINGRIX. Additional information was reported as follows: The batch number and expiry date for SHINGRIX was not reported. The healthcare professional reported that the events fatigue, nausea, shivering and headache resolved in 2 days. The next night, the patient also experienced trouble in breathing and felt heavy pressure on his chest which led to an emergency room visit.
Within 1 hour of taking the 1st dose "I" started urinating excessively. "I" have peed 2-3 times per hour for the last 8 hours.; "I" also felt spacey and difficulty focusing; "I" also felt spacey and difficulty focusing; "I" did not feel dizzy but "I" did feel unsteady; "I" have been very tired; Within 1 hour of taking the 1st dose "I" started urinating excessively; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Mar2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), lamotrigine (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR) and fluticasone propionate/salmeterol xinafoate (ADVAIR); all for unknown indications from unknown dates and unknown if ongoing. On 12Mar2021 at 10:30, within 1 hour of taking the 1st dose, the patient started urinating excessively and had peed 2-3 times per hour for the last 8 hours, also felt spacey, difficulty focusing, the patient did not feel dizzy but did feel unsteady and had been very tired. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events urinating excessively, peed 2-3 times per hour for the last 8 hours, felt spacey, difficulty focusing, felt unsteady and  very tired was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient received both FLUZONE High Dose and PREVNAR 13 on 10/18. Called the pharmacy the net day stating that she felt very weak, ached in muscles and had headache pain. This is something that many elderly patients are reporting to me after getting both shots (Pneumo and Flu) at same time.
Pt had trouble breathing, swelling in throat, and coughing. Pt also felt cold. I gave her Epipen shot with her consent. She immediately felt better. We called 911. Her BP was 94/73. EMS came and took her vital signs. She felt better so she did not go to hospital.
Itchy around mouth and nose; Flush in the face; itchy around IS; Redness around IS; COVID Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID Arm), THROAT IRRITATION (Itchy around mouth and nose), FLUSHING (Flush in the face), VACCINATION SITE PRURITUS (itchy around IS) and VACCINATION SITE ERYTHEMA (Redness around IS) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm). On 17-Feb-2021, the patient experienced THROAT IRRITATION (Itchy around mouth and nose), FLUSHING (Flush in the face), VACCINATION SITE PRURITUS (itchy around IS) and VACCINATION SITE ERYTHEMA (Redness around IS). On 13-Feb-2021, VACCINATION SITE REACTION (COVID Arm) had resolved. At the time of the report, THROAT IRRITATION (Itchy around mouth and nose), FLUSHING (Flush in the face), VACCINATION SITE PRURITUS (itchy around IS) and VACCINATION SITE ERYTHEMA (Redness around IS) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up received included no new information.
Dose received 3; Just tired; Muscle pain; This is a spontaneous report from a contactable consumer (other healthcare professional) reported for herself. A 28-year-old non-pregnant female patient received third booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FF8841), via an unspecified route of administration, administered in right arm on 05Oct2021 (at the age of 28-year-old) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in right arm on 13Jan2021 (at the age of 27-year-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL1283) via an unspecified route of administration, administered in right arm on 04Feb2021 (at the age of 27-years-old) both as a single dose for covid-19 immunization. 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 an unspecified date in 2021, patient experienced muscle pain and was just tired. Facility was reported as other. Prior to the vaccination, the patient was not diagnosed with COVID-19. The clinical outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information expected.
Severe cramping and vaginal bleeding for 3 days. On the first day it started a mild cramping with some spotting but got progressively worse for the next day.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced HEADACHE (headache). In 2021, HEADACHE (headache) had resolved.            No concomitant medication was reported. The treatment information was unknown
20OCT became ill, chills, fever, aches, pains (highest 101) 5PM; felt weak, tired, achey x 3 wks p/vax; seen by MD 25DEC93; dx w/influenza from the vax;
This spontaneous report as received from a consumer (report received from patient's friend) refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX. On an unknown date, the patient experienced shingles. The patients friend reported that the patient had shingles about 5 times, some before having ZOSTAVAX and some after. The outcome of shingles was unknown. The causality was not reported. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to a 26 year old female patient. No medical history or drug allergies were reported. On unknown dates (also reported as at an unspecified time in the past) the patient received two doses of (Oka/Merck) VARIVAX 1350 U (dose, route of administration, lot number and expiration date were not reported). On unknown dates (also reported as in the past, prior to the titers being drawn) the patient received two MMR II (dose, route of administration, lot number and expiration date were not reported). None concomitant medication was reported. On an unknown date approximately in 2014 (also reported as earlier this year) the patient had blood tests which showed negative titers for varicella, measles, rubella and mumps. On 07-NOV-2014 the patient was diagnosed with varicella (chickenpox). The patient sought medical attention by an office visit, but it was unspecified whether any treatment was given for adverse events. The outcome of adverse events was reported as not recovered. The relatedness between (Oka/Merck) VARIVAX, MMR II and adverse events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.