chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was dizzy again this morning/Dizziness was strange/Had to hold on the way back from the car to her apartment due to the dizziness; Weakness in the legs like one gets when they are scared to death/Weakness feels like she is going to collapse and stated that it is strange feeling/Legs are weak; Almost like a vertigo where the head is spinning; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Was dizzy again this morning/Dizziness was strange/Had to hold on the way back from the car to her apartment due to the dizziness), ASTHENIA (Weakness in the legs like one gets when they are scared to death/Weakness feels like she is going to collapse and stated that it is strange feeling/Legs are weak) and VERTIGO (Almost like a vertigo where the head is spinning) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Cholesterol high. Concomitant products included SIMVASTATIN for Cholesterol high, APIXABAN (ELIQUIS) for an unknown indication.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Was dizzy again this morning/Dizziness was strange/Had to hold on the way back from the car to her apartment due to the dizziness), ASTHENIA (Weakness in the legs like one gets when they are scared to death/Weakness feels like she is going to collapse and stated that it is strange feeling/Legs are weak) and VERTIGO (Almost like a vertigo where the head is spinning). At the time of the report, DIZZINESS (Was dizzy again this morning/Dizziness was strange/Had to hold on the way back from the car to her apartment due to the dizziness), ASTHENIA (Weakness in the legs like one gets when they are scared to death/Weakness feels like she is going to collapse and stated that it is strange feeling/Legs are weak) and VERTIGO (Almost like a vertigo where the head is spinning) had not resolved.            Concomitant drugs included blood pressure medications.  It was reported that patient was asked by doctor to stop taking Eliquis and other medications and asked to drink water. It was reported that patient felt like about to collapse and crash any moment on the cement. She felt the dizziness was strange and had to hold on the way back from the car to her apartment. She also stated that the first dose was a breeze but for the second dose, the vaccinator went too high to the bone, to the top of the shoulder and was very hurtful.  Treatment medications were not provided.
TOOK 2 DOSES OF OPENED VIVOTIF; This spontaneous case (PVX2019-1212) was received from a pharmacist on 15-May-2019. It describes a 12-year-old female consumer who "took 2 doses of opened Vivotif". The consumer was receiving oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer had trouble in swallowing pills in general, so that, her caregiver opened two doses of Vivotif and placed them in water so that it became easy to swallow.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took 2 doses of opened Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 2 doses of opened Vivotif" was considered as not applicable.
Sob Extreme fatigue Hot and cold chills No appetite  Stayed in bed for ten days straightmay
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL8982), administration date: 20Jan2021, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The caller said that they were both fully vaccinated. The caller mentioned that they had a sore arm and that was the biggest side effect that they had.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101068839 same product and event, different patients
pain under the arm after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain under the arm after receiving the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain under the arm after receiving the vaccine). At the time of the report, PAIN IN EXTREMITY (pain under the arm after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2015, the patient was inoculated (by an unspecified healthcare professional person) with ZOSTAVAX at a pharmacy, recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, she was treated (by an unspecified healthcare professional) at a facility for urgent care for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Patient experienced nausea, vomiting, puffy eyes, itchy eyes, fever, chills, and abdominal pain. Patient was treated with Benadryl and Odansetron 8mg. Patient symptoms have sense stabilized and progressively  resolving.
Office visit and immunization for trip not leaving until Feb/March 06. All immunizations up to date at that visit with MD except Yellow Fever vaccine which was given 08/16/2005. the mother of this young lady called today 09/14/2005 to say that she felt her daughter had a reaction to the Yellow fever vaccine. Described the reaction as follows; About 2-3 days post vaccination patient felt ill with a fever that spiked to 102, some nausea, chills and a rash on her upper torso, she went to see her own DR because a girl was staying at their home who had Mono. The MD saw her and did some lab work which seems was not abnormal. It was too soon to have bee mono. The mom and MD felt it could have been from the Yellow Fever vaccine. She had no further follow up and seemed well after about a week. the mother is calling us today about a billing issue and decided to mention th AE. I discussed this with Dr and told her i would file VERS form based on the information given above.
Information has been received from a licensed practical nurse (LVN) as part of the pregnancy registry concerning a 17 year old female with penicillin allergy and drug reaction/allergy to DARVOCET, and VICODIN. She had no other concurrent medical conditions, or significant past medical history including no history or pregnancies.  On 17-OCT-2006, the patient was vaccinated with first dose of Gardasil (yeast) (lot # 654540/0800F also reported as 653937/0637F) 0.5 ml IM. There was no concomitant medication. The patient's last menstrual period was 18-OCT-2006. Medical attention was sought. On 11-DEC-2006, an ultrasound was performed that revealed pregnancy of 8 weeks and 2 days (estimated date of delivery 25-JUL-2007). On approximately 11-DEC-2006, maternal serum alpha-fetoprotein (MSAFP) test was performed that indicated the baby was at increased risk (positive) for neural tube defect (NTD). Medication taken during the pregnancy included prenatal vitamins. The patient was scheduled for follow-up testing with a perinatologist. No other information was available at the time of reporting. Additional information has been requested.
Myalgia, Nausea, headache, chills, diarrhea x 10 days.
Pt recvd 1st dose of Engerix-B for Hep B vax exp a rash, icthing over entire body, nausea, vomiting, flu-like sx (muscles aches & pains), but not fever; 26JUL91, next day, pt exp sl h/a, fever blister; pt given meds;
his mom isn't feeling great after her second dose; This is a spontaneous report from a non-contactable consumer reporter for his mom. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The reporter stated that his mom isn't feeling great after her second dose on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021238643 same reporter/drug/event, different patient
Fever of 101.6, headache, dizziness, nausea, bad body aches, fatigue, bad sweeping and redness at injection site.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. No information was provided regarding the pt's past medical history, concurrent conditions and concomitant medications. On an unknown day in 2016, the pt was vaccinated at the medical office with the dose of zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location and route of administration were not provided) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at the medical office for shingles. On an unknown day, the pt was hospitalized due to shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the pt suffered and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown demographics. The patient's medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosage information, lot number and expiry date were not reported). Concomitant medications were not reported. The pharmacist reported that, on an unknown date the patient developed rash at injection site. On an unknown date, after the vaccination with ZOSTAVAX, the patient went to hospital for an unspecified reason. Pharmacist also reported that the patient went hospital for another issues that was not related to ZOSTAVAX. The patient did seek the medical attention by visiting the pharmacist, on an unknown date. The reporter considered the adverse event serious due to hospitalization. The outcome of events was unknown. The reporter considered the adverse event not to be related with ZOSTAVAX. Causality of rash at injection site was not provided. No product quality complaint was reported. Additional information has been requested.
Patient presents to the ED for confusion, cough, congestion Found to have urinary retention Will place foley catheter UA neg Lactic acidosis at 2.2, hx of CHF with mild pulm edema on CXR with borderline oxygen saturations Will c/w monitoring Avoid aggressive fluid administration given COVID positive No orthopnea     The administration of 30 mL/kg of intravenous fluids would be detrimental or harmful for the patient despite having severe sepsis, hypotension, lactic acid ?4 mmol/L, or documentation of septic shock; AND the patient has one of the conditions below.  I am ordering 0  IV fluids (exact amount or mL/kg ordered is required) now and will reevaluate after given.   Condition(s) affecting decision to limit IV fluids: advanced or end stage heart failure with symptoms with minimal exertion or symptoms at rest or with an activity. Pulm edema on CXR   BNP elevated Will give IV lasix   Given confusion with borderline low oxygen sats with sitting up ~90%, likely benefit from diuresis and tx for COVID   HBS consulted
Syncope  "c/o tired, diaphoretic, loss her urine, arm swollen and hot"  Narrative:  Patient was at the ER for 6 hours.
Hot; Super fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot) and FATIGUE (Super fatigued) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced FEELING HOT (Hot) and FATIGUE (Super fatigued). At the time of the report, FEELING HOT (Hot) and FATIGUE (Super fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
achy in his legs; feels off for a day; fever; soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (achy in his legs), MALAISE (feels off for a day), VACCINATION SITE PAIN (soreness at the injection site) and PYREXIA (fever) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and ADULT MULTIVITAMIN for an unknown indication.    On 25-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Nov-2022, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 26-Nov-2022, the patient experienced PAIN IN EXTREMITY (achy in his legs), MALAISE (feels off for a day) and PYREXIA (fever). On 26-Nov-2022, MALAISE (feels off for a day) had resolved. At the time of the report, PAIN IN EXTREMITY (achy in his legs), VACCINATION SITE PAIN (soreness at the injection site) and PYREXIA (fever) outcome was unknown.            The patient reports that his experience with the Moderna vaccines had generally been a positive one.  No treatment information was provided.   This case was linked to MOD-2022-669831, MOD-2022-669169 (Patient Link).
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. On 29-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX, intramuscularly (also reported as unknown route) (dose and lot number unspecified) that had expired on 18-AUG-2012. No concomitant medications were reported. This is one of the two reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacy manager via a company representative refers to a 50 year old female patient. On 10-FEB-2014 the patient was vaccinated with ZOSTAVAX, (lot#, expiration date, dose, frequency, route and indication not reported). The unspecified patient experienced anaphylaxis after being administered ZOSTAVAX on 10-FEB-2014. The patient was taken to an unspecified emergency room and given BENADRYL (manufacturer unknown) and SOLU-MEDROL (manufacturer unknown). The patient was released from the emergency room on an unspecified date. The outcome of the event was unknown. Additional information has been requested.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 14-year-old male patient, who was allergic to cephalexin and had no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the first dose of GARDASIL (intramuscular, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported, on 06-FEB-2014 at 11:02 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00AM). The patient's parent never called back. No adverse event was reported for the patient. The reporter reported the outcome as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
The day after the injection, fever 2F, chills, fatigue, generalized body aches and fatigue. Sunday through Wednesday HA. Tuesday and Wednesday severe enough to take Tylenol and ibuprofen with no relief of symptoms. Wednesday, was also fatigued to the point I had to take a nap, unusual for me. By Thursday, symptoms had resolved.
Full blown measles. Head to toe red spots/rash. High fever and itchy skin. Dr. prescribed ibuprofen & BENADRYL.
Information has been received from a physician concerning an "about 66 year old" female who "a few weeks ago" on approximately 11-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On the same day as the vaccination the patient developed a rash about 2 inches around the injection site.  Unspecified medical attention was sought.  There were no lab studies performed.  Subsequently the patient recovered.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
Information has been received from a medical assistant referring to a 3 month old male patient. No relevant medical history or concurrent conditions were not reported. ON 23-JUN-2015, the patient was inadvertently vaccinated with improperly stored oral, ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
- Redness in area: upper part of arm = elbow to the top arm (red band) that is "itchy and painful" - Administered on 8/20/20 and pain began on Friday approx. in AM and still persisting on 8/24/20 - Ibuprofen provides relief (pain tolerable & only to the touch)
Pt experienced chest pain while waiting in line for vaccine. 5 out of 10 chest pain persisted post vaccination. Reported feeling nervous, anxious, cold sweats. Pt with hx of HTN, on cardizem. Denied hx of afib. Denied other past medical hx. Pt with elevated BP 160s with labile pulse, ranging from 30-80s. O2sat 99%. Pt escorted to ED.
Customer came in today to show me her arm which was warm to the touch and rash at injection site.  ZOSTAVAX was administered 6/2/08.  I told her that Benadryl may help and I called her physician to let her know.
Patient awoke at 0600am with chest pain.  He took two nitro and tried to go back to sleep.  At 0800am he awoke again with the chest pain and took 2 nitro which again helped the pain.  At that time he did experience shortness of breath and diaphoresis.  He was found to have decreased O2 sats when the EMTs got to him and he was placed on a non-rebreather.  On x-ray the patient was found to have a right pneumothorax, cardiac markers were negative.  A chest tube was placed and the patient was transferred to a hospital.
I had a circumstance where I could not write with my right hand for about 5 minutes. My hand would not do what I wanted it to do. It was diagnosed as a TIA. I did not lose consciousness, I did not have symptoms. I was doing a crossword and then suddenly I could not hold a pen or write, or do anything I wanted it to do. And this lasted for about 5 to 6 minutes before it passed. I also feel way more fatigued than usual.
Pt given 0.48ml of Moderna Covid immunizatoin, 6mo-<5years instead of 0.25ml.  Discovered that single dose vial is overfilled.  Discussed with mom, pt did not have any reactions / issues with initial dose.
Atrial fibrillation at 2:15AM (110-138 BPM)  - resolved at 9AM. Fatigue - onset 4/11 at 5AM , resolved at 9PM.
Arthritic like pain in fingers for approximately 3 months after the vaccination.  Fingers ached especially at night.  Physician diagnosed arthritis.
Upon leaving the clinic per mother, pt fainted, Dr responded, SPO2 100-98%. Pulse low. Oxygen given to pt after 10 min. Pt able to stand ambulate and was responsive (vomited 1 time).
sore arm with all 3 doses; sore arm with all 3 doses; sore arm with all 3 doses; This is a spontaneous report from contactable consumer (female patient) via Pfizer sponsored program.  A female patient of an unspecified age received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via unknown route on unknown date, dose 3, booster single for COVID-19 immunization. The patient's medical history included autoimmune disease, cancer from an unknown date and unknown if ongoing. The concomitant medications were reported as none. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via unknown route on unknown date as dose 1, single for COVID-19 immunization. The patient previously received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via unknown route on unknown date as dose 2, single for COVID-19 immunization. The patient developed sore arms for all 3 doses on an unknown date. The outcome of events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.